natgillin/translations-raw huggingface dataset:
• The usual starting dose of GONAL-f is 75 to 150 IU (0.12 to 0.24 mL) each day.
• Uobičajena početna doza lijeka GONAL-f je 75 do 150 IU (0,12-0,24 ml) svakog dana.
HOW TO PREPARE AND USE THE GONAL-f POWDER AND SOLVENT
Kako se priprema i primjenjuje prašak i otapalo GONAL-f
Turn the dose setting knob forward to dial up Turn the dose setting knob backward to correct the dose
Okrećite gumb za podešavanje doze povećanje prikazanog broja unatrag za ispravak doze
• Each vial contains 1,200 IU of follitropin alfa.
• Svaka bočica sadrži 1200 IU folitropina alfa.
Each multidose vial contains 33 micrograms follitropin alfa equivalent to 450 IU.
Svaka višedozna bočica sadrži 33 mikrograma folitropina alfa, što odgovara 450 IU.
Turn the dose setting knob until your intended dose shows in the Dose Feedback Window.
5.2 Okrećite gumb za podešavanje doze sve dok se na prozorčiću za prikaz doze ne pojavi željena doza.
• Check that the Dose Feedback Window shows “0”.
• Provjerite da je na prozorčiću za prikaz doze prikazana „0“.
• Swirl gently the vial of GONAL-f prepared in step 3, do not shake.
• Lagano okrećite bočicu s lijekom GONAL-f pripremljenu u 3. koraku.
PHARMACEUTICAL FORM AND CONTENTS 1 vial of powder for solution for injection.
OBLIK I SADRŽAJ 1 bočica s praškom za otopinu za injekciju.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen.
OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici.
Slovenská republika Merck spol.
Slovenská republika Merck spol. s r.o.
• Sacs of fluid within the ovaries (ovarian cysts)
• Vrećice s tekućinom u jajnicima (ciste na jajnicima)
• Attach the needle for preparation to the pre-filled syringe, insert it into the powder vial and slowly inject all the solvent.
• Pričvrstite iglu za pripremu otopine na napunjenu štrcaljku, umetnite je u bočicu s praškom i polagano injicirajte otopinu.
INFORMATION IN BRAILLE gonal-f 75 iu
16. PODACI NA BRAILLEOVOM PISMU gonal-f 75 iu
You can reduce the risk of multiple pregnancy by using the right dose of GONAL-f at the right times.
Rizik višeplodne trudnoće može se smanjiti na najmanju mjeru ako se koriste preporučene doze i pridržava rasporeda uzimanja lijeka GONAL-f.
Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Reakcije na mjestu injiciranja (bol, crvenilo, modrica, oticanje i/ili iritacija na mjestu injiciranja)
No direct comparison of GONAL-f/LH versus human menopausal gonadotropin (hMG) has been performed.
Dosad nisu izravno uspoređene terapija lijekom GONAL-f/luteinizirajućim hormonom i terapija humanim menopauzalnim gonadotropinom (hMG).
• Screw the threaded tip of the GONAL-f pre-filled pen into the outer needle cap until you feel a light resistance.
• Spojite spojnicu za iglu s navojima napunjene brizgalice lijeka GONAL-f s vanjskim zatvaračem igle tako što ćete je zavrtati sve dok ne osjetite lagani otpor.
This side effect is very rare (may affect up to 1 in 10,000 people).
Ta je nuspojava vrlo rijetka (mogu se javiti u manje od 1 na 10 000 osoba).
• GONAL-f is intended to be given by injection just under the skin (subcutaneously).
• GONAL-f je namijenjen za potkožnu primjenu injekcijom (supkutano).
The powder is presented in 3 mL vials (Type I glass), with rubber stopper (bromobutyl rubber) and aluminium flip-off cap.
Prašak je u bočicama od 3 ml (staklo tip I), s gumenim čepom (bromobutil guma) i aluminijskim „flip-off“ zatvaračem.
How to store GONAL-f
Kako čuvati GONAL-f
Each multidose vial contains 44 micrograms follitropin alfa* equivalent to 600 IU.
