FrancophonIA/ELRC3.0 huggingface dataset:
English: • Each pre-filled pen of Pergoveris (300 IU + 150 IU)/0.48 mL contains 300 IU (International
Croatian: • Jedna napunjena brizgalica lijeka Pergoveris (300 IU + 150 IU)/0,48 ml sadrži 300 IU
English: Pack of 1 Pergoveris (450 IU + 225 IU)/0.72 mL pre-filled pen and 7 injection needles.
Croatian: Pakiranje s 1 Pergoveris (450 IU + 225 IU)/0,72 ml napunjenom brizgalicom i 7 injekcijskih igala.
English: 1 vial of powder.
Croatian: 1 bočica s praškom.
English: • Contains 1.44 mL of Pergoveris solution
Croatian: • Sadrži 0,48 ml Pergoveris otopine
English: Pack of 1 Pergoveris (900 IU + 450 IU)/1.44 mL pre-filled pen and 14 injection needles.
Croatian: Pakiranje s 1 Pergoveris (900 IU + 450 IU)/1,44 ml napunjenom brizgalicom i 14 injekcijskih igala.
English: Getting the syringe ready for injection
Croatian: Priprema štrcaljke za injiciranje
English: • Sucrose, arginine monohydrochloride, poloxamer 188, methionine, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate and water for injections.
Croatian: • Saharoza, argininklorid, poloksamer 188, metionin, fenol, natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat hidrat i voda za injekcije.
English: and show the dose of follitropin alfa.
Croatian: International Units - IU) i pokazuju dozu folitropina alfa.
English: Attach the needle.
Croatian: Spojite iglu.
English: How to store Pergoveris
Croatian: Kako primjenjivati Pergoveris
English: Powder: disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbate 20, sucrose, sodium hydroxide (for pH adjustment) and concentrated phosphoric acid (for pH adjustment).
Croatian: Prašak: natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat hidrat, metionin, polisorbat 20, saharoza, natrijev hidroksid (za podešavanje pH) i koncentrirana fosfatna kiselina (za podešavanje pH).
English: • Each pre-filled pen of Pergoveris (450 IU + 225 IU)/0.72 mL contains 450 IU (International
Croatian: • Jedna napunjena brizgalica lijeka Pergoveris (450 IU + 225 IU)/0,72 ml sadrži 450 IU
English: • Contains 900 IU follitropin alfa and 450 IU lutropin alfa.
Croatian: • Sadrži 300 IU folitropina alfa i 150 IU lutropina alfa.
English: • Each pre-filled pen of Pergoveris (900 IU + 450 IU)/1.44 mL contains 900 IU (International
Croatian: • Jedna napunjena brizgalica lijeka Pergoveris (900 IU + 450 IU)/1,44 ml sadrži 900 IU
English: Reusing a pen It is NOT required to check for a droplet of liquid.
Croatian: NIJE potrebno provjeravati je li prisutna kapljica tekućine.
English: Each Pergoveris (900 IU + 450 IU)/1.44 mL pre-filled pen contains 1.44 mL of solution for injection and can deliver six doses of Pergoveris 150 IU/75 IU.
Croatian: Jedna Pergoveris (900 IU + 450 IU)/1,44 ml napunjena brizgalica sadrži 1,44 ml otopine za injekciju i može isporučiti šest doza lijeka Pergoveris 150 IU/75 IU.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 450 IU r-hFSH-225 IU r-hLH/0.72 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 450 IU r-hFSH-225 IU r-hLH/0,72 ml
English: Pergoveris 150 IU/75 IU powder and solvent for solution for injection Follitropin alfa/Lutropin alfa
Croatian: Pergoveris 150 IU/75 IU prašak i otapalo za otopinu za injekciju folitropin alfa/lutropin alfa
English: INFORMATION IN BRAILLE pergoveris (450 iu + 225 iu)/0.72 ml pen 17.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU pergoveris (450 iu + 225 iu)/0,72 ml brizgalica
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (450 IU + 225 IU)/0.72 mL injection Follitropin alfa/Lutropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Pergoveris (450 IU + 225 IU)/0,72 ml injekcija folitropin alfa/lutropin alfa
English: Excipients: sucrose, arginine monohydrochloride, poloxamer 188, methionine, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide and concentrated phosphoric acid (for pH adjustment), and water for injections.
