qanastek/EMEA-V3 huggingface dataset:
Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.
Proċeduri u eżaminazzjonijiet minn barra, li jikkawżaw ftit uġiġħ jew uġiġħ moderat fejn ikun hemm bżonn li trażżan, traqqad u sserraħ mill- uġiġħ fil- klieb u qtates.
Premedication in cats before induction and maintenance of general anaesthesia with ketamine.
Premedikazzjoni fil- qtates fil- bidu u waqt anestesija ġenerali bil- ketamina.
Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.
Rqad fil- fond u serħan mill- uġiġħ fil- klieb meta jintuża flimkien ma ’ butorfanol għal proċeduri mediċi u proċeduri kirurġiċi żgħar.
Premedication in dogs before induction and maintenance of general anaesthesia.
Premedikazzjoni fil- klieb fil- bidu u waqt anestesija ġenerali bil- ketamina.
Do not use in puppies below 6 months of age or in kittens below 5 months of age.
Tużax fi ġriewi ta ’ anqas minn sitt xhur u fi friegħ ta ’ qtates ta ’ anqas minn 5 xhur.
Do not use in animals with cardiovascular disorders.
Tużax f’ annimali bi problemi tal- qalb.
Do not use in animals with severe systemic disease or in animals that are moribund.
Tużax f’ annimali li għandhom mard sistemiku gravi jew f’ annimali li waslu biex imutu.
Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
Tużax f’ każi fejn hu magħruf li hemm allerġija għas- sustanza attiva jew għal xi wieħed mill - ingredjenti.
4.4 Special warnings for each target species
4. 4 Twissijiet speċjali < għal kull speċi li għaliha hu indikat il- prodott >
The safety of dexmedetomidine has not been established in males intended for breeding.
Il- ħarsien tas- saħħa ta ’ dexmedetomidine f’ annimali irġiel miżmuma għat- tnissil, ma ġiex stabbilit.
In cats, corneal opacities may occur during sedation.
Jista ’ jkun hemm ċpar fil- kornea tal- qtates waqt li traqqad.
The eyes should be protected by a suitable eye lubricant.
L- għajnejn għandhom jiġu protetti b’ żejt apposta. a
Treated animals should be kept warm and at a constant temperature, both during the procedure and recovery.
Annimali li qed jiġu ttrattati għandhom jinżammu sħan u f’ temperatura kostanti kemm waqt il - proċedura kif ukoll waqt li jkunu qed jirpiljaw.
The eyes should be protected by a suitable lubricant.
L- għajnejn għandhom jiġu protetti b’ żejt apposta.
To be used with precaution in elderly animals.
Għandu jintuża b’ kawtela f’ annimali xjuħ.
Nervous, aggressive or excited animals should be given the possibility to calm down before initiation of treatment.
Annimali nervużi, aggressivi jew eċċitati għandhom jingħataw il- possibilita li jikkalmaw qabel jinbeda t- trattament.
Frequent and regular monitoring of respiratory and cardiac function should be performed.
Il- funzjoni tan- nifs u tal- qalb għandha tiġi ċċekkjata ta ’ spiss u b’ mod regolari.
Pulse oximetry may be useful but is not essential for adequate monitoring.
Jista ’ jkun ta ’ għajnuna li tkejjel il- livell ta ’ ossiġnu fid- demm minn fejn il- polz, iżda dan mhuwiex meħtieġ biex ikun hemm iċċekkjar xieraq.
Equipment for manual ventilation should be available in case of respiratory depression or apnoea when dexmedetomidine and ketamine are used sequentially to induce anaesthesia in cats.
Għandu jkun hemm apparat li jagħti l- arja bl- idejn f’ każ li jkun hemm nuqqas jew qtugħ ta ’ nifs fil- qtates meta dexmedetomidine u ketamina jintużaw wara xulxin biex tinbeda l- anestesija.
It is also advisable to have oxygen readily available, should hypoxaemia be detected or suspected.
Tajjeb li jkun hemm ukoll ossiġnu għal- lest jekk wieħed jinduna jew jissuspetta nuqqas ta ’ ossiġnu fid- demm.
Sick and debilitated dogs and cats should only be premedicated with dexmedetomidine before induction and maintenance of general anaesthesia based on a risk-benefit assessment.
Premedikazzjoni b’ dexmedetomidine, fil- bidu u waqt l- anestesija ġenerali, fuq klieb u qtates morda u debboli, għandha issir biss skond il- valutazzjoni tal- benefiċċju u r- riskju.
Use of dexmedetomidine as a premedicant in dogs significantly reduces the amount of induction drug required for induction of anaesthesia.
L- użu ta ’ dexmedetomidine bħala premedikazzjoni fil- klieb, inaqqas b’ mod sostanzjali l- ammont ta ’ mediċina li hemm bżonn biex tibda l- anestesija.
Attention should be given during the administration of intravenous induction drugs to effect.
Għandha tingħata attenzjoni fuq l- effett waqt l- użu ta ’ mediċini għal bidu ta ’ l- anestesija li jingħataw bil- vina.
Volatile anaesthetic requirements for maintenance anaesthesia are also reduced.
Il- bżonn għal anestetiċi volatili għal waqt l- anestesija, jonqos ukoll.
In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Fil- każ ta ’ teħid mill- ħalq jew ta ’ injezzjoni fuqek stess aċċidentali, fittex parir mediku minnufih u uri l- fuljett ta ’ tagħrif li hemm fil- pakkett lit- tabib.
Avoid skin, eye or mucosal contact; the use of impermeable gloves is advisable.
Evita l- kuntatt mal- ġilda, ma ’ l- għajnejn jew mal- membrani mukużi; huwa rrakkomandat l- użu ta ’ ingwanti impermeabbli.
In case of skin or mucosal contact, wash the exposed skin immediately after exposure with large amounts of water and remove contaminated clothes that are in direct contact with skin.
Fil- każ ta ’ kuntatt mal- ġilda jew mal- membrani mukużi, laħlaħ b’ ħafna ilma l- ġilda esposta minnufih wara l- espożizzjoni, u neħħi l- ħwejjeġ ikkontaminati li huma f’ kuntatt dirett mal- ġilda.
In case of eye contact, rinse abundantly with fresh water.
Fil- każ ta ’ kuntatt ma ’ l- għajnejn, laħlaħ b’ ħafna il- ma frisk.
If symptoms occur, seek the advice of a physician.
Jekk ikun hemm xi sintomi, fittex il- parir ta ’ tabib.
If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.
Dan minħabba li jistgħu jseħħu kontrazzjonijiet ta ’ l- utru kif ukoll tnaqqis fil- pressjoni tad- demm tal - fetu wara espożizzjoni aċċidentali.
