FrancophonIA/ELRC3.0 huggingface dataset:
English: • Adults with advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
Slovenian: • odraslih z napredovalim hipereozinofilnim sindromom (HES) ali kronično eozinofilno levkemijo (KEL), tj. boleznima, pri kateri se eozinofilci (vrsta belih krvničk) začnejo nenadzorovano razraščati.
English: • Children with chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control.
Slovenian: • otrok s kronično mieloično levkemijo (KML), tj. rakom belih krvničk, pri katerem se granulociti (vrsta belih krvničk) začnejo nenadzorovano razraščati.
English: Why is Imatinib medac approved?
Slovenian: Zakaj je bilo zdravilo Imatinib medac odobreno?
English: It is not intended to provide practical advice on how to use Imatinib medac.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: How has Imatinib medac been studied?
Slovenian: Kako je bilo zdravilo Imatinib medac raziskano?
English: How does Imatinib medac work?
Slovenian: Kako zdravilo Imatinib medac deluje?
English: How is Imatinib medac used?
Slovenian: Kako se zdravilo Imatinib medac uporablja?
English: Allergic-type reactions are rare.
Slovenian: Alergične reakcije so redke.
English: EXP: {month/year}
Slovenian: Exp : {mesec/leto}
English: ATC vet code : QI07AO01.
Slovenian: Oznaka ATC vet koda : QI07AO01.
English: For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glej poglavje 6.1.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Slovenian: a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti v živih živalih ali v živilih ali v drugih proizvodih, pridobljenih iz zdravljenih živali.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Slovenian: Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
English: Sodium chloride Water for injections
Slovenian: Natrijev klorid Voda za injekcije
English: Vaccination should not prevent other measures taken to reduce exposure to sandflies.
Slovenian: Cepljenje ne sme ovirati ukrepov za zmanjšanje izpostavljenosti peščeni mušici.
English: Pharmacotherapeutic group: Immunologicals for canidae - dog - inactivated parasitic vaccine.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za Canidae - pse - inaktivirano parazitno cepivo.
English: In very rare cases, serious hypersensitivity reactions have been observed which could be fatal.
Slovenian: V zelo redkih primerih so opazili hude hipersenzitivne reakcije, ki so lahko usodne.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Slovenian: Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 2 leti.
English: After injection, moderate and transient local reactions such as swelling, nodule, pain on palpation or erythema are common, but these reactions resolve spontaneously within 2 to 15 days.
Slovenian: Po dajanju so običajne zmerne in prehodne lokalne reakcije, kot so oteklina, vozlički, bolečina na otipavanje ali eritem, toda te reakcije spontano minejo v 2 do 15 dneh.
English: In very rare cases a more severe reaction at the injection site (injection site necrosis, vasculitis) has been reported.
Slovenian: V izjemno redkih primerih so poročali, da je na mestu injiciranja prišlo do močnejše reakcije (nekroza injiciranega mesta, vaskulitis).
English: Antibodies due to vaccination can be differentiated from antibodies due to natural infection by using a rapid diagnostic serological test as a first step to a differential diagnosis.
Slovenian: Protitelesa, ki se pojavijo zaradi cepljenja, je mogoče razlikovati od protiteles, ki se pojavijo zaradi naravne okuženosti, z uporabo hitrih diagnostičnih seroloških testov, kot prvi korak za diferencialno diagnozo.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Slovenian: Za vse informacije o tem zdravilu za uporabo v veterinarski medicini se obrnite na lokalnega predstavnika imetnika dovoljenja za promet.
English: Vaccinate only healthy animals.
Slovenian: Cepite le zdrave živali.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO »SAMO ZA ŽIVALI« IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
English: Onset of immunity: 4 weeks after the primary vaccination course.
Slovenian: Nastop imunosti: 4 tedne po primarnem cepljenju.
English: Any person intending to import, sell, supply and/or use CaniLeish must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Slovenian: Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati CaniLeish, se mora posvetovati s pristojnimi organi države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ali uporabo.
