FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/95/001/027 10 vials of powder for solution for injection.
Slovenian: EU/1/95/001/027 10 vial s praškom za raztopino za injiciranje 10 napolnjenih injekcijskih brizg z vehiklom
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) should not be mixed with other medicines in the same injection.
Slovenian: Zdravila GONAL-f 300 i.e./0,50 ml (22 mikrogramov/0,50 ml) se ne sme mešati z drugimi zdravili v isti injekciji.
English: • The solvent is a clear colourless liquid in a glass vial, each containing 1 mL.
Slovenian: • Vehikel je bistra, brezbarvna tekočina v stekleni viali po 1 ml.
English: What GONAL-f contains
Slovenian: Kaj vsebuje zdravilo GONAL-f
English: A set of administration syringes graduated in FSH units is supplied in the GONAL-f multidose box.
Slovenian: Škatla z zdravilom GONAL-f za večkratno odmerjanje vsebuje komplet injekcijskih brizg za dajanje zdravila, ki so graduirane v FSH enotah.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Discard any unused solution.
Slovenian: ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Zavrzite vso neuporabljeno raztopino.
English: Common (may affect up to 1 in 10 people):
Slovenian: Pogosti (prizadenejo lahko največ 1 od 10 bolnikov):
English: Pack of one pre-filled pen and 8 needles to be used with the pen for administration.
Slovenian: Pakiranje z enim napolnjenim injekcijskim peresnikom in 8 injekcijskimi iglami, ki se uporabijo z injekcijskim peresnikom za dajanje zdravila.
English: GONAL-f Pre-filled pen 300 IU/0.5 mL
Slovenian: GONAL-f napolnjen injekcijski peresnik 300 i.e./0,5 ml
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) must be reconstituted with the 2 mL solvent provided before use.
Slovenian: Zdravilo GONAL-f 1050 i.e./ 1,75 ml (77 mikrogramov/1,75 ml) se mora pred uporabo rekonstituirati z 2 ml priloženega vehikla.
English: Do not use this medicine after the expiry date which is stated on the cartridge label or carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na vložku ali škatlici poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) is not designed to allow the cartridge to be removed.
Slovenian: Zdravilo GONAL-f 450 i.e./0,75 ml (33 mikrogramov/0,75 ml) je oblikovano tako, da ne dopušča odstranitve vložka.
English: that means there are 600 IU (44 micrograms) in each millilitre of solution.
Slovenian: da je v enem mililitru raztopine 600 i.e. (44 mikrogramov).
English: Storing the GONAL-f pre-filled pen.
Slovenian: Shranjevanje GONAL-f napolnjenega injekcijskega peresnika
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%
Slovenian: IME ZDRAVILA IN POT(I) UPORABE vehikel za uporabo z zdravilom GONAL-f 1050 i.e./1,75 ml voda za injekcije, 0,9 % benzilalkohol
English: Pack of one pre-filled pen and 20 needles to be used with the pen for administration.
Slovenian: Pakiranje z enim napolnjenim injekcijskim peresnikom in 20 injekcijskimi iglami, ki se uporabijo z injekcijskim peresnikom za dajanje zdravila.
English: • After reconstitution, there are 1,050 IU (77 micrograms) of follitropin alfa in 1.75 mL solution,
Slovenian: • Po rekonstituciji je v 1,75 ml raztopine 1.050 i.e. (77 mikrogramov) folitropina alfa, kar pomeni, da je v enem mililitru raztopine 600 i.e. (44 mikrogramov).
English: GONAL-f Pre-filled pen 450 IU/0.75 mL
Slovenian: GONAL-f napolnjen injekcijski peresnik 450 i.e./0,75 ml
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.
Slovenian: • Ko so jajčeca pripravljena, boste prejeli eno injekcijo z 250 mikrogrami "rekombinantnega hCG" (r-hCG, v laboratoriju izdelan hCG s posebno tehnologijo rekombinantne DNA), ali 5.000 do 10.000 i.e. hCG, 24 do 48 ur po zadnji injekciji zdravila GONAL-f.
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) should not be mixed with other medicines in the same injection.
Slovenian: Zdravila GONAL-f 450 i.e./0,75 ml (33 mikrogramov/0,75 ml) se ne sme mešati z drugimi zdravili v isti injekciji.
