natgillin/translations-raw huggingface dataset:
Do not use this medicine after the expiry date which is stated on the cartridge label and carton after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici uloška i na kutiji iza oznake EXP.
How to store REKOVELLE 
Kako čuvati REKOVELLE
• Turn the dose knob clockwise until the prescribed dose lines up with the dose indicator in the dose display window. 
• Okrećite izbornik za podešavanje doze u smjeru kazaljke na satu sve dok se propisana doza ne poravna s pokazivačem doze u prozorčiću za prikaz doze.
Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici napunjene brizgalice i na kutiji iza oznake EXP.
This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancy. 
Smatra se da je to posljedica razlika u roditeljskim karakteristikama (npr. dob majke,
INFORMATION IN BRAILLE REKOVELLE 12 micrograms/0.36 mL 
16. PODACI NA BRAILLEOVOM PISMU REKOVELLE 12 mikrograma/0,36 mL
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 12 mcg/0.36 mL 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 12 μg/0,36 mL
Each cartridge contains 0.36 mL of solution. 
Svaki uložak sadrži 0,36 mL otopine.
Supplies you will need to give your REKOVELLE injection 
Što Vam je potrebno za primjenu injekcije lijeka REKOVELLE
No teratogenic risk has been reported, following controlled ovarian stimulation, in clinical use with gonadotropins. 
Nakon kontrolirane stimulacije jajnika kod kliničke primjene gonadotropina, nije prijavljen rizik od teratogenosti.
Suomi/Finland Ferring Lääkkeet Oy 
Danmark Ferring Lægemidler A/S
Each cartridge contains 1.08 mL of solution. 
Svaki uložak sadrži 1,08 mL otopine.
Disposal of Needle - (Step 13) 
Odlaganje igle - (Korak 13) Korak 13:
0 and 1 line (Dial to 0 plus 1 click) 
0 i 1 linija (Okrenite do 0 plus 1 klik)
Step 6: • Pull off the inner needle cap and throw it away. 
• Skinite unutarnji zatvarač igle i bacite ga.
• Mood swings 
• Promjene raspoloženja
• gynaecological haemorrhages of unknown aetiology (see section 4.4) 
• ginekološka krvarenja nepoznate etiologije (vidjeti dio 4.4) • karcinom jajnika, maternice ili dojke (vidjeti dio 4.4)
• Firmly replace the pen cap on the pen for protection between injections. 
• Vratite čvrstim pritiskom zatvarač na brizgalicu u svrhu zaštite brizgalice između injiciranja.
Information about your REKOVELLE pre-filled pen The pen can be dialed to give doses from 0.33 micrograms to 20 micrograms of REKOVELLE in marked increments of 0.33 micrograms. 
Brizgalica se može podesiti za ispručivanje doze od 0,33 mikrograma do 20 mikrograma lijeka
REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use. 
REKOVELLE se može čuvati na temperaturi od ili ispod 25 °C tijekom najviše 3 mjeseca, što uključuje period nakon prve primjene.
2 and 1 line (Dial to 2 plus 1 click) 
2 i 1 linija (Okrenite do 2 plus 1 klik)
See “Giving a split-dose of REKOVELLE“ at Page 22 to 231 for examples of how to calculate and record your split dose. 
Pogledajte primjere kako izračunati i zabilježiti Vašu podijeljenu dozu u „Primjena podijeljene doze lijeka REKOVELLE“ na stranicama 22 do 231.
Use only needles that come with your REKOVELLE pre-filled pen or that your healthcare provider prescribes. 
REKOVELLE napunjenom brizgalicom ili koje Vam propiše Vaš zdravstveni djelatnik.
Patients with renal and hepatic impairment 
Bolesnice s oštećenjem bubrega ili jetre
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) 
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
Do not use the pre-filled pen if the solution contains particles or if the solution does not look clear. 
Nemojte upotrijebiti napunjenu brizgalicu ako otopina sadrži čestice ili ako otopina ne izgleda bistro.
The cartridge is designed to be used in conjunction with the REKOVELLE injection pen. 
Uložak je dizajniran za uporabu u kombinaciji s REKOVELLE brizgalicom za injekciju.
Needles: 
Igle:
For use only with the REKOVELLE injection pen. 
Samo za primjenu uz REKOVELLE brizgalicu za injekciju.
