FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing controlled ovarian stimulation for ART than following natural conception.
Slovenian: Prekinitev nosečnosti Pojavnost prekinitve nosečnosti zaradi spontanega splava ali splava je večja pri bolnicah z nadzorovanim spodbujanjem jajčnikov v postopku asistirane reprodukcije kot pri naravnem spočetju.
English: Elderly There is no relevant use of REKOVELLE in the elderly population.
Slovenian: Starejše bolnice Zdravilo REKOVELLE ni namenjeno za uporabo pri starejši populaciji.
English: • Only use the single-use click-on needles supplied with the pen.
Slovenian: • Uporabljajte samo zaskočne igle za enkratno uporabo, ki so priložene injekcijskemu peresniku.
English: 18 and 2 lines (Dial to 18 plus 2 clicks)
Slovenian: (obrnite do 18 plus 2 klika)
English: For use only with the REKOVELLE injection pen.
Slovenian: Samo za uporabo z injekcijskim peresnikom REKOVELLE.
English: Polycystic ovarian syndrome patients with anovulatory disorders Anovulatory patients with polycystic ovarian syndrome have not been studied.
Slovenian: Bolnice s sindromom policističnih jajčnikov z anovulacijo Bolnice z anovulacijo in sindromom policističnih jajčnikov niso bile vključene v raziskave.
English: • Call your healthcare provider if you have questions about how to calculate your split-dose.
Slovenian: • Če imate kakršno koli vprašanje o tem, kako izračunati deljeni odmerek, se obrnite na zdravstvenega delavca.
English: For instructions on the administration with the REKOVELLE injection pen, see the ”Instructions for Use” supplied with the pen.
Slovenian: Za navodila o uporabi zdravila REKOVELLE z injekcijskim peresnikom glejte »Navodilo za uporabo«, priloženo injekcijskemu peresniku.
English: Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment with REKOVELLE.
Slovenian: Druga zdravstvena stanja Pred začetkom zdravljenja z zdravilom REKOVELLE je treba oceniti tudi zdravstvena stanja, ki so kontraindicirana za nosečnost.
English: Patients undergoing stimulation of follicular growth may experience ovarian enlargement and may be at risk of developing OHSS.
Slovenian: Pri bolnicah v postopku spodbujanja rasti foliklov se lahko povečajo jajčniki, izpostavljene pa so tudi tveganju za razvoj SHSJ.
English: • Mood swings
Slovenian: • nihanja razpoloženja,
English: • 12 micrograms/0.36 mL
Slovenian: • 12 mikrogramov/0,36 ml
English: Sodium sulphate decahydrate Disodium phosphate dodecahydrate Phosphoric acid, concentrated (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
Slovenian: L-metionin natrijev sulfat dekahidrat natrijev hidrogenfosfat dodekahidrat fosforjeva(V) kislina, koncentrirana (za uravnavanje vrednosti pH) natrijev hidroksid (za uravnavanje vrednosti pH) voda za injekcije
English: A single injection of 250 micrograms recombinant human chorionic gonadotropin (hCG) or 5,000 IU hCG is administered to induce final follicular maturation.
Slovenian: Za sprožitev končnega zorenja foliklov se injicira ena injekcija z 250 mikrogrami rekombinantnega človeškega horionskega gonadotropina (hCG) ali 5.000 i.e. hCG.
English: REKOVELLE is dosed in micrograms (see section 5.1).
Slovenian: Zdravilo REKOVELLE se odmerja v mikrogramih (glejte poglavje 5.1).
English: INFORMATION IN BRAILLE REKOVELLE 72 micrograms/2.16 mL
Slovenian: PODATKI V BRAILLOVI PISAVI REKOVELLE 72 mikrogramov/2,16 ml
English: The medicine may be stored at or below 25 °C for up to 3 months including the period after first use.
Slovenian: Zdravilo lahko shranjujete pri temperaturi do 25 °C do 3 mesece, vključno z obdobjem po prvi uporabi.
English: If you have a history of tubal disease, you have an increased risk of ectopic pregnancy.
Slovenian: Če imate ali ste kdaj imeli bolezen jajcevoda, je tveganje za zunajmaternično nosečnost pri vas večje.
English: REKOVELLE is used in the treatment of female infertility and in women undergoing assisted reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI).
