FrancophonIA/ELRC3.0 huggingface dataset:
English: A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG is administered 24-48 hours after the last GONAL-f injection to induce final follicular maturation.
Croatian: Jedna injekcija od 250 mikrograma rekombiniranog r-hCG ili 5000 od najviše 10 000 IU hCG daje se od 24 do 48 sati nakon zadnje injekcije lijeka GONAL-f kako bi se potaknulo konačno sazrijevanje folikula.
English: 1 pre-filled syringe of 2 mL solvent.
Croatian: 1 napunjena štrcaljka s 2 ml otapala.
English: Solvent for solution for injection
Croatian: Otapalo za otopinu za injekciju
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHTAND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: The solvent for reconstitution is presented in 1 mL pre-filled syringes (Type I glass) with a rubber stopper.
Croatian: Otapalo za rekonstituciju nalazi se u napunjenim štrcaljkama od 1 ml (staklo tip I) s gumenim čepom.
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) should not be mixed with other medicines in the same injection.
Croatian: GONAL-f 300 IU/0,50 ml (22 mikrograma/0,50 ml) ne smije se miješati s drugim lijekovima u istoj injekciji.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S 1 BOČICOM I 1 NAPUNJENOM ŠTRCALJKOM
English: NAME OF THE MEDICINAL PRODUCT GONAL-f 900 IU/1.5 mL (66 micrograms/1.5 mL) solution for injection in pre-filled pen.
Croatian: NAZIV LIJEKA GONAL-f 900 IU/1,5 ml (66 mikrograma/1,5 ml) otopina za injekciju u napunjenoj brizgalici.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 900 IU follitropin alfa, equivalent to 66 micrograms, per 1.5 mL.
Croatian: Svaka višedozna napunjena brizgalica osigurava primjenu 900 IU folitropina alfa, što odgovara 66 mikrograma, u 1,5 ml.
English: • 1 pre-filled syringe containing the solvent (the clear liquid)
Croatian: • 1 napunjenu štrcaljku koja sadrži otapalo (bistru tekućinu)
English: GONAL-f pre-filled pen Treatment Diary
Croatian: Dnevnik liječenja lijekom GONAL-f u napunjenoj brizgalici
English: Each pre-filled pen with multidose cartridge delivers 450 IU (33 micrograms) in 0.75 mL.
Croatian: Svaka napunjena brizgalica s višedoznim uloškom osigurava primjenu 450 IU (33 mikrograma) u 0,75 ml.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.75 mL/pre-filled syringe
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,75 ml/napunjena štrcaljka
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S 1 BOČICOM I 1 BOČICA
English: 6 disposable syringes for administration graduated in FSH units.
Croatian: 6 štrcaljki za jednokratnu uporabu za primjenu lijeka graduiranih u FSH jedinicama.
English: Pack of one pre-filled pen and 20 needles to be used with the pen for administration.
Croatian: Pakiranje s 1 napunjenom brizgalicom i 20 igala za upotrebu s brizgalicom za primjenu lijeka.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) must be reconstituted with the 2 mL solvent provided before use.
Croatian: GONAL-f 1050 IU/1,75 ml (77 mikrograma/1,75 ml) mora se prije uporabe rekonstituirati s 2 ml priloženog otapala.
English: GONAL-f 900 IU/1.5 mL (66 micrograms/1.5 mL) solution for injection in a pre-filled pen Follitropin alfa
Croatian: GONAL-f 900 IU/1,5 ml (66 mikrograma/1,5 ml) otopina za injekciju u napunjenoj brizgalici folitropin alfa
English: 15 disposable syringes.
Croatian: 15 štrcaljki za jednokratnu uporabu.
English: INFORMATION IN BRAILLE gonal-f 450 iu
Croatian: 16. PODACI NA BRAILLEOVOM PISMU gonal-f 450 iu
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) should not be mixed with other medicines in the same injection.
Croatian: GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) ne smije se miješati s drugim lijekovima u istoj injekciji.
English: Prepare your needle for Injection
Croatian: 4.3 Pripremite iglu za injekciju
English: Sharps disposal container
Croatian: Spremnik za odlaganje oštrih predmeta
English: • The 900 IU pen maximum single-dose setting is 450 IU and the smallest single-dose setting is
Croatian: • Najviša doza koja se može podesiti na brizgalici od 900 IU iznosi 450 IU, a najniža doza koja se može podesiti iznosi 12,5 IU.
English: 4 disposable syringes for administration graduated in FSH units.
