FrancophonIA/ELRC3.0 huggingface dataset:
English: 300 mg QD (coadministered with voriconazole 400 mg BID)
Croatian: 300 mg QD (primijenjeno istodobno s vorikonazolom u dozi od 400 mg BID)
English: Voriconazole Cmax  49% Voriconazole AUC  69%
Croatian: Vorikonazol Cmax  49% Vorikonazol AUC  69%
English: • This medicinal product is for single use only and any unused solution should be discarded.
Croatian: • Ovaj lijek je samo za jednokratnu uporabu.
English: VFEND 200 mg powder for solution for infusion:
Croatian: VFEND 200 mg prašak za otopinu za infuziju:
English: VFEND is a single dose unpreserved sterile lyophile.
Croatian: VFEND je sterilni liofilizat bez konzervansa za jednokratnu primjenu.
English: Voriconazole Cmax  34% Voriconazole AUC  39%
Croatian: Vorikonazol Cmax  34% Vorikonazol AUC  39%
English: Voriconazole Cmax  4% Voriconazole AUC  32%
Croatian: Vorikonazol Cmax  4% Vorikonazol AUC  32%
English: The spike in the vial adapter will penetrate the vial seal.
Croatian: Šiljak u nastavku za bočicu probit će zaštitni zatvarač bočice.
English: Voriconazole Cmax  18% Voriconazole AUC  23%
Croatian: Vorikonazol Cmax  18% Vorikonazol AUC  23%
English: Compared to efavirenz 600 mg QD, Efavirenz Cmax ↔ Efavirenz AUC  17%
Croatian: Efavirenz Cmax ↔ Efavirenz AUC  17%
English: A measuring cup (graduated to indicate 23 ml), 5 ml oral syringe and a press-in bottle adaptor
Croatian: 1 boca od 45 g odmjerna čašica (s oznakom za 23 ml), štrcaljka za usta volumena 5 ml i nastavak koji se utisne u grlo boce.
English: Mode of Action
Croatian: Način primjene
English: In an independent published study, Voriconazole AUC0-  59%
Croatian: Vorikonazol AUC0-∞  59%
English: Eye disorders visual impairment retinal haemorrhage optic nerve disorder papilloedema oculogyric crisis, diplopia, scleritis, blepharitis optic atrophy, corneal opacity
Croatian: Poremećaji oka oštećenje vida krvarenje u retini poremećaj vidnog živca papiloedem okulogirična kriza, diplopija, skleritis, blefaritis atrofija vidnog živca, zamućenje rožnice
English: Patients 40 kg and above*
Croatian: Peroralno Bolesnici tjelesne težine 40 kg i više*
English: Tablets Patients 40 kg and above Patients less than 40 kg
Croatian: Bolesnici tjelesne težine manje od 40 kg
English: Voriconazole Cmax  23% Voriconazole AUC  7%
Croatian: Vorikonazol Cmax  23% Vorikonazol AUC  7%
English: SLOWLY push down the plunger of the oral syringe.
Croatian: POLAGANO pritišćite klip štrcaljke za usta.
English: VFEND oral suspension contains sucrose and should not be given to patients with rare hereditary problems of fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, nedostatkom sukraze-izomaltaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: Пфайзер Люксембург САРЛ, Клон България Тел.
Croatian: Pfizer Luxembourg SARL Filialas Lietuvoje Tel.
English: Each tablet contains 200 mg voriconazole.
Croatian: Jedna tableta sadrži 200 mg vorikonazola.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C (in a refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja lijeka prije primjene odgovornost su korisnika i obično ne bi smjeli premašiti 24 sata na temperaturi od 2°C do 8°C (u hladnjaku), osim ako priprema nije provedena u kontroliranim i validiranim aseptičkim uvjetima.
English: Infusion site reaction
Croatian: Sadržaj kompleta za infuziju
English: Open the Twist-off port.
Croatian: Odvijte zatvarač s ulaznog otvora.