Croatian: Pomoćne tvari: saharoza, argininklorid, poloksamer 188, metionin, fenol, natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat hidrat, natrijev hidroksid i koncentrirana fosfatna kiselina (za podešavanje pH) i voda za injekcije.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (300 IU + 150 IU)/0.48 mL injection Follitropin alfa/Lutropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Pergoveris (300 IU + 150 IU)/0,48 ml injekcija folitropin alfa/lutropin alfa
English: Pergoveris pre-filled pen treatment diary
Croatian: Dnevnik liječenja Pergoveris napunjenom brizgalicom
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 IU r-hFSH/75 IU r-hLH
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 150 IU r-hFSH/75 IU r-hLH
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 IU r-hFSH-150 IU r-hLH/0.48 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 300 IU r-hFSH-150 IU r-hLH/0,48 ml
English: • Contains 0.48 mL of Pergoveris solution • Contains 300 IU follitropin alfa and 150 IU lutropin alfa.
Croatian: • Sadrži 1,44 ml Pergoveris otopine • Sadrži 900 IU folitropina alfa i 450 IU lutropina alfa.
English: Each Pergoveris (450 IU + 225 IU)/0.72 mL pre-filled pen contains 0.72 mL of solution for injection and can deliver three doses of Pergoveris 150 IU/75 IU.
Croatian: Jedna Pergoveris (450 IU + 225 IU)/0,72 ml napunjena brizgalica sadrži 0,72 ml otopine za injekciju i može isporučiti tri doze lijeka Pergoveris 150 IU/75 IU.
English: Each pre-filled pen contains 450 IU (equivalent to 33 micrograms) of follitropin alfa (r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa (r-hLH) in 0.72 mL.
Croatian: Jedna napunjena brizgalica sadrži 450 IU (što odgovara 33 mikrograma) folitropina alfa (r-hFSH) i 225 IU (što odgovara 9 mikrograma) lutropina alfa (r-hLH) u 0,72 ml.
English: • Pergoveris (900 IU + 450 IU)/1.44 mL is supplied in packs of 1 multidose pre-filled pen and
Croatian: • Pergoveris (900 IU + 450 IU)/1,44 ml isporučuje se u pakiranjima s 1 višedoznom napunjenom brizgalicom i 14 injekcijskih igala za jednokratnu uporabu..
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA Pergoveris (300 IU + 150 IU)/0,48 ml otopina za injekciju u napunjenoj brizgalici
English: Units) of follitropin alfa and 450 IU of lutropin alfa in 1.44 mL and can deliver six doses of Pergoveris 150 IU/75 IU.
Croatian: (međunarodnih jedinica) folitropina alfa i 450 IU lutropina alfa u 1,44 ml i može isporučiti šest doza lijeka Pergoveris 150 IU/75 IU.
English: Each pre-filled pen contains 900 IU (equivalent to 66 micrograms) of follitropin alfa (r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa (r-hLH) in 1.44 mL.
Croatian: Jedna napunjena brizgalica sadrži 900 IU (što odgovara 66 mikrograma) folitropina alfa (r-hFSH) i 450 IU (što odgovara 18 mikrograma) lutropina alfa (r-hLH) u 1,44 ml.
English: Units) of follitropin alfa and 225 IU of lutropin alfa in 0.72 mL and can deliver three doses of Pergoveris 150 IU/75 IU.
Croatian: (međunarodnih jedinica) folitropina alfa i 225 IU lutropina alfa u 0,72 ml i može isporučiti tri doze lijeka Pergoveris 150 IU/75 IU.
