FrancophonIA/ELRC3.0 huggingface dataset:
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) - 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: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja jednog 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: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar koja se sastoji od tvari biološkog podrijetla, namijenjenih za stvaranje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: Amount per 2 ml dose (cattle)
Croatian: Količina po dozi od 2 ml (goveda)
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: To stimulate active immunity against Schmallenberg virus in cattle and sheep.
Croatian: Za stimuliranje aktivnog imuniteta protiv virusa Schmallenberg u goveda i ovaca.
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 IH IMA
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva ukoliko se primjenjuje zajedno s bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: Shake the vial before use.
Croatian: Protresti bočicu prije upotrebe.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated.
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati i prevoziti na hladnom.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrjebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda moraju se odlagati u skladu s lokalnim propisima.
English: No information is available on the use of the vaccine in seropositive animals including those with maternally-derived antibodies.
Croatian: Nisu dostupne informacije o primjeni cjepiva u seropozitivnih životinja uključujući i one koje posjeduju antitijela od majki
English: Provide data to support the effectiveness of the antimicrobial preservative at the end of shelf life
Croatian: Osigurati podatke koji će dokazati učinkovitost antimikrobnog konzervansa na kraju roka valjanosti
English: Pharmacotherapeutic group: immunologicals for bovidae, inactivated viral vaccines for cattle.
Croatian: Farmakoterapijska grupa: imunološki pripravak za goveda, inaktivirano virusno cjepivo za goveda.
English: Zoetis Česká republika, s.r.o.
Croatian: Česká republika Zoetis Česká republika, s.r.o.
English: PHARMACEUTICAL FORM Suspension for injection.
Croatian: Suspenziju za injekciju.
English: Provide batch records for a second batch of finished product manufactured according to the dossier
Croatian: Osigurati podatke o seriji za drugu po redu seriju gotovih proizvoda proizvedenih sukladno dosjeu
English: Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Croatian: Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet: Zoetis Manufacturing & Research Spain, S.L.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH
English: Intramuscular use (in the neck).
Croatian: Intramuskularna primjena (u vrat).
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated Schmallenberg virus (RP ≥ 1/dose)
Croatian: Inaktivirani virus Schmallenberg (RP ≥ 1/doza)
English: Subcutaneous use (in the axillar region behind the elbow).
Croatian: Subkutana primjena (u području pazuha iza lakta).
English: • OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES The MAH shall complete, within the stated timeframe, the following measures: Description
Croatian: Nositelj odobrenja treba u zadanom vremenskom razdoblju ispuniti sljedeće mjere:
English: Sheep: subcutaneous use.
Croatian: Ovce: subkutana primjena.
English: Deutschland Zoetis Deutschland GmbH Tel: +49 30 330063 0
Croatian: Zoetis Deutschland GmbH Tel: +49 30 330063 0
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/178/001
Croatian: EU/2/14/178/001
English: 0.1 mg * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species
Croatian: 0,1 mg *Relativna potencija (test potencije na miševima) u usporedbi s referentnim cjepivom koje je pokazalo djelotvornost u ciljnih vrsta životinja
English: SC (sheep)
Croatian: ml (ovce)
English: Cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.
Croatian: Kartonska kutija s 1 bočicom od polietilena visoke gustoće (HDPE) s klorobutilnim čepom i aluminijskom poklopcem, koja sadrži 50 ml cjepiva.
English: 0.1 mg * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species.
Croatian: 0,1 mg * Relativna potencija (test potencije na miševima) u usporedbi s referentnim cjepivom koje je pokazalo djelotvornost u ciljnih vrsta životinja.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Cattle:
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
English: Booster vaccination: administer two doses of 2 ml three weeks apart, every twelve months.
Croatian: Nadocjepljivanje: primijenite dvije doze od 2 ml s razmakom od tri tjedna, svakih dvanaest mjeseci.
English: Booster vaccination: - For non-breeding sheep: administer one dose of 1 ml, every 6 months.
Croatian: Nadocjepljivanje: - Ovce koje nisu za rasplod: primijenite jednu dozu od 1 ml,svakih 6 mjeseci.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU
English: Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 8 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy.
Croatian: Cijepljenje rasplodnih ovaca prije graviditeta u skladu s preporučenim rasporedom, opisanim u odjeljku 8 rezultira smanjenjem viremije* i transplacentalne infekcije povezanima s infekcijom virusom Schmallenberg tijekom prvog tromjesečja graviditeta.
English: PACKAGE LEAFLET FOR: ZULVAC SBV suspension for injection for cattle and sheep
Croatian: UPUTA O VMP ZA: ZULVAC SBV suspenzija za injekciju za goveda i ovce
English: Primary vaccination: - For cattle from 3.5 months of age: administer two doses of 2 ml three weeks apart.