English: In order to facilitate the quick implementation of such treatment, should an anaphylactic reaction occur, an observation of the dog by the owner during the hours following vaccination is recommended.
Slovenian: Da bi olajšali hitro izvedbo takega zdravljenja, če bi se morda pojavila anafilaktična reakcija, priporočamo, da lastnik opazuje psa nekaj ur po cepljenju .
English: In dogs developing a leishmaniosis (active infection and/or disease) despite vaccination, proceeding with vaccine injections showed no benefit.
Slovenian: Za pse, ki so kljub cepljenju razvili leishmaniozo (aktivno okuženost in/ali bolezen), nadaljevanje dajanja cepiva ni pokazalo nobene koristi.
English: The impact of the vaccine in terms of public health and control of the human infection cannot be estimated from available data.
Slovenian: Vpliva cepiva na zdravje ljudi in obvladovanje okuženosti ljudi ni mogoče oceniti iz razpoložljivih podatkov.
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Slovenian: Ne uporabljajte v primeru preobčutljivosti na zdravilno učinkovino, dodatek ali katere koli pomožne snovi.
English: • an enhancement of the leishmanicidal activity of the macrophages,
Slovenian: • povečanje dejavnosti leismanocidnih makrofagov,
English: Other transient signs seen following vaccination such as hyperthermia, apathy and digestive disorders lasting 1 to 6 days are common.
Slovenian: Po cepljenju so običajni tudi drugi prehodni znaki, kot so hipertermija, apatija, prebavne motnje, ki trajajo od 1 do 6 dni.
English: The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure in zones with high infection pressure.
Slovenian: Učinkovitost cepiva je bila dokazana pri psih, ki so bili izpostavljeni številnim naravnim parazitom na območjih, kjer je okuženost zelo razširjena.
English: Read the package leaflet before use.
Slovenian: Pred uporabo preberite navodila.
English: • a positive T-cell-mediated immune response, directed against the Leishmanian antigen (skin test).
Slovenian: • pozitiven T-limfocitni imunski odziv, neposredno proti Leishmania antigenu(kožni test).
English: In areas of low or no infection pressure a benefit/risk assessment must be undertaken by the veterinarian before deciding to use the vaccine in dogs.
Slovenian: Na območjih, kjer je okuženost nizka ali je sploh ni, mora veterinar oceniti razmerje korist/tveganje, preden se odloči za uporabo cepiva pri psih.
English: The import, sale, supply and/or use of CaniLeish is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Slovenian: Uvoz, prodaja, oskrba in/ali uporaba CaniLeish je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
English: Vaccination induces a cell-mediated immunity evidenced by:
Slovenian: Dejstvo, da cepljenje inducira celično posredovano imunost dokazuje sledeče:
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Slovenian: BESEDILO »SAMO ZA ŽIVALI«
English: • the appearance of specific IgG2 antibodies to Leishmania infantum excreted secreted proteins,
Slovenian: • pojavljanje specifičnih IgG2 protiteles proti Leishmania infantumekskrecijsko-sekrecijskim proteinom,
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini..
English: The efficacy of vaccination in dogs already infected has not been investigated and therefore cannot be recommended.
Slovenian: Učinkovitost cepiva pri že okuženih psih ni bila proučena, zato cepljenje ni priporočljivo.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: POGOJI IN OMEJITVE GLEDE OSKRBE IN UPORABE
English: The appearance of the reconstituted product is reddish-brown.
Slovenian: Izgled rekonstituiranega zdravila je rdeče-rjave barve.
English: Mannitol
Slovenian: Manitol
English: Store and transport refrigerated (2 C - 8 C).
Slovenian: Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini med brejostjo in laktacijo ni bila ugotovljena.
