natgillin/translations-raw huggingface dataset:
In the absence of specific information, the use in animal suffering from Cushing’ s syndrome shall be based on the risk-benefit assessment.
Če ne razpolagamo s specifičnimi podatki, se živali, ki imajo Cushingov sindrom, Zdravi v skladu z oceno razmerja korist/ tveganje.
Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age) shall be based on the risk-benefit assessment and subject to regular clinical evaluations.
Ker je znano, da glukokortikosteroidi upočasnjujejo rast, se mora pri mladih živalih (ki še nimajo 7 mesecev) zdravilo uporabljati v skladu z oceno razmerja korist/ tveganje in odvisno od rednega kliničnega ocenjevanja.
2 Avoid contact with eyes.
2 Zdravilo ne sme priti v stik z očmi.
Do not spray on naked flame or any incandescent material.
Ne pršite na odrpti ogenj ali na žareče snovi.
Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
Uporabite le v skladu z oceno razmerja korist/ tveganje odgovornega veterinarja
Cutaneous use.
Dermalna uporoba.
Before administration, screw the pump spray on the bottle.
Pred uporoba na vsebnik privijte zaporko z mehanskim pršilnikom.
The recommended dosage is 1.52 µg of hydrocortisone aceponate/ cm2 of affected skin per day.
Priporočen odmerek je 1, 52 µg hidrokortizon aceponata/ cm2 prizadete kože na dan.
In case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the veterinary medicinal product to the risk-benefit assessment.
V primeru, da stanje zahteva podaljšano zdravljenje, mora odgovorni veterinar o uporabi zdravila presojati v skladu z oceno razmerja korist/ tveganje.
4.10 Overdose (symptoms, emergency procedures, antidotes)
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
Tolerance studies using 3 and 5 times the recommended dosage for twice the recommended duration of treatment resulted in a reduced capacity for production of cortisol that is fully reversible within 7 to 9 weeks after the end of treatment
Študije tolerance, pri katerih so uporabljali odmerke 3 in 5 krat večje od priporočenih, v obdobju zdravljenja, ki je trajalo dvakrat dlje od priporočenega, so pokazale zmanjšano sposobnost proizvajanja kortizola, ki pa je bila v obdobju 7 do 9 tednov po končanem zdravljenju popolnoma reverzibilna.
3 4.11 Withdrawal periods
4. 11 Karenca
QD07AC.
Farmakoterapevtska skupina: glukortikosteroidi, dermatiki Oznaka ATC vet QD07AC.
Hydrocortisone aceponate (HCA) is a dermocorticoid with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to a quick improvement of skin lesions observed in case of inflammatory and pruritic dermatosis.
Hidrokortizon aceponat (HCA) je dermokortikoid z močnim intrinzičnim glukokortikoidnim delovanjem, ki pomeni olajšanje tako vnetja kot pruritisa, in pripelje do hitrega celjenje kožnih poškodb, ki so zaznavnepri vnetljivh in pruritičnih dermatozah.
HCA belongs to the diesters class of the glucocorticosteroids.
HCA spada v diestre iz razreda glukokortikosteroidov.
HCA thus accumulates in the dog’ s skin allowing local efficacy at low dosage.
Na ta način se HCA v koži psa akumulira in pri nizkih odmerkih omogoča lokalno učinkovitost.
Propylene glycol methyl ether
Propilenglikol metileter
2 years.
2 leta.
Box containing a polyethylene terephtalate (PET) bottle filled with 76 ml of solution, closed with an aluminium screw cap or a white plastic screw cap and a pump spray.
V škatli sta plastenka iz polietilen tereftalata (PET), ki vsebuje 76 ml raztopine, zaprt z aluminijskim navojnim zamaškom ali pa z belim plastičnim pokrovčkom z navojem in razpršilec.
