natgillin/translations-raw huggingface dataset:
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%
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%
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 1050 IU/1.75 ML (77 MICROGRAMS/1.75 ML), VIAL LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE GONAL-f 1050 IU/1,75 ml (77 MIKROGRAMA/1,75 ML), NALJEPNICA BOČICE
GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) must be reconstituted with the 1 mL solvent provided before use.
GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) mora se prije uporabe rekonstituirati s 1 ml priloženog otapala.
EU/1/95/001/025 1 vial of powder for solution for injection.
EU/1/95/001/025 1 bočica s praškom za otopinu za injekciju.
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.
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.
GONAL-f Pre-filled pen 450 IU/0.75 mL
GONAL-f 450 IU/0,75 ml napunjena brizgalica
• The solvent is a clear colourless liquid in a glass vial, each containing 1 mL.
• Otapalo je bistra bezbojna tekućina u staklenoj bočici od kojih svaka sadrži 1 ml.
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%
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%
12 injection needles
Injiciranje doze
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.
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.
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.
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.
PARTICULARS TO APPEAR ON THE PEN GONAL-f 300 IU/0.5 mL
PODACI KOJI SE MORAJU NALAZITI NA BRIZGALICI GONAL-f 300 IU/0,5 ml
• After reconstitution, there are 1,050 IU (77 micrograms) of follitropin alfa in 1.75 mL solution,
• 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).
PARTICULARS TO APPEAR ON THE PEN GONAL-f 900 IU/1.5 mL
PODACI KOJI SE MORAJU NALAZITI NA BRIZGALICI GONAL-f 900 IU/1,5 ml
Excipients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Pomoćne tvari: saharoza, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat dihidrat, metionin, polisorbat 20, koncentrirana fosfatna kiselina i natrijev hidroksid.
Bioequivalence has been demonstrated between equivalent doses of the monodose presentation and the multidose presentation of GONAL-f.
Između odgovarajućih doza monodoznog i višedoznog oblika lijeka GONAL-f dokazana je bioekvivalentnost.
• The pre-filled syringe containing the solvent (the clear liquid)
• Napunjenu štrcaljku koja sadrži otapalo (bistru tekućinu)
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 mL/pre-filled syringe
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2 ml/napunjena štrcaljka
Getting ready the syringe for injection
Priprema štrcaljke za injiciranje
Verify that the Dose-Feedback Window reads "0".
5. Provjerite je li na prozorčiću za prikaz doze prikazana „0“.
• Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing may occur.
• Katkad se mogu pojaviti alergijske reakcije kao što su osip, crvenilo kože, koprivnjača, otekline lica i poteškoće pri disanju.
Excipients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Pomoćne tvari: saharoza, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat dihidrat, koncentrirana fosfatna kiselina i natrijev hidroksid.
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.
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.
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 450 IU follitropin alfa, equivalent to 33 micrograms, per 0.75 mL.
Svaka višedozna napunjena brizgalica osigurava primjenu 450 IU folitropina alfa, što odgovara 33 mikrograma, na 0,75 ml.
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.
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.
6 disposable syringes.
6 štrcaljki za jednokratnu uporabu.
Each pre-filled pen with multidose cartridge delivers 300 IU (to 22 micrograms) in 0.5 mL.
U svakoj je napunjenoj brizgalici s višedoznim uloškom osigurana primjena 300 IU (do 22 mikrograma) u 0,5 ml.
4 disposable syringes.
4 štrcaljke za jednokratnu uporabu.
GONAL f is presented as a powder and solvent for injection.
GONAL-f je dostupan u obliku praška i otapala za injekciju.
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.
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.
GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) powder and solvent for solution for injection Follitropin alfa
GONAL-f 1050 IU/1,75 ml (77 mikrograma/1,75 ml) prašak i otapalo za otopinu za injekciju folitropin alfa
NAME OF THE MEDICINAL PRODUCT GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) powder and solvent for solution for injection.
NAZIV LIJEKA GONAL-f 300 IU/0,50 ml (22 mikrograma/0,50 ml) prašak i otapalo za otopinu za injekciju.
NAME OF THE MEDICINAL PRODUCT GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in pre-filled pen.
NAZIV LIJEKA GONAL-f 300 IU/0,5 ml (22 mikrograma/0,5 ml) otopina za injekciju u napunjenoj brizgalici.
