FrancophonIA/ELRC3.0 huggingface dataset:
English: Fertility REKOVELLE is indicated for use in infertility (see section 4.1).
Croatian: Plodnost REKOVELLE je indiciran za primjenu kod neplodnosti (vidjeti dio 4.1).
English: Symptoms may include pain, discomfort or swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing.
Croatian: Simptomi mogu uključivati bol, nelagodu ili oticanje trbuha, mučninu, povraćanje, proljev, debljanje ili otežano disanje.
English: Occurrence of ovarian torsion has been reported for ART cycles.
Croatian: Torzija jajnika Pojava torzije jajnika je bila prijavljena kod primjene MPO ciklusa.
English: Somnolence Dizziness
Croatian: Somnolencija Omaglica
English: PHARMACEUTICAL FORM Solution for injection in a pre-filled pen (injection).
Croatian: OBLIK Otopina za injekciju u napunjenoj brizgalici (injekcija).
English: • Do not throw the outer needle cap away.
Croatian: • Nemojte baciti vanjski zatvarač igle.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 • tumori hipotalamusa ili hipofize
English: Step 14:
Croatian: Korak 14:
English: • Discomfort of the abdomen
Croatian: Konstipacija Nelagoda u abdomenu
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
Croatian: • povećanje jajnika ili cista na jajnicima koja nije posljedica sindroma policističnih jajnika
English: Sodium sulphate decahydrate Disodium phosphate dodecahydrate Phosphoric acid, concentrated (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
Croatian: Natrijev hidrogenfosfat dodekahidrat Fosfatna kiselina, koncentrirana (za podešavanje pH)
English: You will need to give a split-dose injection or throw away (dispose of) your current pen and use a new pen for your injection.
Croatian: Morat ćete primijeniti injekciju u podijeljenim dozama ili baciti sadašnju brizgalicu i upotrijebiti novu.
English: Immunogenicity in terms of development of anti-FSH antibodies is a potential risk of gonadotropin therapy (see section 5.1).
Croatian: Imunogenost u smislu razvoja anti-FSH antitijela mogući je rizik kod liječenja gonadotropinima
English: There is no clinical trial experience with REKOVELLE in the long GnRH agonist protocol.
Croatian: Nema iskustva u kliničkim ispitivanjima s lijekom REKOVELLE kod produljenog protokola s GnRH
English: • Check the expiration on the pen label.
Croatian: • Provjerite datum isteka roka valjanosti na naljepnici brizgalice.
English: The medicine may be stored at or below 25 °C for up to 3 months including the period after first use.
Croatian: Lijek se može čuvati na temperaturi od ili ispod 25 °C tijekom najviše 3 mjeseca, što uključuje period nakon prve primjene.
English: mcg: micrograms
Croatian: mikrograma.
English: Excipients: phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide, water for injections
Croatian: Pomoćne tvari: fenol, polisorbat 20, L-metionin, natrijev sulfat dekahidrat, natrijev hidrogenfosfat dodekahidrat, koncentrirana fosfatna kiselina, natrijev hidroksid, voda za injekcije.
English: • Press the injection button all the way in and hold.
Croatian: • Pritisnite dugme za ubrizgavanje do kraja i držite tako.
English: - The active substance is follitropin delta.
Croatian: Što REKOVELLE sadrži - Djelatna tvar je folitropin delta.
English: • Pelvic pain and discomfort, including of ovarian origin
Croatian: • Bol i nelagoda u zdjelici, uključujući onu uzrokovanu jajnicima
English: Giving a split-dose of REKOVELLE
Croatian: Primjena podijeljene doze lijeka REKOVELLE
English: One mL of solution contains 33.3 micrograms of follitropin delta* *recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6) by recombinant DNA technology.
Croatian: * rekombinantni humani folikulostimulirajući hormon (FSH) proizveden tehnologijom rekombinantne DNK u ljudskoj staničnoj liniji (PER.C6).
English: • The pen cap will not fit over a needle.
Croatian: • Zatvarač brizgalice se neće moći vratiti preko igle.