English: • Check that the Dose Feedback Window shows “0”.
Slovenian: • Preverite, ali prikazuje okence za prikaz odmerka "0".
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 mL/pre-filled syringe
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2 ml/napolnjeno injekcijsko brizgo
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) must be reconstituted with the 0.75 mL solvent provided before use.
Slovenian: Zdravilo GONAL-f 300 i.e./0,50 ml (22 mikrogramov/0,50 ml) se mora pred uporabo rekonstituirati z 0,75 ml priloženega vehikla.
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%
Slovenian: IME ZDRAVILA IN POT(I) UPORABE vehikel za uporabo z zdravilom GONAL-f 300 i.e./0,50 ml voda za injekcije, 0,9 % benzilalkohol
English: if "0", injection complete ifnot"0",needsecond injection Inject this amount ..........using new pen
Slovenian: Če ni "0",potrebujete drugo injekcijo Injicirajte to količino..........z novim injekcijskim peresnikom
English: Then GONAL-f is started approximately two weeks after start of agonist treatment.
Slovenian: Nato se približno dva tedna po začetku zdravljenja z agonistom začne zdravljenje z zdravilom GONAL-f. Nato se dajeta zdravilo GONAL-f in agonist GnRH do želenega razvoja foliklov.
English: Reservoir holder
Slovenian: • Navodilo shranite.
English: 4 disposable syringes.
Slovenian: 4. prostor za tekočino
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) must be reconstituted with the 1 mL solvent provided before use.
Slovenian: Zdravilo GONAL-f 450 i.e./ 0,75 ml (33 mikrogramov/0,75 ml) se mora pred uporabo rekonstituirati z 1 ml priloženega vehikla.
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.
Slovenian: IME ZDRAVILA GONAL-f 1050 i.e./ 1,75 ml (77 mikrogramov/1,75 ml) prašek in vehikel za raztopino za injiciranje
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
Slovenian: IME ZDRAVILA IN POT(I) UPORABE GONAL-f 75 i.e. (5,5 μg) prašek za raztopino za injiciranje folitropin alfa s.c.
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.
Slovenian: Zdravilo je na voljo v pakiranju, ki vsebuje 1 vialo s praškom, 1 napolnjeno injekcijsko brizgo z vehiklom za rekonstitucijo in 15 injekcijskih brizg za dajanje zdravila za enkratno uporabo, ki so graduirane v FSH enotah.
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.
Slovenian: Zdravilo je na voljo v pakiranju, ki vsebuje 1 vialo s praškom, 1 napolnjeno injekcijsko brizgo z vehiklom za rekonstitucijo in 6 injekcijskih brizg za dajanje zdravila za enkratno uporabo, ki so graduirane v FSH enotah.
English: • Abdominal pain • Feeling sick, vomiting, diarrhoea, abdominal cramps and bloating
Slovenian: • bolečina v trebuhu • občutek slabosti, bruhanje, driska, trebušni krči in napenjanje
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.
Slovenian: 0,75 ml raztopine za injiciranje v 3 ml vložku (steklo tipa I) z batnim zamaškom (halobutilna guma) in aluminijasto zgibano zaporko s črno gumijasto notranjo prevleko.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) powder and solvent for solution for injection Follitropin alfa
Slovenian: GONAL-f 1050 i.e./1,75 ml (77 mikrogramov/1,75 ml) prašek in vehikel za raztopino za injiciranje folitropin alfa
English: • Once opened, it may be stored for a maximum of 28 days outside of the fridge (at or below
Slovenian: • Odprto zdravilo lahko zunaj hladilnika (do 25 °C) shranjujete največ 28 dni.
English: • The 300 IU pen maximum single-dose setting is 300 IU and the smallest single-dose setting is
Slovenian: • Največja nastavitev enega odmerka injekcijskega peresnika je 300 i.e. in najmanjša nastavitev odmerka je 12,5 i.e.. 5.2.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the solution contains 600 IU of follitropin alfa*, (equivalent to 44 micrograms).
Slovenian: En mililiter raztopine vsebuje 600 i.e. folitropina alfa* (kar ustreza 44 mikrogramom).
