FrancophonIA/ELRC3.0 huggingface dataset:
English: Imatinib medac is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Croatian: Lijek Imatinib medac koristi se za liječenje odraslih bolesnika s DFSP-om koji nisu podobni za kirurški zahvat i odraslih bolesnika koji nisu podobni za kirurški zahvat u slučaju kada se rak ponovo razvio nakon prethodnog liječenja ili je metastazirao u druge dijelove tijela.
English: Imatinib medac is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Croatian: Lijek Imatinib medac koristi se za liječenje bolesnika koji imaju „pozitivan Philadelphia kromosom” (Ph+).
English: Imatinib medac is used to treat adults with MDS/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Croatian: Lijek Imatinib medac koristi se za liječenje odraslih bolesnika s MD/MPD-om s preraspodjelom gena za receptor za faktor rasta koji potječe od trombocita (PDGFR);
English: Because Imatinib medac is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Glivec.
Croatian: Budući da je lijek Imatinib medac generički lijek, ispitivanja na bolesnicima bila su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku Glivec.
English: Other information about Imatinib medac
Croatian: Ostale informacije o lijeku Imatinib medac
English: Imatinib medac is a ‘generic medicine'.
Croatian: Lijek Imatinib medac je „generički lijek”.
English: Imatinib medac is an anticancer medicine that contains the active substance imatinib.
Croatian: Lijek Imatinib medac je antikancerogeni lijek koji sadrži djelatnu tvar imatinib.
English: Imatinib medac is used in combination with other anticancer medicines in patients who have been newly diagnosed with Ph+ ALL.
Croatian: Lijek Imatinib medac koristi se zajedno s drugim antikancerogenim lijekovima u bolesnika s novodijagnosticiranim Ph+ ALL-om.
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.
Croatian: • djece s kroničnom mijeloičnom leukemijom (KML), rakom bijelih krvnih stanica u kojem granulociti (tip bijele krvne stanice) počinju nekontrolirano rasti.
English: It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
Croatian: Lijek Imatinib medac također se koristi samostalno za liječenje recidirajućeg Ph+ ALL-a nakon prethodnog liječenja ili u osoba koje ne reagiraju na druge lijekove;
English: • Adults and children with Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
Croatian: • odraslih osoba i djece s akutnom limfoblastičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ ALL), tipom raka u kojem se limfociti (drugi tip bijele krvne stanice) prebrzo umnožavaju.
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.
Croatian: • odraslih osoba s uznapredovalim hipereozinofilnim sindromom (HES) ili kroničnom eozinofilnom leukemijom (KEL), bolestima u kojima eozinofili (drugi tip bijele krvne stanice) počinju nekontrolirano rasti.
English: Why is Imatinib medac approved?
Croatian: Zašto je lijek Imatinib medac odobren?
English: The Committee recommended that Imatinib medac be approved for use in the EU.
Croatian: Odbor je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Imatinib medac is used in children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant.
Croatian: Lijek Imatinib medac primjenjuje se u djece s novodijagnosticiranim Ph+ KML-om te u kojih se transplantacija koštane srži ne smatra prvom linijom liječenja.
English: How does Imatinib medac work?
Croatian: Kako djeluje Imatinib medac?
English: How is Imatinib medac used?
Croatian: Kako se Imatinib medac koristi?
English: How has Imatinib medac been studied?
Croatian: Kako je lijek Imatinib medac ispitivan?
English: Allergic-type reactions are rare.
Croatian: Alergijske reakcije su rijetke.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Croatian: Za bilo koju informaciju o ovom veterinarsko medicinskom proizvodu molim da kontaktirate lokalnog zastupnika nositelja odobrenja za stavljanje u promet.
English: The appearance of the reconstituted product is reddish-brown.
Croatian: Izgled rekonstituiranog proizvoda je crvenkasto-smeđ.
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.
Croatian: a) će primjena veterinarsko-medicinskog proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole i eradikacije bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
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).
Croatian: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
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:
Croatian: Sukladno članku 71. Direktive 2001/82/EV i Europskog Parlamenta i Vijeća koja je dopunjena, države članice zabranjuju ili mogu zabraniti uvoz, prodaju, opskrbu i/ili primjenu veterinarsko-medicinskog proizvoda na cijelom teritoriju ili na jednom njegovom dijelu ako je utvrđeno da:
English: In very rare cases a more severe reaction at the injection site (injection site necrosis, vasculitis) has been reported.
Croatian: U vrlo rijetkim slučajevima prijavljene su teže reakcije na mjestu aplikacije (nekroze na mjestu injekcije, vaskulitis).
