FrancophonIA/ELRC3.0 huggingface dataset:
English: Where cattle and/or pigs have already been approved as target species and provided that the maximum total dose, as recommended in the product information, does not exceed 12 mg gentamicin base per kg bw in cattle and 50 mg gentamicin base per kg bw in pigs, the wording below relating to the relevant species should be used:
Croatian: Ako su goveda i/ili svinje već odobrene kao ciljna vrsta i uz uvjet da najveća ukupna doza, sukladno preporukama iz informacija o VMP-u ne prelazi 12 mg gentamicina po kilogramu tjelesne težine u goveda i 50 mg gentamicina po kilogramu tjelesne težine u svinja, potrebno je koristiti tekst u nastavku koji se odnosi na odgovarajuće vrste:
English: In renewal assessment reports as assessed by the Belgian NCA, a study was identified supporting the withdrawal period for Genta-kel 5% in calves (MAH: Kela).
Croatian: U izvješćima o ocjeni produljenja koje je provelo belgijsko nacionalno nadležno tijelo utvrđeno je ispitivanje koje podupire razdoblje karencije u teladi za VMP Genta-kel 5% (nositelj odobrenja za stavljanje VMP-a u promet: Kela).
English: Delete, where applicable, any references to subcutaneous use in calves and piglets.
Croatian: Gdje je to primjenjivo, potrebno je izbrisati sva upućivanja na supkutanu primjenu u teladi i prasadi.
English: Cattle (calves), pigs (piglets), birds (chicks, turkeys), dogs, cats
Croatian: Goveda (telad), svinje (prasad), ptice (pilići, purani), psi, mačke
English: Another study in calves was submitted in relation to the product Vetrigen (MAH: Ceva Sante Animale), but is not GLP-compliant.
Croatian: Drugo dostavljeno ispitivanje na teladi odnosi se na VMP Vetrigen (nositelj odobrenja za stavljanje VMP-a u promet: Ceva Sante Animale), ali nije usklađeno sa zahtjevima DLP-a.
English: Groups of 5 animals were treated at a dose of 4 mg/kg bw once a day for 3 days, and slaughtered at days 30, 40, 50 and 60 after the last administration.
Croatian: Skupine od pet životinja tretirane su dozom od 4 mg/kg tjelesne težine jedanput na dan tijekom tri dana te su zaklane 30, 40, 50, i 60 dana nakon posljednje primjene.
English: Kidney, liver, fat, muscle and injection site (with no surrounding sample) were analysed using a validated LC-MS/MS method; however the results for fat are not available.
Croatian: Provedena je analiza u bubrezima, jetri, masnom tkivu, mišiću i na mjestu injekcije (bez uzorka okolnog područja) primjenom LC-MS/MS metode; međutim, nisu dostupni rezultati za masno tkivo.
English: This study is GLP-compliant and it is considered by the MAH (Fatro) as a preliminary study.
Croatian: Ispitivanje je usklađeno sa zahtjevima DLP-a, a nositelj odobrenja za stavljanje VMP-a u promet (Fatro) smatra ga pripremnim ispitivanjem.
English: IM, IV: Meat and offal: 103 days.
Croatian: IM/IV: Meso i iznutrice: 103 dana.
English: Cattle, pigs, horses declared as not intended for slaughter for human consumption, dogs, cats
Croatian: Goveda, svinje, konji koji nisu predviđeni za klanje za prehranu ljudi, psi, mačke
English: Residues in both kidney and liver fall below the MRL at day 28.
Croatian: Rezidue u bubrezima i jetri pale su 28. dana ispod najveće dopuštene količine.
English: IM, IV: Meat and offal: 139 days.
Croatian: IM/IV: Meso i iznutrice: 139 dana.
English: Cattle, pigs, horses
Croatian: Goveda, svinje, konji
English: In pigs do not administer more than 50 mg gentamicin per injection site.
Croatian: Ne primjenjuje se više od 50 mg gentamicina po mjestu injiciranja u svinja.