Croatian: 4 štrcaljke za jednokratnu uporabu za primjenu lijeka graduiranih u FSH jedinicama.
English: GONAL-f Pre-filled pen 300 IU/0.5 mL
Croatian: GONAL-f 300 IU/0,5 ml napunjena brizgalica
English: Each pre-filled pen with multidose cartridge delivers 900 IU (66 micrograms) in 1.5 mL.
Croatian: Svaka napunjena brizgalica s višedoznim uloškom osigurava primjenu 900 IU (66 mikrograma) u 1,5 ml.
English: • It is supplied in packs with 1 pre-filled pen and 20 disposable needles.
Croatian: • Isporučuje se u pakiranju s 1 napunjenom brizgalicom i 20 igala za jednokratnu upotrebu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT PRE-FILLED SYRINGE TEXT
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TEKST NA NAPUNJENOJ ŠTRCALJKI S OTAPALOM
English: INFORMATION IN BRAILLE gonal-f 900 iu/1.5 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU gonal-f 900 iu/1,5 ml
English: Removable needle
Croatian: Uklonjiva igla
English: • After preparation of the final solution for injection, there are 75 IU (5.5 micrograms) of follitropin alfa in each millilitre of solution.
Croatian: • Nakon pripreme završne otopine za injekciju u svakom se mililitru otopine nalazi 75 IU
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for use with GONAL-f 1050 IU/1.75 mL Water for injections, benzyl alcohol 0.9%
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za uporabu s lijekom GONAL-f 1050 IU/1,75 ml Voda za injekcije, benzilni alkohol 0,9%
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 75 IU (5.5 μg) powder for solution for injection Follitropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 75 IU (5,5 μg) prašak za otopinu za injekciju folitropin alfa s.c.
English: 0.75 mL of solution for injection in 3 mL cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
Croatian: 0,75 ml otopine za injekciju u ulošku od 3 ml (staklo tip I), s čepom klipa (halobutilna guma) i aluminijskim zatvaračem s unutarnjom oblogom od crne gume.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-F 75 IU (5.5 MICROGRAMS) VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI ZA GONAL-f 75 IU (5,5 MIKROGRAMA)
English: The solvent for reconstitution is presented in 2 mL pre-filled syringes (Type I glass) with a rubber stopper.
Croatian: Otapalo za rekonstituciju nalazi se u napunjenim štrcaljkama od 2 ml (staklo tip I) s gumenim čepom.
English: PARTICULARS TO APPEAR ON THE PEN GONAL-f 450 IU/0.75 mL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA BRIZGALICI GONAL-f 450 IU/0,75 ml
English: INFORMATION IN BRAILLE gonal-f 300 iu/0.5 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU gonal-f 300 iu/0,5 ml
English: • Remove the protective cap from the solvent vial.
Croatian: • Uklonite zaštitni zatvarač s bočice s otapalom.
English: The medicinal product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 15 disposable syringes for administration graduated in FSH units.
Croatian: Lijek je dostupan u pakiranju od 1 bočice s praškom s 1 napunjenom štrcaljkom s otapalom za rekonstituciju i 15 štrcaljki za jednokratnu uporabu za primjenu lijeka graduiranih u FSH jedinicama.
English: Exacerbation or aggravation of asthma Gastrointestinal disorders Common:
Croatian: Egzacerbacija ili pogoršanje astme
English: NAME OF THE MEDICINAL PRODUCT GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA GONAL-f 1050 IU/1,75 ml (77 mikrograma/1,75 ml) prašak i otapalo za otopinu za injekciju.
English: GONAL-f Pre-filled pen 900 IU/1.5 mL
Croatian: GONAL-f 900 IU/1,5 ml napunjena brizgalica
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for use with GONAL-f 300 IU/0.50 mL Water for injections, benzyl alcohol 0.9%
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za uporabu s lijekom GONAL-f 300 IU/0,50 ml Voda za injekcije, benzilni alkohol 0,9%
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 1050 IU/1.75 ML (77 MICROGRAMS/1.75 ML), VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE GONAL-f 1050 IU/1,75 ml (77 MIKROGRAMA/1,75 ML), NALJEPNICA BOČICE
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) must be reconstituted with the 1 mL solvent provided before use.
Croatian: GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) mora se prije uporabe rekonstituirati s 1 ml priloženog otapala.
English: EU/1/95/001/025 1 vial of powder for solution for injection.
Croatian: EU/1/95/001/025 1 bočica s praškom za otopinu za injekciju.
English: The medicinal product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 6 disposable syringes for administration graduated in FSH units.