English: REKOVELLE pre-filled pen follitropin delta
Croatian: Upute za uporabu REKOVELLE napunjena brizgalica folitropin delta
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED PEN
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA BRIZGALICA
English: 12 and 1 line (Dial to 12 plus 1 click)
Croatian: 12 i 1 linija (Okrenite do 12 plus 1 klik)
English: • have abdominal pain, discomfort or swelling
Croatian: • imate bol, nelagodu ili oticanje trbuha
English: How to use REKOVELLE
Croatian: Kako primjenjivati REKOVELLE
English: INFORMATION IN BRAILLE REKOVELLE 72 micrograms/2.16 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU REKOVELLE 72 mikrograma /2,16 mL
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmola natrija (23 mg) po dozi, tj. zanemarivu količinu natrija.
English: INFORMATION IN BRAILLE REKOVELLE 36 micrograms/1.08 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU REKOVELLE 36 mikrograma /1,08 mL
English: The most frequently reported adverse reactions during treatment with REKOVELLE are headache, pelvic discomfort, OHSS, pelvic pain, nausea, adnexa uteri pain and fatigue.
Croatian: Najčešće prijavljene nuspojave tijekom primjene lijeka REKOVELLE su glavobolja, nelagoda u zdjelici, OHSS, bol u zdjelici, mučnina, bol u adneksima maternice i umor.
English: • you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus
Croatian: • ako imate tumor maternice, jajnika, dojki, hipofize ili hipotalamusa
English: There have been reports of ovarian and other reproductive system tumours in women who had undergone infertility treatment.
Croatian: Prijavljeni su slučajevi tumora jajnika i drugih reproduktivnih organa u žena koje su podvrgnute liječenju neplodnosti.
English: REKOVELLE is developed for use in the REKOVELLE injection pen.
Croatian: REKOVELLE je razvijen za primjenu s REKOVELLE brizgalicom za injekciju.
English: Breast-feeding REKOVELLE is not indicated during breastfeeding.
Croatian: Dojenje REKOVELLE nije indiciran za primjenu tijekom dojenja.
English: Ferring Pharmaceuticals A/S Kay Fiskers Plads 11
Croatian: Ferring Pharmaceuticals A/S Kay Fiskers Plads 11 2300 Copenhagen S Danska
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 36 mcg/1.08 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 36 μg/1,08 mL
English: REKOVELLE is intended for subcutaneous use, preferably in the abdominal wall.
Croatian: REKOVELLE je namijenjen za supkutanu primjenu, po mogućnosti u trbušnu stijenku.
English: 0 and 2 lines (Dial to 0 plus 2 clicks)
Croatian: 0 i 2 linije (Okrenite do 0 plus 2 klika)
English: Sodium content REKOVELLE contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Croatian: Sadržaj natrija REKOVELLE sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarivu količinu natrija.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 72 mcg/2.16 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 72 μg/2,16 mL
English: Replace pen cap - (Step 14)
Croatian: Vraćanje zatvarača na brizgalicu - (Korak 14)
English: • Do not use the pen if the medicine contains particles or if the medicine is not clear.
Croatian: • Nemojte koristiti brizgalicu ukoliko lijek sadrži čestice ili nije bistar.
English: Gastrointestinal disorders
Croatian: Poznati gastrointestinalni simptomi povezani s
English: Each cartridge contains 2.16 mL of solution.
Croatian: Svaki uložak sadrži 2,16 mL otopine.
English: Do not use this medicine after the expiry date which is stated on the cartridge label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici uloška i na kutiji iza oznake EXP.
English: How to store REKOVELLE
Croatian: Kako čuvati REKOVELLE
English: • Turn the dose knob clockwise until the prescribed dose lines up with the dose indicator in the dose display window.
Croatian: • 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.
English: Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici napunjene brizgalice i na kutiji iza oznake EXP.
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancy.
Croatian: Smatra se da je to posljedica razlika u roditeljskim karakteristikama (npr. dob majke,
English: INFORMATION IN BRAILLE REKOVELLE 12 micrograms/0.36 mL
Croatian: 16. PODACI NA BRAILLEOVOM PISMU REKOVELLE 12 mikrograma/0,36 mL
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 12 mcg/0.36 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 12 μg/0,36 mL
English: Each cartridge contains 0.36 mL of solution.