English: 3b Screw the syringe onto the vial adapter.
Croatian: 3b Navijte štrcaljku na nastavak za bočicu.
English: Breathing difficulties
Croatian: Oštećenje jetre
English: VFEND is an antifungal medicine.
Croatian: VFEND je lijek za liječenje gljivičnih infekcija.
English: Reconstituted VFEND concentrate needs to be further diluted with sodium chloride (0.9%) infusion solution within the infusion bag before it is infused.
Croatian: Pripremljeni koncentrat lijeka VFEND mora se prije infuzije dodatno razrijediti otopinom natrijevog klorida za infuziju od 9 mg/ml (0,9%).
English: VFEND contains sodium
Croatian: VFEND sadrži natrij
English: Read the package leaflet before use Reconstitute and dilute before use.
Croatian: Prije primjene lijek se mora rekonstituirati i razrijediti.
English: VFEND contains sucrose
Croatian: VFEND sadrži saharozu
English: Batch
Croatian: Boca
English: Push and screw the syringe securely onto Blue port. 2c Withdraw exactly 19 mL of the solution and unscrew the syringe.
Croatian: 2c Izvucite točno 19 ml otopine i odvijte štrcaljku.
English: VFEND 200 mg film-coated tablets voriconazole
Croatian: VFEND 200 mg filmom obložene tablete vorikonazol
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika i obično ne bi smjeli premašiti 24 sata na temperaturi od 2°C do 8°C, osim ako rekonstitucija nije provedena u kontroliranim i validiranim aseptičkim uvjetima.
English: VFEND 200 mg powder for solution for infusion: 30 ml clear Type I glass vial with rubber stopper and aluminium cap with plastic seal.
Croatian: Staklena bočica od 30 ml (prozirno staklo tipa I) s gumenim čepom i aluminijskom kapicom s plastičnim zaštitnim zatvaračem.
English: VFEND 200 mg powder for solution for infusion
Croatian: VFEND 200 mg prašak za otopinu za infuziju
English: Oral suspension Patients 40 kg and above Patients less than 40 kg
Croatian: Oralna suspenzija Bolesnici tjelesne težine 40 kg i više
English: Acute breathing difficulty, chest pain, swelling of the face (mouth, lips and around eyes), fluid accumulation in the lungs
Croatian: nesvjestica - nizak krvni tlak, upala vene (može biti povezana sa stvaranjem krvnog ugruška) - akutno otežano disanje, bol u prsima, oticanje lica (usne šupljine, usana i oko očiju),
English: Tel: + 385 1 3908 777
Croatian: Pfizer Croatia d.o.o. Tel: +385 1 3908 777
English: Breakthrough IFI - Day 180 1 (1.0%)
Croatian: Pojava invazivne gljivične infekcije - 180. dan Uspjeh na 180. dan*
English: If infused through a multiple-lumen catheter, TPN needs to be administered using a different port from the one used for VFEND.
Croatian: Ako se primjenjuju putem višelumenskog katetera, za pripravak potpune parenteralne prehrane i VFEND moraju se koristiti različiti ulazi.
English: VFEND 50 mg film-coated tablets voriconazole
Croatian: VFEND 50 mg filmom obložene tablete vorikonazol
English: If not used immediately, in-use storage times and conditions of the reconstituted vial prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja rekonstituirane bočice prije primjene odgovornost su korisnika i obično ne bi smjeli premašiti 24 sata na temperaturi od 2°C do 8°C, osim ako rekonstitucija nije provedena u kontroliranim i validiranim aseptičkim uvjetima.
English: VFEND 200 mg powder for solution for infusion voriconazole
Croatian: VFEND 200 mg prašak za otopinu za infuziju vorikonazol
English: • A sterile, single use vial adapter.
Croatian: • sterilnu štrcaljku za jednokratnu uporabu
English: Turn the bottle upside down while holding the oral syringe in place.
