Patent Publication Number: US-2022213299-A1

Title: Inhaler

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of commonly-owned U.S. patent application Ser. No. 15/301,260 filed Sep. 30, 2016, which is a 371 of International Patent Application No. PCT/EP2015/000657 filed Mar. 27, 2015, which claims the benefit of priority to European Patent Application No. 14001187.5 filed Mar. 31, 2014, the contents of which are incorporated herein by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The present invention relates to an inhaler. In particular, the present invention relates to an inhaler for horses or other large animals, with an adapter for a nostril or other respiratory orifice. 
     Description of Related Art 
     The invention further relates to inhalers which, on each actuation, dispense a defined dose or amount of a medicinal fluid held under excess pressure, for which reason these inhalers are also known as “pressurized metered-dose inhalers” (pMDI). 
     A pMDI has a reservoir, which is filled with a medicament preparation and is kept under pressure by means of a propellant gas. The reservoir further comprises a metering valve for dispensing the medicament fluid. The metering valve is able to dispense a specified or measured amount of the medicament fluid on each activation. The fluid is dispensed by the movement of a valve element of the metering valve. 
     U.S. Pat. No. 5,666,948 A discloses a pMDI with a nostril adapter for a horse. During operation, the reservoir is normally used above the animal&#39;s head or with the valve directed downwards. A valve element of the valve is connected to the inhaler and the reservoir is movable relative to the inhaler or the valve element. For activation, the reservoir can be pressed downwards manually or be pulled down by means of a trigger button, thus dispensing a dose of the medicament fluid. 
     In conjunction with their use in large animals, such as horses, inhalers have the disadvantage of requiring a very robust, relatively large and complex construction, which is expensive to manufacture. At the same time, their use in large animals, unless the animals are physically restrained, rapidly leads to soiling by secretions or the like, which prevent longer-term use or re-use of the inhaler. 
     It has also been found that inhalers developed for use in human medicine are unsatisfactory for use on large animals. On the one hand, the amount delivered has to be many times greater, for example, 10 to 30 times greater, which is expensive and error-prone. On the other hand, known inhalers are awkward and are difficult to operate in rough conditions or wearing gloves or the like. 
     SUMMARY OF THE INVENTION 
     The object of the present invention is therefore to provide an inhaler, which is robust and/or ergonomic, compact and accurate in use on large animals and capable of being operated with little effort. 
     The above object is achieved by an inhaler as described herein. 
     The proposed inhaler is preferably designed for use in horses or other large animals. It comprises a reservoir for delivering a medicament preparation held under excess pressure, a discharge nozzle for forming an aerosol with the medicament preparation and a chamber for receiving and temporarily storing the aerosol, which may also be termed the spacer. The chamber further comprises, or forms, an adapter for a respiratory orifice, particularly a nostril. The adapter may also be formed separately from the chamber and/or connected to the chamber. 
     According to a first aspect of the present invention, which can also be implemented independently, the reservoir is secured in position, at least in the axial direction. Preferably, the reservoir is held by interlocking engagement, in particular, in the inhaler so as to prevent axial movement at least when the inhaler is in operation. The reservoir is preferably secured in position with respect to the inhaler, particularly an inhaler housing, the chamber and/or the adapter for the respiratory orifice. 
     In inhalers, the reservoir is normally moved relative to the inhaler in order to activate it. Instead, in the proposed inhaler, the reservoir is fixed, or not moved, during the activation of the dispensing of the medicament preparation. However, other solutions are also possible, particularly with a movable reservoir. 
     It has surprisingly been shown that fixing the reservoir enables actuation to be carried out more easily, cheaply, precisely and robustly, particularly when using an operating element such as an operating lever. This gives rise to advantages in terms of the handling properties of the inhaler as a whole, particularly for use on large animals such as horses. 
     It is also advantageous that, with the reservoir being immovable during activation, the entire mass of the reservoir does not have to be moved, which would require complex mechanics when used in conjunction with large animals and might lead to vibrations, which could interfere with application particularly to large animals. Also, fixing the reservoir makes it possible to have a closed construction, at least in the region of the bottom of the reservoir. This confers improved protection against the ingress of pathogens, particularly when used in stables or outside. 
     According to a second aspect of the present invention which can also be implemented independently, the discharge nozzle has a direction of discharge for the aerosol which encloses an angle or is inclined by more than 5°, preferably more than 10° or 15° and/or less than 50°, preferably less than 45° or 1°, particularly less than 35°, relative to a central axis of the reservoir or a direction of actuation for dispensing the aerosol. 
     The direction of discharge according to the present invention preferably is a main or primary direction of discharge, in particular of the discharge nozzle or nozzle opening(s) of the discharge nozzle. In particular, the direction of discharge corresponds to or at least essentially complies with a middle axis or center axis of a spray mist or spray cone produced while forming the aerosol. The direction of discharge according to the present invention preferably at least essentially corresponds to or complies with a (symmetry or middle) axis of nozzle openings of the discharge nozzle. 
     Preferably, the adapter for the respiratory orifice has a dispensing opening for dispensing the aerosol, which is laterally offset relative to the central axis of the reservoir or has a direction of dispensing which is laterally offset and/or skewed relative to the central axis of the reservoir. This has advantages with respect to anatomical shape and consequent ease of handling of the inhaler, particularly when it is used in large animals with the operator&#39;s arm stretched upwards. Thanks to the proposed direction of dispensing, depositing of aerosol on the walls of the chamber or adapter can be prevented or reduced. The proposed dispensing angle therefore permits good handling and ergonomics of the inhaler while at the same time achieving precise and efficient dosing. 
     The terms “discharge” and “dispensing” are preferably synonymous or interchangeable. In the following description, purely for greater clarity, the term “discharge” is always used, without loss of generality, in conjunction with the discharge nozzle or the aerosol formation and the term “dispensing” is used in conjunction with the aerosol that has already been produced. 
     A discharge nozzle in the sense of the present invention is preferably a nozzle, which is suitable for dispensing the medicament preparation while forming a preferably respirable aerosol. In particular, the discharge nozzle is a nozzle, which is suitable for nebulizing liquids. 
     According to a third aspect of the present invention, which can also be implemented independently, the reservoir comprises a dispensing valve arranged on the top in the position of use of the inhaler. The use of a reservoir in an upright position or with the dispensing valve at the top is unusual in inhalers. However, it has been found that such a configuration, particularly in inhalers for large animals, allows a substantially more compact, inexpensive and ergonomic construction, which is economical with materials, compared with the overhead operation with a valve at the bottom which is conventional in inhalers. 
     In particular, the upright arrangement of the reservoir leads to easier interchanging and reusing of the inhaler. The upright arrangement assists with the formation of an aerosol in the position of use at least substantially upwards, which in the proposed inhaler for use in large animals makes it possible to achieve a compact and ergonomic construction, particularly for animals with respiratory orifices which may be higher than the chest of the user or veterinary surgeon or animal handler. 
     Moreover, actuation using an operating lever can be achieved without complicated mechanics, thus contributing to a robust and inexpensive construction, which is economical with materials. Also, the reservoir may be insertable from below in the operating position. This confers improved protection against the ingress of dirt and pathogens even in external areas or stables when used on large animals. 
     Preferably, the reservoir comprises a riser tube, which is fluidically connected to the dispensing valve of the reservoir. This provides a simple and inexpensive way of dispensing the medicinal liquid with the valve at the top. 
     Moreover, the inhaler may comprise an actuating lever for triggering the aerosol formation. It allows a robust construction which enables the inhaler to be operated reliably even when wearing gloves or in dirty conditions. The actuating lever may be synergistically combined with the reservoir, which comprises a valve directed upwards in the operating position and/or is axially fixed. Surprisingly, it has been found that the actuating lever enables the production of an aerosol even under adverse conditions, outside or in stables, and even when operated while wearing gloves. It has also advantageously been found that with the actuating lever an upwardly directed valve can be operated particularly easily and reliably. In addition, a combination with a fixed reservoir allows a particularly robust and reliable construction with few mechanical parts, thus substantially improving reliability in rural use. The combination of fixed reservoir, valve directed upwards in the position of use, and the actuating lever for actuating the valve is therefore particularly preferred. 
     In another aspect, the discharge nozzle may comprise at least three, preferably at least four or five discharge openings. The discharge openings may have a cumulative outlet surface of more than 0.1 mm 2 , preferably more than 0.15 mm 2 . This has proved favorable for the rapid dispensing of respirable aerosol, particularly for an inhaler for large animals. Surprisingly, it has been found that using the proposed discharge nozzle makes the administration of the medicament preparation to large animals substantially easier, since, compared with inhalers with the otherwise conventional discharge nozzles, the number of actuation steps for a whole dose and the time taken to give the treatment can be reduced considerably. 
     The inhaler preferably has a holder for an insert, the insert comprising the reservoir, is axially insertable into the holder and/or has been inserted into the inhaler. As a result, the inhaler can be re-used. 
     The holder may be a retaining portion for at least axially retaining the reservoir or insert comprising the reservoir. In particular, the retaining portion may be a flap or latching means. In this way, it is possible to secure the reservoir even if the insert is exchangeable. The reservoir may be covered by the flap, at least at the bottom. This has proved advantageous as it prevents the ingress of dirt and interference with operation caused by dirt. 
     Particularly preferably, in the position of use, the reservoir is fully accommodated in the inhaler at least at its end, particularly at opposite ends. In this way, the ingress of dirt can be prevented. 
     The holder is preferably formed by or in a handle or gripping means. The handle or gripping means may be at least substantially cylindrical and/or elongate and/or have a diameter of more than 3 cm, preferably more than 3.5 cm and/or have a length of more than 10 cm, preferably more than 13 cm. This allows a large gripping surface for use in large animals such as horses, even when the user is wearing gloves, while at the same time producing a compact inhaler, as the holder is formed in the gripping surface and the gripping surface is formed around the holder, synergistically resulting in a saving of space and on materials. 
     The holder preferably comprises an orientation portion for orienting the insertion of the insert. In this way, the dispensing direction for the aerosol into the chamber can be fixed, particularly when the chamber is inclined relative to the central axis of the reservoir, the insert and/or the discharge nozzle. 
     The holder may alternatively or additionally comprise a release portion for releasing the dispensing of the medicament preparation by insertion of the insert. This ensures that the medicament preparation can only be dispensed when the insert has been inserted fully and correctly. This is for safety reasons, as, particularly in the case of medicaments for large animals, accidental release outside the inhaler could affect living creatures in the surrounding area. 
     Preferably, the orientation portion comprises the release portion or vice versa, and preferably the dispensing of the medicament preparation can be released by fully inserting the insert in the intended orientation. The orientation portion and the release portion may synergistically be the same part, thus saving on construction and materials. 
     According to another aspect of the present invention, the inhaler may comprise an exchangeable counter, the counter preferably being insertable into the holder. In particular, the counter may be exchanged together with the insert. However, it may also be exchanged separately. The possibility of exchanging it means that if the inhaler is used several times the correct count for the particular reservoir can always be displayed. 
     Aspects relating to an insert that can preferably be inserted into or used in the holder of the inhaler will be described in more detail hereinafter. However, by contrast, it is also possible for the inhaler itself to comprise individual ones or all of the components of the insert, or for individual ones or all of the components of the insert to be individually exchangeable. However, it is particularly preferable for the inhaler to be of modular construction. Therefore, the invention is hereinafter always described with an insert for or in the inhaler. It will be understood that the inhaler may also comprise the parts of the insert without them being present as an insert. Alternatively or additionally, the insert may be incorporated in the inhaler in fixed, non-exchangeable, non-insertable or non-removable manner, even though it is preferable for the insert to be insertable, removable or exchangeable. 
     The insert, which may also be produced independently, can be inserted into the inhaler, particularly for a horse. This insert comprises a reservoir for a medicament preparation held under excess pressure, said reservoir comprising a valve. Moreover, the insert has a nebulizer held directly on the reservoir and a discharge nozzle associated with the nebulizer and fluidically connected to the valve, for forming an aerosol with the medicament preparation. 
     The proposed insert can preferably be inserted into an inhaler and/or removed from an inhaler. In particular, the insert can be accommodated or received by the inhaler for use. The insert may be exchangeable, as a result of which an inhaler is suitable for repeated or universal use. 
     The nebulizer may also be produced independently and constitutes a particular aspect of the invention in its own right. 
     The nebulizer is preferably non-detachably connected or connectable to the reservoir. In particular, the nebulizer is clipped onto the reservoir or otherwise held thereon, preferably by latching. In this way a construction unit can be formed with the nebulizer and the reservoir, thus doing away with the replacement of individual parts. 
     The discharge nozzle is particularly preferably held and/or mounted on the reservoir by means of the nebulizer. In this way, a construction unit can be formed with the nebulizer, the reservoir and the discharge nozzle. 