English: Each Pergoveris (300 IU + 150 IU)/0.48 mL pre-filled pen contains 0.48 mL of solution for injection and can deliver two doses of Pergoveris 150 IU/75 IU.
Croatian: Jedna Pergoveris (300 IU + 150 IU)/0,48 ml napunjena brizgalica sadrži 0,48 ml otopine za injekciju i može isporučiti tri doze lijeka Pergoveris 150 IU/75 IU.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (900 IU + 450 IU)/1.44 mL injection Follitropin alfa/Lutropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Pergoveris (900 IU + 450 IU)/1,44 ml injekcija folitropin alfa/lutropin alfa
English: • Pergoveris (300 IU +150 IU)/0.48 mL is supplied in packs of 1 multidose pre-filled pen and
Croatian: • Pergoveris (300 IU + 150 IU)/0,48 ml isporučuje se u pakiranjima s 1 višedoznom napunjenom brizgalicom i 5 injekcijskih igala za jednokratnu uporabu.
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA Pergoveris (450 IU + 225 IU)/0,72 ml otopina za injekciju u napunjenoj brizgalici
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa* (r-hFSH) and 75 IU (equivalent to 3 micrograms) of lutropin alfa* (r-hLH).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 bočica sadrži 150 IU (što odgovara 11 mikrograma) folitropina alfa* (r-hFSH) i 75 IU (što odgovara 3 mikrograma) lutropina alfa* (r-hLH).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (300 IU + 150 IU)/0.48 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PERGOVERIS (300 IU + 150 IU)/0,48 ML OTOPINA ZA INJEKCIJU U NAPUNJENOJ BRIZGALICI
English: • Pergoveris (450 IU + 225 IU)/0.72 mL is supplied in packs of 1 multidose pre-filled pen and
Croatian: • Pergoveris (450 IU + 225 IU)/0,72 ml isporučuje se u pakiranjima s 1 višedoznom napunjenom brizgalicom i 7 injekcijskih igala za jednokratnu uporabu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (450 IU + 225 IU)/0.72 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PERGOVERIS (450 IU + 225 IU)/0,72 ML OTOPINA ZA INJEKCIJU U NAPUNJENOJ BRIZGALICI
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (900 IU + 450 IU)/1.44 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PERGOVERIS (900 IU + 450 IU)/1,44 ML OTOPINA ZA INJEKCIJU U NAPUNJENOJ BRIZGALICI
English: Units) of follitropin alfa and 150 IU of lutropin alfa in 0.48 mL and can deliver two doses of Pergoveris 150 IU/75 IU.
Croatian: (međunarodnih jedinica) folitropina alfa i 150 IU lutropina alfa u 0,48 ml i može isporučiti dvije doze lijeka Pergoveris 150 IU/75 IU.
English: Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Croatian: Pergoveris (450 IU + 225 IU)/0,72 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa/lutropin alfa
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA Pergoveris (900 IU + 450 IU)/1,44 ml otopina za injekciju u napunjenoj brizgalici
English: Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Croatian: Pergoveris (300 IU + 150 IU)/0,48 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa/lutropin alfa
English: These may be the symptoms of ovarian hyperstimulation syndrome (OHSS).
Croatian: Ovarian hyperstimulation syndrome, OHSS).