Croatian: Držeći štrcaljku za usta na mjestu, preokrenite bocu nazad u uspravan položaj.
English: * Primary endpoint of study ** Using a margin of 5%, non inferiority is demonstrated *** Difference in proportions, 95% CI obtained after adjustment for randomization
Croatian: * Primarni ishod ispitivanja ** Uz primjenu granice od 5%, dokazana je neinferiornost ***Razlika u udjelima, 95%-tni CI dobivene nakon prilagodbe za randomizaciju
English: Lactose monohydrate Pregelatinised starch Croscarmellose sodium Povidone
Croatian: Jezgra tablete: laktoza hidrat škrob, prethodno geliran karmelozanatrij, umrežena povidon magnezijev stearat
English: The pharmacokinetics of orally administered voriconazole are not affected by renal impairment.
Croatian: Oštećenje bubrega ne utječe na farmakokinetiku peroralno primijenjenog vorikonazola.
English: 400 mg (10 ml) every 12 200 mg (5 ml) every 12
Croatian: 400 mg (10 ml) svakih 12
English: Long-Acting Opiates [CYP3A4 substrates]
Croatian: Opijati dugog djelovanja [supstrati CYP3A4]
English: Vial contains 200 mg of voriconazole.
Croatian: Jedna bočica sadrži 200 mg vorikonazola.
English: Powder for oral suspension White to off-white powder
Croatian: Bijeli do gotovo bijeli prašak.
English: Voriconazole was compared to itraconazole as primary prophylaxis in an open-label, comparative, multicenter study of adult and adolescent allogeneic HSCT recipients without prior proven or probable IFI.
Croatian: Primarna profilaksa invazivnih gljivičnih infekcija - djelotvornost u primatelja transplantacije hematopoetskih matičnih stanica (HSCT, engl. hematopoietic stem cell transplant) bez prethodne dokazane ili vjerojatne invazivne gljivične infekcije Vorikonazol je uspoređen s itrakonazolom kao primarna profilaksa u otvorenom, usporednom, multicentričnom ispitivanju u odraslih i adolescentnih primatelja alogene HSCT bez prethodne dokazane ili vjerojatne invazivne gljivične infekcije.
English: Visual impairment (change in vision including blurred vision, visual color alterations, abnormal intolerance to visual perception of light, colour blindness, eye disorder, halo vision, night blindness, swinging vision, seeing sparks, visual aura, visual acuity reduced, visual brightness, loss of part of the usual field of vision, spots before the eyes)
Croatian: halo vid, noćnu sljepoću, ljuljajuću sliku, iskrenje pred očima, vizualnu auru, smanjenu oštrinu vida, vizualnu svjetlinu, gubitak dijela uobičajenog vidnog polja, točke pred očima) - vrućica - osip - mučnina, povraćanje, proljev - glavobolja - oticanje udova - bolovi u trbuhu - otežano disanje
English: 8 mg/kg twice daily
Croatian: 8 mg/kg dvaput na dan
English: Long-acting opiates (CYP3A4 substrate)
Croatian: Opijati dugog djelovanja (supstrati CYP3A4)
English: chills infusion site reaction, influenza like illness
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija bol u prsištu, edem lica astenija, zimica reakcija na mjestu injekcije, bolest nalik gripi
English: VFEND 200 mg powder and solvent for solution for infusion:
Croatian: VFEND 200 mg prašak i otapalo za otopinu za infuziju:
English: Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended when coadministered with voriconazole since methadone levels increased following coadministration of voriconazole.
Croatian: Budući da je nakon istodobne primjene s vorikonazolom došlo do povećanja razine metadona, kod istodobne primjene metadona i vorikonazola preporučuju se česte kontrole zbog mogućih nuspojava i toksičnih učinaka metadona, uključujući produljenje QTc-intervala.
English: Stomach pains
Croatian: Bubrežne nuspojave
English: Unscrew the syringe and discard the vial adaptor and vial.