REKOVELLE 12 micrograms/0.36 mL solution for injection REKOVELLE 36 micrograms/1.08 mL solution for injection REKOVELLE 72 micrograms/2.16 mL solution for injection 
REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju
Table 3 Ongoing pregnancy rate and ongoing implantation rate in ESTHER-1 trial REKOVELLE in an individualised dosing regimen (N=665) 
REKOVELLE primijenjen prema individualiziranom režimu doziranja (N=665)
Common (may affect up to 1 in 10 people): 
Česte (mogu se javiti u manje od 1 na 10 osoba) • Glavobolja
AMH (pmol/L) 
Za žene s AMH ≥15 pmol/L
REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen 
REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju u napunjenoj brizgalici REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju u napunjenoj brizgalici REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju u napunjenoj brizgalici
• Calculate and write down the remaining dose to inject in column C by subtracting the number in column B from the number in column A. Use a calculator to check your math if needed. 
• Izračunajte preostalu dozu koju treba injicirati tako da oduzmete broj iz stupca B od broja iz stupca
Attaching needle - (Step 2 to 6) 
Postavljanje igle - (Korak 2 do 6) Važno:
Pelvic pain Adnexa uteri pain Pelvic discomfort 
Bol u adneksima maternice Nelagoda u zdjelici
Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment with REKOVELLE. 
Prije nego se počne s liječenjem lijekom REKOVELLE, potrebno je uzeti u obzir medicinska stanja koja kontraindiciraju trudnoću.
One millilitre of solution contains 33.3 micrograms of follitropin delta in each millilitre of solution. 
Jedan mililitar otopine sadrži 33,3 mikrograma folitropina delta.
• are vomiting 
• Povraćanje
REKOVELLE is a clear and colourless solution for injection (injection). 
Kako REKOVELLE izgleda i sadržaj pakiranja REKOVELLE je bistra i bezbojna otopina za injekciju (injekcija).
REKOVELLE 72 micrograms/2.16 mL solution for injection One multidose cartridge contains 72 micrograms follitropin delta* in 2.16 mL solution. 
REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju Jedan višedozni uložak sadrži 72 mikrograma folitropina delta* u 2,16 mL otopine.
REKOVELLE 72 micrograms/2.16 mL solution for injection 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber). 
REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju Višedozni uložak od 3 mL (staklo tip I) s klipom (halobutil guma) i zatvaračem (aluminij) s umetkom (guma).
REKOVELLE 72 micrograms/2.16 mL solution for injection One pre-filled multidose pen delivers 72 micrograms follitropin delta* in 2.16 mL solution. 
REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju Jedna višedozna napunjena brizgalica isporučuje 72 mikrograma folitropina delta* u 2,16 mL otopine.
REKOVELLE is a clear and colourless solution for injection in a pre-filled pen (injection). 
Kako REKOVELLE izgleda i sadržaj pakiranja REKOVELLE je bistra i bezbojna otopina za injekciju (injekcija) u napunjenoj brizgalici.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 6 pen injection needles 
OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici 1 višedozna napunjena brizgalica sa 6 igala za brizgalicu za injekciju
Step 10: 
Korak 10:
• gain weight 
• se debljate
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 9 pen injection needles 
OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici 1 višedozna napunjena brizgalica s 9 igala za brizgalicu za injekciju
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 3 pen injection needles 
OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici 1 višedozna napunjena brizgalica s 3 igle za brizgalicu za injekciju
• Turn the dose knob clockwise until a symbol of a droplet lines up with the dose indicator. 
• Okrenite izbornik za podešavanje doze u smjeru kazaljke na satu dok se simbol kapljice ne poravna s pokazivačem doze.
Do not use the cartridge if the solution contains particles or if the solution does not look clear. 
Nemojte upotrijebiti uložak ako otopina sadrži čestice ili ako otopina ne izgleda bisto.
If a pen is damaged, contact your healthcare provider or local representative of the marketing authorisation holder (please refer to patient information leaflet for contact details). 
Vašeg zdravstvenog djelatnika ili lokalnog predstavnika nositelja odobrenja (molimo vidjeti uputu o lijeku za podatke o kontaktu).
Each multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of solution. 
Svaki višedozni uložak sadrži 12 mikrograma folitropina delta u 0,36 mililitara otopine.
Your body weight will also be measured before you start treatment. 