• Grip the outer needle cap and unscrew the needle by turning anticlockwise.
• Čvrsto držeći vanjski zatvarač igle, odvojite iglu zakretanjem u smjeru suprotnom od kazaljke na satu.
• Place the outer needle cap on a flat surface.
• Postavite vanjski zatvarač igle na ravnu površinu.
• The solvent is a clear colourless liquid in a pre-filled syringe, each containing 2 mL.
• Otapalo je bistra bezbojna tekućina u napunjenoj štrcaljki, svaka sadrži 2 ml.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 300 IU/0.5 ML (22 MICROGRAMS/0.5 ML) PEN, PEN LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE GONAL-f 300 IU/0,5 ML (22 MIKROGRAMA/0,5 ML) BRIZGALICA, NALJEPNICA BRIZGALICE
GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) preparation must not be reconstituted with any other GONAL-f containers.
Pripravak lijeka GONAL-f 300 IU/0,50 ml (22 mikrograma/0,50 ml) ne smije se rekonstituirati s drugim spremnicima lijeka GONAL-f.
MARKETING AUTHORISATION NUMBER EU/1/95/001/032
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/032
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.
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.
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 300 IU follitropin alfa, equivalent to 22 micrograms, per 0.5 mL.
Svaka višedozna napunjena brizgalica osigurava primjenu 300 IU folitropina alfa (odgovara 22 mikrograma) u 0,5 ml.
1 pre-filled syringe of 1 mL solvent.
1 napunjena štrcaljka s 1 ml otapala.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 450 IU/0.75 ML (33 MICROGRAMS/0.75 ML) PEN, PEN LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE GONAL-f 450 IU/0,75 ML (33 MIKROGRAMA/0,75 ML) BRIZGALICA, NALJEPNICA BRIZGALICE
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mL/pre-filled syringe
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 ml/napunjena štrcaljka
• The solvent is a clear colourless liquid in a pre-filled syringe, each containing 1 mL.
• Otapalo je bistra bezbojna tekućina u napunjenoj štrcaljki, svaka sadrži 1 ml.
GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) powder and solvent for solution for injection Follitropin alfa
GONAL-f 300 IU/0,50 ml (22 mikrograma/0,50 ml) prašak i otapalo za otopinu za injekciju folitropin alfa
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.
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.
NAME OF THE MEDICINAL PRODUCT GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) powder and solvent for solution for injection.
NAZIV LIJEKA GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) prašak i otapalo za otopinu za injekciju.
GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in a pre-filled pen Follitropin alfa
GONAL-f 300 IU/0,5 ml (22 mikrograma/0,5 ml) otopina za injekciju u napunjenoj brizgalici folitropin alfa
1 pre-filled syringe of solvent.
1 napunjena štrcaljka s otapalom.
How to use the GONAL-f pre-filled pen
Kako koristiti napunjenu brizgalicu lijeka GONAL-f
• 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.
• 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.
GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) preparation must not be reconstituted with any other GONAL-f containers.
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.
Please write on the GONAL-f pre-filled pen the day you first use it.
Na napunjenu brizgalicu s lijekom GONAL-f napišite datum prve primjene.
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.
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.
• After reconstitution, there are 300 IU (22 micrograms) of follitropin alfa in 0.5 mL solution,
• 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).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 300 IU/0.50 mL powder for solution for injection Follitropin alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 300 IU/0,50 ml prašak za otopinu za injekciju. folitropin alfa s.c.
Dose setting knob
Prijavljivanje nuspojava
GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) preparation must not be reconstituted with any other GONAL-f containers.
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.
NAME OF THE MEDICINAL PRODUCT GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in pre-filled pen.
NAZIV LIJEKA GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) otopina za injekciju u napunjenoj brizgalici.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 450 IU/0.75 ML (33 MICROGRAMS/0.75 ML), VIAL LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE GONAL-f 450 IU/0,75 ml (33 MIKROGRAMA/0,75 ML), NALJEPNICA BOČICE
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 300 IU/0.50 ML (22 MICROGRAMS/0.50 ML), VIAL LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE GONAL-f 300 IU/0,50 ML (22 MIKROGRAMA/0,50 ML), NALJEPNICA BOČICE
• After reconstitution, there are 450 IU (33 micrograms) of follitropin alfa in 0.75 mL solution,
• 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).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT PRE-FILLED SYRINGE
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ŠTRCALJKA NAPUNJENA OTAPALOM
MARKETING AUTHORISATION NUMBER EU/1/95/001/021
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/021
Getting your GONAL-f pre-filled pen ready for injection 4.1.