Croatian: Odvijte štrcaljku i uklonite nastavak za bočicu i bočicu.
English: Short-acting opiates (CYP3A4 substrate)
Croatian: Opijati kratkog djelovanja (supstrati CYP3A4)
English: Short-acting Opiates [CYP3A4 substrates]
Croatian: Opijati kratkog djelovanja [supstrati CYP3A4]
English: VFEND powder for solution for infusion will be reconstituted and diluted to the correct concentration by your hospital pharmacist or nurse.
Croatian: VFEND prašak za otopinu za infuziju će bolnički ljekarnik ili medicinska sestra pripremiti i razrijediti do točne koncentracije (Dodatne informacije navedene su na kraju ove upute o lijeku).
English: Refer to the patient leaflet for more detailed instructions for use.
Croatian: Za detaljnije upute o primjeni lijeka pročitajte Uputu o lijeku.
English: Constitution instructions:
Croatian: Upute za pripremu:
English: While the bottle is upright, on a flat surface, insert the tip of the oral syringe into the adaptor.
Croatian: Stavite bocu uspravno na ravnu površinu i gurnite vrh štrcaljke za usta u nastavak za bocu.
English: Constipation, indigestion, inflammation of the lips Jaundice, inflammation of the liver and liver injury Skin rashes which may lead to severe blistering and peeling of the skin characterized by a flat, red area on the skin that is covered with small confluent bumps, redness of the skin Itchiness
Croatian: nakupljanje tekućine u plućima - zatvor, probavne tegobe, upala usana - žutica, upala jetre i oštećenje jetre kožni osipi koji mogu dovesti do jakog stvaranja mjehurića i ljuštenja kože karakterizirani ravnim, crvenim područjem kože koje je prekriveno malim izraslinama koje se spajaju, crvenilo kože - svrbež - gubitak kose - bol u leđima - zatajenje bubrega, krv u mokraći, promjene u testovima funkcije bubrega
English: IFI to day 180
Croatian: 180. dana
English: Allergic skin reactions (sometimes severe), including rapid swelling (oedema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, irritation of the skin and mucous membranes, life-threatening skin condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below
Croatian: - prekomjerna aktivnost štitnjače - propadanje moždane funkcije koje je ozbiljna komplikacije jetrene bolesti - gubitak većine vlakana vidnog živca, zamagljenje rožnice, neželjeni pokreti oka - povećana osjetljivost na svjetlost popraćena mjehurićima - poremećaj u kojem imunološki sustav tijela napada dio perifernog živčanog sustava - problemi s ritmom ili provođenjem srca (ponekad opasni po život) - alergijska reakcija opasna po život - poremećaj u zgrušavanju krvi - alergijska reakcija kože (katkad ozbiljna), uključujući brzo oticanje (edem) kože, potkožnog tkiva, sluzokože i podsluzokože, svrab ili bolni dijelovi debele, crvene kože sa srebrnastim kožnim ljuskicama, nadraženost kože i sluzokože, kožna stanja opasna po život koja uzrokuju odvajanje velikih površina epidermisa, gornjeg sloja kože, od donjih dijelova kože - male suhe ljuskaste mrlje na koži, katkad debele sa šiljcima ili "rogovima"
English: Enlarged lymph glands (sometimes painful), failure of blood marrow, increased eosinophil Depressed function of the adrenal gland, underactive thyroid gland Abnormal brain function, Parkinson-like symptoms, nerve injury resulting in numbness, pain, tingling or burning in the hands or feet
Croatian: povećani limfni čvorovi (ponekad bolni), zatajenje koštane srži, povećani broj eozinofila - smanjena funkcija nadbubrežne žlijezde, smanjena aktivnost štitnjače - poremećaj moždane funkcije, simptomi slični Parkinsonovoj bolesti, ozljeda živca s posljedičnom utrnulošću, boli, trncima ili žarenjem u šakama ili stopalima - smetnje ravnoteže ili koordinacije - oticanje mozga - dvoslike, ozbiljna stanja oka uključujući: bol i upalu očiju i vjeđa, neuobičajeni očni pokreti,
English: 3a Remove the adaptor casing from the vial adaptor and discard.
