FrancophonIA/ELRC3.0 huggingface dataset:
English: No adverse reactions were observed after an overdose administration (10 doses of lyophilisate and 2 doses of suspension) of the veterinary medicinal product other than those mentioned in section 4.6 except local reactions that can last longer (from 5 to 6 weeks at the most).
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Poslije predoziranja (10 doza liofilizata + dvije doze suspenzije ) veterinarsko-medicinskog proizvoda nisu primijećene druge nuspojave od onih već spomenutih u dijelu 4.6., osim lokalnih reakcija koje mogu trajati duže (najviše od 5-6 tjedana).
English: Lyophilisate:
Croatian: Liofilizat:
English: LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats
Croatian: Leucofeligen FeLV/RCP, liofilizat i suspenzija za suspenziju za injekciju za mačke
English: Live attenuated feline viral rhinotracheitis virus (strain F2)
Croatian: Atenuirani živi virus mačjeg rinotraheitisa (soj F2)
English: - feline viral rhinotracheitis to reduce clinical signs and viral excretion, - feline panleucopenia to prevent leucopenia and to reduce clinical signs, - feline leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Croatian: - virusnog rinotraheitisa mačaka, radi smanjenja kliničkih simptoma i izlučivanja virusa, - panleukopenije mačaka radi prevencije panleukopenije i smanjenja kliničkih simptoma, - leukemije mačaka, radi prevencije trajne viremije i kliničkih simptoma iste bolesti.
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.
Croatian: Cjepivo protiv virusnog rhinotraheitisa mačaka, kalicivirusa, panleukopenije i leukemije mačaka.
English: Live attenuated feline panleucopenia virus (strain LR 72)
Croatian: Atenuirani živi virus panleukopenije mačaka (soj LR 72)
English: Shelf life after reconstitution: use immediately.
Croatian: Rok valjanosti nakon rekonstitucije: primijeniti odmah.
English: Administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Croatian: Potkožno aplicirati jednu dozu (1 mL) VMP prema sljedećem režimu cijepljenja:
English: Sodium chloride Disodium phosphate anhydrous Potassium dihydrogen phosphate Aluminium hydroxide gel Quillaja saponaria Water for injections
Croatian: Kalijev hidroksid Laktoza monohidrat Glutaminska kiselina Kalijev dihidrogen fosfat Dikalij fosfat Voda za injekcije Natrijev klorid Bezvodni dinatrijev fosfat
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Croatian: 14. RIJEČI “ČUVATI IZVAN POGLEDA
English: Plastic or cardboard box of 10 lyophilisate vials and 10 suspension vials.
Croatian: Plastična ili kartonska kutija s 10 bočica s liofilizatom i 10 bočica sa suspenzijom.
English: For the leukaemia component, protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.
Croatian: Kod 73% mačaka, 3 tjedna nakon prvog cijepljenja, uočena je, za komponentu leukemije, zaštita od trajne viremije.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNEIH TVARI I PROIZVOĐAČI ODGOVORANI ZA PUŠTANJE SERIJE U PROMET
English: STATEMENT OF ACTIVE SUBSTANCES
Croatian: SASTAV DJELATNIH TVARI
English: After the primary vaccination course, the duration of immunity lasts for one year for all components.
Croatian: Trajanje imuniteta je godinu dana od prve vakcinacije za sve komponente.
English: A moderate and transient local reaction (<2 cm) is commonly observed after the first injection.
Croatian: Nakon prve primjene često su primijećene lokalne (≤ 2 cm) i prolazne reakcije.
English: The feline calicivirus and feline panleucopenia virus vaccine strains can spread.
Croatian: Cjepni sojevi mačjeg kalicivirusa i panleukopenije mogu se širiti.
English: Special warnings for each target species: Vaccinate healthy animals only.
Croatian: Posebna upozorenja za svaku od ciljnih vrsta životinja:
English: Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated for the leukaemia component.
Croatian: Nakon dodatnog cijepljenja, godinu dana nakon prvog cijepljenja, imunitet traje 3 godine za leukemiju.
English: Plastic or cardboard box of 50 lyophilisate vials and 50 suspension vials.
Croatian: Plastična ili kartonska kutija s 50 bočica s liofilizatom i 50 bočica sa suspenzijom .
English: LEUCOFELIGEN FeLV/RCP, lyophilisate for cats
Croatian: FeLV/RCP, liofilizat za mačke
English: Pain at palpation, sneezing or conjunctivitis may be noted in rare cases.