     Preferably, the discharge nozzle is secured against removal, taking off or pulling off, by means of the nebulizer, or in the nebulizer. The discharge nozzle is thus preferably (in)separable from the insert, from the nebulizer or from the reservoir. In this way it can be ensured that replacement of the reservoir is accompanied by the replacement of the discharge nozzle. 
     Preferably, the nebulizer is non-detachably held on the reservoir. In particular, the nebulizer and/or the discharge nozzle forms an inseparable construction unit with the reservoir and preferably with the valve. The inseparable construction unit ensures that when the reservoir is exchanged or when the inhaler is reused the discharge nozzle is changed. 
     “Inseparable” or “non-detachable” in the sense of the present invention means, in particular that, at least after assembly is complete, separation is only possible with greater effort, cannot be done without tools or manually and is possible only by damaging or destroying the item. 
     Particularly when used in connection with animals, the discharge nozzle may have a tendency to become clogged or otherwise blocked up with secretions or the like. The proposed insert, by providing for only total replacement or by the formation of the inseparable construction unit, advantageously makes it possible to prevent possibly unreliable, blocked or worn discharge nozzles from being re-used with a new or freshly filled reservoir. Consequently, when the inhaler is reused, reliable operation and dosing can be guaranteed. 
     The proposed insert ensures that the valve, particularly a metering chamber volume of the valve, corresponds to or is adapted to a concentration of active substance in the medicament preparation. In this way, correct dosing can be ensured. 
     The metering chamber volume is preferably more than 200 μl, particularly preferably more than 250 μl, particularly more than 300 μl and/or less than 1000 μl, preferably less than 800 μl, particularly less than 600 or 10 μl. A metering chamber volume of 280 μl to 31 μl is most particularly preferred. It is possible to use the inhaler universally for different large animals, and at the same time, minimize of number of necessary actuation steps. In particular, only one to three actuations or a total dose of between 300 μl and 900 μl are particularly advantageous. 
     With the proposed insert, it can be ensured, alternatively or additionally, that the valve, particularly a metering chamber volume of the valve, corresponds to or fits the discharge nozzle. 
     Preferably, a dose of the medicament preparation or a metering chamber volume of the valve can be converted into an, in particular, respirable aerosol within a sufficiently short time span, preferably within a time span of less than a second, particularly less than half a second. It is therefore preferable for the discharge nozzle to be able to dispense at least one metering chamber volume per second, preferably at least twice the metering chamber volume per second. 
     Too small a metering chamber volume in relation to the amount discharged may lead to inaccuracies of dosing. Therefore, it is preferable if the discharge nozzle is able to dispense less than ten times the metering chamber volume per second. 
     With the proposed insert, an optimum ratio of metering chamber volume of the valve to the discharge speed of the discharge nozzle is obtained, leading to good reliability and metering accuracy. 
     With the proposed insert, it may alternatively or additionally be ensured that a discharge nozzle suited to the particular medicament preparation is used. In particular, the discharge nozzle may suit the properties of the medicament preparation, particularly its viscosity and flow properties. In this way, accurate dosing and/or a sufficiently fine aerosol can be obtained. 
     Overall, with the proposed insert, it can be ensured that a combination of medicament preparation, valve and discharge nozzle is always used which leads to reliable dosing and aerosol formation. The proposed insert thus ensures satisfactory cooperation of the components even when an inhaler is re-used. 
     The discharge nozzle can be guided by the nebulizer in axial, linear and/or rotationally connected manner. As a result of the axial or linear guiding, the valve can be reliably actuated by the discharge nozzle or by movement of the discharge nozzle. As a result of rotationally connected guiding, it can be ensured that the orientation of the discharge nozzle remains unchanged. 
     The discharge nozzle may be axially or linearly moveable for opening the valve or dispensing the medicament preparation. However, it is preferable if this axial mobility of the discharge nozzle is restricted at least to the direction of removal or dispensing for the medicament preparation or to a direction leading away from the reservoir, particularly by the nebulizer. 
     The discharge nozzle is preferably fluidically connected to the valve. It is also preferable if the discharge nozzle is mechanically connected to the valve, particularly to a valve element of the valve. In this way, axial movement of the discharge nozzle can move the valve element. The medicament preparation can be dispensed by the movement of the valve element. Thus, a preferably axial movement of the discharge nozzle can open the valve and activate the dispensing of the medicament preparation. 
     “Axial” in the sense of the present invention is preferably a movement or direction along or parallel to the central axis or an axis of symmetry of the reservoir or the insert or a movement or direction along or parallel to an axis of symmetry of the valve or valve element. In particular, the central axis corresponds to the axis of symmetry or vice versa. Moreover, the terms “central axis” or “axis of symmetry” preferably relate to a position of use of the insert or the valve. In particular, reference to the central axis or axis of symmetry is also possible irrespective of whether the insert has been inserted into the inhaler or the like. 
     Preferably, the direction of actuation is axial and/or corresponds or complies with a direction of movement or direction along or parallel to the central axis or an axis of symmetry of the reservoir or the insert or a movement or direction along or parallel to an axis of symmetry of the valve or valve element. 
     For dispensing the medicament preparation, it is preferable for the valve to be opened. In this way, medicament preparation is able to reach intake openings of the discharge nozzle and be dispensed through the dispensing openings. Preferably, the medicament preparation is dispensed through the discharge openings under a corresponding pressure or at a corresponding velocity or the like such that the aerosol is formed. 
     In a variant, different proposed inserts with, in particular, different medicament preparations can be used one after the other or alternately in the same inhaler. By using inserts with different medicament preparations, a respirable aerosol based on different medicament preparations can be produced and dispensed with the same inhaler or type of inhaler. This allows the inhaler to be used universally and produced efficiently in large production runs. 
     Features of the medicament preparation are preferably visible or displayed on the inhaler, for example through a window in the inhaler. This can prevent mix-ups. 
     Alternatively or additionally an insert may in particular be mechanically insertable into, or usable in, only one corresponding inhaler. The insert is preferably coded in the manner described, or in some other way, for a corresponding inhaler, particularly by orientation means, which will be discussed in more detail hereinafter. This, too, can prevent mix-ups. 
     Preferably, the orientation means corresponds to the orientation portion of the holder of the inhaler. In particular, the orientation means and the orientation portion are embodied to be complementary to one another, constitute a coding, can be inserted in one another or secure an orientation of the insert or the nebulizer with respect to the holder or the inhaler according to the lock and key principle. 
     The insert is preferably not designed for self-sufficient operation or cannot be used on its own as an inhaler. Preferably, the insert is protected from actuation outside an inhaler or otherwise embodied for use solely with or in an inhaler. 
     The insert is preferably free from adapters for respiratory orifices. 
     The insert is preferably configured to avoid, prevent or block the dispensing of medicament outside the inhaler. 
     The insert may comprise a cover, particularly a cap, which covers the discharge nozzle or prevents the medicament preparation from being dispensed outside the inhaler. 
     Particularly preferably, the insert comprises a blocking device, which is embodied to prevent accidental actuation, actuation in the non-inserted state of the insert and/or actuation after reaching or exceeding a given number of actuating steps. 
     The blocking device preferably corresponds to the release portion of the holder of the inhaler. In particular, the blocking device and the release portion are of complementary construction, they constitute a coding, can be inserted in one another or are configured so as to release a blocking arrangement of the actuation, particularly the opening of the valve, using the lock and key principle. This can prevent accidental actuation independently of the inhaler, which could have an effect on other living creatures particularly in the case of medicaments for large animals. 
     Alternatively or additionally, actuation can be prevented once a given number of actuation processes has been reached or exceeded. This can be done by means of the blocking device and/or the counter. The advantage of this is that actuation is prevented when the dosage might possibly be inaccurate, particularly when there is a reduction in the pressure in the reservoir or the like. 
     In another aspect of the present invention, the insert or the nebulizer may be configured to dispense the medicament preparation in a direction of discharge which corresponds at least substantially to a central axis of the reservoir and/or which extends diagonally with respect to the central axis of the reservoir. This has the advantage that no or very little deflection of the medicament preparation is needed and consequently a loss in pressure can be minimized. 
     As already mentioned in conjunction with the inhaler, it is also particularly preferred, in relation to the insert, if the direction of discharge is inclined by more than 5°, particularly more than 10° or 15° and/or less than 50°, preferably less than 45° or 1°, particularly less than 35° relative to the central axis of the reservoir or if such an angle is enclosed between the central axis and the direction of discharge. This advantageously makes it possible to prevent aerosol being deposited on the walls of a chamber for receiving and temporarily storing aerosol or on the walls of an adapter for a respiratory orifice, particularly while the aerosol can be dispensed from the chamber or through the adapter for the respiratory orifice, in laterally offset and/or skewed manner with respect to the central axis of the reservoir. The dispensing of the aerosol in laterally offset and/or skewed manner with respect to the central axis of the reservoir has advantages in terms of the anatomical shaping and consequent ease of handling of the inhaler. 
     The insert or the nebulizer may comprise the counter, which can be driven by the triggering of the dispensing of the medicament preparation. The counter preferably forms an inseparable construction unit with the reservoir and/or with the nebulizer and/or the dispensing nozzle and/or the valve. This ensures that an insert that has already been emptied or partially emptied can be recognized as such independently of an inhaler. The counter is preferably rotatable mounted in the nebulizer. 
     The insert or the nebulizer preferably comprises an, in particular, axially movable activating element, the medicament preparation being adapted to be dispensed by the movement of the activating element. The activating element is preferably embodied to move the valve element or to open the valve by some other means. 
     The counter may be drivable by the movement of the activating element. 
     The activating element may be blocked and released by the total insertion of the insert in the intended orientation. 
     Preferably, the activating element guides and/or moves the discharge nozzle in the nebulizer. 
     The activating element may be arranged between the discharge nozzle and a housing of the nebulizer held on the reservoir. 
     The activating element is preferably fixed to the discharge nozzle or formed by the discharge nozzle. The activating element may be held by latching on the housing. This allows a quick and easy and/or non-separable assembly. In particular, the activating element is or forms a shoulder for the axial movement of the discharge nozzle. 
     In one variant, the activating element is movable independently of the discharge nozzle. In this case, the discharge nozzle can be immovably held by the nebulizer and/or on the reservoir. 
     The insert or the nebulizer may comprise a frame or a shoulder, which is immovable with respect to the reservoir, the activating element being adjacent to the frame or the shoulder. The frame or the shoulder may surround, enclose and/or envelop the activating element. In this way, accidental triggering can be prevented. 
     The frame or the shoulder may be connected to the nebulizer or be formed by the nebulizer, particularly by a housing of the nebulizer, which is connected or connectable to the reservoir. However, other solutions are also possible. 
     A further aspect of the present invention, which can also be implemented independently, relates to a medical use of the insert, the reservoir, the nebulizer and/or the inhaler, in particular as described above. 
     In a further aspect, the present invention concerns the insert, the reservoir, the nebulizer and/or the inhaler for the use (in a method) for the management/treatment, preferably of airway disease, in particular in equines, preferably horses, preferably wherein the airway disease is a pulmonary disease, more preferably the airway disease is selected from the group consisting of: recurrent airway obstruction (RAO), summer pasture associated obstructive pulmonary disease (SPAOPD), and inflammatory airway disease (IAD). 
     The invention further concerns a method of treating an airway disease comprising administering a therapeutic effective amount of an active substance or a pharmaceutically acceptable salt thereof using said insert, reservoir, nebulizer and/or inhaler to a patient, preferably an equine patient, more preferably a horse, in need thereof. Preferably the airway disease is a pulmonary disease, more preferably the airway disease is selected from the group consisting of: recurrent airway obstruction (RAO), summer pasture associated obstructive pulmonary disease (SPAOPD), and inflammatory airway disease (IAD). 
     The term “equine” means of or belonging to the family Equidae, which includes the horses, asses, and zebras, preferably horses. In addition, the term “equine” encompasses also hybrids of members of the family Equidae (e.g., mules, hinnies, etc.) 
     The term “patient” or “subject” embraces mammals such as primates including humans. The term “patient” or “subject” as used herein relates specifically to horses, especially horses suffering from airway disease (particularly pulmonary disease), preferably from recurrent airway obstruction (RAO) also called heaves or equine COPD and/or summer pasture associated obstructive pulmonary disease (SPAOPD) also called Summer Pasture Associated Recurrent Airway Obstruction (SPARAO) and/or inflammatory airway disease (IAD), most preferably from RAO. 
     The term “airway disease” in horses means the following: recurrent airway obstruction (RAO) also called heaves or equine COPD, Summer Pasture Associated Obstructive Pulmonary disease (SPAOPD), inflammatory airway disease (IAD), exercise induced pulmonary hemorrhage (EIPH), infectious diseases, chronic interstitial lung disease and upper respiratory tract functional disorders. 