English: Common (more than 1 but less than 10 animals in 100 animals), Uncommon (more than 1 but less than 10 animals in 1,000 animals), Rare (more than 1 but less than 10 animals in 10,000 animals), Very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 živali med enim ciklom zdravljenja) - pogosti (pri več kot 1 a manj kot 10 živali od 100 živali) - občasni (pri več kot 1 a manj kot 10 živali od 1.000 živali) - redki (pri več kot 1 a manj kot 10 živali od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: Leishmania infantum Excreted Secreted Proteins (ESP) at least 100 µg Adjuvant:
Slovenian: Leishmania infantum ekskrecijko-sekrecijski proteini (Excreted Secreted Proteins - ESP) najmanj 100 µg Dodatek:
English: EXP: {month/year} Use immediately after reconstitution.
Slovenian: Exp : {mesec/leto} Zdravilo porabite takoj po rekonstituciji.
English: Primary vaccination course: - First dose from 6 months of age, - Second dose 3 weeks later, - Third dose 3 weeks after the 2
Slovenian: Osnovno cepljenje: - prvi odmerek od starosti 6 mesecev, - drugi odmerek 3 tedne kasneje, - tretji odmerek 3 tedne po drugem odmerku.
English: Purified extract of Quillaja saponaria (QA-21): 60 µg
Slovenian: Prečiščeni ekstrakt Quillaja saponaria (QA-21): 60 µg
English: Lyophilisate: beige freeze-dried fraction Solvent: colourless liquid
Slovenian: Liofilizat: liofilizirana frakcija bež barve Vehikel: brezbarvna tekočina
English: Duration of immunity: 1 year after the last (re-)vaccination.
Slovenian: Trajanje imunosti: 1 leto po zadnjem cepljenju oz. ponovnem cepljenju.
English: Shelf life after first opening the immediate packaging: use immediately after reconstitution.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj po rekonstituciji.
English: Purified extract of Quillaja saponaria (QA-21) Trometamol
Slovenian: Prečiščeni ekstrakt Quillaja saponaria (QA-21) Trometamol
English: For the active immunization of Leishmania negative dogs from 6 months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum.
Slovenian: Za aktivno imunizacijo na Leishmanio negativnih psov, starejših od 6 mesece,, za zmanjšanje tveganja okužbe in kliničnih znakov bolezni, po stiku s parazitom Leishmania infantum.
English: After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the following vaccination schedule: Primary vaccination course: - First dose from 6 months of age, - Second dose 3 weeks later, - Third dose 3 weeks after the 2
Slovenian: Subkutana uporaba.Po rekonstituciji liofilizata z vehiklom rahlo pretresite in dajte takoj subkutano en odmerek po 1 ml, v skladu s sledečimi programom cepljenja: Osnovno cepljenje: - prvi odmerek od starosti 6 mesecev, - drugi odmerek 3 tedne kasneje, - tretji odmerek 3 tedne po drugem odmerku.
English: darprocedure@virbac.com
Slovenian: dar@virbac.com
English: CaniLeish lyophilisate
Slovenian: CaniLeish liofilizat
English: In rare cases anorexia and emesis have been reported.
Slovenian: V redkih primerih poročajo o anoreksiji in bruhanju.
English: Therefore, the use is not recommended during pregnancy and lactation.
Slovenian: Zato uporaba med brejostjo in laktacijo ni priporočljiva.
English: Each dose of 1 ml vaccine contains: L. infantum Proteins (ESP) ≥ 100 µg
Slovenian: Vsak odmerek po 1 ml cepiva vsebuje : Leishmania infantum proteini (ESP) ≥ 100 µg
English: L. infantum Proteins (ESP) ≥ 100 µg
Slovenian: L. infantum proteini (ESP) ≥ 100 µg
English: Box of 10 vials of lyophilisate and 10 vials of solvent Box of 15 vials of lyophilisate and 15 vials of solvent Box of 25 vials of lyophilisate and 25 vials of solvent Box of 30 vials of lyophilisate and 30 vials of solvent Box of 50 vials of lyophilisate and 50 vials of solvent
Slovenian: Škatla s 10 vialami liofilizata in 10 vialami vehikla Škatla z 15 vialami liofilizata in 15 vialami vehikla Škatla z 25 vialami liofilizata in 25 vialami vehikla Škatla z 30 vialami liofilizata in 30 vialami vehikla Škatla z 50 vialami liofilizata in 50 vialami vehikla
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJE DOVOLJENJA ZA PROMET
English: Injection of the vaccine to dogs already infected by Leishmania infantum did not show any specific adverse reactions other than those described in section 4.6.