Croatian: 1a Odlijepite zaštitni pokrov s nastavka za bočicu.
English: Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly haematological malignancy).Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.
Croatian: U bolesnika u kojih nisu uočeni dodatni faktori rizika zabilježene su uglavnom prolazne jetrene reakcije, uključujući hepatitis i žuticu.
English: 4 mg/kg twice daily 200 mg twice daily 100 mg twice daily
Croatian: Doza nakon prva 24 sata 200 mg dvaput na dan 100 mg dvaput na dan (doza održavanja)
English: Intravenous use only Not for bolus injection
Croatian: Lijek nije namijenjen za primjenu u obliku bolusne injekcije.
English: Double vision, serious conditions of the eye including: pain and inflammation of the eyes and eyelids, abnormal eye movement, damage to the optic nerve resulting in vision impairment, optic disc swelling
Croatian: oštećenje očnog živca s posljedičnim oštećenjem vida, oticanje optičkog diska
English: Use the oral syringe provided in the pack to measure the correct dose.
Croatian: Za odmjeravanje točne doze koristite priloženu štrcaljku za usta.
English: Loading dose regimen (first 24 hours)
Croatian: Udarna doza (prva 24 sata)
English: Acute renal failure has been observed in severely ill patients undergoing treatment with VFEND.
Croatian: Tijekom primjene lijeka VFEND u teških je bolesnika zamijećeno akutno zatajenje bubrega.
English: VFEND 200 mg powder and solvent for solution for infusion
Croatian: VFEND 200 mg prašak i otapalo za otopinu za infuziju
English: • Serious dermatological adverse reactions (including SCC) The frequency of phototoxicity reactions is higher in the paediatric population.
Croatian: Učestalost fototoksičnih reakcija veća je u pedijatrijskoj populaciji.
English: Vivian Corporation Ltd. Tel : +356 21344610
Croatian: Tel : +356 21344610
English: VFEND 200 mg film-coated tablets White to off-white, capsule-shaped tablet, debossed “Pfizer” on one side and “VOR200”on the reverse.
Croatian: Bijela ili gotovo bijela tableta u obliku kapsule s utisnutom oznakom “Pfizer” na jednoj i “VOR200” na suprotnoj.
English: Disorder of blood clotting system
Croatian: Srce i krvne žile
English: Red, scaly patches or ring-shaped skin lesions that may be a symptom of an autoimmune disease called cutaneous lupus erythematosus
Croatian: Druge značajne nuspojave čija učestalost nije poznata, ali moraju se odmah prijaviti Vašem liječniku: - rak kože - upala tkiva oko kosti - crvene, ljuskaste mrlje ili prstenasta oštećenja na koži koji mogu biti simptomi autoimune bolesti zvane kožni eritemski lupus
English: Other Candida spp.
Croatian: Druge vrste iz roda Candida
English: VFEND 50 mg film-coated tablets White to off-white, round tablet, debossed “Pfizer” on one side and “VOR50”on the reverse.
Croatian: Bijela ili gotovo bijela okrugla tableta s utisnutom oznakom "Pfizer" na jednoj i "VOR50" na suprotnoj.
English: VFEND 200 mg powder and solvent for solution for infusion Voriconazole
Croatian: VFEND 200 mg prašak i otapalo za otopinu za infuziju vorikonazol
English: The syringe, vial and vial adapter can then be discarded.
Croatian: Nakon toga se štrcaljka, bočica i nastavak za bočicu mogu zbrinuti.
English: 1 bottle of 45 g
Croatian: 1 nastavak za bočicu
English: Timepoint
Croatian: Rok valjanosti
English: Oral
Croatian: Peroralno
English: No dose adjustment
Croatian: Nije potrebna prilagodba doze.