     The term “pulmonary disease” means: recurrent airway obstruction (RAO) also called heaves or equine COPD, Summer Pasture Associated Obstructive Pulmonary disease (SPAOPD), inflammatory airway disease (IAD), exercise induced pulmonary hemorrhage (EIPH), infectious diseases, chronic interstitial lung disease. 
     The term “recurrent airway obstruction (RAO)” in horses means the following: a chronic syndrome of mature horses with reversible airway obstruction in the stable showing periods of laboured breathing at rest during exacerbation. 
     The term “Summer Pasture Associated Obstructive Pulmonary disease (SPAOPD)” in horses means the following: a chronic syndrome, which shares many clinical and pathological similarities with RAO at rest on the pasture, suggesting similar pathogenesis, however, it is caused by different antigens. 
     The term “inflammatory airway disease (IAD)” in horses means the following: a chronic syndrome of horses showing poor performance or coughing or excess tracheal mucus without showing periods of laboured breathing at rest. 
     The term “effective amount” as used herein means an amount sufficient to achieve a reduction of airway disease in a horse when ciclesonide is administered at a dosage as described herein. The progress of the therapy (improvement of airway disease, particularly pulmonary disease, preferably recurrent airway obstruction (RAO) and/or Summer Pasture Associated Obstructive Pulmonary disease (SPAOPD) and/or inflammatory airway disease (IAD), most preferably RAO as described herein) can be monitored by standard airway/pulmonary diagnosis, for example, by clinical examination, airway fluid cytology, endoscopy, lung function measurement, or blood-gas analysis. 
     The term “pharmaceutically acceptable derivative thereof” means, but is not limited to, pharmaceutically acceptable salts, derivatives, metabolites or pro-drugs of a drug. Derivatives as used herein include, but are not limited to, any hydrate forms, solvates, isomers, enantiomers, racemates, racemic conglomerate and the like of the compound of choice. Suitable pharmaceutically acceptable salts are well known in the art and may be formed with an inorganic or organic acid, such as hydrochloric acid, hydrobromic acid, sulfuric acid, phosphoric acid, nitric acid, acetic acid, glycolic acid, lactic acid, pyruvic acid, malonic acid, succinic acid, glutaric acid, fumaric acid, malic acid, mandelic acid, tartaric acid, citric acid, ascorbic acid, palmitic acid, maleic acid, hydroxymaleic acid, benzoic acid, hydroxybenzoic acid, phenylacetic acid, cinnamic acid, salicylic acid, methanesulfonic acid, benzenesulfonic acid and toluenesulfonic acid. 
     In a preferred aspect of the present invention, the active substance administered using the insert, the reservoir, the nebulizer and/or the inhaler of the present invention is a glucocorticoid, preferably ciclesonide and/or budesonide and/or fluticasone, most preferably ciclesonide. 
     The term “glucocorticoid” refers to a class of steroid hormones that bind to the glucocorticoid receptor (GR), which is present in almost every vertebrate animal cell. The name glucocorticoid (glucose+cortex+steroid) derives from its role in the regulation of the metabolism of glucose, its synthesis in the adrenal cortex, and its steroidal structure. 
     Glucocorticoids are part of the feedback mechanism in the immune system that turns immune activity (inflammation) down. They are therefore used in medicine to treat diseases caused by an overactive immune system, such as allergies, asthma, autoimmune diseases, and sepsis. 
     Preferred glucocorticoids according to the present invention are ciclesonide and/or budesonide and/or fluticasone. 
     The term “ciclesonide” ((11β,16α)-16,17-[[(R)-Cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)pregna-1,4-diene-3,20-dione, C32H44O7, Mr=51.7 g/mol) is well known in the art and means/describes a glucocorticoid used to treat asthma and allergic rhinitis in humans. It is marketed for application in humans under the brand name Alvesco™ for asthma and Omnaris™/Omniair™ for hay fever in the US and Canada. Ciclesonide is a prodrug. It is transformed into the active metabolite C21-C21-desisobutyrylciclesonide (=desciclesonide) via hydrolysis by intracellular esterases in the lung. Ciclesonide is a non-halogenated glucocorticoid, which predominantly exists in its form as R-Enantiomer. 
     
       
         
         
             
             
         
       
     
     As used herein the term “prodrug” refers to (i) an inactive form of a drug that exerts its effects after metabolic processes within the body converting it to a usable or active form, or (ii) a substance that gives rise to a pharmacologically active metabolite, although not itself active (i.e. an inactive precursor). 
     The terms “prodrug” or “prodrug derivative” mean a covalently-bonded derivative, carrier or precursor of the parent compound or active drug substance which undergoes at least some biotransformation prior to exhibiting its pharmacological effect(s). Such prodrugs either have metabolically cleavable or otherwise convertible groups and are rapidly transformed in vivo to yield the parent compound (also called the active metabolite), for example, by hydrolysis in blood or by activation via oxidation as in case of thioether groups. Most common prodrugs include esters and amide analogues of the parent compounds. The prodrug is formulated with the objectives of improved chemical stability, improved patient acceptance and compliance, improved bioavailability, prolonged duration of action, improved organ selectivity, improved formulation (e.g., increased hydrosolubility), and/or decreased side effects (e.g., toxicity). In general, prodrugs themselves have weak or no biological activity and are stable under ordinary conditions. Prodrugs can usually be readily prepared from the parent compounds using methods known in the art. 
     The medicament preparation according to the present invention preferably comprises the active substance or a pharmaceutically acceptable salt thereof. The medicament preparation preferably is a fluid or liquid, in particular comprising the active substance or the pharmaceutically acceptable salt thereof. The medicament preparation preferably comprises one or more solvents, in particular water, alcohol, ethanol or the like. The medicament preparation in particular is a solution and/or suspension from the active substance or a pharmaceutically acceptable salt thereof, in particular an aquenous, alcoholic, and/or ethanolic solution and/or suspension. 
     In a further aspect of the present invention, which can also be realized independently, an aerosol is produced with the insert, the reservoir, the nebulizer and/or the inhaler according to the present invention, from or with the medicament preparation comprising the active substance or a pharmaceutically acceptable salt thereof. It has been surprisingly shown that producing the aerosol and administering the aerosol is particularly efficient and effective in this case. In particular, the amount of the active substance or the pharmaceutically acceptable salt thereof that can be resorbed by a lung can be increased by means of the combination of the liquid medicament preparation comprising the active substance and the insert, the reservoir, the nebulizer and/or the inhaler for generating the aerosol with the medicament preparation and, preferably the chamber forming a spacer, preferably with the respiratory orifice adapter. 
     The aspects mentioned above and described hereinafter can be implemented individually and in combination and also independently of one another. In particular, it is possible that the inhaler with the operating lever, the inhaler with the reservoir with the valve uppermost in the position of use, the inhaler with the operating lever and the reservoir with the valve uppermost in the position of use, the inhaler with the operating lever and the discharge nozzle with the direction of discharge at an angle relative to the central axis of the reservoir, the inhaler with the nebulizer, the nebulizer with the discharge nozzle, the nebulizer with the counter, the nebulizer with the discharge nozzle and the counter, the discharge nozzle with the activating device, the discharge nozzle with the activating device in conjunction with the nebulizer, the nebulizer with the inhaler, the discharge nozzle with the inhaler, and other combinations of the different aspects constitute independent inventions and are therefore implemented separately, independently of one another or in combination. 
     Further aspects, advantages and properties of the present invention will be apparent from the claims and the drawings and the following description of preferred embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic perspective view of a proposed insert; 
         FIG. 2  is a side view of a proposed reservoir; 
         FIG. 3  is a schematic sectional view of the proposed reservoir taken along the section line III-III in  FIG. 2 ; 
         FIG. 4  is a side view of the proposed insert; 
         FIG. 5  is a schematic sectional view of the proposed insert taken along the section line V-V in  FIG. 4 ; 
         FIG. 6  is a perspective view of a proposed nebulizer; 
         FIG. 7  is another perspective view of a proposed nebulizer; 
         FIG. 8  is a perspective view of a counter; 
         FIG. 9  is a side view of the proposed nebulizer; 
         FIG. 10  is a schematic proposed reservoir of the proposed nebulizer taken along section line X-X in  FIG. 9 ; 
         FIG. 11  is an enlarged view of the encircled detail at the left side of the proposed nebulizer in  FIG. 10 ; 
         FIG. 12  is an enlarged view of the encircled detail at the top of the discharge nozzle in  FIG. 10 ; 
         FIG. 12 a    is another enlarged view of the encircled detail at the top of the discharge nozzle from  FIG. 10 ; 
         FIG. 13  is a perspective view of a discharge nozzle according to a second embodiment; 
         FIG. 14  is a partial section through the discharge nozzle according to the second embodiment; 
         FIG. 15  is a perspective view of a discharge nozzle according to a third embodiment; 
         FIG. 16  is a side view of the discharge nozzle according to the third embodiment; 
         FIG. 17  is a sectional view of the discharge nozzle according to the third embodiment taken along the section line XVII-XVII in  FIG. 16 ; 
         FIG. 18  is a sectional view of the discharge nozzle according to the third embodiment taken along the section line XVIII-XVIII in  FIG. 16 ; 
         FIG. 19  is a perspective view of a discharge nozzle according to a fourth embodiment; 
         FIG. 20  is a side view of the discharge nozzle according to the fourth embodiment; 
         FIG. 21  is a sectional view of the discharge nozzle according to the fourth embodiment taken along the section line XXI-XXI in  FIG. 20 ; 
         FIG. 22  is a section through the discharge nozzle according to the fourth embodiment taken along the section line XXII-XXII in  FIG. 20 ; 
         FIG. 23  is a perspective view of a discharge nozzle according to a fifth embodiment; 
         FIG. 24  is a side view of the discharge nozzle according to the fifth embodiment; 
         FIG. 25  is a sectional view of the discharge nozzle according to the fifth embodiment taken along the section line XXV-XXV in  FIG. 24 ; 
         FIG. 26  is a sectional view of through the discharge nozzle according to the fifth embodiment taken along the section line XXVI-XXVI in  FIG. 24 ; 
         FIG. 27  is a schematic side view of a proposed inhaler; 
         FIG. 28  is a schematic sectional view of the proposed inhaler taken along the section line XXVIII-XXVIII in  FIG. 27  with the insert inserted; and 
         FIG. 29  is a schematic sectional view of the proposed inhaler taken along the section line XXVIII-XXVIII in  FIG. 27  without an insert. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In the following, the same reference numerals have been used for identical or similar parts where identical or similar properties and advantages can be achieved, even if the relevant description has not been repeated. 
       FIG. 1  shows, in perspective view, a proposed insert  1  having a reservoir  2 . 
       FIG. 2  shows an elevation and  FIG. 3  shows a section through the reservoir  2 . The reservoir  2  is preferably configured to hold a medicament preparation  3 . 
     The medicament preparation  3  is preferably a liquid, particularly a solution and/or suspension. In particular, it is a medicament preparation  3 , which is held under pressure. For this purpose, the reservoir  2  may comprise or contain a propellant  4 , such as a propellant gas. Alternatively or additionally, the medicament preparation  3  may contain the propellant  4 . The reservoir  2  may be at least partly filled or fillable with a mixture of medicament preparation  3  and propellant  4 . 
     The reservoir  2  preferably forms an inner space sealed off in a pressuretight manner for receiving the preferably pressurized medicament preparation  3 . 
     The reservoir  2  has a wall  6 . The wall  6  forms a container with an opening  7 , which is preferably closed off, particularly in a gastight manner. In the embodiment shown, the opening  7  is closed off by a lid, normally referred to as a valve plate  8 , or by some other closure means into which a valve  9  is preferably insertable or inserted. However, other solutions are also possible here, e.g., known aerosol dispensing container closures. 
     The reservoir  2  preferably comprises the valve  9 . Particularly preferably, the valve  9  is arranged in the lid or valve plate  8 . The valve  9  may be received or held by the valve plate  8  or the other closure means. In particular, the valve  9  is sealingly mounted, for example pressed into the valve plate  8  or sealingly held therein in some other way. 
     The valve  9  is preferably a metering valve. A metering valve may be configured to dispense a certain quantity or dose when actuated. A metering valve is thus particularly configured not to provide a continuous fluid connection between the inlet and outlet. Preferably, when the valve  9  is actuated, a fluid connection from a dispensing opening  13  of the valve  9  is established only with a metering chamber  10  of the valve and/or is not continuously formed with the inner space  5  of the reservoir  2 . 