Advice to doctors:
Parir lit- tobba:
Dexdomitor is an α 2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Dexdomitor huwa α2- adrenoreceptor agonist, sintomi wara assorbiment jistgħu jinvolvu effetti kliniċi inkluż sedazzjoni dipendenti fuq id- doża, dipressjoni respiratorja, bradikardja, pressjoni għolja b’ mod anormali, ħalq xott, u ipergliċemija.
Ventricular arrhythmias have also been reported.
Ġiet irrapportata wkoll arrhythmias ventrikolari.
The specific α 2 – adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.
Sintomi respiratorji u emodinamiċi għandhom jiġu ttrattati b’ mod sintomatiku L - antagonist α2– adrenoceptor speċifiku, atipamezole, li huwa approvat għall- użu f’ annimali żgħar, intuża fin- nies biex jantagonizza l- effetti ta ’ dexmedetomidine, b’ mod sperimentali biss.
Persons with known hypersensitivity to the active substance or any of the excipients should administer the product with caution.
Persuni fejn hu magħruf li għandhom sensittività għas- sustanza attiva jew għal xi wieħed mill - ingredjenti, għandhom jamministraw il- prodott bil- għaqal.
By virtue of its α 2-adrenergic activity, dexmedetomidine causes a decrease in heart rate and body temperature.
Minħabba li dexmedetomidine għandu attivita α2- adrenerġika, din twassal għal tnaqqis fir- rata ta ’ taħbit tal- qalb u tnaqqis tat- temperatura tal- ġisem.
Blood pressure will increase initially and then return to normal or below normal.
Il- pressjoni tad- demm titla ’ fil- bidu, u wara tinżel għan- normal jew taħt in- normal.
In some dogs and cats, a decrease in respiratory rate may occur.
F’ xi klieb u qtates, jista ’ jkun hemm tnaqqis fir- rata tan- nifs.
Due to peripheral vasoconstriction and venous desaturation in the presence of normal arterial oxygenation, the mucous membranes may appear pale and/ or with a blue tinge.
Billi jkun hemm vasokostrizzjoni periferali u nuqqas ta ’ saturazzjoni fil- vini fil- presenza ta ’ ossiġinazzjoni normali fl- arterji, il - membrani mukożi jistgħu jidhru ċari u/ jew ta ’ lewn ikħal.
Rare instances of pulmonary oedema have been reported.
Ġew irrapportati każijiet rari ta ’ edema pulmonari.
Vomiting may occur 5-10 minutes after injection.
Jista ’ jkun hemm remettar 5- 10 minuti wara l- injezzjoni.
Some dogs and cats may also vomit at the time of recovery.
Xi klieb u qtates jistgħu ukoll jirremettu hekk kif jirpiljaw.
Muscle tremors may occur during sedation.
Jista ’ jkun hemm rogħda fil- muskoli waqt li traqqad.
Corneal opacities may occur during sedation (see also section 4.5).
Jista ’ jkun hemm ċpar fil- kornea waqt li traqqad (ara ukoll sezzjoni 4. 5).
When dexmedetomidine and ketamine are used sequentially, with a 10 minute interval, cats may occasionally experience AV-block or extrasystole.
Meta dexmedetomidine u ketamina jintużaw wara xulxin b’ intervall ta ’ 10 minuti, xi drabi l- qtates jista ’ jkollhom AV- block jew taħbit tal- qalb barra minn ħinu.
Expected respiratory events are bradypnoea, intermittent respiratory patterns, hypoventilation, and apnoea.
Effetti respiratorji li wieħed jistenna huma li tieħu n- nifs bil- mod, xejra respiratorja li tiġi u tmur, nuqqas ta ’ arja fil- pulmun u qtugħ ta ’ nifs.
In clinical trials the incidence of hypoxaemia was common, especially within the 15 first minutes into dexmedetomidine-ketamine anaesthesia.
Fi studji kliniċi kienu ta ’ spiss il- każi ta ’ nuqqas ta ’ ossiġnu fid- demm b’ mod speċjali fl- ewwel 15- il minuta ta ’ anestesija b’ dexmedetomidine u ketamina.
Vomiting, hypothermia and nervousness have been reported after such use.
Meta intuża b’ dan il- mod, ġew irrapportati każi ta ’ remettar, temperatura baxxa u nervożiżmu.
When dexmedetomidine and butorphanol are used concomitantly in dogs, bradypnoea, tachypnoea, an irregular respiratory pattern (20-30 sec apnoea followed by several rapid breaths), hypoxaemia, muscle twitch or tremor or paddling, excitation, hypersalivation, retching, vomiting, urination, skin erythema, a sudden arousal, or prolonged sedation may occur.
Meta dexmedetomidine u butarfanol jintużaw flimkien fil- klieb, jista ’ jkun hemm nifs bil- mod jew mgħaġġel, xejra respiratorja irregolari (20- 30 sekonda qtugħ ta ’ nifs, segwiti minn ħafna nifsijiet mgħaġġla), nuqqas ta ’ ossiġnu fid- demm, ġibda jew rogħda fil- muskoli, qdif bir- riġlejn, eċċitament, produzzjoni għolja ta ’ bżieq, tqalligħ, remettar, tluq ta ’ l- urina, eritima tal- ġilda, tistembaħ f’ daqqa jew irqad fit- tul.
Brady- and tachyarrhythmias have been reported.
Taħbit tal- qalb bil- mod jew mgħaġġel ġew irrapportati.
These may include profound sinus bradycardia, 1st and 2nd degree AV block, sinus arrest or pause, as well as atrial, supraventricular and ventricular premature complexes.
Dawn jistgħu jinkludu sinus bradycardia fil- fond, AV block ta ’ l- ewwel u ta ’ t- tieni grad, pawsa jew waqfien tas- sinus kif ukoll kumplessi prematuri atrijali, supraventrikulari u ventrikulari.
When dexmedetomidine is used as a premedicant in dogs bradypnoea, tachypnoea and vomiting may occur.
Meta dexmedetomidine jintuża bħala premedikazzjoni fil- klieb, jista ’ jkun hemm nifs bil- mod jew mgħaġġel.
Brady- and tachyarrhythmias have been reported and include profound sinus bradycardia, 1st and 2nd degree AV block and sinus arrest.
Taħbit tal- qalb bil- mod jew mgħaġġel ġew irrapportati u jinkludu sinus bradycardia fil - fond, AV block ta ’ l- ewwel u ta ’ t- tieni grad u waqfien tas- sinus.
Supraventricular and ventricular premature complexes, sinus pause and 3rd degree AV block may be observed in rare cases.
F’ każi rari jistgħu jidhru kumplessi prematuri supraventrikulari u ventrikulari, pawsa tas- sinus u AV block tat- tielet grad.