English: Thromboembolism, usually associated with severe OHSS Respiratory, thoracic and mediastinal disorders Very rare:
Croatian: Tromboembolija, obično povezana s teškim OHSS-om
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PERGOVERIS (450 IU + 225 IU)/0.72 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN, PEN LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE PERGOVERIS (450 IU + 225 IU)/0,72 ML OTOPINA ZA INJEKCIJU U NAPUNJENOJ BRIZGALICI, NALJEPNICA NA BRIZGALICI
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 900 IU (equivalent to 66 micrograms) of follitropin alfa* (r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa* (r-hLH) in 1.44 mL solution.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna višedozna napunjena brizgalica sadrži 900 IU (što odgovara 66 mikrograma) folitropina alfa* (r-hFSH) i 450 IU (što odgovara 18 mikrograma) lutropina alfa* (r-hLH) u 1,44 ml otopine.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PERGOVERIS (900 IU + 450 IU)/1.44 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN, PEN LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE PERGOVERIS (900 IU + 450 IU)/1,44 ML OTOPINA ZA INJEKCIJU U NAPUNJENOJ BRIZGALICI, NALJEPNICA NA BRIZGALICI
English: Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Croatian: Pergoveris (900 IU + 450 IU)/1,44 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa/lutropin alfa
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PERGOVERIS (300 IU + 150 IU)/0.48 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN, PEN LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE PERGOVERIS (300 IU + 150 IU)/0,48 ML OTOPINA ZA INJEKCIJU U NAPUNJENOJ BRIZGALICI, NALJEPNICA NA BRIZGALICI
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 450 IU (equivalent to 33 micrograms) of follitropin alfa* (r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa* (r-hLH) in 0.72 mL solution.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna višedozna napunjena brizgalica sadrži 450 IU (što odgovara 33 mikrograma) folitropina alfa* (r-hFSH) i 225 IU (što odgovara 9 mikrograma) lutropina alfa* (r-hLH) u 0,72 ml otopine.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris 150 IU/75 IU powder for solution for injection Follitropin alfa/Lutropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Pergoveris 150 IU/75 IU prašak za otopinu za injekciju folitropin alfa/lutropin alfa s.c.
English: seconds to ensure you inject the full dose (Fig. 10).
Croatian: • Držite kotačić za namještanje doze pritisnutim najmanje 5 sekundi kako biste bili sigurni da ste ubrizgali cijelu dozu (Sl. 10).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa* (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa* (r-hLH) in 0.48 mL solution.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna višedozna napunjena brizgalica sadrži 300 IU (što odgovara 22 mikrograma) folitropina alfa* (r-hFSH) i 150 IU (što odgovara 6 mikrograma) lutropina alfa* (r-hLH) u 0,48 ml otopine.
English: Solvent: 3 mL vials (Type I glass) with a Teflon coated rubber stopper and aluminium flip-off cap. 1 vial of solvent contains 1 mL of water for injections.
Croatian: Otapalo: bočice od 3 ml (staklo tipa I) s gumenim čepom obloženim teflonom i aluminijskim „flip-off“ zatvaračem.
English: 10 vials of solvent.
Croatian: 10 bočica s otapalom.
English: This side effect is common.
Croatian: Ova je nuspojava česta.
English: Subcutaneous use
Croatian: Tupferi natopljeni
English: Preparing the solution
Croatian: Priprema pribora
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa (r-hFSH) and 75 IU (equivalent to 3 micrograms) of lutropin alfa (r-hLH).
Croatian: Jedna bočica sadrži 150 IU (što odgovara 11 mikrograma) folitropina alfa (r-hFSH) i 75 IU (što odgovara 3 mikrograma) lutropina alfa (r-hLH).
English: • Check that the Dose Feedback Window shows
Croatian: Prozorčić za prikaz doze*
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) Each pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa (r-hLH) in 0.48 mL.
Croatian: Jedna napunjena brizgalica sadrži 300 IU (što odgovara 22 mikrograma) folitropina alfa (r-hFSH) i 150 IU (što odgovara 6 mikrograma) lutropina alfa (r-hLH) u 0,48 ml.
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Phosphoric acid, concentrated (for pH adjustment) Water for injections
Croatian: Prašak saharoza polisorbat 20 metionin natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat hidrat fosfatna kiselina, koncentrirana (za podešavanje pH) natrijev hidroksid (za podešavanje pH)
English: • Record this remaining dose in the “Amount Set to Inject” section in the next row (column 6).