English: Cattle (calves up to 250 kg), pigs (suckling pigs), horses not intended for human consumption, dogs, cats
Croatian: Goveda (telad do 250 kg), svinje (svinje koje sisaju), konji koji nisu predviđeni za prehranu ljudi, psi, mačke
English: A further GLP study concerning both cattle and pigs was conducted with Gentamicin 40 mg/ml solution for injection (MAH: Vetprom), using an enzyme-linked immunoassay as the analytical method.
Croatian: Provedeno je dodatno ispitivanje usklađeno sa zahtjevima DLP-a na govedu i svinjama u kojem je primijenjen VMP Gentamicin 40 mg/ml otopina za injekciju (nositelj odobrenja za stavljanje VMP-a u promet: Vetprom), a kao analitička metoda proveden je imunoenzimski test.
English: IM (cattle, pigs), IV (horses), SC (dogs, cats)
Croatian: IV (konji) SC (psi, mačke)
English: At day 49, the last sampling point, levels in kidney and liver were above the MRLs in all samples, with some values being more than 2x MRL in kidney and more than 3x MRL in liver.
Croatian: Na posljednjoj vremenskoj točki uzorkovanja, 49. dana, razine u bubrezima i jetri bile su iznad najvećih dopuštenih količina u svim uzrocima, a neke vrijednosti bile su dvostruko veće od najveće dopuštene količine u bubrezima i trostruko veće od najveće dopuštene količine u jetri.
English: C. For Gentavall 5 mg/ml listed in Annex I (Marketing Authorisation Holder: Mevet S.A.U.)
Croatian: Za Gentavall 5 mg/ml naveden u Prilogu I. (nositelj odobrenja za stavljanje VMP-a u promet: Mevet S.A.U.)
English: IM, IV: Meat and offal: 192 days.
Croatian: IM/IV: Meso i iznutrice: 192 dana.
English: Therefore, no reliable withdrawal period can be established from these data.
Croatian: Stoga se na temelju tih podataka ne može utvrditi pouzdano razdoblje karencije.
English: CVMP EPMAR for gentamicin (EMEA/MRL/803/01)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2009/11/WC500014350.pdf statistical method as per CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)
Croatian: CVMP EPMAR for gentamicin (EMEA/MRL/803/01)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2009/11/WC500014350.pdf
English: IM, IV: Meat and offal: 228 days.
Croatian: IM/IV: Meso i iznutrice: 228 dana.
English: Cattle, pigs
Croatian: Goveda, svinje IM
English: The study is not GLP-compliant.
Croatian: Ispitivanje nije usklađeno sa zahtjevima DLP-a.
English: C-17, Km 17 08150 Parets del Valles (Barcelona)
Croatian: 08150 Parets del Valles (Barcelona)
English: CVMP Note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004496.pdf CVMP EPMAR for gentamicin (EMA/CVMP/619817/2015)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2016/03/WC500203742.pdf
Croatian: CVMP Note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004496.pdf
English: A study is available concerning the product Aagent 50 mg/ml solution for injection (MAH: Fatro).
Croatian: Dostupno je ispitivanje koje se odnosi na VMP Aagent 50 mg/ml otopinu za injekciju (odobrenja za stavljanje VMP-a u promet: Fatro).
English: Intramuscular or intravenous use: Meat and offal: 103 days.
Croatian: Intramuskularna ili intravenska primjena: Meso i iznutrice: 103 dana.
English: A. For Aagent 50 mg/ml listed in Annex I (Marketing Authorisation Holder: Fatro S.p.A.)
Croatian: Za Aagent 50 mg/ml naveden u Prilogu I. (nositelj odobrenja za stavljanje VMP-a u promet: Fatro S.p.A.)
English: A GLP study concerning both cattle and pigs was conducted with Gentamicin 40 mg/ml solution for injection (MAH: Vetprom), using an enzyme-linked immunoassay as the analytical method.
