FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Tybost, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Tybost pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Studies showed that Tybost was as effective as ritonavir as a booster for atazanavir, and a similar effect is expected for darunavir based on data on the impact of Tybost on the darunavir levels in the body.
Croatian: Ispitivanja su pokazala da je Tybost učinkovit kao i ritonavir te kao pojačivač za atazanavir te se očekuje sličan učinak za darunavir na temelju podataka o utjecaju lijeka Tybost na razine darunavira u tijelu.
English: By blocking CYP3A, Tybost slows down the rate at which atazanavir and darunavir are broken down, thereby prolonging the length of time they act in the body.
Croatian: Blokadom enzima CYP3A Tybost usporava brzinu pri kojoj se razgrađuju atazanavir i darunavir pa stoga produljuje duljinu vremena njihovog djelovanja u tijelu.
English: The active substance in Tybost, cobicistat, blocks the action of a group of liver enzymes called CYP3A, which are involved in breaking down medicines in the body.
Croatian: Djelatna tvar u lijeku Tybost, kobicistat blokira djelovanje skupine jetrenih enzima zvanih CYP3A koji su uključeni u razgradnji lijekova u tijelu.
English: Treatment with Tybost and atazanavir or darunavir does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS, when combined with other standard HIV-1 medicines.
Croatian: Liječenje lijekom Tybost i atazanavirom ili darunavirom ne liječi infekciju virusom HIV-1 ili AIDS, ali može odgoditi oštećenje imunološkog sustava i razvoj infekcija i bolesti povezanih s HIV-om kad se kombiniraju s drugim standardnim lijekovima za liječenje HIV-1.
English: Tybost is a medicine that contains the active substance cobicistat.
Croatian: Tybost je lijek koji sadrži djelatnu tvar kobicistat.
English: The study compared these two medicines when used to boost the effects of atazanavir, given in combination with another standard HIV-1 medicine containing emtricitabine and tenofovir.
Croatian: Ispitivanje je usporedilo ta dva lijeka kad se koriste za pojačavanje učinaka atazanavira u kombinaciji s drugim standardnim lijekovima protiv virusa HIV-1, a koji sadrže emtricitabin i tenofovir.
English: What is Tybost and what is it used for?
Croatian: Što je Tybost za što se koristi?
English: Tybost does not treat HIV directly but is given to boost the effects of atazanavir or darunavir, which are used with other standard medicines to treat HIV-1.
Croatian: Tybost ne liječi izravno HIV, ali se primjenjuje za pojačavanje učinaka atazanavira ili darunavira koji se koriste s drugim standardnim lijekovima za liječenje infekcije virusom HIV-1.
English: How does Tybost work?
Croatian: Kako Tybost djeluje?
English: How is Tybost used?
Croatian: Kako se Tybost koristi?
English: Tybost can only be obtained with a prescription.
Croatian: Ovaj se lijek izdaje samo na liječnički recept.
English: For the full list of all side effects reported with Tybost, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Tybost potražite u uputi o lijeku.
English: The product is intended for:
Croatian: Ovaj je proizvod namijenjen za:
English: The product is not intended for repeat injections.
Croatian: Proizvod nije namijenjen za ponavljano injiciranje.
English: The elimination half-life (t½) is 40-50 minutes.
Croatian: Poluvrijeme eliminacije (t½) iznosi 40-50 minuta.
English: It is also advisable to have oxygen readily available, should hypoxaemia be detected or suspected.
Croatian: Također je uputno imati odmah dostupan kisik u slučaju da se detektira hipoksemija ili da se na nju posumnja.
English: After treatment, the animal should not be given water or food before it is able to swallow.
Croatian: Nakon liječenja, životinji se ne smije dati voda ili hrana prije nego što je sposobna gutati.
English: Vomiting, hypothermia and nervousness have been reported after such use.
Croatian: Povraćanje, hipotermija i nervoza zabilježeni su nakon takve primjene.
English: Do not use in animals with severe systemic disease or in animals that are moribund.
Croatian: Ne primjenjivati na životinjama s teškim sistemskim bolestima ili na životinjama koje su na umoru.
English: The Marketing Authorisation Holder must ensure that the system of pharmacovigilance, as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
Croatian: Nositelj odobrenja treba osigurati da je sustav farmakovigilancije, kako je opisano u Dijelu I zahtjeva za izdavanje odobrenja, uspostavljen i funkcionalan prije i za vrijeme stavljanja veterinarsko medicinskog proizvoda u promet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV Djelatna tvar:
English: In cases of overdosing the following recommendations should be followed:
Croatian: U slučajevima predoziranja treba poštivati sljedeće preporuke:
English: In a clinical study, the requirement for propofol was reduced by 50%.