Slovenian: Dajanje cepiva psom, ki so že okuženi s parazitom Leishmania infantum, ni pokazalo neželenih učinkov, razen tistih, ki so navedeni v poglavju 4.6.
English: De-worming of infested dogs prior to vaccination is recommended.
Slovenian: Pred cepljenjem priporočamo dehelmintizacijo okuženih psov.
English: Solvent: Sodium chloride solution 9 mg/ml (0.9%)
Slovenian: Vehikel: Raztopina natrijevega klorida 9 mg/ml (0.9%) 1 ml
English: After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the vaccination schedule.
Slovenian: Po rekonstituciji liofilizata z vehiklom rahlo pretresite in dajte takoj subkutano en odmerek po 1 ml, v skladu s sledečimi programom.
English: Annual re-vaccination: - One booster injection of a single dose should be given 1 year after the third injection and annually thereafter.
Slovenian: Letno ponovno cepljenje: - Krepitvena injekcija-en odmerek 1 leto po tretjem odmerku in nato enkrat letno.
English: CaniLeish lyophilisate and solvent for suspension for injection for dogs
Slovenian: CaniLeish liofilizat in vehihel za suspenzijo za injiciranje za pse.
English: Each dose of 1 ml vaccine contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak odmerek po 1 ml cepiva vsebuje:
English: Injection of the vaccine to dogs already infected by Leishmania infantum did not show any specific adverse reactions other than those described in section 6.
Slovenian: Dajanje cepiva psom, ki so že okuženi s parazitom Leishmania infantum, ni pokazalo neželenih učinkov, razen tistih, ki so navedeni v poglavju 6.
English: Sodium chloride 9 mg/ml (0.9%)
Slovenian: 9 mg/ml (0.9%) natrijevega klorida.
English: Tel. 0033/4.92.08.73.00
Slovenian: Tel. 0033/4.92.08.73.00 Faks.
English: The detection of Leishmania infection using a rapid serological diagnostic test is recommended prior to vaccination.
Slovenian: Pred cepljenjem je priporočljivo izvesti hiter serološki diagnostični test za ugotavljanje okuženosti z Leishmanio.
English: A symptomatic treatment should be rapidly implemented and clinical monitoring should be maintained until symptoms resolve.
Slovenian: Potrebno je hitro simptomatsko zdravljenje in treba je vzdrževati klinični nadzor, dokler dokler simptomi niso odpravljeni.
English: In case of anaphylactic reaction appropriate symptomatic treatment should be administered and clinical monitoring should be maintained until symptoms resolve.
Slovenian: V primeru anafilaktične reakcije je treba uvesti primerno simptomatsko zdravljenje in klinični nadzor je treba vzdrževati, dokler simptomi niso odpravljeni.
English: BATCH NUMBER
Slovenian: SERIJSKA ŠTEVILKA
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Slovenian: BESEDILO »ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM«
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalcabiološke zdravilne učinkovine)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJE, ČE STA RAZLIČNA Imetnik dovoljenja za promet z zdravilom in izdelovalec:
English: 4.5 Special precautions for use
Slovenian: 4.5 Posebni previdnosti ukrepi
English: Active substance:
Slovenian: Zdravilne učinkovine:
English: 1 dose
Slovenian: 1 odmerkom
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca) zdravila, odgovornega za sprostitev serije
English: Transient antibodies against Leishmania detected by immunofluorescence antibody test (IFAT) may appear after vaccination.
Slovenian: Po cepljenju se lahko razvijejo prehodna protitelesa proti Leshmania, ki jih odkrije imunofluorescenčni test za ugotavljanje protiteles (IFAT).