4 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
06516 Carros FRANCE 0033/ 4.92.08.73.00 0033/ 4.92.08.73.48 dar@virbac. fr
0033/ 4. 92. 08. 73. 48 e- pošta: dar@ virbac. fr
27 October 2005
27 October 2005
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN( ODGOVORNI) ZA SPROŠČANJE SERIJE
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN( ODGOVORNI) ZA SPROŠČANJE SERIJE
VIRBAC SA 1ère Avenue - 2065 m – L. I. D 06516 Carros, France
VIRBAC SA 1ère Avenue - 2065 m – L. I. D 06516 Carros, Francija
9 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9 PODATKI NA ZUNANJI OVOJNINI
Carton box
Škatla iz lepenke
CORTAVANCE 0.584 mg/ ml cutaneous spray solution for dogs.
CORTAVANCE 0, 584 mg/ ml raztopina (razpršilo) za kozo za pse.
Contains no preservative.
Ne vsebuje konzervansov.
Bottle containing 76 ml of solution.
Plastenka s 76 ml raztopine.
SPECIAL WARNING(S), IF NECESSARY
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Otherwise, use only according to the risk-benefit assessment by the responsible veterinarian and subject the dog to regular clinical evaluations.
EXP {mesec/ leto} Rok uporabnosti po prvem odpiranju:
EXP {MM/ AA/ AA} Once opened, use by 6 months.
6 mesecev.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Neuporabljeni preparat in odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z nacionalnimi predpisi.
06516 Carros FRANCE
06516 Carros FRANCIJA
Batch {number}
Številka serije{ številka}
11 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
11 PODATKI, KI MORAJO BITI NAVEDENI NA ZUNANJI OVOJNINI
Total body surface treated should not exceed a surface corresponding for example to a treatment of two flanks from the spine to the mammary chains including the shoulders and the thighs.
Skupna površina telesa, ki jo zdravimo, ne sme presegati površine, ki, na primer, ustreza zdravljenju Obeh bočnih strani, od hrbtenice do verig prsnih žlez, vključno z ramenoma in bedroma.
Otherwise, use only according to the risk-benefit assessment by the responsible veterinarian and subject the dog to regular clinical evaluations.
Drugače pa Zdravilo uporabljajte le v skladu z oceno razmerja korist/ tveganje, ki jo bo dal odgovorni veterinar, in Odvisno od rednega kliničnega ocenjevanja živali.
CORTAVANCE 0.584 mg/ ml cutaneous spray solution for dogs
CORTAVANCE 0, 584 mg/ ml raztopina (razpršilo) za kožo za pse
1ère avenue 2065 m L. I. D 06516 Carros FRANCE
1ère avenue 2065 m L. I. D 06516 Carros FRANCIJA
Hydrocortisone aceponate
Hidrokortizon- aceponat
Contains no preservative
Ne vsebuje ohranjevalnih snovi.
For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.
Za simptomsko zdravljenje vnetnih in pruritičnih dermatoz pri psih.
Before administration, screw the pump spray on the bottle.
Preden razpršilec uporabite privijte pumpico na vsebnik.
The recommended dosage is 1.52 µg of hydrocortisone aceponate/ cm2 of affected skin per day.
15 Za zdravljenje prizadetega dela kože se priporoča odmerek z 1, 52 µg hidrokortizon- aceponata/ cm2 na dan.
In case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the product to the risk-benefit assessment by the responsible veterinarian.
V primeru, da stanje zahteva podaljšano zdravljenje, odgovorni veterinar mora o uporabi izdelka presojati v skladu z oceno razmerja korist/ tveganje.
If signs fail to improve within 7 days, treatment should be re-evaluated by the veterinarian
Če po 7 dneh ni nobenih znakov izboljšanja, mora veterinar podati novo oceno stanja.
Flammable.
Izdelek je vnetljiv.
Do not spray on naked flame or any incandescent material.
Ne razpršujte ga na odrpti ogenj ali na žarečo tvar.
Do not smoke while handling the product.
Pri ravnanju z izdelkom kajenje ni dovoljeno.
In the case of concurrent microbial disease or parasitic infestation, the dog should receive appropriate treatment for such condition.