Croatian: U kliničkom je ispitivanju potreba za propofolom smanjena za 50%.
English: EXPIRY DATE EXP: month/year
Croatian: ROK VALJANOSTI EXP: mjesec/godina
English: Ltd, Αγίου Νικολάου 8, 1055 Λευκωσία, Κύπρος, τηλ.
Croatian: Lifepharma (Z.A.M.) Ltd, Αγίου Νικολάου 8, 1055 Λευκωσία, Κύπρος, τηλ.
English: Cats: The maximum plasma concentration is reached about 0.24 h after intramuscular administration.
Croatian: Mačke: Maksimalna koncentracija u plazmi postiže se oko 0,24 h nakon intramuskularne primjene.
English: The mean half-life of elimination of dexmedetomidine increased to 1.6 h and the total exposure (AUC) increased by 50%.
Croatian: Prosječno poluvrijeme eliminacije deksmedetomidina povećalo se na 1.6 h, a ukupna izloženost (AUC) povećala se za 50%.
English: Do not use after the expiry date stated on the label and carton after EXP.
Croatian: Ne koristiti poslije isteka roka valjanosti naznačenog na etiketi i kutiji nakon EXP (skraćenica korištena za rok valjanosti).
English: C. STATEMENT OF THE MRLs Not applicable.
Croatian: IZVJEŠĆE O MRL Nije primjenjivo.
English: The apparent volume of distribution (Vd) is 2.2 L/kg and the elimination half-life (t½) is one hour.
Croatian: Prividni volumen raspodjele (Vd) iznosi 2,2 L/kg, a poluvrijeme eliminacije (t½) jedan sat.
English: Dexdomitor is compatible with butorphanol and ketamine in the same syringe at least for two hours.
Croatian: Dexdomitor je kompatibilan s butorfanolom i ketaminom u istoj štrcaljki kroz najmanje dva sata.
English: The bioavailability of dexmedetomidine is 60% and the apparent volume of distribution (Vd) is 0.9 L/kg.
Croatian: Bioraspoloživost deksmedetomidina iznosi 60%, a prividni volumen raspodjele (Vd) iznosi 0,9 L/kg.
English: Persons with known hypersensitivity to the active substance or any of the excipients should administer the product with caution.
Croatian: Osobe s poznatom preosjetljivošću na djelatnu tvar ili na bilo koju od pomoćnih tvari trebale bi primjenjivati proizvod s oprezom.
English: At high serum concentration of dexmedetomidine sedation is not increased although the level of analgesia does increase with further dose increases.
Croatian: Pri visokim serumskim koncentracijama deksmedetomidina sedacija se ne povećava, iako se razina analgezije povećava s daljnjim povećanjima doze.
English: To be supplied only on veterinary prescription.
Croatian: .Izdaje se samo na veterinarski recept.
English: Biotransformations in the cat occur by hydroxylation in the liver.
Croatian: Biotransformacij se u mačke odvija hidroksilacijom u jetri.
English: Dosage: the following doses are recommended:
Croatian: Doza: preporučene su sljedeće doze:
English: For information on target animal safety in cases of overdosing, see section 4.10.Overdose
Croatian: Za informacije o neškodljivosti ciljnih vrsta životinja u slučajevima predoziranja, vidjeti dio 4.10.
English: The following doses are recommended:
Croatian: Preporučuju se sljedeće doze:
English: Pharmacotherapeutic group: psycholeptic, ATCvet code: QN05CM18.
Croatian: Farmakoterapijska grupa: psiholeptik, ATCvet kod: QN05CM18.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA ” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo Samo za primjenu na životinjama
English: The eyes should be protected by a suitable lubricant.
Croatian: Oči treba zaštititi prikladnim lubrikantom.
English: Advice to doctors: Dexdomitor is an α2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Croatian: Savjet liječnicima: Dexdomitor je agonist α2-adrenergičkih receptora, simptomi nakon apsorpcije mogu uključivati kliničke učinke, uključujući sedaciju ovisnu o dozi, depresiju disanja, bradikardiju, hipotenziju, suhoću usne šupljine i hiperglikemiju.
English: Sedation may be reversed with atipamezole.
Croatian: Sedacija se može prekinuti pomoću atipamezola.