Croatian: Provedeno je ispitivanje usklađeno sa zahtjevima DLP-a na govedima i svinjama u kojem je primijenjen VMP Gentamicin 40 mg/ml otopinom za injekciju (nositelj odobrenja za stavljanje VMP-a u promet: Vetprom), a korištena analitička metoda bila je imunoenzimski test.
English: Intramuscular or intravenous use: Meat and offal: 139 days.
Croatian: Intramuskularna ili intravenska primjena: Meso i iznutrice: 139 dana.
English: Kidney, liver, fat, muscle, and injection site were analysed.
Croatian: Provedena je analiza bubrega, jetre, masnog tkiva, mišića i mjesta injiciranja.
English: Animal species Route of administration
Croatian: Vrsta životinje
English: Cattle, non-food producing horses, pigs, dogs, cats
Croatian: Goveda, konji koji se ne koriste u prehrani ljudi, svinje, psi, mačke
English: Kidney, liver, muscle, fat and the injection site were analysed.
Croatian: Provedena je analiza bubrega, jetre, mišića, masnog tkiva i mjesta injiciranja.
English: IM, IV: Meat and offal: 214 days.
Croatian: IM/IV: Meso i iznutrice: 214 dana.
English: Laboratorios Maymo, S.A.
Croatian: Španjolska Laboratorios Maymo, S.A. Via Augusta, 302
English: The study concerns animals weighing 23 to 27 kg. Groups of only 3 animals were treated at a dose of 4 mg/kg bw every 12 hours for 4.5 days (9 injections), and slaughtered at days 15 and 60 after the last administration.
Croatian: Skupine od samo tri životinje tretirane su dozom od 4 mg/kg tjelesne težine svakih 12 sati tijekom četiri i pol i dana (devet injekcija) te su zaklane 15 i 60 dana nakon posljednje primjene.
English: Intramuscular or intravenous use: Meat and offal: 228 days.
Croatian: Intramuskularna ili intravenska primjena: Meso i iznutrice: 228 dana.
English: Cattle (calves up to 250 kg), nonfood-producing horses
Croatian: Goveda (telad do 250 kg), konji koji se ne koriste u prehrani ljudi
English: Intramuscular or intravenous use: Meat and offal: 192 days.
Croatian: Intramuskularna ili intravenska primjena: Meso i iznutrice: 192 dana.
English: Cattle, dogs, cats IM, IV, SC
Croatian: Goveda, svinje IV, IM, SC
English: Calves, dogs
Croatian: Telad, psi
English: Cattle, calves, pigs
Croatian: Goveda, telad, svinje
English: Cattle, pigs, dogs cattle, pigs: IM dogs: IM or SC
Croatian: Goveda, svinje: IM psi: IM ili SC
English: A GLP-compliant study in calves was submitted concerning the product Aagent 50 mg/ml solution for injection (MAH: Fatro).
Croatian: Dostavljeno je ispitivanje na teladi usklađeno sa zahtjevima DLP-a koje se odnosi na VMP Aagent 50 mg/ml otopinu za injekciju (nositelj odobrenja za stavljanje VMP-a u promet: Fatro).
English: Intramuscular or intravenous use: Meat and offal: 214 days.
Croatian: Intramuskularna ili intravenska primjena: Meso i iznutrice: 214 dana.
English: Bela-Pharm GmbH & Co. KG Lohner Str. 19
Croatian: Bela-Pharm GmbH & Co.
English: Kidney, liver, and the injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Croatian: Provedena je analiza bubrega, jetre i mjesta injiciranja (središta i okolnog područja) primjenom validirane HPLC/MS-MS metode.
English: Where the maximum total dose, as recommended in the product information, does not exceed 12 mg gentamicin base per kg bw in cattle and pigs, the wording below should be used:
Croatian: Ako sukladno preporukama iz informacija o VMP-u najveća ukupna doza ne prelazi 12 mg gentamicina po kilogramu tjelesne težine u goveda i svinja, potrebno je koristiti se tekstom u nastavku:
English: Overall, a withdrawal period cannot be derived from this study.