Croatian: Svaki uložak sadrži 0,36 mL otopine.
English: Supplies you will need to give your REKOVELLE injection
Croatian: Što Vam je potrebno za primjenu injekcije lijeka REKOVELLE
English: No teratogenic risk has been reported, following controlled ovarian stimulation, in clinical use with gonadotropins.
Croatian: Nakon kontrolirane stimulacije jajnika kod kliničke primjene gonadotropina, nije prijavljen rizik od teratogenosti.
English: Suomi/Finland Ferring Lääkkeet Oy
Croatian: Danmark Ferring Lægemidler A/S
English: Each cartridge contains 1.08 mL of solution.
Croatian: Svaki uložak sadrži 1,08 mL otopine.
English: Disposal of Needle - (Step 13)
Croatian: Odlaganje igle - (Korak 13) Korak 13:
English: 0 and 1 line (Dial to 0 plus 1 click)
Croatian: 0 i 1 linija (Okrenite do 0 plus 1 klik)
English: Step 6: • Pull off the inner needle cap and throw it away.
Croatian: • Skinite unutarnji zatvarač igle i bacite ga.
English: • Mood swings
Croatian: • Promjene raspoloženja
English: • gynaecological haemorrhages of unknown aetiology (see section 4.4)
Croatian: • ginekološka krvarenja nepoznate etiologije (vidjeti dio 4.4) • karcinom jajnika, maternice ili dojke (vidjeti dio 4.4)
English: • Firmly replace the pen cap on the pen for protection between injections.
Croatian: • Vratite čvrstim pritiskom zatvarač na brizgalicu u svrhu zaštite brizgalice između injiciranja.
English: 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.
Croatian: Brizgalica se može podesiti za ispručivanje doze od 0,33 mikrograma do 20 mikrograma lijeka
English: REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use.
Croatian: REKOVELLE se može čuvati na temperaturi od ili ispod 25 °C tijekom najviše 3 mjeseca, što uključuje period nakon prve primjene.
English: 2 and 1 line (Dial to 2 plus 1 click)
Croatian: 2 i 1 linija (Okrenite do 2 plus 1 klik)
English: See “Giving a split-dose of REKOVELLE“ at Page 22 to 231 for examples of how to calculate and record your split dose.
Croatian: Pogledajte primjere kako izračunati i zabilježiti Vašu podijeljenu dozu u „Primjena podijeljene doze lijeka REKOVELLE“ na stranicama 22 do 231.
English: Use only needles that come with your REKOVELLE pre-filled pen or that your healthcare provider prescribes.
Croatian: REKOVELLE napunjenom brizgalicom ili koje Vam propiše Vaš zdravstveni djelatnik.
English: Patients with renal and hepatic impairment
Croatian: Bolesnice s oštećenjem bubrega ili jetre
English: 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)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
English: Do not use the pre-filled pen if the solution contains particles or if the solution does not look clear.
Croatian: Nemojte upotrijebiti napunjenu brizgalicu ako otopina sadrži čestice ili ako otopina ne izgleda bistro.
English: The cartridge is designed to be used in conjunction with the REKOVELLE injection pen.
Croatian: Uložak je dizajniran za uporabu u kombinaciji s REKOVELLE brizgalicom za injekciju.
English: Needles:
Croatian: Igle:
English: For use only with the REKOVELLE injection pen.
Croatian: Samo za primjenu uz REKOVELLE brizgalicu za injekciju.
English: 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
Croatian: 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
English: Table 3 Ongoing pregnancy rate and ongoing implantation rate in ESTHER-1 trial REKOVELLE in an individualised dosing regimen (N=665)
Croatian: REKOVELLE primijenjen prema individualiziranom režimu doziranja (N=665)
English: Common (may affect up to 1 in 10 people):
Croatian: Česte (mogu se javiti u manje od 1 na 10 osoba) • Glavobolja
English: AMH (pmol/L)
Croatian: Za žene s AMH ≥15 pmol/L
English: 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
Croatian: 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
English: • 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.