Svaka višedozna bočica sadrži 44 mikrograma folitropina alfa*, što odgovara 600 IU.
Merck Serono S.p.A., Via delle Magnolie 15, I-70026 Modugno (Bari) Italy
Via delle Magnolie 15 I-70026 Modugno (Bari) Italija
Pack of one pre-filled pen and 8 needles to be used with the pen for administration.
Pakiranje s 1 napunjenom brizgalicom i 8 igala za upotrebu s brizgalicom za primjenu.
• The solvent is a clear colourless liquid in a pre-filled syringe, each containing 0.75 mL.
• Otapalo je bistra bezbojna tekućina u napunjenoj štrcaljki, svaka sadrži 0,75 ml.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Discard any unused solution after 28 days.
OD LIJEKA, AKO JE POTREBNO Svu neiskorištenu otopinu bacite nakon 28 dana.
5 pre-filled syringes of 1 mL solvent.
5 napunjenih štrcaljki s 1 ml otapala.
• Your doctor or nurse will show you how to use the GONAL-f pre-filled pen to inject the medicine.
• Vaš liječnik ili medicinska sestra pokazat će Vam kako se injicira napunjena štrcaljka s lijekom
Each vial contains 5.5 micrograms follitropin alfa equivalent to 75 IU.
Svaka bočica sadrži 5,5 mikrograma folitropina alfa što odgovara 75 IU.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 900 IU/1.5 mL
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 900 IU/1,5 ml
Each vial contains 5.5 micrograms of follitropin alfa* equivalent to 75 IU.
Svaka bočica sadrži 5,5 mikrograma folitropina alfa* što odgovara 75 IU.
Turn the vial upside down, gently draw the solution back into the syringe.
Bočicu okrenite naopako te lagano povucite otopinu natrag u štrcaljku.
Phosphoric acid, concentrated Sodium hydroxide
koncentrirana fosfatna kiselina i natrijev hidroksid.
Vascular disorders Very rare:
Krvožilni poremećaji Vrlo rijetko:
• Insert the needle into the solvent vial and push the plunger to expel the air.
• Gurnite iglu u bočicu s otapalom pa pritisnite klip kako biste istisnuli zrak.
Each multidose vial contains 44 micrograms of follitropin alfa* (equivalent to 600 IU), in order to deliver 33 micrograms (equivalent to 450 IU) in 0.75 mL.
Svaka višedozna bočica sadrži 44 mikrograma folitropina alfa* (odgovara 600 IU) kako bi se osigurala primjena 33 mikrograma (odgovara 450 IU) u 0,75 ml.
Then GONAL-f is started approximately two weeks after start of agonist treatment.
Zatim se otprilike 2 tjedna nakon početka primanja liječenja agonistom počinje s davanjem lijeka GONAL-f.
• It is supplied in packs with 1 pre-filled pen and 12 disposable needles.
• Isporučuje se u pakiranjima s 1 napunjenom brizgalicom i 12 igala za jednokratnu upotrebu.
At the end of the treatment any unused solution must be discarded.
Sva neiskorištena otopina mora se baciti na kraju liječenja.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 IU/0.5 mL
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICILIJEKA 300 IU/0,5 ml
• If you use GONAL-f with other medicines which help ovulation (such as hCG or clomiphene citrate), this may increase the response of your follicles.
• Istovremena primjena lijeka GONAL-f i drugih tvari koje stimuliraju ovulaciju (na primjer: hCG, klomifencitrat) može uzrokovati folikularni odgovor.
For the following cycle, your doctor will give you a lower dose of GONAL-f than before.
Za sljedeći ciklus liječnik će Vam propisati GONAL-f u manjoj dozi nego u prethodnom ciklusu.
• Hold the GONAL-f pre-filled pen with the needle pointing upward.
• Držite napunjenu brizgalicu lijeka GONAL-f tako da je igla usmjerena prema gore.
INFORMATION IN BRAILLE gonal-f 300 iu
16. PODACI NA BRAILLEOVOM PISMU gonal-f 300 iu
• It is supplied in packs with 1 pre-filled pen and 8 disposable needles.