English: Type I glass vial containing 1 dose of lyophilisate and type I glass vial containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Slovenian: Viala iz stekla tipa I z 1 odmerkom liofilizata in viala iz stekla tipa I z 1 ml vehikla, zaprti z z zamaškom iz butilelastomera in zapečateni z aluminijastim pokrovčkom.
English: 1 dose.
Slovenian: 1 odmerkom.
English: Lyophilisate and solvent for suspension for injection.
Slovenian: Liofilizat in vehikel -suspenzija za injiciranje.
English: 30 doses.
Slovenian: 30 odmerkov.
English: Efficacy data have shown that a vaccinated dog has 3.6 times less risk to develop an active infection and 4 times less risk to develop a clinical disease than a non-vaccinated dog, on dogs submitted to multiple natural parasite exposure in zones with high infection pressure.
Slovenian: Podatki o učinkovitosti pri psih, ki so bili izpostavljeni številnim naravnim parazitom na območjih, kjer je okuženost zelo razširjena, kažejo, da imajo cepljeni psi 3-krat manj možnosti, da bi se okužili in 4krat manj možnosti, da bi razvili bolezen, kot necepljeni psi..
English: CaniLeish solvent
Slovenian: CaniLeish vehikel
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI OPADNIH SNOVI, ČE OBSTAJAJO
English: • a T-cell lymphoproliferation with the secretion of interferon gamma cytokine,
Slovenian: • proliferacijaT limfocitov z izločanjem interferon- gama citokinov
English: 25 doses.
Slovenian: 25 odmerkov.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
English: 10 doses.
Slovenian: 10 odmerkov.
English: PACKAGE SIZE
Slovenian: VELIKOST OVOJNINE
English: 3 doses.
Slovenian: 3 odmerkov.
English: Box of 3 vials of lyophilisate and 3 vials of solvent Box of 5 vials of lyophilisate and 5 vials of solvent
Slovenian: Škatla s 3 vialami liofilizata in 2 vialami z vehikla Škatla s 5 vialami liofilizata in 5 vialami z vehikla
English: The frequency of adverse reactions is defined using the following convention: Very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment),
Slovenian: Pogostost škodljivih reakcij definiramo tako, da uporabimo naslednji dogovor: - Zelo običajna (več kot 1 od 10 živali kaže znake škodljivih reakcij med potekom enega postopka zdravljenja), - Običajna (več kot 1, toda manj kot 10 živali od 100), - Nepogosta (več kot 1, toda manj kot 10 živali od 1000), - Redka (več kot 1, toda manj kot 10 živali od 10.000), - Zelo redka (manj kot 1 žival od 10.000, vključno z ločenimi poročili)
English: 50 doses.
Slovenian: 50 odmerkov.
English: EU/2/11/121/001-009
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/11/121/001-009
English: Box of 1 vial of lyophilisate and 1 vial of solvent Box of 1 vial of lyophilisate, 1 vial of solvent, 1 syringe and 1 needle.
Slovenian: Škatla z 1 vialo liofilizata in 1 vialo z vehikla Škatla z 1 vialo liofilizata, 1 vialo z vehikla, 1 vbrizgo in 1 iglo.
English: Lyophilisate
Slovenian: Liofilizat
English: 15 doses.
Slovenian: 15 odmerkov.
English: Plastic box containing 1 vial of 1 dose of lyophilisate, 1 vial of 1 ml of solvent, 1 syringe and 1 needle.
Slovenian: Plastična škatla z 1 vialo z 1 dozo liofilizata, 1 vialo z 1 ml topila, 1 brizgo in 1 iglo.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC(IZDELOVALCI) BIOLOŠKE AKTIVNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
English: 5 doses.
Slovenian: 5 odmerkov.
English: METHOD AND ROUTE OF ADMINISTRATION
Slovenian: NAČIN IN POT(IT) UPORABE
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Slovenian: Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem ali farmacevtom.
English: 4.1 Target species
Slovenian: KLINIČNI PODATKI 4.1 Ciljne živalske vrste Psi.