Croatian: • Izračunajte preostalu dozu koju treba injicirati tako da oduzmete broj iz stupca B od broja iz stupca
English: Attaching needle - (Step 2 to 6)
Croatian: Postavljanje igle - (Korak 2 do 6) Važno:
English: Pelvic pain Adnexa uteri pain Pelvic discomfort
Croatian: Bol u adneksima maternice Nelagoda u zdjelici
English: Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment with REKOVELLE.
Croatian: Prije nego se počne s liječenjem lijekom REKOVELLE, potrebno je uzeti u obzir medicinska stanja koja kontraindiciraju trudnoću.
English: One millilitre of solution contains 33.3 micrograms of follitropin delta in each millilitre of solution.
Croatian: Jedan mililitar otopine sadrži 33,3 mikrograma folitropina delta.
English: • are vomiting
Croatian: • Povraćanje
English: REKOVELLE is a clear and colourless solution for injection (injection).
Croatian: Kako REKOVELLE izgleda i sadržaj pakiranja REKOVELLE je bistra i bezbojna otopina za injekciju (injekcija).
English: REKOVELLE 72 micrograms/2.16 mL solution for injection One multidose cartridge contains 72 micrograms follitropin delta* in 2.16 mL solution.
Croatian: REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju Jedan višedozni uložak sadrži 72 mikrograma folitropina delta* u 2,16 mL otopine.
English: 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).
Croatian: 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).
English: REKOVELLE 72 micrograms/2.16 mL solution for injection One pre-filled multidose pen delivers 72 micrograms follitropin delta* in 2.16 mL solution.
Croatian: REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju Jedna višedozna napunjena brizgalica isporučuje 72 mikrograma folitropina delta* u 2,16 mL otopine.
English: REKOVELLE is a clear and colourless solution for injection in a pre-filled pen (injection).
Croatian: Kako REKOVELLE izgleda i sadržaj pakiranja REKOVELLE je bistra i bezbojna otopina za injekciju (injekcija) u napunjenoj brizgalici.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 6 pen injection needles
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici 1 višedozna napunjena brizgalica sa 6 igala za brizgalicu za injekciju
English: Step 10:
Croatian: Korak 10:
English: • gain weight
Croatian: • se debljate
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 9 pen injection needles
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici 1 višedozna napunjena brizgalica s 9 igala za brizgalicu za injekciju
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 3 pen injection needles
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici 1 višedozna napunjena brizgalica s 3 igle za brizgalicu za injekciju
English: • Turn the dose knob clockwise until a symbol of a droplet lines up with the dose indicator.
Croatian: • Okrenite izbornik za podešavanje doze u smjeru kazaljke na satu dok se simbol kapljice ne poravna s pokazivačem doze.
English: Do not use the cartridge if the solution contains particles or if the solution does not look clear.
Croatian: Nemojte upotrijebiti uložak ako otopina sadrži čestice ili ako otopina ne izgleda bisto.
English: 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).
Croatian: Vašeg zdravstvenog djelatnika ili lokalnog predstavnika nositelja odobrenja (molimo vidjeti uputu o lijeku za podatke o kontaktu).
English: Each multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of solution.
Croatian: Svaki višedozni uložak sadrži 12 mikrograma folitropina delta u 0,36 mililitara otopine.
English: Your body weight will also be measured before you start treatment.
Croatian: Prije početka liječenja mjerit će
English: REKOVELLE 36 micrograms/1.08 mL solution for injection follitropin delta
Croatian: REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju folitropin delta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 72 micrograms/2.16 mL injection follitropin delta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA REKOVELLE 72 mikrograma/2,16 mL injekcija folitropin delta
English: REKOVELLE 72 micrograms/2.16 mL solution for injection follitropin delta
Croatian: REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju folitropin delta
English: Each multidose cartridge contains 72 micrograms of follitropin delta in 2.16 millilitre of solution.
Croatian: Svaki višedozni uložak sadrži 72 mikrograma folitropina delta u 2,16 mililitara otopine.
English: 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).
Croatian: 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).
English: Each multidose cartridge contains 36 micrograms of follitropin delta in 1.08 millilitre of solution.
Croatian: Svaki višedozni uložak sadrži 36 mikrograma folitropina delta u 1,08 mililitara otopine.