Croatian: Lijek je dostupan u pakiranju od 1 bočice s praškom s 1 napunjenom štrcaljkom s otapalom za rekonstituciju i 6 štrcaljki za jednokratnu uporabu za primjenu lijeka graduiranih u FSH jedinicama.
English: GONAL-f Pre-filled pen 450 IU/0.75 mL
Croatian: GONAL-f 450 IU/0,75 ml napunjena brizgalica
English: • The solvent is a clear colourless liquid in a glass vial, each containing 1 mL.
Croatian: • Otapalo je bistra bezbojna tekućina u staklenoj bočici od kojih svaka sadrži 1 ml.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for use with GONAL-f 450 IU/0.75 mL Water for injections, benzyl alcohol 0.9%
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za uporabu s lijekom GONAL-f 450 IU/0,75 ml Voda za injekcije, benzilni alkohol 0,9%
English: 12 injection needles
Croatian: Injiciranje doze
English: 1.5 mL of solution for injection in 3 mL cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
Croatian: 1,5 ml otopine za injekciju u ulošku od 3 ml (staklo tipa I), s čepom klipa (halobutilna guma) i aluminijskim zatvaračem s unutarnjom oblogom od crne gume.
English: The medicinal product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 4 disposable syringes for administration graduated in FSH units.
Croatian: Lijek je dostupan u pakiranju od 1 bočice s praškom s 1 napunjenom štrcaljkom s otapalom za rekonstituciju i 4 štrcaljke za jednokratnu uporabu za primjenu lijeka graduiranih u FSH jedinicama.
English: PARTICULARS TO APPEAR ON THE PEN GONAL-f 300 IU/0.5 mL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA BRIZGALICI GONAL-f 300 IU/0,5 ml
English: • After reconstitution, there are 1,050 IU (77 micrograms) of follitropin alfa in 1.75 mL solution,
Croatian: • Nakon pripreme za primjenu, u 1,75 ml otopine nalazi se 1050 IU (77 mikrograma) folitropina alfa, što znači da se u svakom mililitru otopine nalazi 600 IU (44 mikrograma).
English: PARTICULARS TO APPEAR ON THE PEN GONAL-f 900 IU/1.5 mL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA BRIZGALICI GONAL-f 900 IU/1,5 ml
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Croatian: Pomoćne tvari: saharoza, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat dihidrat, metionin, polisorbat 20, koncentrirana fosfatna kiselina i natrijev hidroksid.
English: Bioequivalence has been demonstrated between equivalent doses of the monodose presentation and the multidose presentation of GONAL-f.
Croatian: Između odgovarajućih doza monodoznog i višedoznog oblika lijeka GONAL-f dokazana je bioekvivalentnost.
English: • The pre-filled syringe containing the solvent (the clear liquid)
Croatian: • Napunjenu štrcaljku koja sadrži otapalo (bistru tekućinu)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 mL/pre-filled syringe
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2 ml/napunjena štrcaljka
English: Getting ready the syringe for injection
Croatian: Priprema štrcaljke za injiciranje
English: Verify that the Dose-Feedback Window reads "0".
Croatian: 5. Provjerite je li na prozorčiću za prikaz doze prikazana „0“.
English: • Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing may occur.
Croatian: • Katkad se mogu pojaviti alergijske reakcije kao što su osip, crvenilo kože, koprivnjača, otekline lica i poteškoće pri disanju.
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Croatian: Pomoćne tvari: saharoza, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat dihidrat, koncentrirana fosfatna kiselina i natrijev hidroksid.
English: 0.5 mL of solution for injection in 3 mL cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
Croatian: 0,5 ml otopine za injekciju u ulošku od 3 ml (staklo tip I), s čepom klipa (halobutilna guma) i aluminijskim zatvaračem s unutarnjom oblogom od crne gume.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 450 IU follitropin alfa, equivalent to 33 micrograms, per 0.75 mL.
Croatian: Svaka višedozna napunjena brizgalica osigurava primjenu 450 IU folitropina alfa, što odgovara 33 mikrograma, na 0,75 ml.
English: When an optimal response is obtained, a single injection of 250 micrograms recombinant human choriogonadotropin alfa (r-hCG) or 5,000 IU, up to 10,000 IU hCG should be administered 24-48 hours after the last GONAL-f injection.
Croatian: Kada je postignut optimalan odgovor, potrebno je dati jednu injekciju od 250 mikrograma rekombinantnog ljudskog koriogonadotropina alfa (r-hCG) ili 5000 IU do 10 000 IU hCG od 24 do 48 sati nakon zadnje injekcije lijeka GONAL-f.