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%
Slovenian: IME ZDRAVILA IN POT(I) UPORABE vehikel za uporabo z zdravilom GONAL-f 450 i.e./0,75 ml voda za injekcije, 0,9 % benzilalkohol
English: GONAL-f 900 IU/1.5 mL (66 micrograms/1.5 mL) solution for injection in a pre-filled pen Follitropin alfa
Slovenian: GONAL-f 900 i.e./1,5 ml (66 mikrogramov/1,5 ml) raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa
English: • 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.
Slovenian: • Ko boste dosegli želeni odziv, boste prejeli eno injekcijo z 250 mikrogrami "rekombinantnega hCG" (r-hCG, v laboratoriju izdelan hCG s posebno tehnologijo DNA) ali 5.000 do 10.000 i.e. hCG, 24 do 48 ur po zadnji injekciji zdravila GONAL-f in lutropina alfa.
English: Turn the dose setting knob forward to dial up Turn the dose setting knob backward to correct the dose
Slovenian: Gumb za nastavitev odmerka obračajte nazaj do pravilnega odmerka
English: GONAL-f Pre-filled pen 900 IU/1.5 mL
Slovenian: GONAL-f napolnjen injekcijski peresnik 900 i.e./1,5 ml
English: EU/1/95/001/025 1 vial of powder for solution for injection.
Slovenian: EU/1/95/001/025 1 viala s praškom za raztopino za injiciranje 1 napolnjena injekcijska brizga z vehiklom
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.
Slovenian: 1,5 ml raztopine za injiciranje v 3 ml vložku (steklo tipa I) z batnim zamaškom (halobutilna guma) in aluminijasto zgibano zaporko s črno gumijasto notranjo prevleko.
English: Each pre-filled pen with multidose cartridge delivers 300 IU (to 22 micrograms) in 0.5 mL.
Slovenian: En napolnjen injekcijski peresnik z večodmernim vložkom zagotavlja odmerek 300 i.e. (22 mikrogramov) v 0,5 ml.
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.
Slovenian: Zdravilo je na voljo v pakiranju, ki vsebuje 1 vialo s praškom, 1 napolnjeno injekcijsko brizgo z vehiklom za rekonstitucijo in 4 injekcijske brizge za dajanje zdravila za enkratno uporabo, ki so graduirane v FSH enotah.
English: 5 pre-filled syringes of 1 mL solvent.
Slovenian: 5 vial s praškom za raztopino za injiciranje 5 napolnjenih injekcijskih brizg z 1 ml vehikla
English: The solvent for reconstitution is presented in 1 mL pre-filled syringes (Type I glass) with a rubber stopper.
Slovenian: Vehikel za rekonstitucijo je na voljo v 1 ml napolnjenih injekcijskih brizgah (steklo tipa I) z gumijastim zamaškom.
English: • 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.
Slovenian: • Ko boste dosegli želeni odziv, boste prejeli eno injekcijo z 250 mikrogrami "rekombinantnega hCG" (r-hCG, v laboratoriju izdelan hCG s posebno tehnologijo DNA) ali 5.000 do 10.000 i.e. hCG, 24 do 48 ur po zadnji injekciji zdravila GONAL-f.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mL/pre-filled syringe
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 ml/napolnjeno injekcijsko brizgo
English: Powder
Slovenian: Splav
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.
Slovenian: Zdravila GONAL-f 1050 i.e./1,75 ml (77 mikrogramov/1,75 ml) se ne sme mešati z drugimi vsebniki zdravila GONAL-f v isti viali ali brizgi.
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.
Slovenian: IME ZDRAVILA GONAL-f 300 i.e./0,50 ml (22 mikrogramov/0,50 ml) prašek in vehikel za raztopino za injiciranje
English: This side effect is common (may affect up to 1 in 10 people).
Slovenian: Ta neželeni učinek je pogost (prizadene lahko največ 1 od 10 bolnikov).
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Slovenian: Pomožne snovi: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, metionin, polisorbat 20, koncentrirana fosforjeva(V) kislina in natrijev hidroksid.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) preparation must not be reconstituted with any other GONAL-f containers.
Slovenian: Zdravilo GONAL-f 1050 i.e./ 1,75 ml (77 mikrogramov/1,75 ml) se ne sme rekonstituirati z nobenim drugim vsebnikom zdravila GONAL-f.