English: Dexdomitor, butorphanol and/or ketamine can be mixed in the same syringe as they have been shown to be pharmaceutically compatible.
Croatian: Dexdomitor, butorfanol i/ili ketamin mogu se miješati u istoj štrcaljki, budući da je ustanovljeno da su farmaceutski kompatibilni.
English: Dexdomitor contains dexmedetomidine as the active substance, which produces sedation and analgesia in dogs and cats.
Croatian: Dexdomitor kao djelatnu tvar sadrži deksmedetomidin, koji dovodi do sedacije i analgezije u pasa i mačaka.
English: It is recommended that animals are fasted for 12 hours prior to Dexdomitor administration.
Croatian: Preporuča se da životinje prije primjene Deksdomitora budu 12 sati natašte.
English: In some dogs and cats a decrease in respiratory rate may occur.
Croatian: U nekih pasa i mačaka može doći do smanjenja frekvencije disanja.
English: The eyes should be protected by a suitable eye lubricant.
Croatian: Oči treba zaštititi prikladnim očnim lubrikantom.
English: 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.
Croatian: Kod primjene drugih depresora središnjeg živčanog sustava očekuje se pojačanje učinka deksmedetomidina pa je stoga potrebna odgovarajuća prilagodba doze.
English: For information on adverse reactions, see section 4.6.Adverse reactions.
Croatian: Za informacije o nuspojavama vidjeti dio 4.6. Nuspojave.
English: Dexdomitor doses are based on body surface area:
Croatian: Doze Dexdomitora određuju se prema površini tijela:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS/ MULTI PACKAGE
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA/VIŠESTRUKO PAKOVANJE BOČICA/ VIŠESTRUKO PAKOVANJE
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
Croatian: 3. NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Djelatna tvar:
English: CLINICAL PARTICULARS
Croatian: 4. KLINIČKE POJEDINOSTI
English: After withdrawal of the first dose, the product may be stored for 3 months at 25ºC.
Croatian: Nakon povlačenja prve doze proizvod se može čuvati 3 mjeseca pri temperaturi od 25ºC.
English: ROUTE(S) OF ADMINISTRATION Dogs: IM, IV
Croatian: 4. PUT(EVI) PRIMJENE Psi: i.m., i.v.
English: SPECIAL STORAGE PRECAUTIONS Do not freeze.
Croatian: 11. POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE Ne zamrzavati.
English: When administering in conjunction with butorphanol (0.1 mg/kg) for deep sedation and analgesia, the intramuscular dose of dexmedetomidine is 300 micrograms/square metre body surface area.
Croatian: Kad se primjenjuje istodobno s butorfanolom (0,1 mg/kg) za duboku sedaciju i analgeziju, intramuskularna doza deksmedetomidina iznosi 300 mikrograma/četvornom metru površine tijela.
English: Dexmedetomidine doses are based on body surface area:
Croatian: Doze deksmedetomidina određuju se prema površini tijela:
English: 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.
Croatian: Nakon istodobne izloženosti trostrukom (3X) predoziranju deksmedetomidinom i 15 mg ketamina/kg, atipamezol se može primijeniti u preporučenoj dozi za poništavanje učinaka deksmedetomidina.
English: Dexmedetomidine also induces a number of other α2adrenoceptor mediated effects, which include piloerection, depression of motor and secretory functions of the gastrointestinal tract, diuresis and hyperglycaemia.
Croatian: Deksmedetomidin također dovodi do niza učinaka posredovanih α2-adrenergičkim receptorima, uključujući kostriješenje, smanjenje motornih i sekretornih funkcija gastrointestinalnog sustava, mokrenje i hiperglikemiju.
English: CATS:
Croatian: MAČKE:
English: For information on adverse reactions, see section: Adverse Reactions.
Croatian: Za informacije o nuspojavama, vidjeti dio: Nuspojave.
English: In a clinical study, the requirement for propofol and thiopental was reduced by 30% and 60% respectively.
Croatian: U kliničkom je ispitivanju potreba za propofolom smanjena za 30%, a potreba za tiopentalom za 60%.
English: DOGS:
Croatian: PSI:
English: The specific α2 -adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.
Croatian: Specifični α2 -adrenoreceptorski antagonist, atipamezol, koji je odobren za upotrebu na životinjama, upotrebljavan je u ljudi samo eksperimentalno za poništavanje učinaka deksmedetomidina.
English: The expected sedative and analgesic effects are reached within 15 minutes after administration and are maintained up to 60 minutes after administration.