Slovenian: Zdravilo REKOVELLE se uporablja pri zdravljenju neplodnosti pri ženskah, ki so v postopku oploditve z biomedicinsko pomočjo, kot sta zunajtelesna oploditev jajčne celice (IVF, in vitro fertilisation) ali neposredni vnos semenčice v citoplazmo jajčne celice (ICSI, intracytoplasmic sperm injection).
English: • have abdominal pain, discomfort or swelling
Slovenian: • če imate bolečine v trebuhu, občutite nelagodje ali napihnjenost,
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
Slovenian: • povečanje jajčnikov ali cista na jajčnikih, vendar ne zaradi sindroma policističnih jajčnikov
English: - The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water for injections.
Slovenian: • Druge sestavine so fenol, polisorbat 20, L-metionin, natrijev sulfat dekahidrat, natrijev hidrogenfosfat dodekahidrat, koncentrirana fosforjeva(V) kislina, natrijev hidroksid, voda za injekcije.
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).
Slovenian: Če je injekcijski peresnik poškodovan, se obrnite na zdravstvenega delavca ali lokalnega predstavnika imetnika dovoljenja za promet z zdravilom (kontaktni podatki so navedeni v navodilu za uporabo).
English: Circulating levels of follitropin delta are inversely related to the body weight, which supports individualised dosing based on body weight.
Slovenian: Vrednosti folitropina delta v krvnem obtoku so obratno sorazmerne s telesno maso, kar govori v prid prilagojenemu odmerjanju glede na telesno maso.
English: 12 and 1 line (Dial to 12 plus 1 click)
Slovenian: (obrnite do 12 plus 1 klik)
English: • If needed, the outside of your pen may be cleaned with a cloth moistened with water.
Slovenian: • Po potrebi lahko zunanjost injekcijskega peresnika očistite z vlažno krpo.
English: REKOVELLE is designed for use in conjunction with the REKOVELLE injection pen provided separately.
Slovenian: Zdravilo REKOVELLE je zasnovano za uporabo skupaj z injekcijskim peresnikom REKOVELLE, ki je na voljo ločeno.
English: Women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, severe obesity (body mass index >30 kg/m2) or thrombophilia may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins.
Slovenian: huda debelost (indeks telesne mase > 30 kg/m2) ali trombofilija, je lahko tveganje za pojav venoznih ali arterijskih trombemboličnih dogodkov med zdravljenjem z gonadotropini ali po njem večje.
English: Table 2 Adverse reactions in pivotal clinical trials System Organ Class
Slovenian: Preglednica 2 Neželeni učinki iz ključnih kliničnih preskušanj
English: INFORMATION IN BRAILLE REKOVELLE 36 micrograms/1.08 mL
Slovenian: PODATKI V BRAILLOVI PISAVI REKOVELLE 36 mikrogramov/1,08 ml
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili uporabiti zdravilo REKOVELLE Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Renal and hepatic impairment REKOVELLE has not been studied in patients with moderate/severe renal or hepatic impairment.
Slovenian: Zdravilo REKOVELLE ni bilo raziskovano pri bolnicah z zmerno/hudo okvaro ledvic ali jeter.
English: REKOVELLE pre-filled pen follitropin delta
Slovenian: REKOVELLE napolnjen injekcijski peresnik folitropin delta
English: Disposal of Needle - (Step 13)
Slovenian: Odstranjevanje igle - (13. korak)
English: • The pen does not allow you to dial a larger dose than the dose that is left in the cartridge.
Slovenian: • Injekcijski peresnik ne omogoča nastavitve večjega odmerka od preostalega odmerka v vložku.
English: Breast-feeding REKOVELLE is not indicated during breastfeeding.
Slovenian: Zdravilo REKOVELLE ni indicirano med dojenjem.
English: In use: 28 days when stored at or below 25 °C.
Slovenian: V uporabi: shranjujte največ 28 dni pri temperaturi do 25 °C.
English: Your healthcare provider should show you how to prepare and inject REKOVELLE the right way before you inject it for the first time.
Slovenian: Pred prvo uporabo vam mora zdravstveni delavec pokazati, kako se zdravilo REKOVELLE pravilno pripravi in injicira.
English: OHSS is an intrinsic risk of the ovarian stimulation.
Slovenian: Spodbujanje jajčnikov spremlja intrinzično tveganje za pojav SHSJ.