Prije početka liječenja mjerit će
REKOVELLE 36 micrograms/1.08 mL solution for injection follitropin delta 
REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju folitropin delta
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 72 micrograms/2.16 mL injection follitropin delta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA REKOVELLE 72 mikrograma/2,16 mL injekcija folitropin delta
REKOVELLE 72 micrograms/2.16 mL solution for injection follitropin delta 
REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju folitropin delta
Each multidose cartridge contains 72 micrograms of follitropin delta in 2.16 millilitre of solution. 
Svaki višedozni uložak sadrži 72 mikrograma folitropina delta u 2,16 mililitara otopine.
REKOVELLE 36 micrograms/1.08 mL solution for injection 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber). 
REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju Višedozni uložak od 3 mL (staklo tip I) s klipom (halobutil guma) i zatvaračem (aluminij) s umetkom (guma).
Each multidose cartridge contains 36 micrograms of follitropin delta in 1.08 millilitre of solution. 
Svaki višedozni uložak sadrži 36 mikrograma folitropina delta u 1,08 mililitara otopine.
REKOVELLE 36 micrograms/1.08 mL solution for injection One multidose cartridge contains 36 micrograms follitropin delta* in 1.08 mL solution. 
REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju Jedan višedozni uložak sadrži 36 mikrograma folitropina delta* u 1,08 mL otopine.
REKOVELLE 12 micrograms/0.36 mL solution for injection One multidose cartridge contains 12 micrograms follitropin delta* in 0.36 mL solution. 
REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju Jedan višedozni uložak sadrži 12 mikrograma folitropina delta* u 0,36 mL otopine.
REKOVELLE is dosed in micrograms (see section 5.1). 
GnRH agonistom (vidjeti dio 5.1).
REKOVELLE 12 micrograms/0.36 mL solution for injection 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber). 
REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju Višedozni uložak od 3 mL (staklo tip I) s klipom (halobutil guma) i zatvaračem (aluminij) s umetkom (guma).
REKOVELLE 12 micrograms/0.36 mL solution for injection follitropin delta 
REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju folitropin delta
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 36 micrograms/1.08 mL injection follitropin delta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA REKOVELLE 36 mikrograma/1,08 mL injekcija folitropin delta
REKOVELLE 36 micrograms/1.08 mL solution for injection One pre-filled multidose pen delivers 36 micrograms follitropin delta* in 1.08 mL solution. 
REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju Jedna višedozna napunjena brizgalica isporučuje 36 mikrograma folitropina delta* u 1,08 mL otopine.
How to store REKOVELLE 6. 
3. Kako primjenjivati REKOVELLE
• have nausea 
• imate proljev
Pack size of 1 pre-filled pen and 3 injection needles (stainless steel). 
Pakiranje od 1 napunjene brizgalice i 3 igle za injekciju (nehrđajući čelik).
Pack size of 1 pre-filled pen and 6 injection needles (stainless steel). 
Pakiranje od 1 napunjene brizgalice i 6 igala za injekciju (nehrđajući čelik).
Pack size of 1 cartridge and 6 injection needles (stainless steel) to be used with the REKOVELLE injection pen. 
Pakiranje od 1 uloška i 6 igala za injekciju (nehrđajući čelik) koji se koriste s REKOVELLE
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 12 micrograms/0.36 mL injection follitropin delta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA REKOVELLE 12 mikrograma/0,36 mL injekcija folitropin delta
Pack size of 1 pre-filled pen and 9 injection needles (stainless steel). 
Pakiranje od 1 napunjene brizgalice i 9 igala za injekciju (nehrđajući čelik).
REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen follitropin delta 
REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju u napunjenoj brizgalici folitropin delta
REKOVELLE 12 micrograms/0.36 mL solution for injection One pre-filled multidose pen delivers 12 micrograms follitropin delta* in 0.36 mL solution. 
REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju Jedna višedozna napunjena brizgalica isporučuje 12 mikrograma folitropina delta* u 0,36 mL otopine.
Pack size of 1 cartridge and 3 injection needles (stainless steel) to be used with the REKOVELLE injection pen. 
Pakiranje od 1 uloška i 3 igle za injekciju (nehrđajući čelik) koji se koriste s REKOVELLE
• Write down the dose that is left in your pen in column B. Give the injection using the rest of the medicine that is left in your pen. 