Croatian: U rijetkim slučajevima mogu se javiti bol na dodir, kihanje ili konjuktivitis, koji nestaju bez ikakvog tretmana.
English: - feline calicivirosis to reduce clinical signs, - feline viral rhinotracheitis to reduce clinical signs and viral excretion, - feline panleucopenia to prevent leucopenia and to reduce clinical signs,
Croatian: - kalicivirusa mačaka radi smanjenja kliničkih simptoma, - virusnog rinotraheitisa mačaka, radi smanjenja kliničkih simptoma i izlučivanja virusa, - panleukopenije mačaka radi prevencije leukopenije i smanjenja kliničkih simptoma, - leukemije mačaka, radi prevencije trajne viremije i kliničkih simptoma iste bolesti.
English: Excipient: Buffered isotonic solution to
Croatian: Pomoćna tvar: Izotonična puferska otopina do
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
English: Primary vaccination: - first injection in kittens from 8 weeks of age - second injection 3 or 4 weeks later.
Croatian: Prvo cijepljenje: - prva primjena mačićima starijim od 8 tjedana.
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za otpuštanje serije u promet:
English: SPECIAL STORAGE PRECAUTIONS
Croatian: 11. POSEBNI UVIJETI ČUVANJA
English: LABELLING AND PACKAGE LEAFLET
Croatian: OZNAČAVANJE I UPUTA O VMP
English: Suspension for LEUCOFELIGEN FeLV/RCP, for cats
Croatian: FeLV/RCP, za mačke
English: Type I glass vial containing one dose (1 ml) of the adjuvanted liquid, with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.
Croatian: Staklena bočica od stakla tipa I, koja sadrži jednu dozu (1 mL) tekućine s adjuvansima sa zatvaračem promjera 13 mm od butil elastomera i aluminijskom kapicom.
English: A type I glass vial containing one dose (1 ml) of the adjuvanted liquid vaccine, with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.
Croatian: Bočica od stakla tipa I, koja sadrži jednu dozu (1 mL) tekućeg cjepiva s adjuvansima sa zatvaračem promjera 13 mm od butil elastomera i aluminijskom kapicom.
English: Marketing authorisation holder and manufacturer responsible for the batch release:
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet : Virbac,
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: LYOPHILISATE VIAL
Croatian: Djelatne tvari
English: A type I glass vial containing one dose of freeze-dried attenuated live viral components with a butyl elastomer stopper.
Croatian: Bočica od stakla tipa I, koja sadrži jednu dozu liofilizirane atenuirane žive virusne komponente sa zatvaračem od butil elastomera.
English: Read the package leaflet before use Subcutaneous use
Croatian: Pročitati uputu o VMP prije primjene.
English: SUSPENSION VIAL
Croatian: Bočica sa suspenzijom
English: B. PACKAGE LEAFLET
Croatian: C. IZVJEŠĆE O MRL
English: Sodium chloride
Croatian: Suspenzija za LEUCOFELIGEN
English: if you drink alcohol excessively (either every day or only from time to time).
Croatian: - ako pijete pretjerane količine alkohola (svaki dan ili samo s vremena na vrijeme).
English: This medicine has been prescribed for you only.
Croatian: - Ovaj je lijek propisan samo Vama.
English: • Risk Management Plan (RMP)
Croatian: Plan upravljanja rizikom (RMP)
English: Metformin may act via three mechanisms:
Croatian: Metformin može djelovati putem tri mehanizma:
English: Absolute bioavailability is greater than 80%.
Croatian: Apsolutna bioraspoloživost veća je od 80%.
English: Do not take a double dose to make up for a forgotten tablet.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.
English: County Wicklow Ireland
Croatian: County Wicklow Irska
English: Two-year clinical studies have shown maintenance of this effect.
Croatian: Klinička ispitivanja u trajanju od dvije godine pokazala su održanje tog učinka.
English: You should not use this medicine if you are pregnant.
Croatian: Ne smijete uzimati ovaj lijek ako ste trudni.
English: These patients may be at risk of pregnancy.
Croatian: U tih bolesnica može postojati rizik od trudnoće.
English: 28065 Cerano (NO) Italy
Croatian: 28065 Cerano (NO) Italija
English: if you have blood in your urine that your doctor has not checked.
Croatian: - ako imate krv u mokraći, što Vaš liječnik nije provjerio.
English: The data presented during the current reporting period did not provide new information that would allow for further reduction, mitigation, or characterisation of these risks.