English: • Press the injection button all the way in and hold.
Slovenian: • Gumb za injiciranje pritisnite do konca in ga držite.
English: Excipients: phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide, water for injections
Slovenian: Pomožne snovi: fenol, polisorbat 20, L-metionin, natrijev sulfat dekahidrat, natrijev hidrogenfosfat dodekahidrat, koncentrirana fosforjeva(V) kislina, natrijev hidroksid, voda za injekcije
English: No teratogenic risk has been reported, following controlled ovarian stimulation, in clinical use with gonadotropins.
Slovenian: Pri klinični uporabi z gonadotropini po nadzorovanem spodbujanju jajčnikov niso poročali o tveganju za teratogenost.
English: Ferring Pharmaceuticals A/S Kay Fiskers Plads 11
Slovenian: Ferring Pharmaceuticals A/S Kay Fiskers Plads 11 2300 København S Danska
English: The apparent volume of distribution is about 25 L after subcutaneous administration and the volume of distribution at steady state is 9 L after intravenous administration.
Slovenian: Porazdelitev Navidezni volumen porazdelitve znaša približno 25 l po subkutani uporabi, volumen porazdelitve v stanju dinamičnega ravnovesja po intravenski uporabi pa znaša 9 l. V razponu terapevtskih odmerkov se izpostavljenost folitropinu delta povečuje sorazmerno z odmerkom.
English: You will need it to throw away (dispose of) the needle after injecting the medicine.
Slovenian: Potrebovali ga boste, ko boste iglo po injiciranju zdravila zavrgli (odstranili med odpadke).
English: INFORMATION IN BRAILLE REKOVELLE 12 micrograms/0.36 mL
Slovenian: PODATKI V BRAILLOVI PISAVI REKOVELLE 12 mikrogramov/0,36 ml
English: - The active substance is follitropin delta.
Slovenian: • Učinkovina je folitropin delta.
English: • Call your healthcare provider or local representative of the marketing authorisation holder (please refer to pa-tient information leaflet for contact details) before giving your REKOVELLE injection if you have questions.
Slovenian: • Če imate vprašanja, pokličite zdravstvenega delavca ali lokalnega predstavnika imetnika dovoljenja za promet z zdravilom (kontaktni podatki so navedeni v navodilu za uporabo) preden si injicirate zdravilo REKOVELLE.
English: • You have slowly counted to 5 while you are still holding the injection button in and the needle is still in your skin.
Slovenian: • Medtem, ko ste držali pritisnjen gumb za injiciranje in je bila igla še vedno vstavljena v kožo, ste počasi prešteli do 5.
English: Adherence to the REKOVELLE dose and regimen of administration and careful monitoring of therapy will minimise the incidence of such events.
Slovenian: Za zmanjšanje pojavnosti tovrstnih dogodkov je pomembno upoštevanje priporočenega odmerka in režima uporabe zdravila REKOVELLE ter skrbno spremljanje zdravljenja.
English: Patients with renal and hepatic impairment
Slovenian: Bolnice z okvaro ledvic in jeter
English: Is the priming step necessary before each injection?
Slovenian: Ali je pred vsakim injiciranjem treba izvesti postopek odstranitve zračnih mehurčkov?
English: Attaching needle - (Step 2 to 6)
Slovenian: Namestitev igle - (2. do 6. korak)
English: Step 3: • Pull off the protective foil from the needle.
Slovenian: • Odstranite zaščitno folijo z igle.
English: • Turn the dose knob clockwise until the prescribed dose lines up with the dose indicator in the dose display window.
Slovenian: • Obračajte gumb za odmerjanje v smeri urinega kazalca, dokler se predpisani odmerek ne poravna s kazalnikom odmerka v okencu za odmerjanje.
English: The effects of taking too much of this medicine are unknown.
Slovenian: Če ste uporabili večji odmerek zdravila REKOVELLE, kot bi smeli Učinki prevelikega odmerka tega zdravila niso znani.
English: • See “Examples of how to dial a dose” at Page 20 to 211 if needed.
Slovenian: • Po potrebi glejte razdelek »Primeri nastavitve odmerka« na straneh 20 do 211.
English: The prevalence of ectopic pregnancy after ART has been reported to be higher than in the general population.
Slovenian: Po postopkih asistirane reprodukcije so poročali o večji prevalenci zunajmaternične nosečnosti kot pri splošni populaciji.