The safety of dexmedetomidine has not been established during pregnancy and lactation in the target species.
Il- ħarsien tas- saħħa ta ’ dexmedetomidine ma ġiex stabbilit waqt it- tqala u fi żmien il- ħalib fl- ispeċi li fuqhom għandu jintuża il- prodott.
Therefore the use of the product during pregnancy and lactation is not recommended.
Għalhekk l- użu tal- prodott mhuwiex rakkomandat fit- tqala u fi żmien il- ħalib.
The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made.
L- użu ta ’ sustanzi oħra li jnaqqsu l- effetti tas- sistema ċentrali nervuża hu mistenni li jsaħħaħ l- effetti ta ’ dexmedetomidine u għalhekk għandu jsir tibdil xieraq fid- doża. dexmedetomidine għandhom jintużaw bil- għaqal.
Anticholinergics should be used with caution with dexmedetomidine.
Antikolinerġiċi ma ’
Administration of atipamezole after dexmedetomidine rapidly reverses the effects and thus shortens the recovery period.
L- użu ta ’ atipamezole wara dexmedetomidine, malajr ireġġa ’ lura l- effetti u b’ hekk
Within 15 minutes dogs are normally awake and standing.
Normalment il- klieb ikunu mqajma u fuq saqajhom fi żmien 15- il minuta.
Cats:
4 Qtates:
After administration of 40 micrograms dexmedetomidine/ kg bw intramuscularly concurrently with 5 mg ketamine/ kg bw to cats, the maximum concentration of dexmedetomidine increased twofold but there was no effect on T max.
Wara amministrazzjoni ta ’ 40 mikrogrammi dexmedetomidine / kg piż fil- muskolu flimkien ma ’ 5 mg ketamina / kg piż fil- qtates, l- ogħla konċentrazzjoni ta ’ dexmedetomidine żdiedet b’ darbtejn imma ma kienx hemm effett fuq Tmax.
The mean half-life of elimination of dexmedetomidine increased to 1.6 h and the total exposure (AUC) increased by 50%.
Il- medja tal- half life ta ’ eliminazzjoni ta ’ dexmedetomidine żdiedet għal 1. 6 siegħat u l- ammont totali (AUC) żdied b’ 50%.
4 A dose of 10 mg ketamine/ kg used concurrently with 40 micrograms dexmedetomidine/ kg may cause tachycardia.
Doża ta ’ 10 mg ketamina / kg flimkien ma ’ 40 mikrogrammi dexmedetomidine / kg tista ’ twassal biex il- qalb tħabbat b’ rata mgħaġġla.
For information on adverse reactions, see section 4.6. Adverse reactions.
Għal tagħrif fuq effetti mhux mixtieqa, ara sezzjoni 4. 6 Effetti mhux mixtieqa.
For information on target animal safety in cases of overdosing, see section 4.10. Overdose
Għal tagħrif fuq ħarsien tas- saħħa ta ’ annimali li fuqhom għandu jintuża, f’ każ ta ’ doża eċċessiva, ara sezzjoni 4. 10 Doża eċċessiva.
The product is intended for:
Il- prodott huwa ntenzjonat għal:
- Dogs: intravenous or intramuscular use
- Klieb: injezzjoni fil- vina jew fil- muskolu
- Cats: intramuscular use
- Qtates: injezzjoni fil- muskolu
The product is not intended for repeat injections.
Il- prodott mhuwiex maħsub għal injezzjonijiet ripetuti.
Dexdomitor, butorphanol and/ or ketamine can be mixed in the same syringe as they have been shown to be pharmaceutically compatible.
Dexdomitor, butorphanol u/ jew ketamine jistgħu jitħalltu fl- istess siringa minħabba li ntwerew li huma farmakoloġikament kompatibbli.
Dosage: the following doses are recommended:
Doża: id- dożi rakkomandati huma kif ġej:
DOGS:
KLIEB:
The doses for dogs are based on body surface area.
Id- dożi għall- klieb huma maħduma fuq il- wisgħa tal- wiċċ tal- ġisem.
The intravenous dose is 375 micrograms/ square metre body surface area and the intramuscular dose is 500 micrograms/ square metre body surface area when dexmedetomidine is used as the only agent for sedation and analgesia.
Id- doża fil- vina hija ta ’ 375 mikrogrammi/ metru kwadru tal- wiċċ tal- ġisem u d- doża fil- muskolu hija ta ’ 500 mikrogrammi/ metru kwadru tal- wiċċ tal- ġisem meta dexmedetomidine jintuża waħdu biex iraqqad u jsserraħ mill- uġiġħ.
When administering in conjunction with butorphanol (0.1 mg/ kg) for deep sedation and analgesia, the intramuscular dose is 300 micrograms/ square metre body surface area The premedication dose of dexmedetomidine is 125 – 375 micrograms/ square metre body surface area, administered 20 minutes prior to induction for procedures requiring anaesthesia.
Id- doża ta ’ premedikazzjoni ta ’ dexmedetomidine hija ta ’ 125 – 375 mikrogrammi/ metru kwadru tal- wiċċ tal- ġisem, mogħtija 20 minuta qabel jinbdew proċeduri li jeħtieġu l- anestesija.
The dose should be adjusted to the type of surgery, length of procedure and patient temperament.
Id- doża għandha tkun aġġustata skond it- tip ta ’ kirurġija, it- tul tal- proċedura u t- temperament tal- pazjent.
Concomitant use of dexmedetomidine and butorphanol produces sedative and analgesic effects beginning no later than 15 minutes.
L- użu ta ’ dexmedetomidine u butorfanol flimkien iwassal għal irqad u serħan mill- uġiġħ li jibdew mhux aktar tard minn 15- il minuta.
The peak sedative and analgesic effects are reached within 30 minutes after administration.
L- ogħla effett ta ’ rqad u serħan mill- uġiġħ jintlaħaq fi żmien 30 minuta mill- amministrazzjoni.
Sedation lasts for at least 120 minutes post administration and analgesia lasts for at least 90 minutes.
L- irqad idum mill- anqas 120 minuta wara l- amministrazzjoni u s - serħan mill- uġiġħ idum mill- anqas 90 minuta.
Spontaneous recovery occurs within 3 hours.
L- annimal jirpilja minn jeddu fi żmien 3 siegħat.
Premedication with dexmedetomidine will significantly reduce the dosage of the induction agent required and will reduce volatile anaesthetic requirements for maintenance anaesthesia.
L- użu ta ’ dexmedetomidine bħala premedikazzjoni, inaqqas b’ mod sostanzjali id- doża ta ’ mediċina li hemm bżonn biex tibda l- anestesija u jnaqqas l- anestetiċi volatili għal waqt l- anestesija.