English: Blood cholesterol increased, blood urea increased Allergic skin reactions (sometimes severe), including life-threatening skin condition that causes painful blisters and sores of the skin and mucous membranes, especially in the mouth, inflammation of the skin, hives, sunburn or severe skin reaction following exposure to light or sun, skin redness and irritation, red or purple discoloration of the skin which may be caused by low platelet count, eczema
Croatian: opekline od sunca ili tešku kožnu reakciju uslijed izlaganja svjetlosti ili suncu, crvenilo i nadraženost kože, crvenu ili ljubičastu promjenu boje kože koja može biti prouzročena niskim brojem trombocita, ekcem - reakcija na mjestu infuzije - alergijska reakcija ili pretjerani imunološki odgovor
English: Read enclosed leaflet before use.
Croatian: Za primjenu kroz usta nakon pripreme.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Hair loss
Croatian: Unutarnji šiljak
English: Label on the vial
Croatian: Naljepnica na bočici
English: 200 mg twice a day 100 mg twice a day
Croatian: 100 mg dvaput na dan
English: Invented name Strength Pharmaceutical form Route of administration
Croatian: Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: EU/1/97/045/003 Helicobacter Test INFAI for children of the age 3-11
Croatian: Kroz usta za djecu u dobi od 3-11godina
English: 50 jars, as part of a multicomponent kit with breath bags
Croatian: Posudicu 1 posudicu koja sadrži 75 mg praška 13Curee za oralnu otopinu
English: 1 jar, as part of a multicomponent kit with breath bags
Croatian: Kroz usta za masenu spektrometriju
English: 12 x (1 vial + 1 prefilled syringe + 1 vial adapter with needle + 2 alcohol wipes) (Titration pack)
Croatian: 3 x 14 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
English: Ifirmasta irbesartan
Croatian: irbesartan
English: Ifirmasta is a ‘generic medicine'.
Croatian: Ifirmasta je „generički lijek”.
English: Other information about Ifirmasta:
Croatian: Ostale informacije o lijeku Ifirmasta:
English: The name of the medicine was changed to Ifirmasta on 24 September
Croatian: Naziv lijeka promijenjen je u Ifirmasta dana 24. rujna 2009.
English: Previously known as Irbesartan Krka.
Croatian: Prethodno poznat kao Irbesartan Winthrop.
English: This means that Ifirmasta is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel.
Croatian: To znači da je Ifirmasta sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Aprovel.
English: What are the benefit and risk of Ifirmasta?
Croatian: Koje su koristi i rizici lijeka Ifirmasta?
English: The usual recommended dose of Ifirmasta is 150 mg once a day.
Croatian: Uobičajena preporučena doza lijeka Ifirmasta je 150 mg jedanput na dan.
English: This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Croatian: To omogućuje snižavanje krvnog tlaka, čime se smanjuju rizici povezani s visokim krvnim tlakom, poput moždanog udara.
English: Why has Ifirmasta been approved?
Croatian: Zašto je Ifirmasta odobrena?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ifirmasta.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Ifirmasta.
English: The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Krka on 1 December 2008.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Irbesartan Krka na snazi u Europskoj uniji od 1. prosinca 2008.
English: The Committee recommended that Ifirmasta be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Ifirmasta.
English: In patients with hypertension and type 2 diabetes, Ifirmasta is added to some other treatments for hypertension.
Croatian: U bolesnika s hipertenzijom i šećernom bolešću tipa 2, Ifirmasta se dodaje drugim terapijama za hipertenziju.
English: This document is a summary of the European public assessment report (EPAR) for Ifirmasta.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Ifirmasta.
English: The active substance in Ifirmasta, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Irbesartan, djelatna tvar u lijeku Ifirmasta je „antagonist receptora angiotenzina II”, što znači da ova tvar blokira djelovanje hormona u tijelu naziva angiotenzin II.