     The valve  9  may comprise a valve element  11 . The valve  9  is preferably embodied to be opened and closed by the movement of the valve element  11 . For this purpose, the valve element  11  may be inclined or rotated. Particularly preferably, the valve  9  is embodied to be opened or closed, respectively, by an axial or vertical movement of the valve element  11 . 
     The valve element  11  is preferably biased in the closed position. The valve  9  may be a self-closing valve, in this way or by other means. In particular, the valve element  11  is biased in the closed position and can be moved counter to the bias, thereby opening the valve  9 . 
     The valve  9  may be male or female. Preferably, the valve element  11  allows axial flow, thus enabling a fluid connection to be formed for the dispensing of the medicament preparation  3  through the valve element  11 . However, other solutions are also possible. 
     In the embodiment shown the valve element  11  preferably comprises a valve stem  12 . The valve stem  12  may be integrally formed with the valve element  11 , pushed into the valve element  11  or otherwise attached to the valve element  11 . 
     The valve stem  12  preferably projects beyond the valve plate  8  and is able to actuate the valve  9  by axial movement. Alternatively or additionally, however, the valve  9  may also be embodied as a female valve. For this purpose, the valve  9  may have an opening into which a valve stem  12  by means of which the valve  9  can be actuated can be pushed from outside. However, other solutions are also possible. 
     The valve element  11  is preferably configured so as to produce a fluidic connection between the metering chamber  10  and the dispensing opening  13  preferably formed by the valve stem  12 , particularly by axial movement. 
     The valve element  11  may also be configured to connect the metering chamber  10  fluidically to the inner space  5  of the reservoir  2 . It is particularly preferred if the movement of the valve element  11  can produce either a fluid connection between the inner space  5  of the reservoir  2  and the metering chamber  10  or a fluid connection between the dispensing opening  13  and metering chamber  10 , but preferably not at the same time. 
     In the embodiment shown, the valve element  11  may comprise a collar  14  which is biased against a seal or sealing surface  15 . In this way, the valve  9  can be closed or can block dispensing of the medicament preparation  3  from the inner space  5 . 
     Moreover, the valve stem  12  may have a lateral orifice  16 . The lateral orifice  16  is preferably fluidically connected to the dispensing opening  13 . The orifice  16  may be arranged, in a closed state of the valve  9 , on a side of the sealing surface  15  remote from the metering chamber  10 . This provides ventilation. 
     On a side remote from the dispensing opening  13 , the valve element  11  may have a sealing region  17 . The sealing region  17  may be configured so as to correspond to the valve element  11 . In particular, the sealing region  17  is arranged and configured such that an axial movement of the valve element  11  can block a fluid connection between the inner space  5  and the metering chamber  10 . 
     For actuating or activating the dispensing of the medicament preparation  3 , the valve element  11  may be axially moveable, while an existing fluid connection between the inner space  5  and the metering chamber  10  is preferably closed off at the sealing region  17 , particularly relative to a valve housing  18  or an entry seal  19  arranged there. As the movement continues, the orifice  16  reaches the side of the sealing surface  15 , which faces the metering chamber  10  and provides a fluid connection between the metering chamber  10  and the dispensing opening  13 . However, other solutions are also possible. 
     The valve element  11  is preferably biased into the direction of closing by a spring  20 . In the closed position of the valve  9 , the valve is closed or a fluid connection between the metering chamber  10  and the dispensing opening  13  is blocked. At the same time, a fluid connection may be formed between the metering chamber  10  and the inner space  5 . However, other solutions are also possible. 
     The reservoir  2  preferably comprises an immersion tube  21  or is otherwise embodied so as to be operated by the valve  9 , which is preferably directed upwards in the position of use. 
     The position of use is particularly characterized in that an inhaler I with the insert  1  can be inserted in a respiratory orifice of a living creature so that the medicament preparation  3  can be administered as shown in  FIG. 27 , for example. The position of use may relate to the insert  1 , even if it has not been inserted in the inhaler I. In this case, it is preferable for the position of use to denote an alignment of the insert  1  which the insert  1  would assume within the inhaler I. Alternatively or additionally, the valve  9  in the position of use faces away from the ground. In particular, the position of use of the insert  1  is upright or an upright position. For this purpose, the valve  9  may be directed upwards. 
     In the embodiment shown, the valve  9  is connected with the immersion tube  21  at the inlet end such that an intake opening  22  of the immersion tube  21  is provided in the base region  23  of the reservoir  2 . However, other solutions are also possible, in particular, without an immersion tube  21 . 
     In an alternative embodiment (not shown), the medicament preparation  3  may be arranged in a pouch. The pouch is preferably arranged in the reservoir  2  and forms an inner space, which is connected to the valve  9 . In this case, the propellant  4  may surround the pouch. In such an embodiment, operation independent of position may be possible. 
     However, it is particularly preferred if at least upright operation or dispensing of the medicament preparation  3  is possible with the valve  9  directed upwards in the position of use. 
     In the embodiment according to  FIG. 3 , the reservoir  2  is closed off by the valve plate  8  or other closure means. In particular, the valve plate  8  or closure is flanged with the wall  6  of the reservoir  2 . The reservoir  2  may have a flanged or crimped edge  24  on the valve side. The crimped edge  24  may form an undercut  25 . The undercut  25  is shown as being circumferential in the embodiment shown. However, the undercut  25  may also be formed in some other way than by a crimped edge  25  or may be only partially circumferential or non-circumferential in some other way. 
       FIG. 4  shows a side view of the proposed insert  1  in which a nebulizer  26  is preferably arranged or mounted on the reservoir  2  on the valve end. 
       FIG. 5  shows a section through the insert taken along the section line V-V in  FIG. 4 . The reservoir  2  corresponds to the reservoir  2  described in conjunction with  FIGS. 2 and 3 , and for this reason, reference may be made to the previous remarks. 
     The nebulizer  26  is mounted on the reservoir  2  or is held directly on the reservoir  2  by some other method. In the embodiment shown, the nebulizer  26  comprises a latching surface  27  which can engage in the undercut  25 . The surface latching  27  may be formed, for example, by one or more latching projections. Preferably, and at least substantially continuous and/or circumferential latching surface  27  is used, particularly a bead, a projection or the like. This promotes non-removable holding of the nebulizer  26  on the reservoir  2 . The nebulizer  26  may be secured by latching to the reservoir  2  by this or other means. 
     Alternatively or additionally, the nebulizer  26  may be attached or held on the reservoir  2 , particularly on the wall  6  or crimped edged  24 , by adhesion, clamping, clipping, injection molding or some other method, preferably with interlocking engagement. However, it is also possible for the nebulizer  26  to be rotatably fixed or held on the reservoir  2 . 
     Preferably, the nebulizer  26  is non-removably, i.e., permanently held on or connected to the reservoir  2 . The nebulizer  26  may form an integral unit with the reservoir  2 . In particular, the nebulizer  26  forms a unseparable construction unit with the reservoirs  2 . A construction or integral unit is unseparable/permanently connected, particularly when essential components cannot be separated from one another without being damaged or destroyed. The nebulizer  26  is thus attached to the reservoir  2 , in particular, such that total separation of the nebulizer  26  from the reservoir  2  leads to damage or destruction of the nebulizer  26  or in some other way renders the insert  1  unusable. 
     The nebulizer  26  may also be produced and operated independently of the reservoir  2  or an inhaler I. A separate nebulizer  26  of this kind may, for example, be made available separately as a semi-finished product to a manufacturer or filler of the reservoir  2 . A separate nebulizer  26  is preferably non-separable and/or can only be connected to a reservoir  2  once, particularly can be clipped to the reservoir  2 . However, other solutions are also possible. 
     A discharge nozzle  28  is associated with the nebulizer  26 . Preferably, the nebulizer  26  comprises the discharge nozzle  28 , accommodates it or retains it. The discharge nozzle  28  is preferably embodied so as to dispense the medicament preparation  3  and/or to form an aerosol  29  with the medicament preparation  3 . 
     The discharge nozzle  28  is preferably fluidically connected to the valve  9 . In particular, the discharge nozzle  28  is connected to the valve element  11  or the valve stem  12 . Preferably, the discharge nozzle  28  can move the valve element  11  and thus open the valve  9 . However, other solutions are also possible. 
     It is preferable if the discharge nozzle  28  is mounted in the nebulizer  26  to be axially moveable at least to a limited extent and in particular is mounted to be connected or fixed for rotation. The nebulizer  26  is thus preferably configured to allow axial movement of the discharge nozzle  28 . In addition, the nebulizer  26  is preferably embodied to prevent rotation and removal of the discharge nozzle  28 , particularly to block it by positive engagement. 
     It may be sufficient if the discharge nozzle  28  is not removable when the insert  1  has been installed or the nebulizer  26  is attached to the reservoir  2 . Axial movement or removal of the discharge nozzle  28  from the nebulizer  26  may be blocked in the direction of the reservoir  2  by the reservoir  2  itself. 
     The discharge nozzle  28  preferably comprises a nozzle body  30 . The nozzle body  30  may comprise a fluid channel  31  for fluidically connecting the dispensing opening  13  of the valve  9  to the environment. 
     The activating element  32  is arranged around the nozzle body  30  in the embodiment shown and/or is at least substantially annular. The activating element  32  may, however, be of asymmetric construction, particularly oval, bone-shaped or provided with protrusions, projections or the like, particularly in section at right angles to a central axis of the nozzle body  30  or the channel  31 . These or other means may ensure that the activating element  32  can perform an axial movement but not a rotary or turning movement. 
     The activating element  32  is preferably secured against rotation. Moreover, the activating element  32  preferably secures the discharge nozzle  26  or the nozzle body  30  against rotation. 
     The activating element  32  can accommodate and/or hold the nozzle body  30 , particularly by interlocking and/or frictional engagement. In particular, the nozzle body  30  is fixedly connected, pressed, adhesively bonded or formed in one piece with the activating element  32 . The activating element  32  may block or prevent movement or removal of the nozzle body  30  in a direction A for the aerosol  29 . 
     The activating element  32  may be or form part of the nozzle body  30  or the discharge nozzle  28 . In the embodiment shown, the activating element  32  forms a shoulder of the nozzle body  30  or the discharge nozzle  28 . The activating element  32  may, however, also be formed in a different manner and/or independently of the discharge nozzle  28  or the nozzle body  30 . 
     The activating element  32  is preferably configured so as to allow activation of the dispensing of the medicament preparation  3 . For this purpose, the activating element  32  may interact with the valve  9  or act upon the valve  9 . Particularly preferably, the activating element  32  is embodied to move the valve element  11  axially, in particular, and thereby open the valve  9  or actuate the dispensing of the medicament preparation  3 . 
     In a variant which is not shown in detail, the activating element  32  is produced and/or moveable separately from the discharge nozzle  28  or the nozzle body  30 . In this case too, it is particularly preferable if the activating element  32  is embodied to move the valve element  11 , to open the valve  9  or to dispense the medicament preparation  3 . It is thus possible for the activating element  32  to actuate the valve without moving the nozzle body  30  or the discharge nozzle  28 . 
     In one variant it is possible for the valve element  11  or the valve stem  12  to be moveable within the nozzle body  30  in the manner of a piston. In this way or otherwise, the nozzle body  30  or the discharge nozzle  28  may, in particular, be removable relative to the reservoir  2  during the opening of the valve. 
     The activating element  32  may move the valve stem  12  and/or the valve element  11  without the discharge nozzle  28  or the nozzle body  30  having to be moved. 
     Preferably, however, the activating element  32  forms a construction unit or fixed composite with the discharge nozzle  28 . This has proved to be a particularly robust, simple and inexpensive solution. 
     The activating element  32  is preferably protected from accidental actuation by a frame or a shoulder S. In particular, the frame or the shoulder S is arranged adjacent to the activating element  32 , projects relative to the activating element  32  and/or surrounds the activating element  32 , preferably in the manner of a frame or shoulder. 
     The nebulizer  26  preferably comprises a housing  33  which may form the engagement surface  27  or may be attached to the reservoir  2  or the wall  6  thereof. 
     The frame or the shoulder S is/are preferably formed by the housing  33  or is/are attached to the housing  33  or otherwise rendered immovable relative to the reservoir  2 . This prevents accidental manual movement of the activating element  32  and consequent possible triggering of the dispensing of the medicament preparation  3 . 
     Preferably, the discharge nozzle  28 , the nozzle body  30  or the activating element  32  is or are arranged on or at least partially in the housing  33 . 
     The discharge nozzle  28  and/or the nozzle body  30  and/or the activating element  32  are preferably held in or on the housing in non-removable manner, preferably by interlocking engagement. However, at least axial movement of the activating element  32 , the nozzle body  30  or the discharge nozzle  28  on or in the housing  33  is preferably provided, particularly for actuating the valve  9  or moving the valve element  11 . 