• Zapišite dozu koja je preostala u Vašoj brizgalici u stupac B.
Pack size of 1 cartridge and 9 injection needles (stainless steel) to be used with the REKOVELLE injection pen. 
Pakiranje od 1 uloška i 9 igala za injekciju (nehrđajući čelik) koji se koriste s REKOVELLE
After first use (in-use period): • The pen may be stored for up to 28 days at 2°C to 25°C. 
• Brizgalica se može čuvati najdulje 28 dana pri temperaturi od 2 °C do 25 °C.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Phenol 
PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
Step 1: 
Korak 2:
• Hold the pen with the needle pointing upwards. 
Korak 8: • Držite brizgalicu s iglom usmjerenom prema gore
REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen follitropin delta 
REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju u napunjenoj brizgalici folitropin delta
Each pre-filled pen with multidose cartridge contains 36 micrograms of follitropin delta in 1.08 millilitre of solution. 
Jedna napunjena brizgalica s višedoznim uloškom sadrži 36 mikrograma folitropina delta u 1,08 mililitara otopine.
Each pre-filled pen with multidose cartridge contains 72 micrograms of follitropin delta in 2.16 millilitre of solution. 
Jedna napunjena brizgalica s višedoznim uloškom sadrži 72 mikrograma folitropina delta u 2,16 mililitara otopine.
• Pull off the outer needle cap. 
• Skinite vanjski zatvarač igle.
• Before using the pen for the first time, you need to remove air bubbles from the cartridge 
• Prije prvog korištenja brizgalice, morate ukloniti mjehuriće zraka iz uloška (priprema) kako biste primili točnu dozu lijeka.
Each pre-filled pen with multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of solution. 
Jedna napunjena brizgalica s višedoznim uloškom sadrži 12 mikrograma folitropina delta u 0,36 mililitara otopine.
REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen follitropin delta 
REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju u napunjenoj brizgalici folitropin delta
1 multidose cartridge with 9 pen injection needles 
1 višedozni uložak s 9 igala za brizgalicu za injekciju.
Step 2: • Pull off the pen cap. 
Korak 5: • Skinite vanjski zatvarač igle.
1 multidose cartridge with 6 pen injection needles 
1 višedozni uložak sa 6 igala za brizgalicu za injekciju.
It is available in packs of 1 cartridge and 6 pen injection needles. 
Dostupna je u pakiranjima od 1 uloška i 6 igala za brizgalicu za injekciju.
• Only prime your pen the first time you use it. 
• Brizgalicu treba pripremiti samo kod prvog korištenja.
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 12 micrograms follitropin delta in 0.36 mL One mL of solution contains 33.3 micrograms of follitropin delta 
NAVOĐENJE DJELATNE(IH) TVARI Svaki višedozni uložak sadrži 12 mikrograma folitopina delta u 0,36 mL.
It is available in packs of 1 pre-filled pen and 6 pen injection needles. 
Dostupna je u pakiranjima od 1 napunjene brizgalice i 6 igala za brizgalicu za injekciju.
Ovulatory patients with polycystic ovaries have been included in clinical trials (see section 5.1). 
Bolesnice koje imaju ovulaciju i policistične jajnike bile su uključene u klinička ispitivanja
It is available in packs of 1 cartridge and 9 pen injection needles. 
Dostupna je u pakiranjima od 1 uloška i 9 igala za brizgalicu za injekciju.
• Dizziness 
Dijareja
It is available in packs of 1 pre-filled pen and 9 pen injection needles. 
Dostupna je u pakiranjima od 1 napunjene brizgalice i 9 igala za brizgalicu za injekciju.
Headache 
Umor
NAME OF THE MEDICINAL PRODUCT REKOVELLE 36 micrograms/1.08 mL solution for injection follitropin delta 
Uputa o lijeku: Informacije za korisnika REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju folitropin delta
It is available in packs of 1 cartridge and 3 pen injection needles. 
Dostupna je u pakiranjima od 1 uloška i 3 igle za brizgalicu za injekciju.
NAME OF THE MEDICINAL PRODUCT REKOVELLE 12 micrograms/0.36 mL solution for injection follitropin delta 
Uputa o lijeku: Informacije za korisnika REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju folitropin delta
1 multidose cartridge with 3 pen injection needles 
1 višedozni uložak s 3 igle za brizgalicu za injekciju.