Croatian: Ukupno razmatrajući, iz ovog ispitivanja nije moguće izvesti razdoblje karencije.
English: Germany Bela-Pharm GmbH & Co. KG Lohner Str. 19
Croatian: Njemačka Bela-Pharm GmbH & Co.
English: Package leaflet:
Croatian: Označavanje:
English: Animals were slaughtered at 4, 11, 20, and 89 days after the last administration, in groups of 4 to 5.
Croatian: Skupine od četiri do pet životinja zaklane su 4, 11, 20 i 89 dana nakon posljednje primjene.
English: Cattle, pigs, dogs, cats, pet birds
Croatian: Goveda, svinje, psi, mačke, ptice kao kućni ljubimci
English: No reliable withdrawal period can be established from these data.
Croatian: Na temelju tih podataka ne može se utvrditi pouzdano razdoblje karencije.
English: Where the maximum total dose, as recommended in the product information, does not exceed 5 mg gentamicin base per animal in pigs, the wording below should be used:
Croatian: Ako sukladno preporukama iz informacija o VMP-u najveća ukupna doza ne prelazi 5 mg gentamicina po životinji u svinja, potrebno je koristiti tekst u nastavku:
English: In the milk residue study described in the CVMP EPMAR for gentamicin (EMA/CVMP/619817/2015) five lactating cows were treated with repeated intramuscular doses of 4 mg gentamicin/kg bw/day for 3 days.
Croatian: U ispitivanju o reziduama u mlijeku opisanom u Europskom javnom izvješću o procjeni najvećih dopuštenih količina rezidua (EPMAR) CVMP-a za gentamicin (EMA/CVMP/619817/2015)
English: Cattle (calves up to 250 kg), nonfood producing horses, dogs, cats
Croatian: Goveda (telad do 250 kg), konji koji se ne koriste u prehrani ljudi, psi, mačke
English: Kidney, liver, and the injection site were analysed.
Croatian: Provedena je analiza bubrega, jetre i mjesta injiciranja.
English: Cattle, pigs, horses, dogs
Croatian: Goveda, svinje, konji, psi
English: Kidney, liver, skin+fat, muscle, and injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Croatian: Provedena je analiza bubrega, jetre, masnog tkiva, mišića i mjesta injiciranja (središta i okolnog područja) primjenom validirane HPLC/MS-MS metode.
English: Cattle, horses, dogs, cats
Croatian: Goveda, konji, psi, mačke
English: Lithuania Dopharma Research B.V. Zalmweg 24m
Croatian: Nizozemska Dopharma Research B.V.
English: Where the maximum total dose, as recommended in the product information, is up to 80 mg gentamicin base per kg bw in cattle, the wording below should be used:
Croatian: Ako sukladno preporukama iz informacija o VMP-u najveća ukupna doza ne prelazi 80 mg gentamicina po kilogramu tjelesne težine u goveda, potrebno je koristiti tekst u nastavku:
English: Cattle, calves, pigs, piglets
Croatian: Goveda, telad, svinje, prasad
English: Kidney, liver, fat, muscle, injection site (with no control surrounding sample) were analysed for residue depletion, using an LC-MS/MS method.
Croatian: Provedena je analiza izlučivanja rezidua u bubrezima, jetri, masnom tkivu, mišiću i na mjestu injekcije (bez kontrolnog uzorka okolnog područja) pomoću LCMS/MS metode.
English: Cattle, dogs, cats IM, SC, slow IV
Croatian: Telad, psi, mačke IM, IV
English: Cattle, pigs, dogs, cats
Croatian: Goveda, svinje, psi, mačke
English: Where the maximum total dose, as recommended in the product information, does not exceed 50 mg gentamicin base per kg bw in pigs, the wording below should be used:
Croatian: Ako sukladno preporukama iz informacija o VMP-u najveća ukupna doza ne prelazi 50 mg gentamicina po kilogramu tjelesne težine u svinja, potrebno je koristiti tekst u nastavku:
English: Calves, pigs, dogs
Croatian: Telad, svinje, psi
English: Kidney, liver, skin+fat and injection sites were analysed for residue depletion, using a validated LC-MS/MS method.