Croatian: Podaci predstavljeni tijekom trenutnog izvještajnog razdoblja nisu pružili nove informacije koje bi omogućile daljnje smanjenje, mitigaciju ili karakterizaciju tih rizika.
English: if you have a severe infection or are dehydrated.
Croatian: - ako imate tešku infekciju ili ste dehidrirani.
English: The recommended dose is one tablet taken twice daily.
Croatian: Preporučena doza je jedna tableta dvaput na dan.
English: not known not known
Croatian: nepoznato nepoznato
English: Aluminium/aluminium blisters.
Croatian: Aluminij/aluminij blisteri.
English: In particular, patients have experienced the following serious side effects:
Croatian: Konkretno, bolesnici su imali sljedeće ozbiljne nuspojave:
English: Three of the six identified metabolites are active (M-II, M-III, and M-IV).
Croatian: Tri od šest identificiranih metabolita su aktivni (M-II, M-III i M-IV).
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
Croatian: Ako se ovo odnosi na Vas, koristite odgovarajuću kontracepciju kako biste izbjegli neplaniranu trudnoću.
English: The red blood cells most likely represent a secondary compartment of distribution.
Croatian: Crvene krvne stanice najvjerojatnije predstavljaju sekundarni odjeljak raspodjele.
English: If necessary your doctor may tell you to take a different dose.
Croatian: Ako je potrebno, liječnik Vam može reći da uzmete i drugačiju dozu.
English: de la Industria 30 28108 Alcobendas Madrid
Croatian: Avda. de la Industria 30 28108 Alcobendas Madrid
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako su Vam rekli liječnik ili ljekarnik.
English: Talk to your doctor for further instructions.
Croatian: Obratite se liječniku za daljnje upute.
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Croatian: Prosječna dob ispitivane populacije bila je 62 godine; prosječno trajanje šećerne bolesti bilo je 9,5 godina.
English: Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Croatian: Tjelesnu težinu trebate provjeravati u redovitim vremenskim razmacima; ako Vam se težina poveća, obavijestite o tome svog liječnika.
English: Date of first authorisation: 11 December 2007 Date of latest renewal: 10 November 2017
Croatian: Datum posljednje obnove odobrenja: 10. studenog 2017.
English: Steady state is achieved after 4-7 days of dosing.
Croatian: Stanje dinamičke ravnoteže postiže se nakon 4-7 dana doziranja.
English: The relevance of this finding is unknown.
Croatian: Važnost ovog nalaza nije poznata.
English: if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old.
Croatian: - ako zadržavate vodu (nakupljanje tekućine) ili imate tegobe zatajenja srca, osobito ako ste stariji od 75 godina.
English: What Glubrava is and what it is used for
Croatian: Što je Glubrava i za što se koristi
English: Talk to your doctor before stopping this treatment.
Croatian: Razgovarajte s liječnikom prije nego što prekinete liječenje.
English: The presence of microcrystals exacerbated the hyperplastic response but was not considered to be the primary cause of hyperplastic changes.
Croatian: Prisutnost mikrokristala pogoršala je hiperplastički odgovor, ali nije se smatrala primarnim uzrokom hiperplastičnih promjena.
English: No metabolites have been identified in humans.
Croatian: U ljudi nisu pronađeni metaboliti.
English: Although in very rare cases fatal outcome has been reported, causal relationship has not been established.
Croatian: Iako su u vrlo rijetkim slučajevima zabilježeni smrtni ishodi, uzročno-posljedični odnos nije bio ustanovljen.
English: Plasma protein binding is negligible.
Croatian: Vezanje za proteine plazme je zanemarivo.
English: Children and adolescents Use in children and adolescents under 18 years is not recommended.
Croatian: Ne preporučuje se primjena u djece i adolescenata mlađih od 18 godina.
English: If you wish to become pregnant, your doctor will advise you to discontinue this medicine.
Croatian: Ako želite zatrudnjeti, liječnik će Vam savjetovati da prestanete uzimati ovaj lijek.
English: Tablets should be swallowed with a glass of water.
Croatian: Tablete se trebaju progutati uz čašu vode.
English: Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Croatian: Pioglitazon i svi djelatni metaboliti uglavnom su vezani za proteine plazme (> 99%)
English: The estimated volume of distribution in humans is 0.25 L/kg.
Croatian: Procijenjeni volumen raspodjele u ljudi je 0,25 l/kg.
English: The clinical relevance of this decrease is unknown.