     In addition, the nebulizer  26  may comprise a counter  34 . The counter  34  is preferably configured to be driven by initiating the dispensing of the medicament preparation  3 . In particular, the counter  34  can be driven by the axial movement of the activating element  32 , the nozzle body  30  and/or the discharge nozzle  28 . 
     The nebulizer  26  is hereinafter described in more detail by reference to the prospective drawings in  FIGS. 6 to 8 , where  FIG. 6  shows a prospective view of the nebulizer  26  from diagonally above,  FIG. 7  is a prospective view of the nebulizer  26  from diagonally below and  FIG. 8  shows a prospective view of the counter  34  which is preferably inserted or insertable in the nebulizer  26 . 
     The housing  33  may comprise a window  35  to which the counter  34  is visible from outside. In the embodiment shown, the window  35  is provided as an orifice in the housing  33 . However, the counter  34  may also be visible from outside in some other way. In  FIG. 7 , the counter  34  is inserted in the nebulizer  26 . 
     In the embodiment shown in  FIG. 8 , the counter  34  is at least substantially annular and/or rotatable in configuration. 
     The counter  34  may comprise an indicator  36 , particularly a scale or the like. This is preferably provided on the radially outer edge or on a radially outer or circumferential surface of the counter  34 . However, other solutions are also possible. 
     For example, the indicator  36  may alternatively or additionally be provided axially, at the end face or on other parts of the counter  34 . Arrangement on a radially outer and preferably circumferential surface has the advantage that the counter  34  is easily visibly from outside after the insertion of the proposed insert  1  in a corresponding inhaler I, for example by means of corresponding windows, orifices or openings. 
     The counter  34  preferably comprises a return preventer means  37  and/or a driver  38 . 
     The return preventer means  37  is preferably designed to allow the counter  34  to be moved only in one direction and to block it in any other or opposite direction. With a counter  34  of at least substantially annular construction, the return preventer means  37  may thus be embodied to allow rotation only in one direction and to block it in another direction. 
     The driver  38  is preferably configured to move the counter  34 , particularly to rotate it. 
     The return preventer means  37  and the driver  38  preferably cooperate such that the counter  34  is drivable, particularly rotatable. For this purpose, the driver  38  may cause the counter  34  to rotate in one direction and the return preventer means  37  may prevent it from turning back. In this way the counter  34  may be constantly moveable, particularly rotatable, in one direction. 
     The counter  34  may comprise one or more flexible strips  39 , which are mounted or moulded on the counter  34  or preferably integrally formed with the counter by some other method. 
     The flexible strips  39  may act as springs. The strips  39  may enable the counter  34  to be seated securely in the nebulizer  26 . 
     Alternatively or additionally, the flexible strips  39  may prevent rotation of the counter  34  in one direction and/or permit it only in one direction in the manner of a ratchet. In this way the return preventer means  37  may be formed with the flexible strips  39 . 
     The counter  34  is preferably drivable by actuation of the dispensing of the medicament preparation  3 . 
     The driver  38  preferably comprises drive means  1 , particularly teeth or pawls. In the embodiment shown in  FIG. 8  the driver  38  is embodied as a gear ring. However, other solutions are also possible. 
     It is preferable if the counter  34 , particularly the return preventer means  37  and/or the driver  38  interact with the housing  33 , with the activating element  32 , with the nozzle body  30  and/or with the discharge nozzle  28  so that by axial movement of the activating element  32  the counter  34  can be driven, particularly rotated. 
     The return preventer means  37  of the counter  34  preferably engages on a surface of the nebulizer  26 , particularly of the housing  33 , in the position of use, so that movement of the counter  34  is blocked in one direction, particularly a direction of rotation, preferably by interlocking and/or frictional engagement. 
     The counter  34  may comprise guide means to enable a guided rotary movement of the counter  34  in the housing  33  of the nebulizer  26 . In the embodiment shown in  FIG. 8 , a ring  41  is provided which serves as guide means and may form or carry the indicator  36 . 
     Preferably, the nebulizer  26  comprises a counter drive  42 . The counter drive  42  may be configured to cause advance of the counter  34 , particularly rotation thereof, by axial movement of the activating element  32 , the discharge nozzle  28  or the nozzle body  30 . 
     The counter drive  42  is preferably arranged or fixed on the activating element  32  or formed in one piece with the activating element  32 . 
     In the embodiment according to the  FIG. 7  the counter drive  42  is formed by a flexible strip, a spring arm, a lever or the like. 
     The counter drive  42  may be altered by axial movement of the activating element  32  or of the nozzle body  30  in its angle relative to the activating element  32 , or extended, for example by deformation. In this way, axial movement of the activating element  32 , nozzle body  30  or the discharge nozzle  28  may be converted into rotary movement of the counter  34 . However, again other drive concepts are possible. 
     In the embodiment according to  FIG. 7  the activating element  32  or the discharge nozzle  28  or the nozzle body  30  is guided by a guide  43  axially and/or connected for rotation or to prevent accidental rotation. 
     The guide  43  may alternatively or additionally also be slightly helical in configuration. In one embodiment it is possible for the activating element  32  to be rotated by a helical guide  43  during axial movement. This enables the activating element  32  or discharge nozzle  28  to be rotated as they move axially. The counter drive  42  may transmit a rotary movement of this kind to the counter  34 . 
     The counter drive  42  may comprise a follower or be embodied as a follower. In this way, a rotary movement of the activating element  32  or of the discharge nozzle  28  or nozzle body  30  may be used to drive the counter  34 . 
     For driving the counter  34 , the counter drive  42  may engage in the drive means  1  of the counter  34 , particularly in a latching engagement or in the manner of a ratchet. The return preventer means  37  and the driver  38  may thus be or comprise ratchets rotating in opposition directions, in particular. 
     When the activating element  32  is moved in order to activate the dispensing of the medicament preparation  3 , the counter  34  may be moved in a first direction and, when the activating element  32  is moved back into its starting position, a contrary rotary movement of the counter  34  can be prevented by the return preventer  37 . The counter drive  42  may slide over a pall of the drive means  1  and when the activating element  32  is next moved to activate the dispensing of the medicament preparation  3 , it may be engaged in a next or adjacent detent of the drive means  1 . In this way it is possible to achieve a continuous or steady driving of the counter  34 . 
       FIG. 9  shows a side view of the proposed nebulizer  26  and  FIG. 10  shows a section through the nebulizer  26  on the section line X-X from  FIG. 9 . 
     The dispensing of the medicament preparation  3  from the reservoir  2  can be achieved by actuating the valve  9 . For this purpose, as already described in connection with  FIG. 3 , the valve element  11  is preferably moved axially. In particular, the valve stem  12  is pressed in the direction of the reservoir  2 , as a result of which the valve element  11  is able to produce a fluidic connection between the metering chamber  10  and the dispensing opening  13 . 
     The valve element  11  is preferably moveable by the activating element  32  or the nozzle body  30  or the discharge nozzle  28 . 
     The discharge nozzle  28  or nozzle body  30  preferably has a valve connector  48  for connecting to the valve element  11  or valve stem  12 . 
     In the embodiment shown in  FIG. 5 , the valve stem  12  or the valve element  11  is sealingly accommodated in the valve connector  48  and/or held by the valve connector  48 . 
     The valve connector  48  may comprise an abutment  49 , particularly an annular shoulder, for the valve element  11  or valve stem  12 . In this way the valve element  11  or the valve stem  12  can be moved by the movement of the discharge nozzle  28 , the nozzle body  30  or the activating element  32 . 
     The dispensing of the medicament preparation  3  can be initiated by a preferably axial movement of the valve element  11  or valve stem  12 . The medicament preparation  3  contained in the metering chamber  10  is preferably pressurized and is forced by this excess pressure through the channel  31  in the nozzle body  30 . As a result the medicament preparation  3  can be dispensed and the aerosol  29  formed. 
     The insert  1  or nebulizer  26  preferably comprises a blocking device  44 . The blocking device  44  is preferably configured to prevent initiation of the dispensing of the medicament preparation  3 , particularly to block and/or allow or release this dispensing. 
     In particular, the blocking device  44  is configured to prevent the dispensing of the medicament preparation  3  if the insert  1  had not been inserted, or at least not fully inserted, into a corresponding inhaler I or is not in its position of use for some other reason. 
     Alternatively or additionally, the blocking device  44  is configured for this purpose and/or to allow the dispensing of the medicament preparation  3  when the insert  1  has been inserted in a corresponding inhaler I, preferably oriented and/or completely. The blocking device  44  may block or allow a preferably axial movement of the discharge nozzle  28 , the nozzle body  30  and/or the activating element and/or a movement of the valve element  11 . However, other solutions are also possible for preventing or allowing the dispensing of the medicament preparation  3 , for example by means of an additional valve or the like. 
       FIG. 11  show a magnified detail of the region of the blocking device  44  from  FIG. 10 . 
     The blocking device  44  may comprise an interlocking element  45  which is able to engage in the activating element  32 , particularly in a locking portion  47  of the activating element  32 , for example a recess in the activating element  32 . In this way, or by other means, it is possible to prevent the activating element  32  or the nozzle body  30  or the discharge nozzle  28  from being moved axially, in particular. 
     The nozzle body  30  or the activating element  32  or the discharge nozzle  28  is/are therefore preferably capable of being blocked axially by the blocking device  44 . In this way, actuation of the valve  9  and discharge of the medicament preparation  3  can be prevented. 
     The blocking device  44  is preferably configured so that dispensing of the medicament preparation  3  is prevented outside an inhaler I or until the insert  1  has been inserted in a corresponding inhaler I or has reached its position of use. 
     The blocking device  44  may be required for safety purposes. Advantageously, the blocking device  44  makes it possible to prevent the formation of aerosol outside the inhaler I. The concentration of active substances in the medicament preparation  3  may be high, particularly if the insert  1  or the inhaler I is intended for use in large animal. Accidental actuation and breathing in of the aerosol  29  may therefore have serious consequences. The proposed blocking device  44  prevents accidental actuation outside the inhaler I. 
     The blocking device  44  may be at least partially bendable, flexible and/or deformable. The blocking device  44  is preferably configured to trigger release, irreversibly, preferably by separation or destruction, or reversibly, particularly by sliding or bending. 
     In the embodiment shown in  FIG. 10 , the blocking device  44  has a sloping surface  46 . The sloping surface  46  may be configured to initiate locking by means of the interlocking element  45 . For this purpose, a force F may act on the sloping surface  48 , thereby bending the blocking device  44  or in some other way moving it out of engagement with the locking portion  47 . In this way the blocking device  44  may allow activation of the dispensing of the medicament preparation  3 . 
     The release by the blocking device  44  is preferably effected by the inhaler I during the insertion of the insert  1  or the nebulizer  26  into the inhaler I on the blocking device  44 . 
     In alternative embodiments of the blocking device  44 , not shown here, a rod or bolt may be provided which is in engagement with the discharge nozzle  28 , the nozzle body  30  or the activating element  32  or in some other way blocks or prevents movement of the discharge nozzle  28 , the nozzle body  30  and/or the activating element  32 . In this way, it is possible to prevent activation of the dispensing of the medicament preparation  3 . The bolt or rod may be movable, particularly slidable thus freeing up the activation of the dispensing of the medicament preparation  3 . However, other solutions are also possible. 
     In an alternative embodiment, which is also not shown here, the blocking device  44  may comprise an element having a frangible point, which may be mounted on, adhered to, moulded on or formed in one piece with the discharge nozzle  28 , the nozzle body  30  and/or the activating element  32 . The element is preferably configured to be destructible or separable when the insert  1  is inserted into an inhaler I. This prevents activation outside the inhaler I and/or allows activation by the insertion of the insert  1  into the inhaler I. 
     In general, the blocking device  44  may prevent actuation of the valve  9  in an initial state or delivery state or allow it only after insertion into a corresponding inhaler I. The dispensing of the medicament preparation  3  can be permitted by the blocking device  44 , particularly by preferably fully inserting the insert  1  into the inhaler I, as will be discussed in more detail hereinafter in connection with the description of the inhaler I from  FIGS. 27 to 29 . 
     In an alternative embodiment (not shown) the insert  1 , particularly the blocking device  44 , can prevent actuation of the dispensing of the medicament preparation  3  after a given number of actuating processes has been reached or exceeded. For this purpose, preferably and in particular, axial movement of the valve element  11 , the discharge nozzle  28 , the nozzle body  30  and/or the activating element  32  is prevented or blocked as soon as the predetermined number of actuation processes is reached or exceeded. 
     The counter  34  may be arranged so as to prevent further activation or further, in particular, axial movements of the valve element  11  or valve stem  12  after the predetermined number of actuation processes has been reached or exceeded, preferably counted by the counter  34 . This can be achieved by the fact that the counter  34  acts on the blocking device  44  so that the latter prevents movement of the discharge nozzle  28 , the nozzle body  30  and/or the activating element  32 . 