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“
GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) powder and solvent for solution for injection Follitropin alfa
GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) prašak i otapalo za otopinu za injekciju folitropin alfa
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 450 IU/0.75 mL powder for solution for injection Follitropin alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 450 IU/0,75 ml prašak za otopinu za injekciju. folitropin alfa s.c.
Press the dose setting knob as far as it will go. A tiny drop of liquid will appear at the tip of the needle.
Na vrhu igle pojavit će se kapljica tekućine.
Peel-off seal tab
Odvojiva folija
• 1 vial containing the solvent (the clear liquid)
• 1 bočicu koja sadrži otapalo (bistra tekućina)
GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in a pre-filled pen Follitropin alfa
GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) otopina za injekciju u napunjenoj brizgalici folitropin alfa
This side effect is common (may affect up to 1 in 10 people).
Ta je nuspojava česta (mogu se javiti u manje od 1 na 10 osoba).
• When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last injections of GONAL-f and lutropin alfa.
• Kada se postigne odgovarajući odgovor, daje se jedna injekcija od 250 mikrograma „rekombinantnog hCG“ (r-hCG, hCG dobiven u laboratoriju posebnom DNK tehnikom) ili od 5000 IU do 10 000 IU hCG 24 do 48 sati nakon posljednje injekcije lijeka GONAL-f i lutropina alfa.
• Abdominal pain • Feeling sick, vomiting, diarrhoea, abdominal cramps and bloating
• Bol u abdomenu • Mučnina, povraćanje, proljev, grčevi u trbuhu i nadutost
If you do not see a tiny drop(s) of fluid at or near the tip the first time you use a new pen: 1.
Ako ne ugledate kapljicu (kapljice) tekućine na vrhu ili blizu vrha igle kad prvi put koristite napunjenu brizgalicu: 1. Pažljivo okrenite gumb za podešavanje doze u smjeru kazaljke na satu sve dok se na prozorčiću za prikaz doze ne pojavi 25.
if"0", injection complete if not "0", need second injection Inject this amount ..........using new pen
ako "0", injekcija je potpuna ako nije"0",potrebna je druga injekcija Ubrizgajte ovu količinu.......... pomoću nove brizgalice
Subcutaneous use.
Spontani pobačaj
Contains: One pre-filled syringe of solvent contains: 0.75 mL water for injections, benzyl alcohol
Sadrži: Svaka napunjena štrcaljka otapala sadrži: 0,75 ml vode za injekciju, benzilni alkohol 0,9%.
MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/032 1 vial of powder for solution for injection.
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/032 1 bočica s praškom za otopinu za injekciju.
20 injection needles
1 višedozna napunjena brizgalica 20 igala za injekciju
MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/033 solution for injection in pre-filled pen.
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/033 otopina za injekciju u napunjenoj brizgalici.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 900 IU/1.5 mL (66 micrograms/1.5 mL) solution for injection in pre-filled pen.
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 900 IU/1,5 ml (66 μg/1,5 ml) otopina za injekciju u napunjenoj brizgalici. folitropin alfa s.c.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S OTAPALOM
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Discard any unused solution.
POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI
MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/021 1 vial of powder for solution for injection.
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/021 1 bočica s praškom za otopinu za injekciju.
MARKETING AUTHORISATION NUMBER EU/1/95/001/033
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/033
MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/034 solution for injection in pre-filled pen.
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/034 otopina za injekciju u napunjenoj brizgalici.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mL/vial
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 ml/bočica
MARKETING AUTHORISATION NUMBER EU/1/95/001/034
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/034
MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/005 1 vial of powder for solution for injection.
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/005 1 bočica s praškom za otopinu za injekciju.
MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/035 solution for injection in pre-filled pen.
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/035 otopina za injekciju u napunjenoj brizgalici.
MARKETING AUTHORISATION NUMBER EU/1/95/001/031
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/031
Do not use this medicine after the expiry date which is stated on the vial after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici iza oznake
• When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last GONAL-f injection.