Croatian: Očekivani sedativni i analgetski učinci postižu se unutar 15 minuta nakon primjene i traju do 60 minuta.
English: MANUFACTURER'S BATCH NUMBER Batch:
Croatian: 6. BROJ PROIZVODNE SERIJE Serija:
English: TARGET SPECIES Dogs and cats.
Croatian: CILJNE VRSTE ŽIVOTINJA Psi i mačke.
English: Intravenously: up to 375 micrograms/square metre body surface area Intramuscularly: up to 500 micrograms/square metre body surface area
Croatian: Intravenski: do 375 mikrograma/četvornom metru površine tijela Intramuskularno: do 500 mikrograma/četvornom metru površine tijela
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja neupotrjebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: Sintra Business Park, Nº7, Edifício 1 - Escritório 2K Zona Industrial de Abrunheira 2710-089 Sintra
Croatian: Sintra Business Park, Nº7, Edifício 1Escritório 2K
English: Cats: intramuscular use
Croatian: - Mačke: intramuskularna primjena
English: Special precautions for use in animals
Croatian: Posebne mjere opreze prilikom primjene na životinjama
English: In cats, corneal opacities may occur during sedation.
Croatian: U mačaka za vrijeme sedacije mogu nastati zamućenja rožnice.
English: The specific α2-adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.
Croatian: Specifični antagonist α2adrenergičkih receptora, atipamezol, koji je odobren za upotrebu na životinjama, upotrebljava se u ljudi samo eksperimentalno za poništavanje učinaka deksmedetomidina.
English: After a 40 micrograms/kg bw intramuscular dose the Cmax is 17 nanograms/ml.
Croatian: Nakon intramuskularne doze od 40 mikrograma/kg tjelesne težine Cmax iznosi 17 nanograma/ml.
English: INDICATION(S)
Croatian: 6. INDIKACIJA(E)
English: For higher weight ranges, use DEXDOMITOR 0.5 mg/ml and its dosing tables.
Croatian: Za veće raspone težina, primijeniti DEXDOMITOR 0,5 mg/ml i pripadajuće tablice doziranja.
English: Cats: 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.
Croatian: Mačke: Nakon istodobne intramuskularne primjene 40 mikrograma deksmedetomidina/kg tjelesne mase i 5 mg ketamina/kg tjelesne mase u mačaka, maksimalna se koncentracija deksmedetomidina povećala dva puta, ali nije bilo utjecaja na T max.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE VMP se izdaje na veterinarski recept.
English: For animal treatment only.
Croatian: Samo za primjenu na životinjama
English: 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.
Croatian: Ako trudnice rukuju proizvodom, potreban je poseban oprez kako bi se izbjeglo samo-injiciranje, jer nakon slučajne sistemske izloženosti može doći do kontrakcija maternice i sniženja krvnog tlaka fetusa.
English: 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.
Croatian: Kad se u pasa istodobno upotrebljavaju deksmedetomidin i butorfanol, može doći do bradipneje, tahipneje, nepravilnog obrasca respiracije (apneja u trajanju 20-30 sekundi nakon koje slijedi nekoliko brzih udisaja), hipoksemije, mišićnih trzaja ili tremora, ili „veslanja“, ekscitacije, hipersalivacije, nagona na povraćanje, povraćanja, mokrenja, kožnog eritema, naglog buđenja ili prolongirane sedacije.
English: Dogs: intravenous or intramuscular use
Croatian: - Pse: intravenska ili intramuskularna primjena
English: SPECIAL STORAGE CONDITIONS Do not freeze.
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati od zamrzavanja.
English: 6.5 Nature and composition of immediate packaging Cardboard box with 1 glass (Type I) vial of 20 ml (with filling volume of 15 ml) with a bromobutyl rubber stopper and aluminium cap.
Croatian: Kartonska kutija s 1 staklenom (Tip I) bočicom od 20 ml (s volumenom punjenja od 15 ml) s brombutilnim gumenim čepom
English: Shelf life after first opening: 3 months at 25°C.
Croatian: Jednom otvoren upotrijebiti do: 3 mjeseca na temperaturi od 25 C.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION The product is intended for:
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
English: 4.9 Amounts to be administered and administration route
Croatian: 4.9 Doziranje i način primjene
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 ml, 10 x 10 ml
Croatian: 3. SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 10 ml, 10 x 10 ml
English: Propyl parahydroxybenzoate (E 216)
Croatian: Propil parahidroksibenzoat (E 216)
English: Attention should be given during the administration of intravenous induction drugs to effect.