     Alternatively or additionally, the counter  34  may prevent further, particularly axial, movement of the discharge nozzle, the nozzle body  30  and/or the activating element  32  directly, preferably by interlocking engagement, by means of interlocking engagement means or other blocking means provided on the counter  34 , or may otherwise prevent actuation of the valve  9 . However, other solutions are also possible. 
     The insert  1  or the nebulizer  26  preferably comprise or comprises an orientation device, particularly an orientation projection  50 , for example a lug, tab or the like and/or an orientation recess  51 . 
     The nebulizer  26  or the insert  1  may comprise one or more orientation devices for securing the orientation, particularly the rotary orientation or rotary position, of the nebulizer  26  or insert  1 . 
     The orientation device is preferably configured to allow total insertion or the reaching of a position of use of the insert  1  or the nebulizer  26  in only one specific rotary position of the nebulizer  26  or insert  1 , by corresponding means, and to prevent them in other rotary positions of the insert  1  or nebulizer  26 . 
     By means of the orientation device, the insert  1  can be inserted, placed or pushed into the inhaler I only in a specific position, rotary position and/or orientation of the insert  1  of nebulizer  26 . 
     Alternatively or additionally, the orientation device is configured to allow actuation of the dispensing of the medicament preparation  3  only in the specified position, rotary position and/or orientation of the insert  1  or nebulizer  26 . 
     Preferably, insertion of the insert  1  or nebulizer  26  into the inhaler I is blocked in one or more rotary positions and enabled in one or more rotary positions. In this way, a position, alignment and/or rotary position of the discharge nozzle  28  or the direction of discharge A for the aerosol  29  can advantageously be determined. 
     In the embodiment shown, the nebulizer comprises an orientation projection  50  and/or an orientation recess  51 . Alternatively or additionally, however, the nebulizer  26  or the insert  1  may also comprise a plurality of orientation projections  50  and/or a plurality of orientation recesses  51  and/or other means for securing the orientation, particularly the rotary orientation or rotary position, of the nebulizer  26  or the insert  1 . 
     A rotary position of the insert  1  or nebulizer  26  in the sense of the present invention is preferably a rotary orientation about a central axis M of the reservoir  2  or insert  1 . 
     The reservoir  2  may be at least substantially cylindrical while the cylinder axis may correspond to the central axis M of the reservoir  2 . 
     Particularly advantageously, the orientation device, particularly the orientation recess  51 , and the blocking device  44  may be combined with one another. In the embodiment shown in  FIGS. 10 and 11 , the blocking device  44  is arranged in the orientation recess  51  for this purpose. In this way, the activation of the dispensing of the medicament preparation  3  can advantageously be released only under the precondition with the blocking device  44  that the nebulizer  26  or the insert  1  has been inserted or arranged in an intended orientation. 
     The orientation recess  51  may be arranged on the insert  1  or on the nebulizer  26  on the end face or adjacent to the discharge nozzle  28  or the activating element  32 . Alternatively or additionally, the orientation device may also be arranged at a different position on the nebulizer  26  or reservoir  2 . For example, it is possible to arrange the orientation device laterally on the nebulizer  26 , particularly in the form of the orientation projection  50 . The orientation projection  50  may be embodied to be insertable into a groove or other guide means. 
     In a particularly advantageous alternative embodiment the orientation projection  50  is in the shape of an arrow or otherwise embodied as an orientation indicator and/or as an insertion aid or is wedge-shaped. This makes it easier to insert the insert  1  into the inhaler I with the orientation device. The inhaler I may be embodied to correspond thereto. 
       FIG. 12  shows a detail of the discharge nozzle  28  according to  FIG. 10 . The discharge nozzle  28  is preferably embodied to dispense the medicament preparation  3 . Preferably the discharge nozzle  28  forms the aerosol  29  when the medicament preparation  3  is dispensed. For this purpose the medicament preparation  3  may be capable of being dispensed through discharge openings  52  in the discharge nozzle  28 . The aerosol  29  may be formed by the dispensing of the medicament preparation  3  though the discharge opening  52 . 
     As already mentioned, the medicament preparation  3  is preferably released by excess pressure in the metering chamber  10  from the valve  9  into the channel  31 , when dispensing is activated. The medicament preparation  3  may be conveyed through the channel  31  to the discharge openings  52  of the discharge nozzle  28 . 
     In the embodiment shown, the discharge openings  52  are embodied as orifices. The discharge openings  52  preferably provide a fluid connection between the outside and inside of the discharge nozzle  28 . In particular, the discharge openings  52  connect the channel  31  to the environment. 
     Preferably, nozzle body  30  comprises a nozzle element  53 , particularly a nozzle insert. The nozzle element  53  may cover or seal one end of the channel  31  remote from the valve  9 . The nozzle element  53  preferably comprises the discharge openings  52 . 
     The discharge openings  52  are preferably fluidically connected to the channel  31  of to the valve  9 . In this way the metering chamber  10  can be fluidically connected to the discharge openings  52 . 
     The nozzle element  53  may be pot-shaped and/or may be held in the nozzle body  30  by frictional and/or interlocking engagement. 
     In the embodiment shown, the nozzle element  53  comprises strips  54  or an encircling strip, frame or a preferably encircling edge or a preferably encircling margin  54 . The nozzle element  53  may form a pot-shape with the margin  54 . 
     The nozzle element  53  is preferably inserted, pushed into, clamped into or otherwise preferably sealingly attached to the nozzle body  30 , particularly to the edge  54 . The nozzle element  53  may be held in this way or otherwise and sealed off from the nozzle body  30  at the edges. 
     The discharge nozzle  28  may be embodied such that the aerosol  29  is released in a direction of dispensing A which may correspond at least substantially to the central axis of the reservoir  2 . This promotes a compact construction. 
     Preferably, a dispensing direction A is provided which is different from the central axis M. Particularly preferably, the dispending direction A deviates from the central axis M of the reservoir  2  by more than 5°, preferably more than 10°, 15° or 20° and/or less than 50°, preferably less than 45° or 1°, particularly preferably less than 35°. This enables the dispensing direction A to be adapted to the geometry of an associated inhaler I. 
     The discharge openings  52  are preferably formed by orifices or bores extending diagonally to the surface or main plane of the nozzle element  53 . In particular, the discharge openings may enclose a dispensing angle with the central axis M of the reservoir  2 , in an opening region, which is greater than 5°, preferably greater than 10° or 15° and/or less than 50°, preferably less than 45° or 1°. 
     In an alternative embodiment (not shown in detail) the nozzle body  30  and/or the nozzle insert  50  may slope relative to the central axis M of the reservoir  2 , preferably by more than 5° particularly more than 10° or 15° and/or less than 50°, particularly less than 45° or 1°, particularly less than 35°. 
     Particularly preferably, the dispensing direction A which is inclined relative to the central axis M of the reservoir  2  is produced by the discharge openings  52  and/or a sloping nozzle element  53 . This enables the insert  1  to be axially inserted in an uncompleted manner in an associated inhaler I. Alternatively or additionally, the nozzle body  30  or the discharge nozzle  28  may also be inclined relative to the central axis M in order to enable to preferred direction of discharge A. 
     The preferred direction of discharge A may be achieved by a combination of several measures. In a preferred alternative, the discharge nozzle  28  comprises discharge openings  52  which are inclined relative to the central axis M of the reservoir  2 , which can be combined with a nozzle element  53  that is inclined relative to the central axis M. Alternatively or additionally, the nozzle body  30  may be inclined relative to the central axis M and/or the path of the discharge openings  52  may be inclined relative to the central axis M. Preferably, the preferred direction of dispensing A is achieved by the sum of the slopes provided. 
     An insert  1  with a combination of a direction of discharge A inclined relative to the central axis M of the reservoir  2  and the orientation device is particularly advantageous as in this way it is possible to prevent the aerosol  29  being dispensed in the direction of a wall, which may have the adverse effect of precipitating the medicament composition  3 . 
     In an alternative embodiment the discharge nozzle  28  may be constructed as vortex chamber nozzle. A vortex body  56  may be provided in a vortex chamber  55  which may be formed by or at the end of the channel  31 . However, other solutions are also possible for producing a vortex chamber nozzle. 
     The aerosol  29 , which is to be formed preferably, contains droplets, which have such a small diameter that they are inhalable into the lungs. It has proved advantageous if the discharge nozzle  28  has a plurality of discharge openings  52 . Preferably, the discharge nozzle  28  comprises at least three and preferably at least four discharge openings  52 . In this way, aerosol  29  suitable for inhaling into the lungs can be produced particularly quickly. This has the advantage, particularly when the inhaler I is used on large animals, that correspondingly large quantities of dose can be converted into a respirable aerosol  29  in a relative short time. This avoids a tiresome process for achieving the total dose by numerous actuation processes. 
     The (respective) discharge opening  52  preferably has cross sections or minimum cross sections  57  which are less than 10 μm, preferably less than 300 μm, more particularly less than 250 μm and/or greater than 100 μm, preferably greater than 150 μm, particularly greater than 200 μm. 
     The discharge openings  52  may be fluidically connected to one another at the inlet end. In particular, the discharge openings  52  are joined to one another and/or to the channel  31  by supply channels  58  or other supply means  59 . However, other solutions are also possible. 
     The discharge openings  52  preferably have accumulative outlet surface of more than 0.1 mm 2 , preferably more than 0.15 mm 2 . Particularly preferably, the discharge openings  52  have accumulative outlet surface greater than 0.2 mm 2 , preferably greater than 0.45 mm 2 , particularly greater than 0.6 mm 2  and/or less than 1.8 mm 2 , preferably less than 1.2 mm 2 , particularly less than 1 mm 2 . Most particularly preferred is accumulative outlet surface of between 0.75 mm 2  and 0.9 mm 2 . As a result, particularly where there are five to six discharge openings  52 , a sufficiently large quantity of the medicament preparation  3  can be dispensed or converted into the aerosol  29  in a comparatively short time, particularly in less than one second. 
     A cumulative outlet surface in the sense of the present invention is preferably the sum of all the outlet surfaces or hydraulic cross sections of the discharge openings  52 . The respective cross section is preferably determined by the hydraulic cross section or the smallest cross section of the orifice that forms the particular discharge openings  52 . 
     It is also preferable for the discharge nozzle  28  to be designed to dispense more than 360 μg, preferably more than 450 μg or 480 μg, particularly more than 600 μg of the medicament preparation  3  per second, particularly at an internal pressure of the reservoir  2  or a pressure on the medicament preparation  3 . Alternatively or additionally, the discharge nozzle  28  is embodied to discharge less than 1500 μg per second, preferably less than 1200 μg per second or 960 μg per second, particularly less than 900 μg per second or 720 μg per second of medicament preparation  3 . These values preferably relate to an internal pressure of the reservoir  2  or a pressure on the medicament preparation  3  of 3 to 6 bar, in particular 4 bar. 
     The medicament preparation  3  preferably has a density of more than 1.2 and/or less than 1.5 g per liter at 20° C. 
     The medicament preparation  3  may comprise a liquid propellant. Particularly preferably, the medicament preparation  3  comprises a fluorohydrocarbon, particularly tetrafluoroethane or heptafluoropropane (HFA 134a, HFA 227 or a mixture). These have proved advantageous particularly on account of their low reactivity and their vapor pressure. The medicament preparation  3  preferably consists of more than 80% by weight, preferably more than 85 or 90% by weight, of fluorohydrocarbons, particularly of the above kind, or other propellants. As the above-mentioned propellants change into the gaseous phase as pressure decreases, a very fine, particularly pulmonary aerosol  29  can be obtained in this way. 
     The preferred number of more than 3, preferably more than 4 and/or less than 8, particularly less than 7 or 6 discharge openings  52  and the other properties and dimensions of the discharge nozzle  28  described may also be implemented separately in a discharge nozzle  28  or nozzle element  53  independently of the specific application described here and may be advantageously used as such. 
     The nozzle element  53  may be accommodated or held in a recess  61  in the nozzle body  30 . The term nozzle element  53  is preferably already understood within the present invention. A nozzle element  53  may not only be inserted in the nozzle body  30  but preferably also placed thereon or formed thereby. 
       FIGS. 13 to 23  show alternative embodiments for the discharge nozzle  28 . In connection with this it should be mentioned once again that where identical reference numerals are used, identical or similar properties and advantages can be achieved, although the description has not been repeated for reasons of simplicity. Moreover, only differences from the discharge nozzle  28  according to  FIG. 12 or 12   a  are described hereinafter. 
     In each of the following embodiments it is particularly preferably that, as shown in  FIG. 12 a    in particular, the discharge openings  52  and alternatively or additionally the nozzle body  30  and/or the nozzle element  53  may be arranged or embodied to be inclined or in some other way to produce an inclined direction of discharge A. 