In a clinical study, the requirement for propofol and thiopental was reduced by 30% and 60% respectively.
Fi studju kliniku, il- bżonn ta ’ propofol u thiopental tnaqqas b’ 30% u 60% rispettivament.
All anaesthetic agents used for induction or maintenance of anaesthesia should be administered to effect.
Il- mediċini kollha għal bidu u waqt ta ’ l- anestesija għandhom jingħataw skond l- effett milħuq.
In a clinical study, dexmedetomidine contributed to postoperative analgesia for 0.5 – 4 hours.
Fi studju kliniku dexmedetomidine wassal għal serħan mill- uġiġħ għal 0. 5 – 4 siegħat.
However this duration is dependent on a number of variables and further analgesia should be administered in accordance with clinical judgement.
Imma dan it- tul ta ’ żmien jiddependi minn numru to ’ fatturi varjabbli u aktar serħan mill- uġigħ għandu jingħata skond il - ġudizzju kliniku.
The corresponding doses based on body weight are presented in the following tables.
Id- dożi li jikkorrispondu, bbażati fuq il- piż, jidhru fit- tabelli kif ġej.
Use of an appropriately graduated syringe is recommended to ensure accurate dosing when administering small volumes.
Huwa rakkomandat l- użu ta ’ siringa xierqa biex ikun żgurat li volumi żgħar jitkejjlu sew.
5 Dogs Single-use sedation and analgesia
5 Klieb Doża ta ’ darba biex traqqad u sserraħ mill- uġigħ
Dexmedetomidine
Dexmedetomidine
375 mcg/ m2 intravenously
375 mcg/ m2 fil- vina
500 mcg/ m2 intramuscularly
500 mcg/ m2 fil- muskolu
For deep sedation and
Għal irqad fil- fond u
For premedication prior to general anaesthesia
Għal premedikazzjoni qabel anestesija ġenerali
analgesia with butorphanol
ħelsien mill- uġigħ mal - butorphanol
Dexmedetomidine Dexmedetomidine
Dexmedetomidine Dexmedetomidine
300 mcg/ m2 125 mcg/ m2 intramuscularly intramuscularly
125 mcg/ m2 fil- muskolu
375 mcg/ m2 intramuscularly
375 mcg/ m2 fil- muskolu
6 CATS:
6 QTATES:
The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/ kg bw equal to a dose volume 0.08 ml Dexdomitor/ kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Id- doża għall- qtates hija ta ’ 40 mikrogrammi dexmedetomidine hydrochloride / kg piż li huma daqs volum ta ’ doża ta ’ 0. 08 ml Dexdomitor / kg piż meta jintuża għal proċeduri u eżaminazzjonijiet minn barra, li jikkawżaw ftit uġiġħ jew uġiġħ moderat fejn ikun hemm bżonn li trażżan, traqqad u sserraħ mill- uġiġħ.
When dexmedetomidine is used for premedication in cats, the same dose is used.
Meta dexmedetomidine jintuża għal premedikazzjoni fil- qtates, tintuża l- istess doża.
Anaesthesia can be induced 10 minutes after premedication by intramuscular administration of a target dose of 5 mg ketamine/ kg bw.
L - anestesija tista ’ tinbeda 10 minuta wara l- premedikazzjoni b’ doża ta ’ 5 mg ketamina / kg piż fil - muskolu.
Dosing for cats is presented in the following table.
Id- dożi għall- qtates jidhru fit- tabella kif ġej.
Cats For single-use sedation and analgesia or for premedication
Doża ta ’ darba biex traqqad u sserraħ mill- uġigħ jew għal premedikazzjoni
Dexmedetomidine 40 mcg/ kg intramuscularly
Dexmedetomidine 40 mcg/ kg fil- vina
It is recommended that animals are fasted for 12 hours prior to administration.
Huwa rakkomandat li l- annimali jkunu sajma għal 12- il siegħa qabel l- amministrazzjoni.
Water may be given ad libitum.
Ilma jista ’ jingħata ad libitum.
In cases of overdosage, or if the effects of dexmedetomidine become potentially life- threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area).
F’ każi ta ’ doża eċċessiva, jew fejn l- effetti ta ’ dexmedetomidine jistgħu ikunu ta ’ theddida għal ħajja, id- doża xierqa ta ’ atipamezole hija 10 darbiet aktar mid- doża inizjali ta ’ dexmedetomidine (mikrogrammi / kg piż jew mikrogrammi / metru kwadru tal- wiċċ tal- ġisem).
The dose volume of atipamezole at the concentration of 5 mg/ ml equals the dose volume of Dexdomitor that was given to the dog, regardless of route of administration of Dexdomitor.
Il- volum ta ’ doża ta ’ atipamezole b’ konċentrazzjoni ta ’ 5 mg/ ml huwa daqs il- volum ta ’ doża ta ’ Dexdomitor li ingħata lill - kelb, ikun xi jkun il- mod ta ’ amministrazzjoni ta ’ Dexdomitor.
In cases of overdosage, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose:
F’ każi ta ’ doża eċċessiva, jew fejn l- effetti ta ’ dexmedetomidine jistgħu ikunu ta ’ theddida għal ħajja, l- antagonista xieraq huwa atipamezole, amministrat b’ injezzjoni fil- muskolu bid- doża kif ġej:
5 times the initial dose dexmedetomidine in micrograms/ kg bw.
5 darbiet aktar mid- doża inizjali ta ’ dexmedetomidine f’ mikrogrammi/ kg piż.
After concurrent exposure to a triple (3X) overdose of dexmedetomidine and 15 mg ketamine/ kg, atipamezole can be administered at the recommended dose level for reversal of effects induced by dexmedetomidine.
Wara li tingħata doża eċċessiva ta ’ dexmedetomidine bi tlett darbiet (3X), flimkien ma ’ 15 mg ketamina / kg, atimpamezole jista ’ tingħata fil- livell ta ’ doża rakkomandat biex treġġa ’ lura l- effetti ta ’ dexmedetomidine.
At high serum concentrations of dexmedetomidine sedation is not increased although the level of analgesia does increase with further dose increases.
B’ konċentrazzjonijiet għoljin ta ’ dexmedetomidine fid- demm, l- irqad ma jiżdiedx għalkemm il- livell ta ’ serħan mill- uġiġħ jiżdied hekk kif tiżdied id- doża.
Pharmacotherapeutic group: psycholeptic, ATCvet code:
Grupp Farmako- terapewtiku: psikoleptiku, Kodiċi ATC veterinarja:
7 5.1 Pharmacodynamic properties
7 5. 1 Kwalitajiet Farmakodinamiċi
Dexdomitor contains dexmedetomidine as the active substance, which produces sedation and analgesia in dogs and cats.