Croatian: Potreban je oprez za vrijeme intravenske primjene VMP za uvođenje u anesteziju.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 15 ml, 10 x 15 ml
Croatian: 3. SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 15 ml, 10 x 15 ml
English: Use of dexmedetomidine as a premedicant in dogs and cats significantly reduces the amount of induction drug required for induction of anaesthesia.
Croatian: Upotreba deksmedetomidina u svrhu premedikacije u pasa i mačaka značajno smanjuje količinu VMP potrebnog za uvođenje u anesteziju.
English: 6.5 Nature and composition of immediate packaging Cardboard box with 1 glass (Type I) vial of 10ml with a chlorobutyl or bromobutyl rubber stopper and aluminium cap.
Croatian: Kartonska kutija s 1 staklenom (Tip I) bočicom od 10 ml s klorbutilnim ili brombutilnim gumenim čepom
English: List of excipients:
Croatian: Popis pomoćnih tvari:
English: Cats: IM
Croatian: Mačke: i.m.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/033/003-004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/02/033/003-004
English: Use of dexmedetomidine as a premedicant in dogs significantly reduces the amount of induction drug required for induction of anaesthesia.
Croatian: Primjena deksmedetomidina kao premedikacije u pasa značajno smanjuje količinu VMP potrebnog za uvođenje u anesteziju.
English: Weight
Croatian: NUSPOJAVE
English: Dexmedetomidine 125 mcg/m2
Croatian: Težina psa Deksmedetomidin 125 mcg/m2
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION The product is intended for:
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, METODE I NAČIN PRIMJENE
English: Package size: 10 ml, 10 x10 ml.
Croatian: Veličina pakovanja: 10 ml, 10 x10 ml.
English: A dose of 10 mg ketamine/kg used concurrently with 40 micrograms dexmedetomidine/ kg may cause tachycardia.
Croatian: Istodobna primjena doze od 10 mg ketamina/kg sa 40 mikrograma deksmedetomidina/kg može uzrokovati tahikardiju.
English: When dexmedetomidine is used as a premedicant in dogs, bradypnoea, tachypnoea and vomiting may occur.
Croatian: Kad se deksmedetomidin koristi za premedikaciju u pasa, može doći do bradipneje, tahipneje i povraćanja.
English: Package size: 15 ml, 10 x 15 ml.
Croatian: Veličina pakovanja: 15 ml, 10 x 15 ml.
English: Package size: 10 ml and 10 x 10 ml
Croatian: Veličina pakovanja: 10 ml i 10 x 10 ml
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 0.1 mg/ml dexmedetomidine hydrochloride
Croatian: 2. KOLIČINA DJELATNE(IH) TVARI 0,1 mg/ml deksmedetomidin hidroklorida
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/033/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/02/033/001-002
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 0.5 mg/ml dexmedetomidine hydrochloride
Croatian: 2. KOLIČINA DJELATNE(IH) TVARI 0,5 mg/ml deksmedetomidin hidroklorida
English: One ml contains 0.5 mg dexmedetomidine hydrochloride equivalent to 0.42 mg dexmedetomidine.
Croatian: Jedan ml sadrži 0,5 mg deksmedetomidin hidroklorida ekvivalentno 0,42 mg deksmedetomidina.
English: ROUTE(S) OF ADMINISTRATION Dogs: intravenous or intramuscular use Cats: intramuscular use
Croatian: 4. PUT(EVI) PRIMJENE Psi: intravenska ili intramuskularna primjena Mačke: intramuskularna primjena
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda moraju se odlagati u skladu s lokalnim propisima.
English: Dexmedetomidine 500 micrograms/m2
Croatian: Deksmedetomidin 500 mikrograma/m2
English: The dose volume of atipamezole at the concentration of 5 mg/ml equals one tenth (1/10) the volume of Dexdomitor 0.1 mg/ml that was given to the cat.
Croatian: Volumen doze atipamezola pri koncentraciji od 5 mg/ml jednak je jednoj desetini (1/10) volumena Dexdomitora 0,1 mg/ml koji je primijenjen na mački.
English: Package size: 15 ml and 10 x 15 ml
Croatian: Veličina pakovanja: 15 ml I 10 x 15 ml
English: One ml contains 0.1 mg dexmedetomidine hydrochloride equivalent to 0.08 mg dexmedetomidine.
Croatian: Jedan ml sadrži 0,1 mg deksmedetomidin hidroklorida ekvivalentno 0,08 mg deksmedetomidina.