English: Keep out of the sight and reach of children.
Croatian: Čuvati izvan dosega i pogleda djece.
English: The impact of the vaccine in terms of public health and control of the human infection cannot be estimated from available data.
Croatian: Utjecaj cjepiva na zdravlje i kontrolu infekcije ljudi nije moguće procijeniti na osnovu raspoloživih podataka.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP, molimo obavijestite svog veterinara.
English: Each dose of 1 ml vaccine contains:
Croatian: Svaka doza od 1 ml cjepiva sadrži:
English: The efficacy of vaccination in dogs already infected has not been investigated and therefore cannot be recommended.
Croatian: Djelotvornost cijepljenja već inficiranih pasa nije istraživana te stoga ne može ni biti preporučena.
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.
Croatian: Uvoz, prodaja, opskrba i/ili primjena cjepiva CaniLeish je ili može biti zabranjena u određenim državama članicama na cijelom teritoriju ili na jednom njegovom dijelu sukladno nacionalnim odredbama zaštite zdravlja životinja.
English: EXP: {month/year} Use immediately after reconstitution.
Croatian: EXP {mjesec/godina} Primijeniti odmah nakon rekonstitucije.
English: Store and transport refrigerated (2 C - 8 C).
Croatian: Čuvati i prevoziti rashlađeno (2 C - 8 C).
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: Neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobivenih primjenom tih veterinarsko-medicinskih proizvoda treba odlagati u skladu s lokalnim propisima.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske Agencije za lijekove (EMA) http://www.ema.europa.eu/
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.
Croatian: Tko namjerava uvesti, prodavati, opskrbljivati i/ili primjenjivati CaniLeish mora konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju prije uvoza, prodaje, opskrbe i/ili primjene.
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.
Croatian: Protutijela podrijetlom od cijepljenja moguće je razlikovati od onih nastalih prirodnom infekcijom koristeći brzi dijagnostički serološki test kao prvi korak u diferencijalnoj dijagnostici.
English: Therefore, the use is not recommended during pregnancy and lactation.
Croatian: Zato se ne preporučuje primjena tijekom graviditeta i laktacije.
English: In very rare cases, serious hypersensitivity reactions have been observed which could be fatal.
Croatian: U vrlo rijetkim slučajevima mogu se pojaviti ozbiljne reakcije preosjetljivosti koje mogu dovesti do smrti životinje.
English: b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Croatian: b) je bolest za koju je odnosni veterinarsko-medicinski proizvod namijenjen da pruži imunost, odsutna s tog područja.
English: Vaccination should not prevent other measures taken to reduce exposure to sandflies.
Croatian: Cijepljenje ne bi smjelo sprječavati provođenje ostalih mjera za smanjenje izloženosti pješčanoj mušici.
English: Marketing authorisation holder and manufacturer:
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač:
English: Other transient signs seen following vaccination such as hyperthermia, apathy and digestive disorders lasting 1 to 6 days are common.
Croatian: Ostali prolazni znaci koji se uobičajeno mogu sresti su hiperemija, apatija ili probavni poremećaji u trajanju od 1 - 6 dana.
English: OTHER INFORMATION
Croatian: Ostale informacije
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.
Croatian: Za aktivnu imunizaciju pasa negativnih na lišmaniju u dobi od 6 mjeseci radi reduciranja rizika od razvitka aktivne infekcije i kliničke bolesti nakon kontakta sa Leishmania infantum.
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Croatian: Ne primjenjivati u slučaju preosjetljivosti na djelatnu tvar, na adjuvans ili na bilo koju od pomoćnih tvari.
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.
Croatian: U malo ili nimalo inficiranim područjima veterinar mora napraviti procjenu koristi i rizika prije nego odluči hoće li životinja biti cijepljena.
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološki djelatne tvari:
English: Vaccination induces a cell-mediated immunity evidenced by:
Croatian: Cijepljenje pobuđuje stanični imunitet što se očituje s:
English: • an enhancement of the leishmanicidal activity of the macrophages,
Croatian: • jačanjem lišmanocidnih aktivnosti makrofaga.
English: CaniLeish lyophilisate and solvent for suspension for injection for dogs
Croatian: CaniLeish, liofilizat i otapalo za suspenziju za injekciju za pse
English: Onset of immunity: 4 weeks after the primary vaccination course.