Croatian: Primarno cijepljenje: - Za goveda u dobi od 3,5 mjeseca: primijenite dvije doze od 2 ml s razmakom od tri tjedna.
English: Sheep: Safety data are available to demonstrate the safety of the vaccine when administered to pregnant sheep.
Croatian: Ovce: dostupni su podaci o neškodljivosti koji dokazuju neškodljivost cjepiva kod primjene na gravidnim ovcama.
English: Primary vaccination: - For sheep from 3.5 months of age: administer one dose of 1 ml.
Croatian: Primarno cijepljenje: - Ovce u dobi od 3,5 mjeseca: primijenite jednu dozu od 1 ml.
English: Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 4.9 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy.
Croatian: Cijepljenje rasplodnih ovaca prije graviditeta u skladu s preporučenim rasporedom, opisanim u odjeljku 4.9 rezultira smanjenjem viremije* i transplacentalne infekcije povezanima s infekcijom virusom Schmallenberg tijekom prvog tromjesečja graviditeta.
English: United Kingdom Zoetis UK Limited Tel: +44 (0) 845 300 8034
Croatian: Zoetis UK Limited Tel: +44 (0) 845 300 8034
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Croatian: 11. POSEBNE MJERE PRI ČUVANJU Držati izvan pogleda i dosega djece.
English: België/Belgique/Belgien Zoetis Belgium SA Tél/Tel.
Croatian: België/Belgique/Belgien
English: Onset of immunity: 21 days after vaccination.
Croatian: Početak imuniteta: 21 dan nakon cijepljenja.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC SBV suspension for injection for cattle and sheep
Croatian: ZULVAC SBV suspenzija za injekciju za goveda i ovce
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET
English: Duration of immunity: 6 months after vaccination.
Croatian: Trajanje imuniteta: 6 mjeseci nakon cijepljenja.
English: ZULVAC SBV is available in a cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.
Croatian: ZULVAC SBV dostupan je u kartonskoj kutiji s 1 bočicom koja sadrži 50 ml cjepiva.
English: Duration of immunity: 12 months after completion of the primary vaccination course.
Croatian: Trajanje imuniteta: 12 mjeseci nakon završetka primarnog cijepljenja.
English: Onset of immunity: 14 days after completion of the primary vaccination course.
Croatian: Početak imuniteta: 14 dana nakon završetka primarnog cijepljenja.
English: Cattle: The safety and efficacy of the vaccine have not been established during pregnancy.
Croatian: Goveda: neškodljivost i djelotvornost cjepiva nisu bili utvrđeni tijekom graviditeta.
English: For active immunisation of cattle from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus.
Croatian: Za aktivnu imunizaciju goveda u dobi od 3,5 mjeseca kako bi se smanjila viremija* povezana s infekcijom virusom Schmallenberg.
English: Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1
Croatian: Nositelj odobrenja za stavljanje u promet: Zoetis Belgium SA
English: For active immunisation of sheep from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus.
Croatian: Za aktivnu imunizaciju ovaca u dobi od 3,5 mjeseca kako bi se smanjila viremija* povezana s infekcijom virusom Schmallenberg.
English: Tel: +39 06 3366 8133
Croatian: Zoetis Italia S.r.l. Tel: +39 06 3366 8133
English: Name and address of the manufacturer of the biological active substance and the manufacturer responsible for batch release:
Croatian: Naziv i adresa proizvođača biološki djelatne tvari i proizvođača odgovornog za puštanje serije u promet
English: Cattle: The safety and efficacy of the vaccine has not been established in pregnant cattle.
Croatian: Goveda: neškodljivost i djelotvornost cjepiva nisu utvrđeni u gravidnih goveda.
English: WITHDRAWAL PERIOD Zero days.
Croatian: Karencija: nula dana.
English: The reactions may last for at least 47 days in the form of diffuse swelling of less than 2 cm diameter.
Croatian: Reakcije u obliku difuznih oteknuća manjih od 2 cm u promjeru mogu trajati najmanje 47 dana.
English: Local reactions may very commonly appear in the vaccinated animals in the form of small intramuscular granulomas up to 0.7 cm of diameter, which resolve in a maximum of 10 days.
Croatian: Vrlo često se mogu pojaviti lokalne reakcije kod cijepljenih životinja u obliku malih intramuskularnih granuloma promjera do 0,7 cm, koji nestaju najduže nakon10 dana.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Aluminium hydroxide Saponin
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari
English: Local reactions may very commonly appear in the vaccinated animals in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm.
Croatian: Vrlo često se mogu pojaviti lokalne reakcije kod cijepljenih životinja u obliku malih difuznih oteknuća ili subkutanih granuloma promjera od najviše 8 cm.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
English: ROUTE(S) OF ADMINISTRATION IM (cattle)
Croatian: i.m. (goveda) s.c. (ovce)
English: The reactions may persist for at least 97 days in the form of small granules of less than 0.5 cm of diameter.