V primeru, da sočasno pride do mikrobne bolezni ali parazitskega okuženja, je treba psa na ustrezen način proti tej bolezni zdraviti.
In the absence of specific information, the use in animal suffering from Cushing’ s syndrome shall be based on the risk-benefit assessment.
Če ne razpolagamo s specifičnimi podatki, se zdravljenje tistih živali, ki imajo Cushingov sindrom, izvaja v skladu z oceno razmerja korist/ tveganje.
Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age) shall be based on the risk-benefit assessment and subject to regular clinical evaluations.
Ker je znano, da glukokortikosteroidi upočasnjujejo rast, se pri mladih živalih (ki še nimajo 7 mesecev) zdravilo mora uporabljati v skladu z oceno razmerja korist/ tveganje in odvisno od rednega kliničnega ocenjevanja.
16 Total body surface treated should not exceed a surface corresponding for example to a treatment of two flanks from the spine to the mammary chains including the shoulders and the thighs.
Skupna površina telesa, ki jo zdravimo, ne sme presegati površine, ki, na primer, ustreza zdravljenju obeh bočnih strani od hrbtenice do verige prsnih žlez, vključno z ramenoma in bedroma.
Otherwise, use only according to the risk-benefit assessment and subject the dog to regular clinical evaluations
Drugače pa zdravilo uporabljajte le v skladu z oceno razmerja korist/ tveganje in odvisno od rednega kliničnega ocenjevanja.
Systemic absorption of hydrocortisone aceponate being negligible, it is unlikely for teratogenic, foetotoxic, maternotoxic effects to happen at the recommended dosage in dogs.
Sistemska absorpcija hidrokortizon- aceponata je zanemarljiva; ob uporabi priporočenih doz pri zdravljenju psov ni verjetnosti, da se pojavijo teratogeni učinki ter toksični učinki na fetus ali pa na mater.
Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
Uporabite le v skladu z oceno razmerja korist/ tveganje odgovornega veterinarja.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
16 Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki zdravilo odmerja in ga daje živalim
In case of accidental skin contact, it is recommended to wash thoroughly with water.
V primeru nenamernega kontakta s kožo se priporoča temeljito izpiranje z vodo.
In case of eye irritation, seek medical advice.
Če pride do iritacije očesa, se posvetujte z zdravnikom.
In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to the physician.
V primeru slučajnega zavžitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali pa ovojnino.
In the absence of information, it is recommended not to apply other topical preparations simultaneously on the same lesions.
Ker podatkov o tem ni, sočasno uporabljanje tega in drugih površinskih preparatov za zdravljenje istih ran odsvetujemo.
This results in minimal amounts to reach the blood stream.
Kot je možno zaključiti iz študije o distribuciji radioaktivnosti in iz farmakokinetičnih podatkov, se po nanašanju na kožo hidrokortizon aceponat (HCA) v koži akumulira in presnavlja in ga zaradi tega v krvotok pride le minimalna količina.
This particularity will increase the ratio between the desired local anti-inflammatory effect in the skin and the undesirable systemic effects.
Ta posebnost poveča razmerje med želenim lokalnim protivnetnim učinkom v koži in neželenimi sistemskimi učinki.
HCA applications on the skin lesions provide rapid reduction of the skin redness, irritation and scratching while minimising the general effects.
Nanos HCA na kožne poškodbe zagotavlja hitro zmanjšanje kožne rdečine, draženja in praskanja, ob enem pa so splošni učinki minimalni.
What is DEXDOMITOR?
Kaj je zdravilo DEXDOMITOR?
DEXDOMITOR contains the active substance dexmedetomidine, which belongs to a class of medicines having a psycholeptic (sedative) action.
Zdravilo DEXDOMITOR vsebuje zdravilno učinkovino deksmedetomidin, ki spada v razred zdravil s psiholeptičnimi (pomirjevalnimi) učinki.
It is a solution for injection (0.5 mg/ ml).
Zdravilo je raztopina za injiciranje (0, 5 mg/ ml).
What is DEXDOMITOR used for?