• Kada se postigne odgovarajući odgovor, daje se jedna injekcija od 250 mikrograma „rekombinantnog hCG“ (r-hCG, hCG dobiven u laboratoriju posebnom DNA tehnikom) ili od 5000 IU do 10 000 IU hCG 24 do 48 sati nakon posljednje injekcije lijeka GONAL-f.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in pre-filled pen.
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 450 IU/0,75 ml (33 μg/0,75 ml) otopina za injekciju u napunjenoj brizgalici. folitropin alfa.
MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/031 1 vial of powder for solution for injection.
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/031 1 bočica s praškom za otopinu za injekciju.
Tap the reservoir holder gently.
Tapkajte držač spremnika lagano prstom.
MARKETING AUTHORISATION NUMBER EU/1/95/001/035
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/035
Powder
ŠTRCALJKI
• The other ingredients are sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
• Drugi sastojci su: saharoza, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat dihidrat,
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in pre-filled pen.
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 300 IU/0,5 ml (22 μg/0,5 ml) otopina za injekciju u napunjenoj brizgalici. folitropin alfa.
1 vial of powder for solution for injection.
1 bočica s praškom za otopinu za injekciju.
• Recap the pen.
• Vratite zatvarač na brizgalicu.
Storing the GONAL-f pre-filled pen.
7.4. Čuvanje napunjene brizgalice lijeka GONAL-f OPREZ:
• GONAL-f is supplied in packs of 1 vial of powder with 1 pre-filled syringe of solvent and
• GONAL-f je dostupan u pakiranju od 1 bočice s praškom s 1 napunjenom štrcaljkom s otapalom i 4 štrcaljke za jednokratnu uporabu za primjenu lijeka graduiranih u internacionalnim jedinicama (IU FSH)
Plunger piston
Zatvarač brizgalice
Look closely at the tip of the needle for tiny drop(s) of fluid
Pažljivo pogledajte vidi li se kapljica (kapljice) tekućine na vršku igle
Talk to your doctor immediately,
Odmah se obratite svom liječniku
• You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have treatment for cancer, then there is still a chance you could become pregnant).
• u postmenopauzi ste tj.imate najmanje 50 godina i Vaša zadnja menstruacija je bila prije više od jedne godine (ako su vaše menstruacije prestale zato što ste se liječili od karcinoma, tada još uvijek postoji šansa da možete ostati trudni).
EU/1/07/439/003 (50 tablets) EU/1/07/439/004 (150 tablets) EU/1/07/439/005 (50 x 1 tablets)
EU/1/07/439/003 (50 tableta) EU/1/07/439/004 (150 tableta) EU/1/07/439/005 (50 x 1 tableta)
EU/1/07/439/001 (100 capsules) EU/1/07/439/002 (300 capsules) EU/1/07/439/006 (100 x 1 capsules)
EU/1/07/439/001 (100 kapsula) EU/1/07/439/002 (300 kapsula) EU/1/07/439/006 (100 x 1 kapsula)
• if you are allergic to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na mofetilmikofenolat, mikofenolnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Patients taking Mycophenolate mofetil Teva should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment then monthly through the first year.
Kod bolesnika koji uzimaju Mikofenolat mofetil Teva trebalo bi raditi kompletnu krvnu sliku jedanput tjedno tijekom prvog mjeseca, dva puta mjesečno tijekom drugog i trećeg mjeseca liječenja, a zatim jedanput mjesečno tijekom prve godine.
It is recommended, however, to administer Mycophenolate mofetil Teva at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Preporučuje se, međutim, primjena Mikofenolat mofetila Teva barem jedan sat prije odnosno tri sata nakon uzimanja sevelamera da bi se umanjio utjecaj na apsorpciju MPA.
• For 6°weeks after you stop taking Mycophenolate mofetil Teva.
• razdoblje od 6 tjedana nakon što prestanete uzimati Mikofenolat mofetil Teva.
If neutropenia develops (absolute neutrophil count <°1.3°x 103/°µl) it may be appropriate to interrupt or discontinue Mycophenolate mofetil Teva.
Ako se pojavi neutropenija (apsolutni broj neutrofila < 1,3 x 103/µl), možda će biti primjereno privremeno ili potpuno prekinuti primjenu Mikofenolat mofetila Teva.
Medicinal products that interfere with enterohepatic circulation (e.g. cholestyramine, ciclosporin A, antibiotics)
Lijekovi koji se uključuju u enterohepatičnu cirkulaciju (npr. kolestiramin, ciklosporin A, antibiotici)