English: REKOVELLE 36 micrograms/1.08 mL solution for injection One multidose cartridge contains 36 micrograms follitropin delta* in 1.08 mL solution.
Croatian: REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju Jedan višedozni uložak sadrži 36 mikrograma folitropina delta* u 1,08 mL otopine.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection One multidose cartridge contains 12 micrograms follitropin delta* in 0.36 mL solution.
Croatian: REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju Jedan višedozni uložak sadrži 12 mikrograma folitropina delta* u 0,36 mL otopine.
English: REKOVELLE is dosed in micrograms (see section 5.1).
Croatian: GnRH agonistom (vidjeti dio 5.1).
English: 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).
Croatian: 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).
English: REKOVELLE 12 micrograms/0.36 mL solution for injection follitropin delta
Croatian: REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju folitropin delta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 36 micrograms/1.08 mL injection follitropin delta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA REKOVELLE 36 mikrograma/1,08 mL injekcija folitropin delta
English: REKOVELLE 36 micrograms/1.08 mL solution for injection One pre-filled multidose pen delivers 36 micrograms follitropin delta* in 1.08 mL solution.
Croatian: REKOVELLE 36 mikrograma/1,08 mL otopina za injekciju Jedna višedozna napunjena brizgalica isporučuje 36 mikrograma folitropina delta* u 1,08 mL otopine.
English: How to store REKOVELLE 6.
Croatian: 3. Kako primjenjivati REKOVELLE
English: • have nausea
Croatian: • imate proljev
English: Pack size of 1 pre-filled pen and 3 injection needles (stainless steel).
Croatian: Pakiranje od 1 napunjene brizgalice i 3 igle za injekciju (nehrđajući čelik).
English: Pack size of 1 pre-filled pen and 6 injection needles (stainless steel).
Croatian: Pakiranje od 1 napunjene brizgalice i 6 igala za injekciju (nehrđajući čelik).
English: Pack size of 1 cartridge and 6 injection needles (stainless steel) to be used with the REKOVELLE injection pen.
Croatian: Pakiranje od 1 uloška i 6 igala za injekciju (nehrđajući čelik) koji se koriste s REKOVELLE
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 12 micrograms/0.36 mL injection follitropin delta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA REKOVELLE 12 mikrograma/0,36 mL injekcija folitropin delta
English: Pack size of 1 pre-filled pen and 9 injection needles (stainless steel).
Croatian: Pakiranje od 1 napunjene brizgalice i 9 igala za injekciju (nehrđajući čelik).
English: REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen follitropin delta
Croatian: REKOVELLE 72 mikrograma/2,16 mL otopina za injekciju u napunjenoj brizgalici folitropin delta
English: REKOVELLE 12 micrograms/0.36 mL solution for injection One pre-filled multidose pen delivers 12 micrograms follitropin delta* in 0.36 mL solution.
Croatian: REKOVELLE 12 mikrograma/0,36 mL otopina za injekciju Jedna višedozna napunjena brizgalica isporučuje 12 mikrograma folitropina delta* u 0,36 mL otopine.
English: Pack size of 1 cartridge and 3 injection needles (stainless steel) to be used with the REKOVELLE injection pen.
Croatian: Pakiranje od 1 uloška i 3 igle za injekciju (nehrđajući čelik) koji se koriste s REKOVELLE
English: • 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.
Croatian: • Zapišite dozu koja je preostala u Vašoj brizgalici u stupac B.
English: Pack size of 1 cartridge and 9 injection needles (stainless steel) to be used with the REKOVELLE injection pen.
Croatian: Pakiranje od 1 uloška i 9 igala za injekciju (nehrđajući čelik) koji se koriste s REKOVELLE
English: After first use (in-use period): • The pen may be stored for up to 28 days at 2°C to 25°C.
Croatian: • Brizgalica se može čuvati najdulje 28 dana pri temperaturi od 2 °C do 25 °C.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Phenol
Croatian: PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Step 1:
Croatian: Korak 2:
English: • Hold the pen with the needle pointing upwards.
Croatian: Korak 8: • Držite brizgalicu s iglom usmjerenom prema gore