Za kaj se zdravilo DEXDOMITOR uporablja?
DEXDOMITOR is used to sedate (calm down) dogs and cats in the following situations: • when carrying out mildly to moderately painful procedures and examinations that require the animal to be restrained or sedated, and made less sensitive to pain (analgesia).
Zdravilo DEXDOMITOR se uporablja za sedacijo (pomiritev) psov in mačk v naslednjih primerih: • kadar izvajamo neinvazivne, blago do zmerno boleče postopke in preglede, pri katerih so potrebni mirovanje in sedacija živali ter zmanjšanje občutljivosti na bolečino (analgezija).
It is used in non-invasive procedures, this means that the procedure does not involve breaking the skin or a body cavity, • before inducing general anaesthesia.
Uporablja se pri neinvazivnih posegih, kar pomeni, da pri postopku ne predremo kože ali stene telesne votline; • pred uvajanjem splošne anestezije.
When used in cats, ketamine should be used as the anaesthetic agent, • for deep sedation and analgesia in dogs in combination with butorphanol (a sedative and analgesic) for procedures including minor surgery.
Kadar se uporablja pri mačkah, je treba kot anestetično sredstvo uporabiti ketamin; • za globoko sedacijo in analgezijo pri psih ob sočasni uporabi z butorfanolom (sedativom in analgetikom) za postopke, ki vključujejo manjše kirurške posege.
The dose is chosen according to which species being treated, what it is being used for, whether it is injected into a vein or a muscle and any other medicines that are also being used.
Odmerek izberete glede na vrsto živali, ki jo zdravite, glede na namen dajanja zdravila, glede na to, ali se zdravilo vbrizga v veno ali mišico, in glede na druga sočasno uporabljana zdravila.
The dose depends on the body surface area in dogs (caluclated using body weight) and body weight in cats.
Odmerek je pri psih odvisen od telesne površine (izračuna se s pomočjo telesne teže), pri mačkah pa od telesne teže.
In dogs, DEXDOMITOR is given by intravenous (into a vein) or intramuscular (into a muscle) injection.
Psom zdravilo DEXDOMITOR dajemo z intravensko (v veno) ali intramuskularno (v mišico) injekcijo.
In cats, it is given by intramuscular injection.
Mačkam dajemo zdravilo z intramuskularno injekcijo.
How does DEXDOMITOR work?
Kako zdravilo DEXDOMITOR deluje?
The active substance in DEXDOMITOR, dexmedetomidine, is an alpha2-adrenoceptor agonist.
Zdravilna učinkovina zdravila DEXDOMITOR, deksmedetomidin, je agonist α2 - adrenoreceptorja.
Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Živčni prenašalci so spojine, ki omogočajo medsebojno sporazumevanje živčnih celic.
Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain.
Ker je noradrenalin vpleten v vzdrževanje budnega stanja, zmanjšanje stopnje njegovega sproščanja zniža raven zavesti in občutek bolečine.
Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicines for many years.
Deksmedetomidin je tesno povezan z drugo snovjo, ki se uporablja za sedacijo živali, medetomidinom, ki ga v veterinarskih zdravilih uporabljajo že dolga leta.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has DEXDOMITOR been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo DEXDOMITOR raziskano?
DEXDOMITOR was investigated in studies involving cats and dogs in which its effectiveness was compared with that of medetomidine.
Zdravilo DEXDOMITOR so preučevali v študijah pri mačkah in psih, v katerih so njegovo učinkovitost primerjali z učinkovitostjo medetomidina.
The studies included dogs and cats of various ages and breeds, which were undergoing procedures requiring sedation or analgesia.
Študije so vključevale pse in mačke različnih starosti in pasem, na katerih so morali izvesti postopke, ki so zahtevali njihovo sedacijo ali analgezijo.
In dogs, both intravenous and intramuscular injections of DEXDOMITOR were studied.
Pri psih so preučevali tako intravenske kot intramuskularne injekcije zdravila DEXDOMITOR.