Croatian: • Zabilježite tu preostalu primijenjenu dozu u sljedećem retku u dio
English: Storing the Pergoveris pre-filled pen.
Croatian: 8.4. Čuvanje Pergoveris napunjene brizgalice.
English: VIAL LABEL
Croatian: Kotačić za namještanje
English: Headache
Croatian: Potkožnu
English: • abdominal or pelvic pain
Croatian: • bol u trbuhu ili zdjelici
English: 3 vials of solvent.
Croatian: 3 bočice s otapalom.
English: Renal and hepatic impairment
Croatian: Oštećenje jetre i bubrega
English: MARKETING AUTHORISATION NUMBERS EU/1/07/396/005
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/396/005
English: Dose Feedback Window
Croatian: Prozorčić za prikaz doze
English: MARKETING AUTHORISATION NUMBERS EU/1/07/396/004
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/396/004
English: Important information about the Pergoveris pre-filled pen How to use your Pergoveris pre-filled pen treatment diary Gathering your supplies
Croatian: Kako koristiti svoj dnevnik liječenja Pergoveris napunjenom brizgalicom Priprema pribora
English: MARKETING AUTHORISATION NUMBERS EU/1/07/396/006
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/396/006
English: MARKETING AUTHORISATION NUMBERS EU/1/07/396/001
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/396/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/396/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/006
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/396/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/396/004
English: Powder: 3 mL vials (Type I glass) with a stopper (bromobutyl rubber) and aluminium flip-off cap. 1 vial contains 11 micrograms r-hFSH and 3 micrograms r-hLH.
Croatian: 1 bočica sadrži 11 mikrograma r-hFSH i 3 mikrograma r-hLH.
English: Investigation continuing
Croatian: Istraživanje se nastavlja
English: Testing during and after the transition period
Croatian: Ispitivanje tijekom i nakon prijelaznog razdoblja
English: • If you have any questions about your medicine or any medicine you have taken in the past, speak to your doctor or pharmacist.
Croatian: • Imate li pitanja u vezi s lijekom koji uzimate ili koji ste uzimali u prošlosti, obratite se svojem liječniku ili ljekarniku.
English: 2 International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance: M7(R1)
Croatian: 2 Smjernice Međunarodnog vijeća za harmonizaciju tehničkih zahtjeva za farmaceutske proizvode za primjenu u ljudi (ICH): M7(R1)
English: 17 April 2019 EMA/248364/2019 Rev 1
Croatian: EMA/248364/2019 Rev1
English: • If there is a need for further recalls or other measures, national authorities will inform you of what action to take.
Croatian: • U slučaju potrebe za dodatnim opozivima ili drugim mjerama, nacionalna tijela obavijestit će vas o mjerama koje trebate poduzeti.
English: Following tests, some medicines have been recalled from pharmacies and are no longer used in the EU.
Croatian: Nakon ispitivanja neki su lijekovi povučeni iz ljekarni i više se ne upotrebljavaju u EU-u.
English: The estimates have been extrapolated from animal studies and are very low compared with the lifetime risk of cancer in the EU (1 in 2).
Croatian: Procjene su ekstrapolirane iz ispitivanja provedenih na životinjama i vrlo su niske u usporedbi s rizikom od raka tijekom života u EU-u (u 1 na 2 slučaja).
English: You can also contact your national medicines authority.
Croatian: Možete se obratiti i svojem nacionalnom tijelu nadležnom za lijekove.
English: Candesartan (32 mg) Irbesartan (300 mg) Losartan (150 mg) Olmesartan (40 mg) Valsartan (320 mg)
Croatian: kandesartan (32 mg) irbesartan (300 mg) losartan (150 mg) olmesartan (40 mg) valsartan (320 mg)
English: • Manufacturers must now review their manufacturing processes to avoid the presence of nitrosamines.
Croatian: • Proizvođači moraju preispitati svoje proizvodne procese kako bi se izbjegla prisutnost nitrozamina.