English: 6 disposable syringes.
Croatian: 6 štrcaljki za jednokratnu uporabu.
English: Each pre-filled pen with multidose cartridge delivers 300 IU (to 22 micrograms) in 0.5 mL.
Croatian: U svakoj je napunjenoj brizgalici s višedoznim uloškom osigurana primjena 300 IU (do 22 mikrograma) u 0,5 ml.
English: 4 disposable syringes.
Croatian: 4 štrcaljke za jednokratnu uporabu.
English: GONAL f is presented as a powder and solvent for injection.
Croatian: GONAL-f je dostupan u obliku praška i otapala za injekciju.
English: When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last GONAL-f and lutropin alfa injections.
Croatian: Kada se uspije dobiti optimalan odgovor na terapiju, treba dati jednu injekciju s 250 mikrograma r-hCG ili 5000 do 10 000 IU hCG od 24 do 48 sati nakon zadnje injekcije lijeka GONAL-f i lutropina alfa.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) powder and solvent for solution for injection Follitropin alfa
Croatian: GONAL-f 1050 IU/1,75 ml (77 mikrograma/1,75 ml) prašak i otapalo za otopinu za injekciju folitropin alfa
English: NAME OF THE MEDICINAL PRODUCT GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA GONAL-f 300 IU/0,50 ml (22 mikrograma/0,50 ml) prašak i otapalo za otopinu za injekciju.
English: NAME OF THE MEDICINAL PRODUCT GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in pre-filled pen.
Croatian: NAZIV LIJEKA GONAL-f 300 IU/0,5 ml (22 mikrograma/0,5 ml) otopina za injekciju u napunjenoj brizgalici.
English: • Grip the outer needle cap and unscrew the needle by turning anticlockwise.
Croatian: • Čvrsto držeći vanjski zatvarač igle, odvojite iglu zakretanjem u smjeru suprotnom od kazaljke na satu.
English: • Place the outer needle cap on a flat surface.
Croatian: • Postavite vanjski zatvarač igle na ravnu površinu.
English: • The solvent is a clear colourless liquid in a pre-filled syringe, each containing 2 mL.
Croatian: • Otapalo je bistra bezbojna tekućina u napunjenoj štrcaljki, svaka sadrži 2 ml.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 300 IU/0.5 ML (22 MICROGRAMS/0.5 ML) PEN, PEN LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE GONAL-f 300 IU/0,5 ML (22 MIKROGRAMA/0,5 ML) BRIZGALICA, NALJEPNICA BRIZGALICE
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) preparation must not be reconstituted with any other GONAL-f containers.
Croatian: Pripravak lijeka GONAL-f 300 IU/0,50 ml (22 mikrograma/0,50 ml) ne smije se rekonstituirati s drugim spremnicima lijeka GONAL-f.
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/032
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/032
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
Croatian: Pripravak lijeka GONAL-f 300 IU/0,50 ml (22 mikrograma/0,50 ml) ne smije se miješati s drugim spremnicima lijeka GONAL-f unutar iste bočice ili štrcaljke.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 300 IU follitropin alfa, equivalent to 22 micrograms, per 0.5 mL.
Croatian: Svaka višedozna napunjena brizgalica osigurava primjenu 300 IU folitropina alfa (odgovara 22 mikrograma) u 0,5 ml.
English: 1 pre-filled syringe of 1 mL solvent.
Croatian: 1 napunjena štrcaljka s 1 ml otapala.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 450 IU/0.75 ML (33 MICROGRAMS/0.75 ML) PEN, PEN LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE GONAL-f 450 IU/0,75 ML (33 MIKROGRAMA/0,75 ML) BRIZGALICA, NALJEPNICA BRIZGALICE
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mL/pre-filled syringe
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 ml/napunjena štrcaljka
English: • The solvent is a clear colourless liquid in a pre-filled syringe, each containing 1 mL.
Croatian: • Otapalo je bistra bezbojna tekućina u napunjenoj štrcaljki, svaka sadrži 1 ml.
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) powder and solvent for solution for injection Follitropin alfa
Croatian: GONAL-f 300 IU/0,50 ml (22 mikrograma/0,50 ml) prašak i otapalo za otopinu za injekciju folitropin alfa
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
Croatian: Pripravak lijeka GONAL-f 1050 IU/1,75 ml (77 mikrograma/1,75 ml) ne smije se miješati s ostalim spremnicima lijeka GONAL-f unutar iste bočice ili štrcaljke.