Dexdomitor fih dexmedetomidine bħala sustanza attiva, li traqqad u sserraħ mill- uġiġħ fil- klieb u l - qtates.
The duration and depth of the sedation and analgesia are dose-dependent.
It- tul u l- qawwa ta ’ l- irqad u serħan mill- uġiġħ jiddependu fuq id- doża.
At maximal effect, the animal is relaxed, recumbent and does not respond to external stimulus.
Meta l- effett ikun fl - aqwa tiegħu, l- annimal ikun kalm, mimdud u ma jirrispondix għal stimolu estern.
Dexmedetomidine is a potent and selective α 2-adrenoceptor agonist that inhibits the release of noradrenaline from noradrenergic neurons.
Dexmedetomidine huwa α2- adrenoceptor agonist qawwi u selettiv li jimblokka l- ħruġ ta ’ noradrenalina minn newroni noradrenerġiċi.
Sympathetic neurotransmission is prevented and the level of consciousness decreases.
In- newrotrasmissjoni simpatetika ma titħalliex issir u l - livell ta ’ sensazzjoni jonqos.
Reduced heart rate and temporary AV-block can be seen after administration of dexmedetomidine.
Tnaqqis fir- rata ta ’ taħbit tal- qalb u AV- block temporanju jidhru wara amministrazzjoni ta ’ dexmedetomidine.
Blood pressure decreases to normal or below normal levels after an initial increase.
Il- pressjoni tad- demm, wara li togħla fil- bidu, tinżel għan - normal jew taħt in- normal.
Respiration rate can occasionally decrease.
Xi drabi r- rata tan- nifs tista ’ titbaxxa.
Dexmedetomidine also induces a number of other α 2-adrenoceptor mediated effects, which include piloerection, depression of motor and secretory functions of the gastrointestinal tract, diuresis and hyperglycaemia.
Dawn jinkludu twaqqif tal- pil, tnaqqis fil - moviment u tnixxijiet tas- sistema gastro- intestinali, żieda fil- produzzjoni ta ’ l- urina u żieda fil- livell ta ’ zokkor fid- demm.
A slight decrease in temperature may be observed.
Jista ’ jkun hemm tnaqqis żgħir fit- temperatura.
As a lipophilic compound, dexmedetomidine is well absorbed after intramuscular administration.
Dexmedetomidine jiġi assorbit sew wara injezzjoni fil- muskolu billi huwa sustanza lipofilika.
Dexmedetomidine is also rapidly distributed in the body and penetrates the blood-brain barrier readily.
Dexmedetomidine jinfirex ukoll malajr mal- ġisem u jgħaddi faċilment mid- demm għal ġol- moħħ.
According to studies in rats, the maximum concentration in the central nervous system is several times that of the corresponding concentration in plasma.
Skond studji li saru fil- firien, l- ogħla konċentrazzjoni fis- sistema ċentrali nervuża hija ħafna aktar għolja milli hi fil- plażma.
In the circulation, dexmedetomidine is largely bound to plasma proteins (> 90%).
Dexmedetomidine jabbina ħafna mal- proteini tal- plażma fiċ- ċirkolazzjoni (> 90%).
After an intramuscular dose of 50 micrograms/ kg a maximum concentration in plasma of about 12 ng/ ml is reached after 0.6 hours.
Wara doża fil- muskolu ta ’ 50 mikrogrammi/ kg, l- ogħla konċentrazzjoni fil- plażma, ta ’ madwar 12 ng/ ml tintlaħaq wara 0. 6 ta ’ siegħa.
The bioavailability of dexmedetomidine is 60% and the apparent volume of distribution (Vd) is 0.9 l/ kg.
Il- bioavilibilita fil- ġisem ta ’ dexmedetomidine hija ta ’ 60% u l- volum ta ’ distribuzzjoni (Vd) jidher li huwa ta ’ 0. 9 l/ kg.
Major biotransformations in the dog include hydroxylation, glucuronic acid conjugation and N-methylation in the liver.
Il- half life ta ’ eliminazzjoni (t½) hija ta ’ 40 - 50 minuta. Bio- trasformazzjonijiet maġġuri fil- kelb jinkludu idrossilazzjoni, konjugazzjoni mal- aċidu glukoroniku u N- methylation fil- fwied.
All known metabolites lack pharmacological activity.
Il- metaboliti kollha magħrufa m’ għandhomx attivita farmakoloġika.
Metabolites are excreted mainly in the urine and to a lesser extent in the faeces.
Il- metaboliti jiġu eliminati l- aktar fl- urina u xi ftit anqas fl- ippurgar.
Dexmedetomidine has a high clearance and its elimination depends on the hepatic blood flow.
Dexmedetomidine għandu clearance għoli u l- eliminazzjoni tiegħu tiddependi fuq kemm jgħaddi demm mil- fwied.
A prolonged elimination half-life is therefore expected with overdoses or when dexmedetomidine is coadministered with other substances, which affect hepatic circulation.
Wieħed jistenna li jkun hemm half life ta ’ eliminazzjoni itwal f’ każi ta ’ dożi eċċessivi jew meta dexmedetomidine jingħata fl- istess ħin ma ’ sustanzi oħra li jaffetwaw iċ - ċirkolazzjoni fil- fwied.
The maximum plasma concentration is reached about 0.24 h after intramuscular administration.
L- ogħla konċentrazzjoni fil- plażma tintlaħaq madwar 0. 24 ta ’ siegħa wara amministrazzjoni fil- muskolu.
After a 40 micrograms/ kg bw intramuscular dose the Cmax is 17 ng/ ml.
Wara doża ta ’ 40 mikrogrammi/ kg piż fil- muskolu, is- Cmax hi ta ’ 17 ng/ ml.
The apparent volume of distribution (Vd) is 2.2 l/ kg and the elimination half-life (t½) is one hour.
Il- volum ta ’ distribuzzjoni (Vd) jidher li huwa ta ’ 2. 2 l/ kg u l- half life ta ’ eliminazzjoni (t½) hija ta ’ siegħa.
Biotransformations in the cat occur by hydroxylation in the liver.
Bio- trasformazzjonijiet fil- qattus isiru permezz ta ’ idrossilazzjoni fil- fwied.
Metabolites are excreted mainly in the urine (51% of the dose), and to a lesser extent in the faeces.
Il- metaboliti jiġu eliminati l- aktar fl- urina (51% tad- doża) u xi ftit anqas fl- ippurgar.
As in dogs dexmedetomidine has a high clearance in cats and its elimination depends on the hepatic blood flow.
Bħal fil- klieb, dexmedetomidine jitneħħa mid- demm malajr fil- qtates u l- eliminazzjoni tiegħu tiddependi fuq kemm jgħaddi demm mil - fwied.