English: Active substance (max daily dose)
Croatian: Djelatna tvar (maksimalna dnevna doza)
English: • You should not stop taking any sartan medicines without speaking to your doctor.
Croatian: • Ne smijete prestati uzimati bilo koju vrstu lijeka iz skupine sartana prije nego što razgovarate sa svojim liječnikom.
English: The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under Article 31 of Directive 2001/83/EC.
Croatian: Ocjenjivanje lijekova koji sadržavaju valsartan pokrenuto je 5. srpnja 2018. na zahtjev Europske komisije u skladu s člankom 31. Direktive 2001/83/EZ.
English: For the vast majority of sartan medicines, impurities were either not found or were present at very low levels.
Croatian: U velikoj većini lijekova iz skupine sartana nečistoće nisu pronađene ili su bile prisutne u vrlo niskim razinama.
English: Companies must now take measures to avoid the presence of these impurities and carry out rigorous testing of their products.
Croatian: Tvrtke moraju poduzeti određene mjere kako bi se izbjegla prisutnost tih nečistoća i provesti strogo ispitivanje svojih proizvoda.
English: These medicines are used to treat patients with hypertension (high blood pressure) and those with certain heart or kidney diseases.
Croatian: Ti se lijekovi upotrebljavaju za liječenje bolesnika s hipertenzijom (povišenim krvnim tlakom) i bolesnika s određenim bolestima srca ili bubrega.
English: Products containing either impurity above these limits or products containing both nitrosamines at whatever level will not be allowed in the EU.
Croatian: Proizvodi koji sadržavaju nečistoće u razinama većima od navedenih graničnih vrijednosti ili proizvodi koji sadržavaju oba nitrozamina u bilo kojoj razini neće biti dopušteni u EU-u.
English: NDEA in these medicines could lead to 8 extra cases in 100,000 patients taking the medicine at the highest dose every day for 4 years.1
Croatian: Tvar NDEA u tim lijekovima mogla bi prouzročiti osam slučajeva više u 100 000 bolesnika koji svakodnevno tijekom četiri godine uzimaju najveću dozu lijeka.1
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Croatian: Ocjenjivanje je provelo Povjerenstvo za lijekove za humanu uporabu (CHMP) EMA-e, odgovorno za pitanja koja se odnose na lijekove za humanu uporabu, koje je usvojilo mišljenje Agencije.
English: After the transition period, companies must exclude the presence of even lower levels of NDEA or NDMA in their products (< 0.03 parts per million).
Croatian: Nakon isteka prijelaznog razdoblja tvrtke moraju isključiti prisutnost čak i najnižih razina tvari NDEA i NDMA u svojim proizvodima (< 0,03 dijelova na milijun).
English: EMA's recommendations for NDMA and NDEA were sent to the European Commission, which issued a legally binding decisions.
Croatian: Preporuke EMA-e o tvarima NDMA i NDEA poslane su Europskoj komisiji, koja je donijela pravno obvezujuće odluke.
English: The CHMP opinion was forwarded to the European Commission, which issued final legally binding decisions for the medicines concerned between 2 April and 17 April 2019 that are applicable in all EU Member States.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji, koja je u razdoblju od 2. do 17. travnja 2019. donijela konačne pravno obvezujuće odluke o predmetnim lijekovima koje se primjenjuju u svim državama članicama EU-a.
English: Other medicines of the class which do not have this ring, such as azilsartan, eprosartan and telmisartan, were not included in the review.
Croatian: Ostali lijekovi iz ove skupine koji nemaju takav prsten, kao što su azilsartan, eprosartan i telmisartan, nisu obuhvaćeni ovim ocjenjivanjem.
English: Dividing these by the maximum daily dose for each active substance gives the limit in parts per million (see Table 1).
Croatian: Kada se te količine podijele s maksimalnom dnevnom dozom svake djelatne tvari, dobiva se granična vrijednost izražena u dijelovima na milijun (vidjeti Tablicu 1).