       FIG. 13  shows a discharge nozzle  28  according to a second embodiment with an at least substantially star-shaped or show flake-shaped nozzle element  53 , which comprises the discharge openings  52  and/or forms a nozzle insert. 
     The nozzle element  53  may functionally correspond at least substantially to the novel element  53  according to  FIGS. 12 and 12   a  and for this reason reference is particularly made to the option of an inclined direction of discharge A in describing them. 
     The nozzle element  53  from the embodiment shown in  FIGS. 13 and 14  comprises five arm-like sections, each having discharge openings  52  in or on their ends. However, it is also possible to have more or fewer arm-like sections, for example four or six. Optionally, a further discharge opening  52  may additionally be provided in a central region of the nozzle element  53  on which the arm-like sections are arranged. 
       FIG. 14  shows a perspective section through the discharge nozzle  28  from  FIG. 13 . The channel  31  may be connected to the discharge openings  52  by one or more supply channels  58  or other supply means  59 . In the embodiment shown in  FIGS. 13 and 14  the supply means  59  are preferably star-shaped. 
     Compared with a full-surface supply means  59 , a star-shaped supply means  59  has the advantage that a reduced contact surface is available for the pressurized medicament preparation  3  and consequently force acting on the nozzle element  53  during the dispensing of the medicament preparation  3  can be kept to a minimum. This assists with the secure fixing of the nozzle element  53  to the nozzle body  30 . A star-shaped supply means  59  to the respective discharge openings  52  also reduces the total volume of the supply  59  and consequently the amount of medicament preparation  3  remaining in the supply  59  which is not expelled and consequently represents a loss or may dry up. 
     The preferably plate-like nozzle element  53  in the second embodiment is preferably held in the nozzle body  30  by clamping or latching. In particular, fixing and/or sealing means are provided for holding the nozzle element  53  in the nozzle body  30  and/or for sealing the nozzle element  53  from the nozzle body  30 . In particular, a circumferential bead  60  is provided which holds the nozzle element  53  against the nozzle body  30  at its edges in a clamping and/or sealing action. The bead  60  is provided on the nozzle body  30  in the embodiment shown, and in particular is integrally formed therewith. The bead  60  may, however, also be arranged on the nozzle element  53 . 
     In the embodiment shown, the nozzle body  30  comprises a recess  61  in which the novel element  53  can be arranged. The recess  61  may comprise, on an inner, lateral and/or circumferential edge, the bead  60  for holding the nozzle element  53  by a clamping or latching action. 
     The bead  60  is preferably of continuous and/or circumferential configuration. In this way the nozzle element  53  can be sealed off from the nozzle body  30  and held on the nozzle body  30 . 
     In one alternative, the bead  60  is provided on the nozzle element  53 . However, other alternative possibilities are also conceivable for holding the nozzle element  53  sealingly against the nozzle body  30 , for example by adhesive bonding, clamping, latching, pressing or the like. 
     Holding the nozzle element  53  by means of the bead  60  is preferred as, at comparatively little expense, the nozzle element  53  is simultaneously securely fixed to the nozzle body  30  and the nozzle element  53  can be sealed off from the nozzle body  30 . 
       FIG. 15  shows, in a third embodiment, a proposed discharge nozzle  28  with five discharge openings  52 . However, it is also possible to have a different number of discharge openings  52 . 
       FIG. 16  shows a side view of the discharge nozzle  28  according to  FIG. 15 .  FIG. 17  shows, in a section on the line XVII-XVII from  FIG. 16 , the supply means  59 , which in the present instance is of at least substantially star-shaped configuration. 
     A star-shaped supply  59  with additional fluid connections between adjacent discharge openings  52  represents a good compromise between the contact surface for the pressure and a homogenous distribution of pressure between the discharge openings  52  and a uniform discharge quantity through the respective discharge openings  52 . 
     Adjacent discharge openings  52  may be connected to one another by connecting channels  63 , preferably at the ends or on a side facing to the channel  31  or the respective discharge openings  52 . In particular, ends of the supply channels  58  forming the supply  59  are connected to one another by a connecting channel  63  which is preferably at least substantially circular. In this way, a homogenous pressure distribution can be guaranteed. 
     In the present case the nozzle element  53  is of a cap-like construction. The nozzle element  53  may be a pushed-on part or a protrusion or a cap. 
     The nozzle element  53  is fitted onto the nozzle body  30 , preferably by clipping or latching. This has the advantage of making it easier to exchange, for example to replace it with a nozzle element  53  having different or a different number of discharge openings  52 . 
       FIG. 19  shows, in a third embodiment, another alternative embodiment of the proposed discharge nozzle  28  with a nozzle element  53  inserted in the nozzle body  30 . The nozzle element  53  in the third embodiment is plate-shaped and preferably comprises an edge  54  for clamping, latching and/or sealing assembly. 
       FIG. 20  shows a side view of the discharge nozzle  28  according to  FIG. 19 .  FIG. 21  shows a section through the discharge nozzle  28  along the section line XXI-XXI from  FIG. 20 . 
     As already described in connection with the second embodiment for a proposed discharge nozzle  28  from  FIG. 17 , an at least substantially star-shaped supply means  29  is provided which connects the channel  31  to the discharge openings  52 . However, other alternative embodiments are also possible. Moreover, adjacent discharge openings  52  can additionally be fluidically connected to one another, particularly by connecting channels  63 . 
       FIG. 22  shows a section through the discharge nozzle  28  along the section line XXII-XXII from  FIG. 20 . For reasons of simplicity, the nozzle element  53  is not shown in  FIG. 22 . 
     The nozzle body  30  may comprise a bead  60 , particularly an annular bead, and/or an undercut  62 , particularly a groove or annular groove, for the latching and/or clamping attachment of the nozzle element  53 . These preferably correspond to one another. 
     The nozzle body  30  may comprise a preferably annular or disc-shaped recess  61  for accommodating the nozzle element  53 . The recess  61  may comprise the undercut  62  or another bead or another connecting means suitable for a latching, clamping, interlocking and/or frictionally engaging connection. 
     The bead  60  and the undercut  62  may be axially offset from one another and/or provided on different sides of the recess  61 . In this way, particularly secure positioning can be ensured when the nozzle element  53  is inserted. 
     In the embodiment shown in  FIGS. 19 to 22 , the nozzle element  53  is preferably in the shape of a pot. The nozzle element  53  has a plate section with the discharge openings  52  and a preferably circumferential and/or marginal collar or edge  54  which can preferably be held in the recess  61 . 
       FIG. 23  shows, in perspective view, a fourth embodiment of the proposed discharge nozzle  28 .  FIG. 24  shows a side view of the discharge nozzle  28  according to  FIG. 23 .  FIG. 25  shows a section through the discharge nozzle  28  of  FIG. 23  along the section line XXIV-XXIV from  FIG. 24  and  FIG. 26  shows a section through the discharge nozzle  28  from  FIG. 23  along the section line XXVI-XXVI from  FIG. 24 . 
     The discharge nozzle  28  from  FIG. 23  comprises a plate-like nozzle element  53  with discharge openings  52 . The nozzle element  53  is fixed to the nozzle body  30  by a lock nut  64 . The lock nut  64  preferably has an internal thread, which may correspond to an external thread on the nozzle body  30 . The lock nut may alternatively or additionally also be latched on or otherwise secured or may be replaced by a nozzle element from the third embodiment. 
     The lock nut  64  may comprise mounting elements  65 , particularly recesses for a tool. 
     The nozzle element  53  may be tightened directly against the nozzle body  30 , preferably to form a seal, by the lock nut  64 . In the embodiment shown, the nozzle element  53  abuts on a distributor element  66  for fluidically connecting the discharge openings  52 . 
     The distributor element  66  may be inserted in the nozzle body  30 , fitted onto the nozzle body  30  or otherwise mounted thereon or formed in one piece with the novel body. In particular, the nozzle element  53  is in contact with the nozzle body  30  by means of the distributor element  66 . 
     In the embodiment shown, the nozzle element  53  forms a sandwich-like structure with the distributor element  66  and the nozzle body  30 . 
     The lock nut  64  may preferably secure the nozzle element  53  and/or the distributor element  66  by clamping. However, other solutions are also possible. 
     The distributor element  66  may be elastic and/or formed from a sealing material. 
     The discharge nozzle  28  according to the different embodiments may also constitute separate inventive objects and may be implemented independently of the insert  1  or inhaler I. 
     The proposed insert  1  is preferably inserted or pushed into an inhaler I and particularly preferably received by an inhaler I.  FIG. 27  shows a side view of a proposed inhaler I, particularly for a horse P. 
     The inhaler I may have a chamber  67 , which is configured to receive and store aerosol  29 . The chamber  67  may have an adaptor  68  for a respiratory orifice  69 , preferably of an animal, particularly for a horse&#39;s nostril (merely indicated in  FIG. 27 ). 
     The inhaler I is preferably configured to receive the reservoir  2  and particularly preferably to hold or fix it at least axially or in some other way to prevent axial movement of the reservoir  2 . 
     Preferably, the reservoir  2  forms part of the insert  1 . The insert  1  is inserted in the inhaler I in the embodiment shown in  FIG. 27 . 
     Preferably, the insert  1  or the reservoir  2  is/are fully accommodated by the inhaler I. However, it is possible for the insert  1  or the reservoir  2  to be at least partly visible or accessible from outside. Preferably, a viewing window  70 , particularly an orifice, may be provided through which the insert  1  or the reservoir  2  is or are at least partly visible. In this way a text, label or similar on the insert  1  or reservoir  2  may be visible from outside. 
     The inhaler I preferably comprises a counter window  71 , particularly an orifice, or other means for indicating the status of a counter or the indicator  36  of the counter  34 . In particular, the counter  34  is provided in the insert  1  and can be seen through the counter window  71 . 
       FIG. 28  shows a section through the proposed inhaler I along the section line XXVIII-XXVIII from  FIG. 27  with the insert  1  in the position of use. 
     In the embodiment according to  FIG. 28  the insert  1  has been inserted in the inhaler I. In particular, the reservoir  2  is arranged in the inhaler I or at least substantially accommodated by the inhaler I. 
     The reservoir  2  can be at least axially fixed, held or otherwise secured against axial movement in or on the inhaler I. 
     Preferably, the reservoir  2  is axially secured via or by means of the nebulizer  26 . 
     Preferably, the insert  1  is held between retaining surfaces. In the embodiment shown, the inhaler I has a stop  72  against which the nebulizer  26 , the insert  1  and/or the reservoir  2  may lie. 
     Preferably the housing  33  of the nebulizer  26  abuts directly on the stop  72 . In this way axial movement of the reservoir  2  can be prevented at least in one direction. 
     Preferably, the reservoir  2  or the insert  1  is also secured against axial movement on the side remote from the stop  72 . In the embodiment shown in  FIG. 28  the inhaler I comprises a flap or other retaining portion  73  in order to form an abutment for the reservoir  2  of the insert  1 . 
     The combination of the stop  72  and the retaining portion  73  is able to axially secure the insert  1  or reservoir  2 . However, alternative solutions are also possible, such as for example a clamping or latching fixing or holding of the insert  1 . 
     The insert  1  can preferably be inserted in the inhaler I, removed from the inhaler I and/or replaced. For this purpose the retaining portion  73  may be of flap-like construction or capable of being opened and/or closed by some other means. 
     The insert  1  may be insertable into the inhaler I together with the discharge nozzle  28 . 
     The retaining portion  73  may be opened for the insertion of the insert  1  and then closed and/or locked again. By locking the retaining portion  73  the position of the reservoir  2  can be fixed or the reservoir  2  can be fixed. 
     In an alternative (not shown) the retaining portion  73  is produced by other interlocking means or a fixing element. For example, the retaining portion  73  comprises an engaging lug (not shown) or is formed as an engaging lug, which can hold the reservoir  2  or insert  1  by latching and/or prevent axial movement of the reservoir  2  in the direction away from the stop  72 . 
     The reservoir  2  or insert  1  may also be held solely by a stop  72  and/or without stops, for example, by clamping. 
     The reservoir  2  preferably comprises a valve  9  arranged on the top in the position of use of the inhaler I. The reservoir  2  is thus preferably used upright or is intended for (exclusively) upright use. 
     In the embodiment shown the reservoir  2  comprises an immersion tube  21  through which the medicament preparation  3 , which is arranged in the reservoir  2  and can be immersed in the medicament preparation  3 . By means of the immersion tube  21  the medicament preparation  3  can be forced into the valve  9 , preferably by means of the propellant  4 , particularly propellant gas. 