• Isporučuje se u pakiranjima s 1 napunjenom brizgalicom i 8 igala za jednokratnu upotrebu.
• Each vial contains 600 IU of follitropin alfa.
• Svaka bočica sadrži 600 IU folitropina alfa.
EU/1/95/001/027 10 vials of powder for solution for injection.
EU/1/95/001/027 10 bočica s praškom za otopinu za injekciju.
INFORMATION IN BRAILLE gonal-f 1050 iu
16. PODACI NA BRAILLEOVOM PISMU gonal-f 1050 iu
You can turn the dose knob backwards if you turn it past 25.
Ako ga zakrenete dalje od 25, samo okrenite gumb za podešavanje doze unatrag.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 450 IU/0.75 mL
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 450 IU/0,75 ml
The pen contains 450 IU follitropin alpha.
• Jedna bočica sadrži 450 IU folitropina alfa.
If your body responds too strongly, your treatment with GONAL-f will be stopped and you will not be given any hCG (see section 2, OHSS).
Ako dođe do prejakog odgovora Vašeg organizma, terapiju lijekom GONAL-f treba prekinuti i ukinuti davanje hCG-a (vidjeti dio 2 „Sindrom hiperstimulacije jajnika“).
NAME OF THE MEDICINAL PRODUCT GONAL-f 75 IU (5.5 micrograms) powder and solvent for solution for injection.
NAZIV LIJEKA GONAL-f 75 IU (5,5 mikrograma) prašak i otapalo za otopinu za injekciju.
Each multidose vial contains 33 micrograms of follitropin alfa* (equivalent to 450 IU), in order to deliver 22 micrograms (equivalent to 300 IU) in 0.50 mL.
Svaka višedozna bočica sadrži 33 mikrograma folitropina alfa* (odgovara 450 IU) kako bi se osigurala primjena 22 mikrograma (odgovara 300 IU) u 0,50 ml.
10 vials of powder for solution for injection.
10 bočica s praškom za otopinu za injekciju.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 PRE-FILLED PEN
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S 1 NAPUNJENOM BRIZGALICOM
• The other ingredients are poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, concentrated phosphoric acid, sodium hydroxide and water for injections.
• Drugi sastojci su: poloksamer 188, saharoza, metionin, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat dihidrat, m-krezol, koncentrirana fosfatna kiselina, natrijev hidroksid i voda za injekcije.
• The 300 IU pen maximum single-dose setting is 300 IU and the smallest single-dose setting is
• Najviša doza koja se može podesiti na brizgalici od 300 IU iznosi 300 IU, a najniža doza koja se može podesiti iznosi 12,5 IU.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 900 IU/1.5 ML (66 MICROGRAMS/1.5 ML) PEN, PEN LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE GONAL-f 900 IU/1,5 ML (66 MIKROGRAMA/1,5 ML) BRIZGALICA, NALJEPNICA BRIZGALICE
• GONAL-f is presented as a powder and solvent which are used to prepare a solution for injection.
• GONAL-f se isporučuje kao prašak i otapalo koji se koriste za pripremu otopine za injekciju.
GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) is not designed to allow the cartridge to be removed.
GONAL-f 300 IU/0,5 ml (22 mikrograma/0,5 ml) nije izrađen tako da se uložak može ukloniti.
• Please write on the GONAL-f vial the day you prepared the solution.
• Na bočicu s lijekom GONAL-f napišite datum pripreme otopine.
EU/1/95/001/026 5 vials of powder for solution for injection.
EU/1/95/001/026 5 bočica s praškom za otopinu za injekciju.
• Store in the original container, in order to protect from light.
• Čuvati u originalnom spremniku radi zaštite od svjetlosti.
Contains: One pre-filled syringe of solvent contains: 2 mL water for injections, benzyl alcohol 0.9%.
Sadrži: Svaka napunjena štrcaljka otapala sadrži: 2 ml vode za injekciju, benzilni alkohol 0,9%.
GONAL-f 75 IU (5.5 micrograms) powder and solvent for solution for injection Follitropin alfa
GONAL-f 75 IU (5,5 mikrograma) prašak i otapalo za otopinu za injekciju folitropin alfa
• GONAL-f is supplied in packs of 1 vial of powder with 1 vial of solvent.