DEXDOMITOR was also compared with medetomidine as a premedication in cats about to undergo general anaesthesia with ketamine and for deep sedation of dogs in combination with butorphanol.
Zdravilo DEXDOMITOR so primerjali z medetomidinom tudi kot pripravo na poseg pri mačkah pred uvajanjem splošne anestezije s ketaminom in za globoko sedacijo psov pri sočasni uporabi butorfanola.
Finally, it was studied as a premedication in dogs prior to induction of general anaesthesia.
Nenazadnje so zdravilo preučevali tudi kot pripravo na poseg pri psih pred uvajanjem splošne anestezije.
What benefit has DEXDOMITOR shown during the studies?
Kakšne koristi je zdravilo DEXDOMITOR izkazalo med raziskavami?
The studies showed that DEXDOMITOR had an equivalent level of effectiveness as medetomidine in inducing sedation and analgesia in dogs and cats.
Študije so pokazale, da je imelo zdravilo DEXDOMITOR enakovreden učinek kot medetomidin pri sedaciji in analgeziji psov in mačk.
As for medetomidine, ‘ good’ or ‘ excellent’ analgesia was reached in about 40 to 50% of the animals, supporting its use in non-invasive mildly to moderately painful procedures.
Kar se tiče medetomidina, so pri 40 do 50% živali dosegli „ dobro “ ali „ odlično “ analgezijo, kar je govorilo v prid uporabi tega zdravila pri neinvazivnih, blago do zmerno bolečih posegih.
DEXDOMITOR also showed adequate effectiveness for deep sedation of dogs in combination with butorphanol, and as a premedication before induction of general anaesthetic, reducing the amount of anaesthetic that the dogs needed.
Zdravilo DEXDOMITOR je bilo pri vzpostavljanju stanja splošne anestezije pri mačkah ob sočasni uporabi ketamina vsaj tako učinkovito kot medetomidin Zdravilo DEXDOMITOR je pokazalo primerno učinkovitost tudi pri globoki sedaciji psov ob sočasni uporabi z butorfanolom in kot priprava na poseg pred uvajanjem splošne anestezije, pri čemer je zdravilo zmanjšalo količino anestetika, ki so ga psi potrebovali.
What is the risk associated with DEXDOMITOR?
Kakšna tveganja so povezana z zdravilom DEXDOMITOR?
DEXDOMITOR causes a decrease in heart rate and body temperature.
Zdravilo DEXDOMITOR povzroči upočasnitev bitja srca in zmanjšanje telesne temperature.
Other side-effects can occur when DEXDOMITOR is used with other medicines.
Drugi neželeni učinki se lahko pojavijo, če zdravilo DEXDOMITOR uporabljate sočasno z drugimi zdravili.
For a full list of all side-effects reported with DEXDOMITOR, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila DEXDOMITOR, glejte Navodilo za uporabo.
DEXDOMITOR should not be used in puppies below six months of age or in kittens below five months of age.
Zdravila DEXDOMITOR ne smete uporabljati pri kužkih, mlajših od šest mesecev, ali mačkah, mlajših od pet mesecev.
It should not be used in animals that have problems with their heart or blood vessels, with severe systemic (whole-body) disease, that are moribund (close to death) or that are known to be hypersensitive (allergic) to dexmedetomidine or any of the other ingredients.
Zdravila ne smete uporabljati pri živalih, ki imajo težave s srcem ali žilami, imajo resno sistemsko bolezen (vključuje celo telo), so moribundne (tik pred smrtjo) ali so ugotovljeno preobčutljive za (alergične na) deksmedetomidin ali katerokoli drugo sestavino zdravila.
If DEXDOMITOR is accidentally self-injected or taken by mouth, seek medical advice immediately and show the Package Leaflet or the label to the doctor.
V primeru oralnega zaužitja ali samoinjiciranja zdravila DEXDOMITOR nemudoma poiščite zdravniško pomoč in zdravniku pokažite Navodilo za uporabo ali škatlo zdravila.
However, do not drive due to the risk of sedation and changes in blood pressure.