     The inhaler I may comprise a preferably lever-like actuating element  74 . The actuating element  74  is preferably designed to activate dispensing of the aerosol  29 . The actuating element  74  may at the same time cause an in particular axial movement of the valve element  11  of the valve  9 , by means of which the medicament preparation  3  can be dispensed through the discharge nozzle  28 . 
     In the embodiment shown the actuating element  74  is embodied as an actuating lever. 
     The actuating element  74  may be hinged to one side of the valve  9  or the discharge nozzle  28  and on the other or opposite side of the valve  9  or discharge nozzle  28  it may have an actuating portion  78 . 
     In the embodiment shown, the actuating element  74  comprises a joint  76  by which the actuating element  74  is preferably jointed to the inhaler I or on or in an inhaler housing  77  of the inhaler I. 
     The actuating element  74  is preferably configured so as to embrace the discharge nozzle  28  or the valve element  11 . The actuating element  74  has, in particular, a recess in which the discharge nozzle  28  can be arranged, is arranged in a fork shape around the discharge nozzle  28  or the valve element  11  or is otherwise configured to engage around the discharge nozzle  28  of the valve element  11 . This advantageously makes it possible to actuate the valve  9  symmetrically, as will be described in more detail hereinafter. 
     The actuating element  74  may comprise one or more actuating parts  78  which are configured to move the actuating element  74 , the discharge nozzle  28  or the nozzle body  30  of the nebulizer  26  in the axial direction, in particular. 
     In the embodiment shown, the actuating element  74  comprises two actuating parts  78 . The actuating parts  78  are preferably configured to exert a force on the activating element  32 , the discharge nozzle  28  or the nozzle body  30  in order to move the valve element  11  preferably in the axial direction. In this way the valve  9  can be opened and the medicament preparation  3  dispensed. 
     The actuating element  74  preferably comprises two actuating portions  78 , particularly arranged on opposite sides of the discharge nozzle  28 . The actuating portion or portions  78  may comprise projections or be configured as projections. In the embodiment shown, one of the actuating portions  78  is located behind the section plane and is therefore merely indicated by dashed lines. A second one of the actuating portions  78  is located in front of the section plane and is therefore not shown. 
     The actuating portions  78  are preferably arranged symmetrically to the discharge nozzle  28 , to the valve stem  12  and/or to the channel  31 . In this way it can be ensured that the discharge nozzle  28  does not slope, or slopes only to an insignificant extent, during the actuation process. Advantageously, jamming, wear and other types of malfunction can thus be prevented. 
     The actuating portion  78  or the actuating portions  78  may have a rounded tip or a rounded end which preferably faces or is adjacent to the activating element  32 , the discharge nozzle  28  or the nozzle body  30 . This allows the actuating portion(s)  78  to slide along in a low-friction manner. In this way, reliable operation and a long service life of the inhaler I can be achieved. 
     For operation, the actuating element  74  may be moved on or with the actuating section  75 , particularly in the direction of the inhaler I or the inhaler housing  77 . This movement can be guided by means of the joint  76  and preferably leads to a movement of the actuating portion  78  or actuating portions  78 , which at least includes an axial component. As a result of the movement of the actuating portion  78  or actuating portions  78 , the activating element  32 , the discharge nozzle  28  or the nozzle body  30  may preferably be moved axially, thus enabling the valve  9  to be opened. Theoretically, however, other solutions are also possible for the actuation. 
     In an alternative embodiment which is not shown here, the actuating element may comprise a wedge or a slide or be otherwise configured so that on activation it can preferably move the activating element  32 , the discharge nozzle  28  or the nozzle body  30  axially, so as to enable the valve  9  to be opened. 
     In other alternatives, electrical or electromechanical opening methods are possible. For example, a solenoid may be provided which is able to activate the dispensing of 
     medicament preparation  3 . In such solutions there is no need for the provision of an (axially) movable valve element  9 , an (axially) movable activating element  32 , an (axially) movable discharge nozzle  28  and/or an (axially) movable nozzle body  30 . 
     The chamber  2  for holding and temporarily storing aerosol  29  preferably comprises an inlet opening  79  through which air L can enter. 
     The discharge openings  52  are preferably arranged in the chamber  67 . The aerosol  29  may in this way be formed directly in the chamber  67 . Alternatively, the discharge openings  52  may be arranged in front of the inlet opening  79 . In this case, it is preferable if the aerosol  29  can enter the chamber  67  through the inlet opening  79 . 
     The inlet opening  79  may comprise an inhalation valve  80 . The inhalation valve  80  is preferably embodied as a non-return valve. The inhalation valve  80  may be biased into the closed position or be self-closing in some other way. 
     The inhalation valve  80  can be opened to the atmosphere by negative pressure in the chamber  67 , as a result of which air L is able to flow into or towards the chamber  67 . 
     During an exhalation process in the direction of the chamber  67 , an excess pressure may be produced in the chamber  67 . When there is excess pressure in the chamber  67  the inhalation valve  80  preferably closes automatically. This at least prevents excess contamination of the chamber  67  with secretions or the like. Also, it ensures that aerosol  29  temporarily stored in the chamber  67  is not blown out through the inlet opening  79 . This ensures reliable and accurate dosing. 
     The chamber  67  preferably comprises a dispensing opening O in the region of the adapter  68  for the respiratory orifice  69 . Aerosol  29  can be dispensed through the dispensing opening O. At the same time, to equalize the pressure, air  85  can flow through the inlet opening  79  into the chamber  67 . 
     It is preferable if the dispensing opening O is laterally offset relative to the discharge nozzle  28  or the inlet opening  79  and/or is provided laterally of the chamber  67 . This advantageously provides a continuous transition to the respiratory orifice  69 , particularly in horses P or other large animals. 
     It is preferable if the central axis  11  of the reservoir  2  or the insert  1  or the direction of inflow of air L is skewed in relation to a direction of dispensing R through the dispensing opening O. 
     In the embodiment according to  FIG. 28  the direction of discharge A of the discharge nozzle  28  or for the aerosol  29  is inclined relative to a central axis M of the reservoir  2  or of the insert. In particular, the direction of discharge A and/or a straight line running through the dispensing opening R and the nozzle element  53  or the discharge nozzle  28  encloses with the central axis M and/or a dispensing angle W which is greater than 5°, preferably greater than 10°, particularly greater than 15° and/or less than 50°, preferably less than 45° or 1°, particularly less than 35°. This results in an increased free length of travel for the aerosol  29 , thus decreasing the probability of aerosol ingredients or medicament preparation  3  being deposited on the walls of the chamber  67 . This leads to improved and more accurate dosage. 
       FIG. 29  shows the proposed inhaler I without the insert  1 . 
     The inhaler  1  preferably comprises a holder  81  into which the reservoir  2  or the insert  1  can be inserted. Particularly preferably, the insert  1  or the reservoir  2  can be inserted, particularly pushed, into the holder  81  axially and/or with the nebulizer  26  or the discharge nozzle  28  at the front. 
     It is preferable if the insert  1  can only be inserted in the holder  81  in a specific direction, enabling the aerosol to be dispensed in or through the chamber  67 . 
     It is preferable if the insert  1  or the nebulizer  26  can only be inserted into the holder  81  in a specific rotary position. This ensures that the direction of discharge A corresponds to the shape of the chamber  67 . Alternatively or additionally, determining a rotary position of the insert  1  or the nebulizer  26  makes it possible to obtain a defined alignment of the window  35  for the counter  34 . This ensures that the counter window  71  and the window  35  of the counter  34  are congruent or otherwise correspond to one another, so that the counter  34  is visible or readable. 
     The holder  81  preferably comprises an orientation and/or release portion  82 . 
     The orientation and/or release portion  82  may be configured so as to fix the orientation, particularly rotary orientation, of the insert  1  in the inhaler I and/or to enable activation of the dispensing of the medicament preparation  3 . 
     The orientation and/or release portion  82  is particularly configured to correspond to the orientation device of the insert  1 , particularly to the orientation recess  51 . Particularly preferably, the orientation and/or release portion  82  is arranged and configured to be complementary to the orientation device, particularly to the orientation recess  51 . 
     The insert  1  can preferably only be fully inserted into the holder  81  of the inhaler I, or the position of use of the insert  1  can only be achieved, when the orientation and/or release portion  82  is in alignment with the orientation recess  51  or when the orientation and/or release portion  82  is arranged directly opposite the orientation recess  51 . In this case, the orientation and/or release portion  82  can be inserted into the orientation recess  51 , thus enabling the insert  1  to reach a position of use in the holder  81 . 
     The orientation and/or release portion  82  may alternatively or additionally be used to release the dispensing of the medicament preparation  3 . The orientation and/or release portion  82  may for this purpose act on the blocking device  44  of the insert  1  and thereby remove a blocking arrangement preventing, in particular, axial movement of the activating element  32 , the nozzle body  30 , the discharge nozzle  28  and/or the valve element  11 . In this way the orientation and/or release portion  82  can allow the formation of aerosol. 
     When the insert  1  is inserted into the holder  81  the orientation and/or release portion  82  may both determine an orientation of the insert  1  in the holder  81  and also cause release of the aerosol production. For this purpose the orientation and/or release portion may be capable of being inserted or pushed into the orientation recess  51  only in the intended orientation or rotary orientation, thus releasing the blocking device  44 . However, it is also possible for the orientation and/or release portion  82  simply to determine the orientation or release the dispensing of the medicament preparation  3 . 
     The inhaler I, particularly the holder  81 , may comprise an orientation section  83 . Preferably, the orientation section  83  has a guide, a groove, a notch or other structure, which corresponds to the orientation projection  50  or other orientation device of the insert  1 . In this way, the rotary position of the insert in the inhaler I or in the holder  81  can be fixed. 
     In the embodiment shown in  FIG. 28  the insert  1  is inserted in oriented manner into the holder  81 , with the orientation projection  50  engaging in the orientation section  83  and/or the orientation and/or release portion  82  engaging in the orientation recess  51  and thus particularly preferably acting on the blocking device  44  so that the aerosol formation can be initiated. 
     The orientation and/or release portion  82  and the orientation projection  50  or the orientation section  83  and the orientation recess  51  preferably correspond to one another, preferably so that the insert  1  or the nebulizer  26  can only be inserted into the holder  81  or reach its position of use in a particular rotary position. Theoretically, however, two or more specific rotary positions may be made possible or permitted. 
     The orientation and/or release portion  82  may be formed within the holder  81  and/or by a projection on the stop  72 . This ensures that an insert  1  that is twisted or otherwise wrongly oriented or a twisted or wrongly oriented nebulizer  26  cannot be inserted fully into the holder  81  or up to the stop  72 . This ensures that the (rotary) orientation of the insert  1  or the nebulizer  26  in the holder  81  corresponds to an intended (rotary) orientation. 
     Preferably, the retaining portion  73  is configured such that it only holds or retains the reservoir  2  or the insert  1 , and in particular the flap can only be closed and/or locked, when the insert  1  or the nebulizer  26  is inserted into the holder  81  completely or in oriented manner. This prevents the dispensing of the medicament preparation  3  from being initiated when the nebulizer  26  is inserted incompletely and/or in the incorrect orientation or when the insert  1  is inserted incompletely and/or in the incorrect orientation. 
     During the insertion of the insert  1  or the nebulizer  26  the orientation and/or release portion  82  may exert a force F on the blocking device  44 , particularly only when the insert  1  is inserted in an intended rotary position. As a result, the blocking device  44  may be bent, deformed or otherwise acted upon to permit the dispensing of the medicament preparation  3  to be initiated. 
     In particular, the orientation and/or release portion  82 , particularly as described in conjunction with  FIG. 11 , may release an axial movement of the activating element  32 , the nozzle body  30  and/or the discharge nozzle  28 . The release can enable an axial movement, in particular, of the valve element  11  or actuation of the valve  9 . The actuating element  74  may be used for this purpose. 
     Other forms of blocking devices  44  and corresponding release portions are also possible. For example, a locking bolt or rod may be provided as a blocking device  44  and the orientation and/or release portion  82  or some other release portion may remove a blocking arrangement caused by the locking bolt or rod and release the dispensing of the medicament preparation  3 . 
     In the embodiment in  FIG. 29  the holder  81  is formed in a handle  84  of the inhaler I. In this way it is possible to obtain a compact inhaler I with a robust handle  84 , while the handle  84  protects the insert  1  and enables it to be operated even when wearing gloves. 
     For activating the dispensing of the medicament preparation  3  or for actuating the valve  9 , the actuating element  74  may be hinged to the handle  84 . This enables the opening of the valve  9  and dispensing of the medicament preparation as an aerosol to be carried out particularly with the actuating portion(s)  78 . However, other alternative embodiments are also possible. 
     The proposed inhaler I may also be produced separately or without the insert  1  and constitute an independent aspect of the invention.