• GONAL-f je dostupan u pakiranju od 1 bočice s praškom s 1 bočicom otapala.
10 pre-filled syringes of 1 mL solvent.
10 napunjenih štrcaljki s 1 ml otapala.
For the following cycle, your doctor will give you a higher starting dose of GONAL-f than before.
Za sljedeći ciklus liječnik će Vam propisati GONAL-f u većoj početnoj dozi nego u prethodnom ciklusu.
5 pre-filled syringes of solvent.
5 napunjenih štrcaljki s otapalom.
with a condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause), or malformed reproductive organs.
i bolujete od karcinoma jajnika, maternice ili dojke. i postoji stanje zbog kojeg normalna trudnoća nije moguća, kao što je zatajenje rada jajnika (preuranjena menopauza) ili promjena oblika spolnih organa.
Each pre-filled multidose pen delivers 900 IU (equivalent to 66 micrograms) in 1.5 mL.
Svaka višedozna napunjena brizgalica osigurava primjenu 900 IU (odgovara 66 mikrograma) u 1,5 ml.
Contains: One pre-filled syringe of solvent contains: 1 mL water for injections, benzyl alcohol 0.9%.
Sadrži: Svaka napunjena štrcaljka otapala sadrži: 1 ml vode za injekciju, benzilni alkohol 0,9%.
After reconstitution, do not store above 25°C.
Nakon rekonstitucije, ne čuvati na temperaturi iznad 25 °C.
Pack of one pre-filled pen and 12 needles to be used with the pen for administration.
Pakiranje s 1 napunjenom brizgalicom i 12 igala za upotrebu s brizgalicom za primjenu lijeka.
Prior to reconstitution, do not store above 25°C.
Prije rekonstitucije, ne čuvati na temperaturi iznad 25 °C.
Prescribed Dose
Propis ana doza
INFORMATION IN BRAILLE gonal-f 450 iu/0.75 mL
16. PODACI NA BRAILLEOVOM PISMU gonal-f 450 iu/0,75 ml
The effects of taking too much GONAL-f are unknown, Nevertheless one could expect Ovarian Hyper-Stimulation Syndrome (OHSS) to occur, which is described in section 4.
Učinci predoziranja lijekom GONAL-f nisu poznati, no ipak treba očekivati pojavu sindroma hiperstimulacije jajnika koji je opisan u dijelu 4. No OHSS će se pojaviti samo ako se primjenjuje i hCG (vidjeti dio 2, OHSS).
The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Pacijentici se preporučuje spolni odnos na dan injekcije hCG i dan poslije.
How to use your GONAL-f pre-filled pen Treatment Diary
Kako koristiti dnevnik liječenja lijekom GONAL-f u napunjenoj brizgalici
• Hold the GONAL-f pre-filled pen firmly with one hand, and slip the needle into the outer needle cap.
• Jednom rukom čvrsto držeći napunjenu brizgalicu lijeka GONAL-f, uvucite iglu u vanjski zatvarač igle.
Excipients: Poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, concentrated phosphoric acid, sodium hydroxide and water for injections.
Pomoćne tvari: poloksamer 188, saharoza, metionin, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat dihidrat, m-krezol, koncentrirana fosfatna kiselina, natrijev hidroksid i voda za injekcije.
• The 450 IU pen maximum single-dose setting is 450 IU and the smallest single-dose setting is
• Najviša doza koja se može podesiti na brizgalici od 450 IU iznosi 450 IU, a najniža doza koja se može podesiti iznosi 12,5 IU.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused medicine or waste material should be disposed in accordance with local requirements.
OD LIJEKA, AKO JE POTREBNO Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) must be reconstituted with the 0.75 mL solvent provided before use.
GONAL-f 300 IU/0,50 ml (22 mikrograma/0,50 ml) mora se rekonstituirati s 0,75 ml priloženog otapala prije upotrebe.
15 disposable syringes for administration graduated in FSH units.
15 štrcaljki za jednokratnu uporabu za primjenu lijeka graduiranih u FSH jedinicama.