Croatian: Reakcije u obliku malih granula koje su u promjeru manje od 0,5 cm mogu trajati minimalno 97 dana .
English: In pregnant ewes, a transient increase in rectal temperature, not exceeding 0.8 ºC, may very commonly occur during the first 4 hours after vaccination.
Croatian: U gravidnih ovaca, tijekom prva 4 sata nakon cijepljenja, vrlo često se može javiti prolazno povišenje rektalne temperature, koje ne prelazi 0,8 °C.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial (50 ml)
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: - For female sheep at breeding age:administer one dose of 1 ml at least 14 days prior to breeding.
Croatian: - Ženke ovaca u dobi za rasplod: primijenite jednu dozu od 1 ml najmanje 14 dana prije parenja.
English: Special precautions for use in animals Vaccinate only healthy animals.
Croatian: Cijepite samo zdrave životinje.
English: - For female breeding sheep: administer one dose of 1 ml at least 14 days prior to every breeding.
Croatian: - Ženke ovaca u rasplodnoj dobi: primijenite jednu dozu od 1 ml, najmanje 14 dana prije svakog parenja.
English: In cattle, a transient increase in rectal temperature, not exceeding 1.5 °C, may very commonly occur during the 48 hours following vaccination.
Croatian: U goveda se, tijekom 48 sati nakon cijepljenja, vrlo često može pojaviti prolazno povišenje rektalne temperature, koje ne prelazi 1,5 °C.
English: Suomi/Finland Zoetis Finland Oy Puh/Tel: +358 (0)9 4300 40
Croatian: Zoetis Finland Oy Puh/Tel: +358 (0)9 4300 40
English: Tel: +48 22 2234800
Croatian: Zoetis Polska Sp. z o.o. Tel: +48 22 2234800
English: In sheep, a transient increase in rectal temperature, not exceeding 1.5 ºC, may very commonly occur during the first 24 hours after vaccination.
Croatian: U ovaca se tijekom prvih 24 sata nakon cijepljenja, vrlo često može pojaviti prolazno povišenje rektalne temperature, koja ne prelazi 1,5 °C.
English: Hrvatska
Croatian: KARENCIJA
English: Lactation: The safety and the efficacy of the vaccine have not been established in lactating animals.
Croatian: Neškodljivost i djelotvornost cjepiva nisu utvrđeni u životinja u laktaciji.
English: AUTHORISATION
Croatian: Opis
English: Zoetis Hellas S.A.
Croatian: Zoetis Hungary Kft.
English: Luxembourg/Luxemburg Zoetis Belgium SA Tél/Tel.
Croatian: Luxembourg/Luxemburg
English: On a regular basis
Croatian: SAVJET ZA ISPRAVNU PRIMJENU
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: intramuscular use.
Croatian: Goveda: Intramuskularna primjena (u vrat).
English: Lactation: The safety and the efficacy of the vaccine have not been established during lactation.
Croatian: Neškodljivost i djelotvornost cjepiva nisu utvrđeni tijekom laktacije.
English: Fertility: The safety and the efficacy of the vaccine have not been established in breeding males.
Croatian: Neškodljivost i djelotvornost cjepiva nisu utvrđeni u rasplodnih mužjaka.
English: ADVICE ON CORRECT ADMINISTRATION Shake the vial before use.
Croatian: 4.9 Količine koje se primjenjuju i put primjene Protresite bočicu prije primjene.
English: Magyarország Zoetis Hungary Kft. Tel: +361 224 5222
Croatian: Zoetis Belgium SA Tél/Tel.: +352 8002 4026
English: Special precautions for use in animals: Vaccinate only healthy animals.
Croatian: Posebne mjere opreza prilikom primjene na životinjama:
English: The ‘class' reflects the severity of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity.
Croatian: „Razred” se odnosi na težinu bolesti: „razred II” uključuje blago ograničenje fizičke aktivnosti, a „razred III” odnosi se na veća ograničenja fizičke aktivnosti.
English: Further information on Ambrisentan Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ambrisentan-mylan.
Croatian: Više informacija o lijeku Ambrisentan Mylan dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/ambrisentan-mylan.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Croatian: Dva su lijeka bioekvivalentna ako u tijelu postižu iste razine djelatne tvari i stoga se očekuje da imaju isti učinak.
English: When taken with ciclosporin (a medicine that reduces the activity of the immune system) the dose of Ambrisentan Mylan should be 5 mg daily and the patient should be closely monitored by their doctor.