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) preparation must not be reconstituted with any other GONAL-f containers.
Slovenian: Zdravilo GONAL-f 300 i.e./0,50 ml (22 mikrogramov/0,50 ml) se ne sme rekonstituirati z nobenim drugim vsebnikom zdravila GONAL-f.
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.
Slovenian: Zdravila GONAL-f 300 i.e./0,50 ml (22 mikrogramov/0,50 ml) se ne sme mešati z drugimi vsebniki zdravila GONAL-f v isti viali ali brizgi.
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) preparation must not be reconstituted with any other GONAL-f containers.
Slovenian: Zdravilo GONAL-f 450 i.e./ 0,75 ml (33 mikrogramov/0,75 ml) se ne sme rekonstituirati z nobenim drugim vsebnikom zdravila GONAL-f.
English: • Hold the outer needle cap firmly.
Slovenian: • Trdno držite zunanji pokrovček igle.
English: • The other ingredients are sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Slovenian: • Druge sestavine zdravila so: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, metionin, polisorbat 20, koncentrirana fosforjeva(V) kislina in natrijev hidroksid.
English: In this case lutropin alfa should be reconstituted first and then used to reconstitute GONAL-f powder.
Slovenian: Zdravilo GONAL-f se lahko sočasno pripravi z lutropinom alfa in sočasno injicira z eno samo injekcijo.V tem primeru morate najprej rekonstituirati raztopino lutropina alfa in jo nato uporabiti za rekonstitucijo praška zdravila GONAL-f.
English: • When needed, inject yourself using a second pen, dialing your remaining dose written in the
Slovenian: • Po potrebi uporabite za injiciranje drugi injekcijski peresnik in izberite preostali odmerek zabeležen v poglavju "Količina, prikazana po injiciranju" (8).
English: Always remove the needle from the GONAL-f pre-filled pen before replacing the pen cap.
Slovenian: Preden ponovno namestite pokrovček na GONAL-f injekcijski peresnik, vedno odstranite iglo.
English: • The solvent is a clear colourless liquid in a pre-filled syringe, each containing 2 mL.
Slovenian: • Vehikel je bistra, brezbarvna tekočina, v napolnjeni injekcijski brizgi po 2 ml.
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.
Slovenian: 0,5 ml raztopine za injiciranje v 3 ml vložku (steklo tipa I) z batnim zamaškom (halobutilna guma) in aluminijasto zgibano zaporko s črno gumijasto notranjo prevleko.
English: If the peel-off seal is damaged or loose, do not use the needle.
Slovenian: Igle ne uporabite, če je jeziček, ki se odlepi, poškodovan ali zrahljan.
English: • The other ingredients are sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Slovenian: • Druge sestavine zdravila so: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, koncentrirana fosforjeva(V) kislina in natrijev hidroksid.
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/032
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/95/001/032
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.
Slovenian: IME ZDRAVILA GONAL-f 450 i.e./ 0,75 ml (33 mikrogramov/0,75 ml) prašek in vehikel za raztopino za injiciranje
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Slovenian: Pomožne snovi: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, koncentrirana fosforjeva(V) kislina in natrijev hidroksid.
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.
Slovenian: Zdravila GONAL-f 450 i.e./0,75 ml (33 mikrogramov/0,75 ml) se ne sme mešati z drugimi vsebniki zdravila GONAL-f v isti viali ali brizgi.
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
Slovenian: IME ZDRAVILA IN POT(I) UPORABE GONAL-f 450 i.e. /0,75 ml prašek in vehikel za raztopino za injiciranje folitropin alfa s.c.
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
Slovenian: IME ZDRAVILA IN POT(I) UPORABE GONAL-f 300 i.e. /0,50 ml prašek in vehikel za raztopino za injiciranje folitropin alfa s.c.
English: Do not use GONAL-f if you are pregnant or breast-feeding.
Slovenian: Če ste noseči ali dojite, ne uporabljajte zdravila GONAL-f.
English: The solvent for reconstitution is presented in 2 mL pre-filled syringes (Type I glass) with a rubber stopper.
Slovenian: Vehikel za rekonstitucijo je na voljo v 2 ml napolnjenih injekcijskih brizgah (steklo tipa I) z gumijastim zamaškom.