NAME OF THE MEDICINAL PRODUCT REKOVELLE 72 micrograms/2.16 mL solution for injection follitropin delta 
Uputa o lijeku: Informacije za korisnika REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju folitropin delta
• Wipe the skin of your injection site with an alcohol swab to clean it. Do not touch this area again before you give your injection. 
• Očistite mjesto injiciranja na koži pomoću jastučića natopljenog alkoholom.
It is available in packs of 1 pre-filled pen and 3 pen injection needles. 
Dostupna je u pakiranjima od 1 napunjene brizgalice i 3 igle za brizgalicu za injekciju.
NAME OF THE MEDICINAL PRODUCT REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen follitropin delta 
Uputa o lijeku: Informacije za korisnika REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju u napunjenoj brizgalici folitropin delta
NAME OF THE MEDICINAL PRODUCT REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen follitropin delta 
Uputa o lijeku: Informacije za korisnika REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju u napunjenoj brizgalici folitropin delta
Keep the cartidge in the REKOVELLE injection pen. 
Injicirajte si preostali lijek iz Vaše brizgalice.
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1150/001
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/002 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1150/002
NAME OF THE MEDICINAL PRODUCT REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen follitropin delta 
Uputa o lijeku: Informacije za korisnika REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju u napunjenoj brizgalici folitropin delta
Discard used needles immediately after injection. 
Odmah nakon injiciranja, zbrinite iskorištenu iglu.
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/006 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1150/006
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/004 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1150/004
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/005 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1150/005
Reproductive system neoplasms 
Posljedični režim doziranja lijeka REKOVELLE
Step 9: 
Korak 6:
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/003 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1150/003
Further information on Gilenya can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Gilenya. 
Više informacija o lijeku Gilenya nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Gilenya.
Gilenya is available as capsules (0.25 mg and 0.5 mg). 
Lijek Gilenya dostupan je u obliku kapsula (0,25 mg i 0,5 mg).
The recommended dose for adults is one 0.5 mg capsule taken once a day by mouth, the recommended dose for children depends on body weight. 
Preporučena je doza za odrasle osobe jedna kapsula od 0,5 mg koja se uzima jedanput na dan kroz usta, dok preporučena doza za djecu ovisi o tjelesnoj težini.
The main measure of effectiveness in all the studies was based on the number of relapses the patients experienced each year. 
Glavno mjerilo učinkovitosti u svim ispitivanjima temeljilo se na godišnjem broju relapsa u bolesnika.
In addition, the Agency concluded that all patients should have their heart activity closely monitored after the first dose. 
Osim toga, Agencija je zaključila da nakon prve doze lijeka svim bolesnicima treba pomno nadzirati rad srca.
‘Relapsing-remitting' means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). 
„Relapsno-remitirajuća bolest” znači da u bolesnika dolazi do izbijanja simptoma (relapsi) nakon kojih slijede razdoblja oporavka (remisije).
Women should not become pregnant while taking Gilenya and for two months after treatment has stopped. 
Žene ne smiju zatrudnjeti za vrijeme uzimanja lijeka Gilenya, kao ni dva mjeseca poslije završetka terapije.
What measures are being taken to ensure the safe and effective use of Gilenya? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Gilenya?
Other information about Gilenya 
Ostale informacije o lijeku Gilenya
Side effects reported with Gilenya are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Gilenya pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Because Gilenya decreases the heart rate and can affect the heart's electrical activity and rhythm, the patient's blood pressure and heart activity is checked before starting treatment and during treatment, and also if Gilenya treatment is restarted after an interruption. 
Budući da Gilenya snižava srčanu frekvenciju i može utjecati na električnu aktivnost srca i srčani ritam, provjeravaju se krvni tlak i rad srca bolesnika prije početka i za vrijeme liječenja te u slučaju ponovnog uvođenja terapije lijekom Gilenya nakon prekida.
The pack will also include information on a registry to collect data on babies born to women treated with Gilenya, as well as a patient reminder card for patients or their carers with key safety information. 
Informativni paket također će sadržavati informacije o registru u okviru kojeg će se prikupljati podatci o bebama koje su rodile žene liječene lijekom Gilenya, kao i karticu s podsjetnikom za bolesnike ili njihove njegovatelje s ključnim sigurnosnim informacijama.