Store in the original container, in order to protect from light.
Čuvati u originalnom spremniku radi zaštite od svjetlosti.
GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) is not designed to allow the cartridge to be removed.
GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) nije izrađen tako da se uložak može ukloniti.
If your body responds too strongly, your treatment will be stopped and you will not be given any hCG (see section 2, OHSS).
Ako dođe do prejakog odgovora Vašeg organizma, terapiju treba prekinuti i ne davati hCG-a (vidjeti dio 2 „Sindrom hiperstimulacije jajnika“).
This side effect is uncommon (may affect up to 1 in 100 people).
Ta je nuspojava manje česta (mogu se javiti u manje od 1 na 100 osoba).
10 pre-filled syringes of solvent.
10 napunjenih štrcaljki s otapalom.
• There are 600 IU (44 micrograms) of follitropin alfa in each millilitre of liquid.
• U svakom mililitru tekućine nalazi se 600 IU (44 mikrograma) folitropina alfa.
Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Phosphoric acid, concentrated Sodium hydroxide
Prašak saharoza natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat dihidrat fosfatna kiselina, koncentrirana natrijev hidroksid
How to use GONAL-f
Kako primjenjivati GONAL-f
• When needed, inject yourself using a second pen, dialing your remaining dose written in the
• Po potrebi, dajte si injekciju koristeći drugu brizgalicu nakon što podesite preostalu dozu zabilježenu u dijelu “Količina prikazana nakon injekcije” (8).
GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) should not be mixed with other medicines in the same injection.
GONAL-f 1050 IU/1,75 ml (77 mikrograma/1,75 ml) ne smije se miješati s ostalim lijekovima u istoj injekciji.
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.
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.
1 pre-filled syringe of 2 mL solvent.
1 napunjena štrcaljka s 2 ml otapala.
Solvent for solution for injection
Otapalo za otopinu za injekciju
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.
POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
The solvent for reconstitution is presented in 1 mL pre-filled syringes (Type I glass) with a rubber stopper.
Otapalo za rekonstituciju nalazi se u napunjenim štrcaljkama od 1 ml (staklo tip I) s gumenim čepom.
GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) should not be mixed with other medicines in the same injection.
GONAL-f 300 IU/0,50 ml (22 mikrograma/0,50 ml) ne smije se miješati s drugim lijekovima u istoj injekciji.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S 1 BOČICOM I 1 NAPUNJENOM ŠTRCALJKOM
NAME OF THE MEDICINAL PRODUCT GONAL-f 900 IU/1.5 mL (66 micrograms/1.5 mL) solution for injection in pre-filled pen.
NAZIV LIJEKA GONAL-f 900 IU/1,5 ml (66 mikrograma/1,5 ml) otopina za injekciju u napunjenoj brizgalici.
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 900 IU follitropin alfa, equivalent to 66 micrograms, per 1.5 mL.
Svaka višedozna napunjena brizgalica osigurava primjenu 900 IU folitropina alfa, što odgovara 66 mikrograma, u 1,5 ml.
• 1 pre-filled syringe containing the solvent (the clear liquid)
• 1 napunjenu štrcaljku koja sadrži otapalo (bistru tekućinu)
GONAL-f pre-filled pen Treatment Diary
Dnevnik liječenja lijekom GONAL-f u napunjenoj brizgalici
Each pre-filled pen with multidose cartridge delivers 450 IU (33 micrograms) in 0.75 mL.
Svaka napunjena brizgalica s višedoznim uloškom osigurava primjenu 450 IU (33 mikrograma) u 0,75 ml.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.75 mL/pre-filled syringe
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,75 ml/napunjena štrcaljka
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 VIAL
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S 1 BOČICOM I 1 BOČICA
6 disposable syringes for administration graduated in FSH units.
6 štrcaljki za jednokratnu uporabu za primjenu lijeka graduiranih u FSH jedinicama.
Pack of one pre-filled pen and 20 needles to be used with the pen for administration.
Pakiranje s 1 napunjenom brizgalicom i 20 igala za upotrebu s brizgalicom za primjenu lijeka.
GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) must be reconstituted with the 2 mL solvent provided before use.
GONAL-f 1050 IU/1,75 ml (77 mikrograma/1,75 ml) mora se prije uporabe rekonstituirati s 2 ml priloženog otapala.
GONAL-f 900 IU/1.5 mL (66 micrograms/1.5 mL) solution for injection in a pre-filled pen Follitropin alfa
GONAL-f 900 IU/1,5 ml (66 mikrograma/1,5 ml) otopina za injekciju u napunjenoj brizgalici folitropin alfa
15 disposable syringes.
15 štrcaljki za jednokratnu uporabu.
INFORMATION IN BRAILLE gonal-f 450 iu
16. PODACI NA BRAILLEOVOM PISMU gonal-f 450 iu
GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) should not be mixed with other medicines in the same injection.
GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) ne smije se miješati s drugim lijekovima u istoj injekciji.
Prepare your needle for Injection
4.3 Pripremite iglu za injekciju
Sharps disposal container
Spremnik za odlaganje oštrih predmeta
• The 900 IU pen maximum single-dose setting is 450 IU and the smallest single-dose setting is
• 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.
4 disposable syringes for administration graduated in FSH units.
4 štrcaljke za jednokratnu uporabu za primjenu lijeka graduiranih u FSH jedinicama.
GONAL-f Pre-filled pen 300 IU/0.5 mL
GONAL-f 300 IU/0,5 ml napunjena brizgalica
Each pre-filled pen with multidose cartridge delivers 900 IU (66 micrograms) in 1.5 mL.
Svaka napunjena brizgalica s višedoznim uloškom osigurava primjenu 900 IU (66 mikrograma) u 1,5 ml.
• It is supplied in packs with 1 pre-filled pen and 20 disposable needles.
• Isporučuje se u pakiranju s 1 napunjenom brizgalicom i 20 igala za jednokratnu upotrebu.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT PRE-FILLED SYRINGE TEXT
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TEKST NA NAPUNJENOJ ŠTRCALJKI S OTAPALOM
INFORMATION IN BRAILLE gonal-f 900 iu/1.5 mL
16. PODACI NA BRAILLEOVOM PISMU gonal-f 900 iu/1,5 ml
Removable needle
Uklonjiva igla
• After preparation of the final solution for injection, there are 75 IU (5.5 micrograms) of follitropin alfa in each millilitre of solution.
• Nakon pripreme završne otopine za injekciju u svakom se mililitru otopine nalazi 75 IU
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%
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%
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 75 IU (5.5 μg) powder for solution for injection Follitropin alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 75 IU (5,5 μg) prašak za otopinu za injekciju folitropin alfa s.c.
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.
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.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-F 75 IU (5.5 MICROGRAMS) VIAL LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI ZA GONAL-f 75 IU (5,5 MIKROGRAMA)
The solvent for reconstitution is presented in 2 mL pre-filled syringes (Type I glass) with a rubber stopper.
Otapalo za rekonstituciju nalazi se u napunjenim štrcaljkama od 2 ml (staklo tip I) s gumenim čepom.
PARTICULARS TO APPEAR ON THE PEN GONAL-f 450 IU/0.75 mL
PODACI KOJI SE MORAJU NALAZITI NA BRIZGALICI GONAL-f 450 IU/0,75 ml
INFORMATION IN BRAILLE gonal-f 300 iu/0.5 mL
16. PODACI NA BRAILLEOVOM PISMU gonal-f 300 iu/0,5 ml
• Remove the protective cap from the solvent vial.
• Uklonite zaštitni zatvarač s bočice s otapalom.
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.
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.
Exacerbation or aggravation of asthma Gastrointestinal disorders Common:
Egzacerbacija ili pogoršanje astme
NAME OF THE MEDICINAL PRODUCT GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) powder and solvent for solution for injection.
NAZIV LIJEKA GONAL-f 1050 IU/1,75 ml (77 mikrograma/1,75 ml) prašak i otapalo za otopinu za injekciju.
GONAL-f Pre-filled pen 900 IU/1.5 mL
GONAL-f 900 IU/1,5 ml napunjena brizgalica