Croatian: Nastanak imuniteta: 4 tjedna poslije prvog cijepljenja
English: Purified extract of Quillaja saponaria (QA-21) Trometamol
Croatian: Pročišćeni ekstrakt Quillaja saponaria (QA-21) Trometamol
English: Sodium chloride 9 mg/ml (0.9%)
Croatian: Natrijev klorid 9 mg/ml (0,9%)
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.
Croatian: Cijepljenje pasa već inficiranih sa Leishmania infantum nije ukazao na specifične nuspojave različite od onih opisanih u odjeljku 6.
English: • a positive T-cell-mediated immune response, directed against the Leishmanian antigen (skin test).
Croatian: • pozitivnim T - limfocitnim imunološkim odgovorom protiv lišmanijskog antigena (kožni test).
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
English: In dogs developing a leishmaniosis (active infection and/or disease) despite vaccination, proceeding with vaccine injections showed no benefit.
Croatian: Kod pasa s kliničkim simptomima lišmanioze (aktivna infekcija i/ili bolest), unatoč vakcinaciji, nastavak davanja cjepiva nije dao rezultate.
English: • a T-cell lymphoproliferation with the secretion of interferon gamma cytokine,
Croatian: • proliferacijom T -stanica sa sekrecijom interferon gama citokina.
English: CaniLeish lyophilisate
Croatian: CaniLeish, liofilizat
English: • the appearance of specific IgG2 antibodies to Leishmania infantum excreted secreted proteins,
Croatian: • pojavom specifičnih IgG2 protutijela na ekskrecijsko/sekrecijske proteine Leishmania infantum.
English: Annual re-vaccination: - One booster injection of a single dose should be given 1 year after the third injection and annually thereafter.
Croatian: Jednokratna booster doza cjepiva bi trebala biti dana godinu dana nakon treće injekcije i potom svake godine.
English: Purified extract of Quillaja saponaria (QA-21): 60 µg
Croatian: Adjuvans: Pročišćeni ekstrakt Quillaja saponaria (QA-21): 60 µg
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double-dose of the vaccine.
Croatian: Dodatnih nuspojava u odnosu na one spomenute u odjeljku 4.6 nije bilo nakon aplikacije dvostruke doze cjepiva.
English: Duration of immunity: 1 year after the last (re-)vaccination.
Croatian: Trajanje imuniteta: 1 godinu nakon posljednjeg cijepljenja (ponovnog cijepljenja )
English: GEO. PAVLIDES & ARAOUZOS LTD 25-27 Dimostheni Severi, 1080 CY-1080 Nicosia - CYPRUS Τηλ: + 357 22456117
Croatian: LTD 25-27 Dimostheni Severi, 1080 CY-1080 Nicosia - CYPRUS Τηλ: + 357 22456117
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.
Croatian: Nakon rekonstitucije liofilizata s otapalom, nježno protresti i odmah aplicirati dozu od 1 ml potkožno prema planu cijepljenja.
English: In case of anaphylactic reaction appropriate symptomatic treatment should be administered and clinical monitoring should be maintained until symptoms resolve.
Croatian: U slučaju anafilaktičke reakcije trebalo bi primijeniti odgovarajući simptomatski tretman, a životinju treba nadzirati sve dok se simptomi u potpunosti ne povuku.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samo injiciranja, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: darprocedure@virbac.com
Croatian: E-mail. darprocedure@virbac.com
English: Vial with 1 dose of lyophilisate
Croatian: Bočica s jednom dozom liofilizata
English: Transient antibodies against Leishmania detected by immunofluorescence antibody test (IFAT) may appear after vaccination.
Croatian: Kratkotrajna protutijela na Leishmania mogu po cijepljenju biti otkrivena imunofluorescentnim testom na protutijela (IFAT).
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.
Croatian: Podaci o djelotvornosti dobiveni na psima koji su bili izloženi višekratnom kontaktu s prirodnim uzročnikom i u područjima s njegovim jakim prisustvom, pokazali su da cijepljeni psi imaju 3,6 puta manji rizik od razvitka aktivne infekcije i 4 puta manji rizik od razvitka kliničkog oboljenja od onih koji nisu cijepljeni.
English: The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure in zones with high infection pressure.
Croatian: Podaci o djelotvornosti su dobiveni na psima koji su bili izloženi višekratnom kontaktu s prirodnim uzročnikom u područjima s njegovim jakim prisustvom.
English: Each dose of 1 ml vaccine contains: L. infantum Proteins (ESP) ≥ 100 µg
Croatian: Svaka doza od 1 ml cjepiva sadrži: Leishmania infantum ptoteini (ESP) ≥ 100 µg
English: Pharmacotherapeutic group: Immunologicals for canidae - dog - inactivated parasitic vaccine.