A prolonged elimination half-life is therefore expected with overdoses or when dexmedetomidine is coadministered with other substances, which affect hepatic circulation.
Wieħed jistenna li jkun hemm half life ta ’ eliminazzjoni itwal f’ każi ta ’ dożi eċċessivi jew meta dexmedetomidine jingħata fl- istess ħin ma ’ sustanzi oħra li jaffetwaw iċ- ċirkolazzjoni fil- fwied.
Methyl parahydroxybenzoate (E 218) Propyl parahydroxybenzoate (E 216)
Methyl parahydroxybenzoate (E 218) Propyl parahydroxybenzoate (E 216)
None known.
Ebda inkompatibilità magħrufa.
Dexdomitor is compatible with butorphanol and ketamine in the same syringe at least for two hours.
Dexdomitor huwa kompatibbli ma ’ butorphanol u ma ’ ketamine fl- istess siringa għal mill- inqas sagħtejn.
8 6.3 Shelf life
6. 3 Żmien ta 'kemm il- prodott idum tajjeb
After withdrawal of the first dose, the product may be stored for 28 days at 25ºC.
Wara li tinġibed l- ewwel doża, il- prodott jista ’ jinħażen għal 28 ġurnata f’ 25°C.
Cardboard box with 1 glass (Type I) vial of 10ml with a chlorobutyl or bromobutyl rubber stopper and aluminium cap.
Kaxxa tal- kartun b’ fjala waħda tal- ħġieġ (Tip I) ta ’ 10 ml b’ tapp tal- klorobutil jew tal- bromobutil u għatu tal- aluminjum.
Package size:
Daqs tal- pakkett:
Any unused product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements
Mediċina veterinarja li ma ġietx użata jew materjal żejjed ġej minn dawn il- prodotti veterinarji, għandhom jintremew skond kif jitolbu ħtiġijiet lokali.
13.08.2008
DATA TA ’ META ĠIET RIVEDUTA DIN IL- KITBA
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL - LOTT
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Sid ta 'din l- awtorizzazzjoni tal- kummerċ għandu jagħti tgħarif lill- Kummissjoni Ewropeja dwar il - pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b' din id- deċiżjoni.
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
BOX
KAXXA
One ml contains 0.5 mg dexmedetomidine hydrochloride equivalent to 0.42 mg dexmedetomidine
0. 5 mg dexmedetomidine hydrochloride ekwivalenti għal 0. 42 mg dexmedetomidine f’ kull ml.
Solution for injection.
Soluzzjoni għal injezzjoni
Premedication in cats before induction and maintenance of general anaesthesia with ketamine.
Premedikazzjoni fil- qtates fil- bidu u waqt l- anestesija ġenerali bil- ketamina.
Premedication in dogs before induction and maintenance of general anaesthesia.
Rqad fil- fond u serħan mill- uġiġħ fil- klieb meta jintuża flimkien ma ’ butorfanol għal- proċeduri mediċi u proċeduri kirurġiċi żgħar.
Dogs: intravenous or intramuscular use Cats: intramuscular use Read the package leaflet before use.
Klieb: injezzjoni fil- vina jew fil- muskolu Qtates: injezzjoni fil- muskolu Aqra l- fuljett ta ’ tagħrif qabel tuża.
Do not use in puppies below 6 months of age or in kittens below 5 months of age.
Tużax f’ ġriewi ta ’ anqas minn sitt xhur u fi friegħ tal- qtates ta ’ anqas minn 5 xhur.
EXP: month/ year Shelf life after first opening:
EXP: xahar/ sena
28 days at 25°C.
28 ġurnata f’ 25°C.
Any unused product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew materjal żejjed ġej minn dawn il- prodotti veterinarji, għandhom jintremew skond kif jitolbu ħtiġijiet lokali.
For animal treatment only – to be supplied only on veterinary prescription.
Għat Trattament ta ’ l- Annimali Biss għandu jingħata biss bi preskrizzjoni medika.
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS/ MULTI PACKAGE
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR / PAKKETT MULTIPLU
VIAL/ MULTI PACKAGE
VJALA / PAKKETT MULTIPLU
0.5 mg/ ml Dexmedetomidine hydrochloride
0. 5 mg/ ml dexmedetomidine hydrochloride
Dogs: intravenous or intramuscular use Cats: intramuscular use
Klieb: injezzjoni fil- vina jew fil- muskolu Qtates: injezzjoni fil- muskolu
EXP: month/ year
EXP: xahar/ sena
For animal treatment only.
Għat- trattament ta ’ l- annimali biss.
17 PACKAGE LEAFLET
17 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
List of excipients:
Lista ta ’ ingredjenti:
INDICATION(S)
4 INDIKAZZJONI (JIET)
Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.
Rqad fil- fond u serħan mill- uġiġħ fil- klieb meta jintuża flimkien ma ’ butorfanol għal- proċeduri mediċi u proċeduri kirurġiċi żgħar.
Premedication in dogs before induction and maintenance of general anaesthesia.
Premedikazzjoni fil- klieb fil- bidu u waqt l- anestesija ġenerali
CONTRAINDICATIONS
5 KUNTRADIZZJONIJIET
Do not use in puppies below 6 months of age or in kittens below 5 months of age.
Tużax fi ġriewi ta ’ anqas minn sitt xhur u ff friegħ tal- qtates ta ’ anqas minn 5 xhur.
By virtue of its α 2-adrenergic activity, dexmedetomidine causes decreases in heart rate and body temperature.
Minħabba li dexmedetomidine għandu attivita α2- adrenerġika, din twassal għal tnaqqis fir- rata ta ’ taħbit tal- qalb u tnaqqis tat- temperatura tal- ġisem.
18 In some dogs and cats a decrease in respiratory rate may occur.
F’ xi klieb u qtates, jista ’ jkun hemm tnaqqis fir- rata tan- nifs.
Pulmonary oedema may be observed in rare cases.
F’ xi każijiet, tista ’ tiġi osservata edema pulmonari.
Some dogs and cats may also vomit at the time of recovery.
Xi klieb u qtates jistgħu jirremettu wkoll meta jirpiljaw.
When dexmedetomidine and ketamine are used sequentially, with a 10 minute interval, cats may occasionally experience AV-block or extrasystole.
Meta dexmedetomidine u ketamina jintużaw wara xulxin b’ intervall ta ’ 10 minuti, okkażjonalment il - qtates jista ’ jkollhom AV- block jew taħbit tal- qalb barra minn ħinu.
Vomiting, hypothermia and nervousness have been reported after such use.
Meta ntuża b’ dan il- mod, ġew irrapportati każi ta ’ remettar, temperatura baxxa u nervożiżmu.