Croatian: Klinički značaj tog sniženja nije poznat.
English: If you take more Glubrava than you should
Croatian: Ako uzmete više lijeka Glubrava nego što ste trebali
English: Women of childbearing potential / Contraception in males and females
Croatian: Žene reproduktivne dobi / Kontracepcija u muškaraca i žena
English: This check should be repeated at intervals.
Croatian: Ova se pretraga treba redovito ponavljati.
English: if you recently had a heart attack, have severe circulatory problems including shock, or breathing difficulties.
Croatian: - ako ste nedavno imali srčani udar, imate teške smetnje cirkulacije uključujući šok ili poteškoće s disanjem.
English: Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Croatian: Približno polovica ispitivane populacije imala je najmanje dva kardiovaskularna kriterija za uključenje u ispitivanje.
English: Packs of 14, 28, 30, 50, 56, 60, 90, 98 and 180 tablets.
Croatian: Pakiranja s 14, 28, 30, 50, 56, 60, 90, 98 i 180 tableta.
English: Immune System Disorders hypersensitivity and allergic reactions1
Croatian: Poremećaji imunološkog sustava preosjetljivost i alergijske reakcije1
English: if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye), talk to your doctor if you notice any change to your vision.
Croatian: - ako imate posebni tip dijabetičke bolesti oka koja se zove makularni edem (oteknuće stražnjeg segmenta oka), razgovarajte sa svojim liječnikom ako primijetite bilo kakve promjene vida.
English: Many of these patients reported concurrent peripheral oedema.
Croatian: Mnogi od tih bolesnika istodobno su prijavili periferne edeme.
English: In addition, increased fatty deposition and infiltration were observed.
Croatian: Osim toga, primijećeno je povećano odlaganje i infiltracija masti.
English: It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Croatian: Preporučuje se da kod sebe uvijek imate kocke šećera, bombone, kekse ili slatki voćni sok.
English: However, this did not lead to an increase in mortality in this study.
Croatian: Međutim, to nije povećalo smrtnost u ovom ispitivanju.
English: However if you miss a dose, skip the missed dose and just carry on with the next dose as normal.
Croatian: Međutim, ako propustite uzeti dozu, preskočite propuštenu dozu i jednostavno uzmite sljedeću dozu prema uobičajenom rasporedu.
English: The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Croatian: Maksimalnu dnevnu dozu metformina treba po mogućnosti podijeliti u 2-3 dnevne doze.
English: However patients who experience visual disturbance should be cautious when driving or using machines.
Croatian: Međutim, bolesnici koji imaju poremećaj vida trebaju biti oprezni prilikom upravljanja vozilima i rukovanja strojevima.
English: As a consequence, the conditions or restrictions with regards to the safe and effective use of the medicinal product should be updated to remove the additional risk minimisation measures.
Croatian: Posljedično, potrebno je ažurirati uvjete ili ograničenja vezana uz sigurnu i učinkovitu primjenu lijeka kako bi se uklonile dodatne mjere minimizacije rizika.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Croatian: Metformin povećava transportni kapacitet nekih tipova membranskih transportera glukoze (GLUT-1 i GLUT-4).
English: Other medicines and Glubrava
Croatian: Drugi lijekovi i Glubrava
English: The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Croatian: Najviša zabilježena doza od 120 mg na dan tijekom četiri dana, potom 180 mg na dan tijekom sedam dana, nije bila povezana ni sa kakvim simptomima.
English: On this basis M-IV contribution to efficacy is approximately three-fold that of pioglitazone, whilst the relative efficacy of M-II is minimal.
Croatian: Na temelju toga, doprinos metabolita M-IV djelotvornosti približno je trostruko veći od doprinosa pioglitazona, dok je relativna djelotvornost M-II minimalna.
English: In some cases weight increase may be a symptom of cardiac failure; therefore weight should be closely monitored.
Croatian: U nekim slučajevima, povećanje tjelesne težine može biti simptom zatajenja srca; stoga se tjelesna težina mora pažljivo pratiti.
English: At least once a year (more often if you are elderly or have kidney problems) your doctor will check that your kidneys are working normally.
Croatian: Najmanje jedanput godišnje (češće ako ste starije dobi ili imate tegobe s bubrezima) liječnik će provjeriti rade li Vaši bubrezi normalno.
English: Your doctor will decide when you must stop and when to restart your treatment with Glubrava.
Croatian: Liječnik će odlučiti kada morate prekinuti i kada ćete nastaviti s liječenjem lijekom Glubrava.