Croatian: Kada se uzima s ciklosporinom (lijekom koji smanjuje aktivnost imunosnog sustava), doza lijeka Ambrisentan Mylan trebala bi iznositi 5 mg dnevno, a bolesnika bi pozorno trebao nadzirati njegov liječnik.
English: The dose is increased to 10 mg daily when the medicine is used with tadalafil (another medicine for PAH).
Croatian: Doza se povećava na 10 mg dnevno kada se lijek primjenjuje s tadalafilom (drugim lijekom za liječenje PAH-a).
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Croatian: PAH je abnormalno visok krvni tlak u plućnim arterijama.
English: Ambrisentan Mylan is available as tablets (5 and 10 mg).
Croatian: Lijek Ambrisentan Mylan dostupan je u obliku tableta (5 i 10 mg).
English: Ambrisentan Mylan is used in patients with class II or III disease.
Croatian: Ambrisentan Mylan primjenjuje se u bolesnika s razredom bolesti II ili III.
English: As a result, the amount of oxygen that can get into the blood in the lungs is reduced, making physical activity more difficult.
Croatian: Posljedica je toga smanjena količina kisika koja može dospjeti u krv u plućima, što otežava fizičku aktivnost.
English: This means that Ambrisentan Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Volibris.
Croatian: To znači da Ambrisentan Mylan sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Volibris.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Volibris, and do not need to be repeated for Ambrisentan Mylan.
Croatian: Ispitivanja koristi i rizika djelatne tvari u odobrenoj primjeni već su provedena s referentnim lijekom Volibris i stoga ih nije potrebno ponavljati za lijek Ambrisentan Mylan.
English: The company that markets Ambrisentan Mylan will provide a patient card containing important information on the medicine's side effects and the need to avoid pregnancy during treatment.
Croatian: Tvrtka koja stavlja lijek Ambrisentan Mylan u promet osigurat će karticu za bolesnike s važnim informacijama o nuspojavama lijeka i o potrebi izbjegavanja trudnoće tijekom terapije.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ambrisentan Mylan have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ambrisentan Mylan također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: What measures are being taken to ensure the safe and effective use of Ambrisentan Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ambrisentan Mylan?
English: Because Ambrisentan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Ambrisentan Mylan generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: By blocking the effect of endothelin, Ambrisentan Mylan prevents the vessels becoming too narrow helping to lower the blood pressure and improving symptoms.
Croatian: Blokiranjem učinka endotelina Ambrisentan Mylan sprječava preveliko sužavanje krvnih žila, čime pridonosi snižavanju krvnog tlaka i poboljšanju simptoma.
English: Treatment is started at a dose of 5 mg daily and the doctor may increase it to 10 mg daily depending on response and any side effects experienced by the patient.
Croatian: Terapija lijekom Ambrisentan Mylan započinje dozom od 5 mg dnevno koju liječnik može povećati na 10 mg dnevno, ovisno o odgovoru bolesnika i nuspojavama koje mogu nastupiti u bolesnika.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ambrisentan Mylan has been shown to have comparable quality and to be bioequivalent to Volibris.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da lijek Ambrisentan Mylan ima usporedivu kakvoću te da je bioekvivalentan s lijekom Volibris.
English: Ambrisentan Mylan is a medicine that is used alone or combined with other medicines to treat adults with pulmonary arterial hypertension (PAH).
Croatian: Mylan je lijek koji se primjenjuje kao monoterapija ili u kombinaciji s drugim lijekovima za liječenje odraslih osoba oboljelih od plućne arterijske hipertenzije (PAH).
English: Side effects reported with Ambrisentan Mylan are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ambrisentan Mylan pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What is Ambrisentan Mylan and what is it used for?
Croatian: Što je Ambrisentan Mylan i za što se koristi?
English: Ambrisentan Mylan can only be obtained with a prescription and treatment must be started by a doctor who has experience in the treatment of PAH.
Croatian: Ambrisentan Mylan izdaje se samo na recept, a liječenje mora započeti liječnik s iskustvom u liječenju PAH-a.
English: It causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces the
Croatian: To uzrokuje visoki krvni tlak u žilama koje prenose krv iz srca u pluća te smanjuje dotok krvi u pluća.
English: An overview of Ambrisentan Mylan and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ambrisentan Mylan i zašto je odobren u EU-u
English: PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs.
Croatian: PAH je onesposobljavajuća bolest kod koje dolazi do ozbiljnog suženja krvnih žila u plućima.
English: For more information about using Ambrisentan Mylan, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Ambrisentan Mylan pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: As for every medicine, the company provided studies on the quality of Ambrisentan Mylan.
Croatian: Kao i za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće lijeka Ambrisentan Mylan.
English: What are the benefits and risks of Ambrisentan Mylan?
Croatian: Koje su koristi i rizici od lijeka Ambrisentan Mylan?