When dexmedetomidine and butorphanol are used concomitantly in dogs bradypnoea, tachypnoea, an irregular respiratory pattern (20-30 sec apnoea followed by several rapid breaths), hypoxaemia, muscle twitch or tremor or paddling, excitation, hypersalivation, retching, vomiting, urination, skin erythema, a sudden arousal, or prolonged sedation may occur.
Meta dexmedetomidine u butarfanol jintużaw flimkien fil- klieb, jista ’ jkun hemm nifs bil- mod jew mgħaġġel, xejra respiratorja irregolari (20- 30 sekonda qtugħ ta ’ nifs, segwiti minn ħafna nifsijiet mgħaġġla), nuqqas ta ’ ossiġnu fid- demm, ġibda jew rogħda fil- muskoli, qdif bir- riġlejn, eċċitament, produzzjoni għolja ta ’ bżieq, tqalligħ, remettar, tluq ta ’ l- urina, eritima tal- ġilda, stembieħ f’ daqqa jew irqad fit- tul.
These may include profound sinus bradycardia, 1st and 2nd degree AV block, sinus arrest or pause, as well as atrial, supraventricular and ventricular premature complexes.
Dawn jistgħu jinkludu sinus bradycardia fil- fond, AV block ta ’ l- ewwel u tat- tieni grad, pawsa jew waqfien tas- sinus kif ukoll kumplessi prematuri atrijali, supraventrikulari u ventrikulari.
Supraventricular and ventricular premature complexes, sinus pause and 3rd degree AV block may be observed in rare cases.
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek.
The product is intended for:
Il- prodott għandu jintuża fil -:
Dexdomitor, butorphanol and/ or ketamine can be mixed in the same syringe as they have been shown to be pharmacologically compatible.
Dexdomitor, butorphanol u/ jew ketamine jistgħu jitħalltu fl- istess siringa minħabba li ntwerew li huma farmakoloġikament kompatibbli.
The following doses are recommended:
Doża: id- dożi rakkomandati huma kif ġej:
19 DOGS:
19 KLIEB:
The intravenous dose is 375 micrograms/ square metre body surface area and the intramuscular dose is 500 micrograms/ square metre body surface area when dexmedetomidine is used as the only agent for sedation and analgesia.
Id- doża fil- vina hija ta ’ 375 mikrogrammi/ metru kwadru tal- wiċċ tal- ġisem u d- doża fil- muskola hija ta ’ 500 mikrogrammi/ metru kwadru tal- wiċċ tal- ġisem meta dexmedetomidine jintuża waħdu biex traqqad u sserraħ mill- uġiġħ.
When administering in conjunction with butorphanol (0.1 mg/ kg) for deep sedation and analgesia, the intramuscular dose is 300 micrograms/ square metre body surface area.
Meta tuża flimkien ma ’ butorfanol (0. 1 mg/ kg) għal irqad fil- fond u serħan mill- uġiġħ, id- doża fil - muskolu hija 300 mikrogrammi/ metru kwadru tal- wiċċ tal- ġisem.
The premedication dose of dexmedetomidine is 125 – 375 micrograms/ square metre body surface area, administered 20 minutes prior to induction for procedures requiring anaesthesia.
Id- doża ta ’ premedikazzjoni ta ’ dexmedetomidine hija ta ’ 125 – 375 mikrogrammi/ metru kwadru tal- wiċċ tal- ġisem, mogħtija 20 minuta qabel jinbdew proċeduri li jeħtieġu l- anestesija.
Concomitant use of dexmedetomidine and butorphanol produces sedative and analgesic effects beginning no later than 15 minutes.
L- użu ta ’ dexmedetomidine u butorfanol flimkien iwassal għal irqad u serħan mill- uġiġħ li jibdew f’ mhux aktar tard minn 15- il minuta.
Dogs Single-use sedation and analgesia
Doża ta ’ darba biex traqqad u sserraħ mill- uġigħ
20 Dogs
20 Klieb
For deep sedation and
Għal irqad fil- fond u ħelsien mill- uġigħ mal- butorphanol
300 mcg/ m2 125 mcg/ m2 intramuscularly intramuscularly
125
CATS:
QTATES:
Dexmedetomidine 40 mcg/ kg intramuscularly
Piż Dexmedetomidine 40 mcg/ kg fil- vina (kg) 2- 3 3- 4 4- 6 6- 7 7- 8 8- 10
The expected sedative and analgesic effects are reached within 15 minutes after administration and are maintained up to 60 minutes after administration.
L- effetti mistennija ta ’ rqad u serħan mill- uġiġħ jintlaħqu fi żmien 15- il minuta mill- amministrazzjoni u jibqgħu sa 60 minuta wara l- amministrazzjoni.
It is recommended that animals are fasted for 12 hours prior to administration.
Huwa rakkomandat li l- annimali jkunu msajma għal 12- il siegħa qabel l- amministrazzjoni.
SPECIAL STORAGE PRECAUTIONS
11 PREKAWZJONIJIET SPEĊJALI GĦALL- ĦAŻNA
After withdrawal of the first dose, the product may be stored for 28 days at 25ºC.
Wara li tinġibed l- ewwel doża, il- prodott jista ’ jinħazen għal 28 ġurnata f’ 25°C.
Therefore the use of the product during pregnancy and lactation is not recommended.
Għalhekk l- użu tal- prodott mhuwiex irrakkomandat fit- tqala u fi żmien il- ħalib.
The safety of dexmedetomidine has not been established in males intended for breeding.
Il- ħarsien tas- saħħa ta ’ dexmedetomidine f’ annimali irġiel għat- tnissil, ma ġiex stabbilit.
To be used with precaution in elderly animals.
Għandu jintuża bi prekawzjoni f’ annimali xjuħ.
In cats corneal opacities may occur during sedation.
Jista ’ jkun hemm ċpar fil- kornea tal- qtates waqt li traqqad.
The eyes should be protected by a suitable eye lubricant.
L- għajnejn għandhom jiġu protetti b’ żejt apposta.
The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made.
L- użu ta ’ sustanzi oħra li jnaqqsu l- effetti tas- sistema ċentrali nervuża għandu jsaħħaħ l- effetti ta ’ dexmedetomidine u għalhekk għandu jsir tibdil xieraq fid- doża.
Anticholinergics should be used with caution with dexmedetomidine.
Antikolinerġiċi ma ’ dexmedetomidine għandhom jintużaw bil- għaqal.
After administration of 40 micrograms dexmedetomidine/ kg bw intramuscularly concurrently with 5 mg ketamine / kg bw to cats, the maximum concentration of dexmedetomidine increased twofold but there was no effect on T max.