Vendar pa zaradi tveganja sedacije in sprememb krvnega tlaka ne smete voziti.
Avoid contact with the skin, eyes or mucosa (moist body surfaces).
Izogibajte se stiku s kožo, očmi ali sluznico (vlažnim površinam telesa).
If contact does occur, rinse with large amounts of water.
V primeru stika mesto stika izperite z velikimi količinami vode.
Pregnant women should take special care to avoid self- injection.
Nosečnice bi morale biti posebej previdne, da ne bi prišlo do samoinjiciranja zdravila.
People who are known to be hypersensitive to dexmedetomidine or any of the other ingredients should give the medicine with caution.
Osebe z znano preobčutljivostjo na deksmedetomidin ali katerokoli drugo sestavino zdravila morajo zdravilo dajati previdno.
Page 2/ 3 ©EMEA 2007 Why has DEXDOMITOR been approved?
Stran 2/ 3 ©EMEA 2007 Zakaj je bilo zdravilo DEXDOMITOR odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of DEXDOMITOR exceed the risks in: • non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats, • premedication in cats and dogs before induction and maintenance of general anaesthesia (with ketamine in cats), • deep sedation and analgesia in dogs in concomitant use with butorphal for medical and minor surgical procedures.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je odločil, da so koristi zdravila DEXDOMITOR večje od njegovih tveganj pri: • neinvazivnih, blago do zmerno bolečih postopkih in pregledih psov in mačk, pri katerih so potrebni mirovanje, sedacija in analgezija; • uporabi pri mačkah in psih, kjer zdravilo služi kot priprava na splošno anestezijo (s ketaminom pri mačkah) in za njeno vzdrževanje; • globoki sedaciji in analgeziji psov ob sočasni uporabi z butorfanolom za zdravniške in manjše kirurške posege.
The Committee recommended that DEXDOMITOR be given a marketing authorisation.
Odbor je zato priporočil, da se za zdravilo DEXDOMITOR odobri dovoljenje za promet.
Other information about DEXDOMITOR:
Druge informacije o zdravilu DEXDOMITOR:
The European Commission granted a marketing authorisation valid throughout the European Union for DEXDOMITOR on 30 August 2002.
Evropska Komisija je dovoljenje za promet z zdravilom DEXDOMITOR, veljavno po vsej Evropski uniji, odobrila dne 30. avgusta 2002.
The marketing authorisation was renewed on 02 August 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 2. avgusta 2007.
Information on the prescription status of this product may be found on the label/ outer package.
Podatke o predpisovanju tega zdravila lahko najdete na nalepki/ zunanji ovojnini.
This summary was last updated on 4 September 2007.
Povzetek je bil nazadnje posodobljen 4. septembra 2007.
Page 3/ 3 ©EMEA 2007
Stran 3/ 3 ©EMEA 2007
Withdrawal period
Velikost Karenca pakiranja
Dogs and cats
Mačke, psi
Intravenous use (dogs) Vial (glass) Intramuscular use (dogs and cats)
viala (steklo)
NA
Navedba smiselno ni potrebna
Dexdomitor 0.5 mg/ ml
Raztopina za
Solution for injection
Mačke, psi
Dogs and cats
Psi: intravenska in
Intravenous use (dogs) Vial (glass) Intramuscular use (dogs and cats)
viala
10 ml, 10 x 10 ml
10 ml, 10
NA
Navedba
DEXDOMITOR 0.5 mg/ ml solution for injection
DEXDOMITOR 0, 5 mg/ ml raztopina za injiciranje
One ml contains 0.5 mg dexmedetomidine hydrochloride equivalent to 0.42 mg dexmedetomidine.
1 ml vsebuje 0, 5 mg deksmedetomidinklorida ekvivalent 0, 42 mg deksmedetomidina
Methyl parahydroxybenzoate (E 218) 1.6 mg/ ml Propyl parahydroxybenzoate (E 216) 0.2 mg/ ml
Metilparahidroksibenzoat (E 218) Propilparahidroksibenzoat (E 216)