English: NAME OF THE MEDICINAL PRODUCT GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) prašak i otapalo za otopinu za injekciju.
English: GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in a pre-filled pen Follitropin alfa
Croatian: GONAL-f 300 IU/0,5 ml (22 mikrograma/0,5 ml) otopina za injekciju u napunjenoj brizgalici folitropin alfa
English: 1 pre-filled syringe of solvent.
Croatian: 1 napunjena štrcaljka s otapalom.
English: How to use the GONAL-f pre-filled pen
Croatian: Kako koristiti napunjenu brizgalicu lijeka GONAL-f
English: • When your eggs are ready, you will be given a single injection of 250 micrograms “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special recombinant DNA technique), or 5,000 IU to 10,000 IU of hCG, 24 to 48 hours after the last GONAL-f injection.
Croatian: • Kada su Vaše jajne stanice spremne, daje se jedna injekcija od 250 mikrograma „rekombinantnog hCG“ (r-hCG, hCG dobiven u laboratoriju posebnom DNK tehnikom) ili od 5000 do 10 000 IU hCG 24 do 48 sati nakon posljednje injekcije lijeka GONAL-f.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) preparation must not be reconstituted with any other GONAL-f containers.
Croatian: Pripravak lijeka GONAL-f 1050 IU/1,75 ml (77 mikrograma/1,75 ml) ne smije se rekonstituirati ni s jednim drugim spremnikom lijeka GONAL-f.
English: Please write on the GONAL-f pre-filled pen the day you first use it.
Croatian: Na napunjenu brizgalicu s lijekom GONAL-f napišite datum prve primjene.
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
Croatian: Pripravak lijeka GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) ne smije se miješati s ostalim spremnicima lijeka GONAL-f unutar iste bočice ili štrcaljke.
English: • After reconstitution, there are 300 IU (22 micrograms) of follitropin alfa in 0.5 mL solution,
Croatian: • Nakon pripreme za primjenu, u 0,5 ml otopine nalazi se 300 IU (22 mikrograma) folitropina alfa, što znači da se u svakom mililitru otopine nalazi 600 IU (44 mikrograma).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 300 IU/0.50 mL powder for solution for injection Follitropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 300 IU/0,50 ml prašak za otopinu za injekciju. folitropin alfa s.c.
English: Dose setting knob
Croatian: Prijavljivanje nuspojava
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) preparation must not be reconstituted with any other GONAL-f containers.
Croatian: Pripravak lijeka GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) ne smije se rekonstituirati ni s jednim drugim spremnikom lijeka GONAL-f.
English: NAME OF THE MEDICINAL PRODUCT GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in pre-filled pen.
Croatian: NAZIV LIJEKA GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) otopina za injekciju u napunjenoj brizgalici.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 450 IU/0.75 ML (33 MICROGRAMS/0.75 ML), VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE GONAL-f 450 IU/0,75 ml (33 MIKROGRAMA/0,75 ML), NALJEPNICA BOČICE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 300 IU/0.50 ML (22 MICROGRAMS/0.50 ML), VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE GONAL-f 300 IU/0,50 ML (22 MIKROGRAMA/0,50 ML), NALJEPNICA BOČICE
English: • After reconstitution, there are 450 IU (33 micrograms) of follitropin alfa in 0.75 mL solution,
Croatian: • Nakon pripreme za primjenu, u 0,75 ml otopine nalazi se 450 IU (33 mikrograma) folitropina alfa, što znači da se u svakom mililitru otopine nalazi 600 IU (44 mikrograma).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT PRE-FILLED SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ŠTRCALJKA NAPUNJENA OTAPALOM
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/021
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/021
English: Getting your GONAL-f pre-filled pen ready for injection 4.1.
Croatian: Priprema napunjene brizgalice lijeka GONAL-f za injekciju 4.1 Skinite zatvarač brizgalice 4.2 Provjerite na prozorčiću za prikaz doze da je podešena „0“
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) powder and solvent for solution for injection Follitropin alfa
Croatian: GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) prašak i otapalo za otopinu za injekciju folitropin alfa
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 450 IU/0.75 mL powder for solution for injection Follitropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 450 IU/0,75 ml prašak za otopinu za injekciju. folitropin alfa s.c.
English: Press the dose setting knob as far as it will go. A tiny drop of liquid will appear at the tip of the needle.
Croatian: Na vrhu igle pojavit će se kapljica tekućine.
English: Peel-off seal tab
Croatian: Odvojiva folija