Wara amministrazzjoni ta ’ 40 mikrogrammi dexmedetomidine / kg piż fil- muskolu flimkien ma ’ 5 mg ketamina / kg piż fil- qtates, l- ogħla konċentrazzjoni ta ’ dexmedetomidine żdiedet b’ darbtejn imma ma kienx hemm effett fuq Tmax.
A dose of 10 mg ketamine/ kg used concurrently with 40 micrograms dexmedetomidine/ kg may cause tachycardia.
Doża ta ’ 10 mg ketamina / kg flimkien ma ’ 40 mikrogrammi dexmedetomidine / kg tista ’ twassal biex il- qalb tħabbat b’ rata mgħaġġla.
22 Administration of atipamezole after dexmedetomidine rapidly reverses the effects and thus shortens the recovery period.
22 L- użu ta ’ atipamezole wara dexmedetomidine, ireġġa ’ lura l- effetti malajr u b’ hekk jiqsar il- perjodu li fih jirpilja l- annimal.
Within 15 minutes dogs are normally awake and standing
Normalment il- klieb ikunu mqajma u fuq saqajhom fi żmien 15- il minuta.
For information on adverse reactions, see section Adverse reactions.
Għal tagħrif fuq effetti mhux mixtieqa, ara sezzjoni Effetti mhux mixtieqa.
Frequent and regular monitoring of respiratory and cardiac function should be performed.
Il- funzjoni tan- nifs u tal- qalb għandha tiġi ċċekkjatha ta ’ spiss u b’ mod regolari.
Equipment for manual ventilation should be available in case of respiratory depression or apnoea when dexmedetomidine and ketamine are used sequentially to induce anaesthesia in cats.
Għandu jkun hemm apparat li jagħti l- arja bl- idejn f’ każ li jkun hemm nuqqas jew qtugħ ta ’ nifs fil - qtates meta dexmedetomidine u ketamina jintużaw wara xulxin biex tinbeda l- anestesija.
In cases of overdosing the following recommendations should be followed:
F’ każijiet ta ’ doża eċċessiva għandhom jiġu segwiti ir- rakkomandazzjonijiet kif ġej:
In cases of overdosage, or if the effects of dexmedetomidine become potentially life- threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose:
F’ każi ta ’ doża eċċessiva, jew fejn l- effetti ta ’ dexmedetomidine jistgħu ikunu ta ’ theddida għal ħajja, l- antagonista xieraq huwa atipamezole, amministrat b’ injezzjoni fil- muskolu bid- doża kif ġej:
After concurrent exposure to a triple (3X) overdose of dexmedetomidine and 15 mg ketamine/ kg, atipamezole can be administered at the recommended dose level for reversal of effects induced by dexmedetomidine.
Wara li tingħata doża eċċessiva ta ’ dexmedetomidine bi tlett darbiet (3X), flimkien ma ’ 15 mg ketamina / kg, atimpamezole tista ’ tingħata fil- livell ta ’ doża rakkomandat biex treġġa ’ lura l- effetti ta ’ dexmedetomidine.
At high serum concentration of dexmedetomidine sedation is not increased although the level of analgesia does increase with further dose increases.
B’ konċentrazzjoni għolja ta ’ dexmedetomidine fid- demm, l- irqad ma jiżdiedx għalkemm il- livell ta ’ serħan mill- uġiġħ jiżdied hekk kif tiżdied id- doża.
The specific α 2 – adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.
Sintomi respiratorji u emodinamiċi għandhom jiġu ttrattati b’ mod sintomatiku L - antagonistα2– adrenoceptor speċifiku, atipamezole, li huwa approvat għall- użu f’ annimali żgħar, intuża fin- nies biex jantagonizza l- effetti ta ’ dexmedetomidine, b’ mod sperimentali biss.
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
10 ml, 10 x 10 ml Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ.
España Pfizer Salud Animal Tel: +34 91 490 9900
España Pfizer Salud Animal. Tel: +34 91 490 9900
Pfizer Animal Health Tel: +421 2 3355 5500
Pfizer Animal Health Tel: + 421 2 3355 5500
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR).
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L - għan tiegħu huwa li jispjega kif il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasal għar- rakkomandazzjonijiet dwar il - kundizzjonijiet tal- użu.
This document cannot replace a face-to-face discussion with your veterinarian.
Dan id- dokument ma jistax jissostitwixxi diskussjoni wiċċ imbwiċċ mal- veterinarju tiegħek.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk tixtieq iktar informazzjoni dwar il- kundizzjoni medika jew il- kura tal- annimali tiegħek ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Dicural?
X’ inhu Dicural?
Dicural contains the active substance difloxacin, which is an antibiotic.
Dicural fih is- sustanza attiva difloxacin, li hija antibijotiku.
It is available as an oral solution for chickens and turkeys (100 mg/ ml), as tablets for dogs (15 mg, 50 mg, 100 mg and 150 mg), and as a solution for injection for cattle and dogs (50 mg/ ml).
Jiġi bħala soluzzjoni orali għat - tiġieġ u d- dundjani (100 mg/ ml), bħala pilloli għall- klieb (15 mg, 50 mg, 100 mg u 150 mg), u bħala soluzzjoni għall- injezzjoni għall- ifrat u l- klieb (50 mg/ ml).
What is Dicural used for?
Għal xiex jintuża Dicural?
Dicural is used to treat infections caused by bacteria: • in chickens and turkeys, Dicural is used to treat certain infections affecting the respiratory system (lungs and air sacs).
Dicural jintuża fit- trattament ta ’ infezzjonijiet ikkawżata mill- batterji: • fit- tiġieġ u d- dundjani, Dicural jintuża fit- trattament ta ’ ċerti infezzjonijiet li jaffettwaw is - sistema respiratorja (il- pulmun u l- boroż tal- arja).
Dicural is only used in young turkeys of up to 2 kg body weight.
Dicural jintuża biss f’ dundjani żgħar li ma jiżnux iktar minn 2 kg f’ piż tal- ġisem.
For both chickens and turkeys it is given in the drinking water for five days; • in dogs, Dicural is used to treat acute (short-lived) infections of the bladder and to treat pyoderma (a skin infection with a rash and raised lumps).
Kemm għat- tiġieġ kif ukoll għad- dundjani jingħata fl- ilma tax- xorb għal ħamest ijiem; • fil- klieb, Dicural jintuża fit- trattament ta ’ infezzjonijiet akuti (li ma jdumux) fil- borża tal - awrina u fit- trattament tal- pyoderma (infezzjoni tal- ġilda b’ raxx u b’ infafet).
It is given as tablets by mouth once a day for at least five days until the infection has been cured.
Jingħata bħala pilloli mill- ħalq darba kuljum għal ħamest ijiem sakemm l- infezzjoni ma tkunx ġiet ikkurata.