English: Your blood sugar could fall below the normal level and can be increased by taking sugar.
Croatian: Šećer u krvi bi Vam mogao pasti ispod normalne razine što se može normalizirati uzimanjem šećera.
English: Patients and/or care-givers should be informed on the risk of lactic acidosis.
Croatian: Bolesnici i/ili njegovatelji moraju biti informirani o riziku od laktacidoze.
English: In case of suspected symptoms, the patient should stop taking Glubrava and seek immediate medical attention.
Croatian: U slučaju sumnje na simptome, bolesnik treba prestati uzimati Glubrava i odmah potražiti pomoć liječnika.
English: Not known - inflammation of the liver (hepatitis) - liver does not work as well as it should (changes in liver enzymes)
Croatian: Nepoznato upala jetre (hepatitis) - jetra ne funkcionira onako dobro kako bi trebala (promjene jetrenih enzima)
English: If ALT levels remain > 3 x the upper limit of normal, therapy should be discontinued.
Croatian: Ako razine ALT ostanu > 3 x iznad gornje granice normale, terapiju treba prekinuti.
English: The mean Vd ranged between 63-276 L.
Croatian: Raspon prosječnog Vd bio je između 63 l i 276 l.
English: You should swallow the tablets with a glass of water.
Croatian: Tablete trebate progutati uz čašu vode.
English: The level of sugar in your blood or urine should be checked regularly.
Croatian: Trebate redovito provjeravati razinu šećera u krvi ili mokraći.
English: Do not take Glubrava: if you are allergic to pioglitazone, metformin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati lijek Glubrava: - ako ste alergični na pioglitazon, metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Thus free (unbound) pioglitazone concentration is unchanged.
Croatian: Stoga je koncentracija slobodnog (nevezanog) pioglitazona neizmijenjena.
English: During treatment with Glubrava, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Croatian: Tijekom liječenja lijekom Glubrava, liječnik će Vam provjeravati funkciju bubrega najmanje jedanput godišnje ili češće ako ste starija osoba i/ili ako Vam se funkcija bubrega pogoršava.
English: Previous anti-diabetic medicinal products were discontinued for 12 weeks prior to baseline measurements.
Croatian: Prethodna primjena antidijabetičkih lijekova bila je prekinuta tijekom 12 tjedana prije početnih mjerenja.
English: This study showed an increase in reports of heart failure; however this did not lead to an increase in mortality in this study.
Croatian: U ovom je ispitivanju zabilježen povećani broj slučajeva zatajenja srca; međutim, to nije izazvalo povećanje smrtnosti u ovom ispitivanju.
English: Proportional increases of the plasma concentration were observed for doses from 2-60 mg.
Croatian: Proporcionalno povišenje koncentracije u plazmi bilo je primijećeno kod doza od 2 mg do 60 mg.
English: Metformin is contra-indicated
Croatian: Metformin je kontraindiciran
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: Njihova je učestalost definirana na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: if you have severely reduced kidney function.
Croatian: - ako imate jako smanjenu funkciju bubrega.
English: FOR CALENDARISED PACKS: Mon. 1
Croatian: ZA KALENDARSKA PAKIRANJA Pon 1
English: No increase in mortality from heart failure was observed.
Croatian: Nije primijećeno povećanje smrtnosti zbog zatajenja srca.
English: The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Croatian: Srednja vrijednost poluvremena eliminacije neizmijenjenog pioglitazona iz plazme u čovjeka iznosi 5 do 6 sati, a za njegove djelatne metabolite ukupno 16 do 23 sata.
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Italy Lilly S.A., Avda.
Croatian: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Irska Delpharm Novara S.r.l, Via Crosa, 86, I-28065 Cerano (NO), Italija Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Španjolska
English: Glubrava with alcohol
Croatian: Glubrava s alkoholom
English: Based on the data presented, the risk minimisation measures in the approved product information are considered adequate for the listed safety concerns.
Croatian: Temeljem predstavljenih podataka, mjere minimizacije rizika u odobrenim informacijama o lijeku smatraju se dostatnima za navedena sigurnosna pitanja.
English: They are supplied in aluminium/aluminium blister in packs of 14, 28, 30, 50, 56, 60, 90, 98 or 180 tablets.
Croatian: Isporučuju se u aluminij/aluminij blisteru u pakiranjima od 14, 28, 30, 50, 56, 60, 90, 98 ili 180 tableta.