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) powder and solvent for solution for injection Follitropin alfa
Slovenian: GONAL-f 300 i.e./0,50 ml (22 mikrogramov/0,50 ml) prašek in vehikel za raztopino za injiciranje folitropin alfa
English: What GONAL-f is used for
Slovenian: Za kaj uporabljamo zdravilo GONAL-f
English: GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in a pre-filled pen Follitropin alfa
Slovenian: GONAL-f 300 i.e./0,5 ml (22 mikrogramov/0,5 ml) raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa
English: How to store GONAL-f
Slovenian: Shranjevanje zdravila GONAL-f
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/021
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/95/001/021
English: Date:
Slovenian: Primer:
English: • After reconstitution, there are 300 IU (22 micrograms) of follitropin alfa in 0.5 mL solution,
Slovenian: • Po rekonstituciji je v 0,5 ml raztopine 300 i.e. (22 mikrogramov) folitropina alfa, kar pomeni, da je v enem mililitru raztopine 600 i.e. (44 mikrogramov).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 PRE-FILLED PEN
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 1 NAPOLNJENIM INJEKCIJSKIM PERESNIKOM
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/005 1 vial of powder for solution for injection.
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/95/001/005 1 viala s praškom za raztopino za injiciranje
English: 300 IU
Slovenian: 300 i.e.
English: • The solvent is a clear colourless liquid in a pre-filled syringe, each containing 1 mL.
Slovenian: • Vehikel je bistra, brezbarvna tekočina v napolnjeni injekcijski brizgi po 1 ml.
English: • If you are a woman: with large ovaries or sacs of fluids within the ovaries (ovarian cysts) of unknown origin.
Slovenian: • če ste ženska: s povečanjem jajčnika ali vrečkami tekočine znotraj jajčnikov (ciste jajčnika) neznanega izvora; z ginekološkimi krvavitvami nepojasnjenega vzroka; z rakom jajčnika, maternice ali dojke; s stanjem, ki običajno onemogoča normalno nosečnost, kot je odpoved jajčnikov (prezgodnja menopavza) ali malformacijo spolnih organov;
English: Take off the pen cap
Slovenian: Potisnite iglo v kožo
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) powder and solvent for solution for injection Follitropin alfa
Slovenian: GONAL-f 450 i.e./0,75 ml (33 mikrogramov/0,75 ml) prašek in vehikel za raztopino za injiciranje folitropin alfa
English: PARTICULARS TO APPEAR ON THE PEN GONAL-f 450 IU/0.75 mL
Slovenian: PODATKI NA NAPOLNJENEM INJEKCIJSKEM PERESNIKU GONAL-f 450 i.e./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.
Slovenian: Ko je dosežen optimalen odziv, se mora dati eno samo injekcijo 250 mikrogramov rekombinantnega humanega horionskega gonadotropina alfa (r-hCG) ali 5.000 i.e. do 10.000 i.e. hCG-ja, 24 do 48 ur po zadnji injekciji zdravila GONAL-f. Bolnici se priporoča spolni odnos na isti dan, ko je prejela hCG in naslednji dan.
English: 10 pre-filled syringes of 1 mL solvent.
Slovenian: 10 vial s praškom za raztopino za injiciranje 10 napolnjenih injekcijskih brizg z 1 ml vehikla
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/033
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/95/001/033
English: Please write on the GONAL-f pre-filled pen the day you first use it.
Slovenian: Na napolnjen injekcijski peresnik zdravila GONAL-f zapišite datum prve uporabe.
English: There is no relevant use of GONAL-f in the elderly population.
Slovenian: Zdravilo GONAL-f ni namenjeno za uporabo pri starejših bolnikih.
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.
Slovenian: GONAL-f 900 i.e./1,5 ml (66 mikrogramov/1,5 ml) raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in a pre-filled pen Follitropin alfa
Slovenian: GONAL-f 450 i.e./0,75 ml (33 mikrogramov/0,75 ml) raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/034 solution for injection in pre-filled pen.
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/95/001/034 Raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/033 solution for injection in pre-filled pen.
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/95/001/033 Raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/035 solution for injection in pre-filled pen.
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/95/001/035 Raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/034
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/95/001/034