Croatian: Provedena je analiza izlučivanja rezidua u bubrezima, jetri, koži i masnom tkivu te na mjestu injiciranja primjenom validirane LC-MS/MS metode.
English: Ctra.
Croatian: Cipar
English: Cattle, pigs, horses, dogs, cats
Croatian: Goveda, svinje, konji, psi, mačke
English: la Selva 135
Croatian: Filipestii de Padure
English: Cattle (calves up to 250 kg), nonfood-producing horses, dogs
Croatian: Goveda (telad do 250 kg), konji koji se ne koriste u prehrani ljudi, psi
English: Cattle, calves, pigs, piglets, horses, dogs, cats
Croatian: Goveda, telad, svinje, prasad, konji, psi, mačke
English: Calves, pigs, dogs, cats
Croatian: Telad, svinje, psi, mačke
English: Cattle, calves, pigs, horses, foals, dogs, cats
Croatian: Goveda, telad, svinje, konji, ždrijebad, psi, mačke
English: Calves, dogs, cats
Croatian: Prasad, psi, mačke
English: Cattle, calves, pigs, piglets, weaners, horses, foals, dogs, cats
Croatian: Goveda, telad, svinje, prasad, odbijena prasad, konji, ždrijebad, psi, mačke
English: GENTAMICINA FP 10% gentamicin 100 mg/ml
Croatian: FP 10% gentamicin 100 mg/ml
English: Calves, piglets, dogs, cats
Croatian: Telad, prasad, psi, mačke
English: It must not be used in women who are more than three months pregnant.
Croatian: Ne smije se primjenjivati u žena koje su trudne dulje od tri mjeseca.
English: It is available as tablets (75, 150 and 300 mg).
Croatian: Dostupan je u obliku tableta (75, 150 i 300 mg).
English: Previously known as Irbesartan Winthrop.
Croatian: Prethodno poznat kao Irbesartan Winthrop.
English: This summary was last updated in 07-2013.
Croatian: Sažetak je posljednji put obnovljen 07.2013.
English: Its use during the first three months of pregnancy is not recommended.
Croatian: Ne preporučuje se primjena ovog lijeka tijekom prva tri mjeseca trudnoće.
English: The medicine can only be obtained with a prescription.
Croatian: Ovaj se lijek se izdaje samo na liječnički recept.
English: The name of the medicine was changed to Irbesartan Zentiva on 6 February 2012.
Croatian: Naziv lijeka je promijenjen u Irbesartan Zentiva dana 6. veljače 2012.
English: The full EPAR for Irbesartan Zentiva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Irbesartan Zentiva može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide.
Croatian: Ako se krvni tlak ne može dostatno kontrolirati, doza se može povećati na 300 mg jedanput na dan ili se mogu dodati drugi antihipertenzivi, poput hidroklorotiazida.
English: The usual recommended dose of Irbesartan Zentiva is 150 mg once a day.
Croatian: Uobičajena preporučena doza lijeka Irbesartan Zentiva je 150 mg jedanput na dan.
English: Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
Croatian: Liječenje se započinje sa 150 mg jedanput na dan, te je uobičajeno povećanje na 300 mg jedanput na dan.
English: A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Croatian: Početna doza od 75 mg može se koristiti u bolesnika koji primaju hemodijalizu (tehnika čišćenja krvi) ili u bolesnika starijih od 75 godina.
English: The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Croatian: Glavna mjera djelotvornosti bilo je smanjenje u dijastoličkom krvnom tlaku (krvnom tlaku izmjerenom između dva otkucaja srca).
English: The main benefit was on the effect on blood creatinine levels.
Croatian: Glavna korist je bilo djelovanje na razine kreatinina u krvi.
English: For more information about treatment with Irbesartan Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Irbesartan Zentiva pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: When used with hydrochlorothiazide, the effects of the two medicines were additive.