Croatian: Farmakoterapijska grupa: imunološki proizvodi za kanide; psi; inaktivirano parazitsko cjepivo, ATCvet kod: QI07AO01
English: Solvent: Sodium chloride solution 9 mg/ml (0.9%)
Croatian: Otapalo: Natrijev klorid 9 mg/ml (0.9%)
English: Pack sizes:
Croatian: Veličina pakovanja:
English: Leishmania infantum Excreted Secreted Proteins (ESP) at least 100 µg Adjuvant:
Croatian: Leishmania infantum ekskrecijsko sekrecijski protein (Excreted Secreted Proteins, ESP) ne manje od 100 µg
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 2 godine Rok valjanosti nakon otvaranja unutarnjeg pakovanja: primijeniti odmah nakon rekonstitucije.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: In rare cases anorexia and emesis have been reported.
Croatian: U rijetkim slučajevima mogu se pojaviti anoreksija i intenzivno povraćanje.
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.
Croatian: Pojavi li se anafilaktička reakcija, a da bi se olakšala i ubrzala simptomatska terapija, preporuča sa da vlasnik nadzire životinju nekolko sati nakon primjene VMP.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Dodatnih nuspojava u odnosu na one spomenute u odjeljku 4.6 nije bilo nakon aplikacije dvostruke doze cjepiva.
English: INDICATION
Croatian: INDIKACIJA
English: The detection of Leishmania infection using a rapid serological diagnostic test is recommended prior to vaccination.
Croatian: Prije cijepljenja preporučuje se provođenje brze serološke dijagnostike infekcije na lišmaniju.
English: Batch: {number}
Croatian: Lot {broj}
English: Lyophilisate: beige freeze-dried fraction Solvent: colourless liquid
Croatian: Liofilizat i otapalo za suspenziju za injekciju Liofilizat: Bež liofilizirana tableta Otapalo: bezbojna tekućina
English: A symptomatic treatment should be rapidly implemented and clinical monitoring should be maintained until symptoms resolve.
Croatian: U takvom slučaju odmah treba primijeniti simptomatsku terapiju, te nadzirati životinju dok se simptomi u potpunosti ne povuku.
English: Plastic box containing 1 vial of 1 dose of lyophilisate, 1 vial of 1 ml of solvent, 1 syringe and 1 needle.
Croatian: Plastična kutija s 1 bočicom s 1 dozom liofilizata, 1 bočicom s 1 ml otapala, 1 štrcaljka i 1 igla.
English: Interactions with other medicinal products
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Croatian: 11. POSEBNE MJERE PRI ČUVANJU Čuvati izvan dosega i pogleda djece.
English: Primary vaccination course: - First dose from 6 months of age, - Second dose 3 weeks later, - Third dose 3 weeks after the 2
Croatian: Osnovno cijepljenje: -Prva doza od 6 mjeseci starosti.
English: ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
Croatian: F-06516 Carros Tel: 33 (0) 4 92 08 73 00
English: De-worming of infested dogs prior to vaccination is recommended.
Croatian: Prije cijepljenja trebalo bi sprovesti dehelmintizaciju pasa.
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.
Croatian: Poslije injekcije može doći do pojave prolaznih lokalnih reakcija poput otekline, čvorića, bola na dodir ili eritema.
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.
Croatian: Kutija s 1 bočicom liofilizata i jednom bočicom otapala, 1 štrcaljkom i 1 iglom.
English: L. infantum Proteins (ESP) ≥ 100 µg
Croatian: Leishmania infantum ptoteini (ESP) ≥ 100 µg
English: Sucrose
Croatian: Otapalo
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.
Croatian: Cijepljenje pasa već inficiranih s Leishmania infantum nije ukazao na specifične nuspojave različite od onih opisanih u odjeljku 4.6. Prije cijepljenja preporučuje se provođenje brze serološke dijagnostike infekcije na leišmaniju.
English: The frequency of adverse reactions is defined using the following convention:
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima:
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.
Croatian: U slučaju da nehotice dođe do samo injiciranja, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: To be supplied on veterinary subscription.
Croatian: Izdaje se samo na veterinarski recept.
English: STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
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.
Croatian: Obje zatvorene butil elastomerom i zapečaćene aluminijskom kapicom.
English: Plastic box containing 3 vials of 1 dose of lyophilisate and 3 vials of 1 ml of solvent.
Croatian: Plastična kutija s 3 bočice s 1 dozom liofilizata i 3 bočice s 1 ml otapala.
English: CaniLeish solvent
Croatian: CaniLeish, otapalo