Croatian: Kad se koristio s hidroklorotiazidom ta dva lijeka ostvarila su kombinirani učinak.
English: By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Croatian: Blokirajući receptore na koje se normalno vezuje angiotenzin II, irbesartan zaustavlja djelovanje hormona, čime omogućuje širenje krvnih žila.
English: Irbesartan Zentiva was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Croatian: Irbesartan Zentiva je uspoređen s placebom (liječenjem bez aktivne tvari) u 712 bolesnika i s drugim antihipertenzivima (atenololom, enalaprilom ili amlodipinom) u 823 bolesnika.
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 Irbesartan Zentiva.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi ocijenilo lijek da bi donijelo svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te svoje preporuke o uvjetima za primjenu lijeka Irbesartan Zentiva.
English: EPAR summary for the public irbesartan
Croatian: EPAR, sažetak za javnost irbesartan
English: In patients with hypertension and type 2 diabetes, Irbesartan Zentiva is added to some other treatments for hypertension.
Croatian: U bolesnika s hipertenzijom i šećernom bolešću tipa 2, Irbesartan Zentiva dodaje se drugim terapijama za hipertenziju.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Croatian: Angiotenzin II je snažan vazokonstriktor (djelatna tvar koja sužava krvne žile).
English: Other information about Irbesartan Zentiva
Croatian: Druge informacije o lijeku Irbesartan Zentiva
English: The active substance in Irbesartan Zentiva, 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 Irbesartan Zentiva je „antagonist receptora angiotenzina II”, što znači da ova tvar blokira djelovanje hormona u tijelu naziva angiotenzin II.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Winthrop on 19 January 2007.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za lijek Irbesartan Zentiva vrijedi na prostoru Europske unije od 19. siječnja 2007.
English: There was a 23% relative risk reduction compared with amlodipine.
Croatian: U usporedbi s amlodipinom došlo je do 23%-tnog smanjenja relativnog rizika.
English: One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine.
Croatian: Jedno je ispitivanje istražilo markere oštećenja funkcije bubrega tako što je mjereno jesu li bubrezi otpuštali protein albumin u urin.
English: The second study looked at whether Irbesartan Zentiva increased the time taken until the patients' blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
Croatian: Drugo je ispitivanje istražilo je li Irbesartan Zentiva povećao vrijeme potrebno da se razine kreatinina u krvi bolesnika udvostruče (marker bolesti bubrega), dok im je bila potrebna transplantacija bubrega ili dijaliza, odnosno do njihove smrti.
English: In this study, Irbesartan Zentiva was compared with placebo and with amlodipine.
Croatian: U ovom ispitivanju Irbesartan Zentiva je uspoređen s placebom i s amlodipinom.
English: This medicine is the same as Aprovel, which is already authorised in the European Union (EU).
Croatian: Ovaj je lijek jednak lijeku Irbesartan Zentiva, koji je već odobren u Europskoj uniji (EU).
English: Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
Croatian: Također je ispitana primjena lijeka Irbesartan Zentiva u kombinaciji s hidroklorotiazidom u 1.736 bolesnika.
English: Irbesartan Zentiva must not be used in people who are hypersensitive (allergic) to irbesartan or any of the other ingredients.
Croatian: Irbesartan Zentiva se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na irbesartan ili na bilo koju drugu pomoćnu tvar.
English: This is a summary of the European public assessment report (EPAR) for Irbesartan Zentiva.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Irbesartan Zentiva.
English: The company that makes Aprovel has agreed that its scientific data can be used for Irbesartan Zentiva.
Croatian: Tvrtka koja proizvodi Irbesartan Zentiva dala je svoj pristanak da se njezini znanstveni podaci iskoriste za Irbesartan Zentiva.
English: Irbesartan Zentiva is a medicine that contains the active substance irbesartan.
Croatian: Irbesartan Zentiva je lijek koji sadrži djelatnu tvar irbesartan.