English: 0 and 2 lines (Dial to 0 plus 2 clicks)
Slovenian: (obrnite do 0 plus 2 klika)
English: The instructions for using the injection pen supplied with the pen including loading the cartridge must be followed carefully.
Slovenian: Skrbno upoštevajte navodila za uporabo injekcijskega peresnika, ki so priložena injekcijskemu peresniku, vključno z navodili za polnjenje vložka.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 72 mcg/2.16 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 72 μg/2,16 ml
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 36 mcg/1.08 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 36 μg/1,08 ml
English: Step 6: • Pull off the inner needle cap and throw it away.
Slovenian: • Snemite notranji pokrovček igle in ga zavrzite.
English: The REKOVELLE pre-filled pen is a disposable, dial-a-dose pen that can be used to give more than 1 dose of REKOVELLE.
Slovenian: Napolnjen injekcijski peresnik REKOVELLE je injekcijski peresnik za enkratno uporabo z gumbom za odmerjanje odmerka, ki ga lahko uporabimo za več odmerkov zdravila REKOVELLE.
English: See “Examples of how to dial a dose” at Page 20 to 211.
Slovenian: Oglejte si razdelek »Primeri nastavitve odmerka« na straneh od 20 do 211.
English: • Hold the pen so the dose display window is visible during injection.
Slovenian: • Injekcijski peresnik držite tako, da je med injiciranjem vidno okence za odmerjanje.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 12 mcg/0.36 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 12 μg/0,36 ml
English: Needles:
Slovenian: Igle:
English: Step 13:
Slovenian: 13. korak:
English: • Perform Step 7 to 9 even if you do not see air bubbles.
Slovenian: • Tudi če mehurčkov ne vidite, izvedite korake 7 do 9.
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
Slovenian: REKOVELLE 12 mikrogramov/0,36 ml raztopina za injiciranje REKOVELLE 36 mikrogramov/1,08 ml raztopina za injiciranje REKOVELLE 72 mikrogramov/2,16 ml raztopina za injiciranje
English: Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant.
Slovenian: Težave s strjevanjem krvi (trombembolični dogodki) Pri nosečih ženskah obstaja večja verjetnost za strdke v žilah (venah ali arterijah).
English: REKOVELLE is developed for use in the REKOVELLE injection pen.
Slovenian: Zdravilo REKOVELLE je razvito za uporabo skupaj z injekcijskim peresnikom REKOVELLE.
English: REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use.
Slovenian: Zdravilo REKOVELLE se lahko shranjuje pri temperaturi do 25 °C do 3 mesece, vključno z obdobjem po prvi uporabi.
English: 0 and 1 line (Dial to 0 plus 1 click)
Slovenian: (obrnite do 0 plus 1 klik)
English: • Check the expiration on the pen label.
Slovenian: • Preverite rok uporabnosti na nalepki injekcijskega peresnika.
English: • 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.
Slovenian: • Obrišite mesto injiciranja z alkoholno blazinico, da ga očistite.
English: What REKOVELLE contains
Slovenian: Kaj vsebuje navodilo
English: One millilitre of solution contains 33.3 micrograms of follitropin delta in each millilitre of solution.
Slovenian: En mililiter raztopine vsebuje 33,3 mikrograma folitropina delta v vsakem mililitru raztopine.
English: The most frequently reported adverse reactions during treatment with REKOVELLE are headache, pelvic discomfort, OHSS, pelvic pain, nausea, adnexa uteri pain and fatigue.
Slovenian: Najpogosteje poročani neželeni učinki med zdravljenjem z zdravilom REKOVELLE so glavobol, nelagodje v medenici, SHSJ, bolečina v medenici, navzea, bolečina v materničnih priveskih in utrujenost.
English: Keep the cartidge in the REKOVELLE injection pen.
Slovenian: Vložek shranjujte v injekcijskem peresniku REKOVELLE.
English: 2 and 1 line (Dial to 2 plus 1 click)
Slovenian: (obrnite do 2 plus 1 klik)
English: Each cartridge contains 2.16 mL of solution.
Slovenian: En vložek vsebuje 2,16 ml raztopine.
English: • Check the pen to see that it is not damaged.
Slovenian: • Prepričajte se, da injekcijski peresnik ni poškodovan.
English: Each cartridge contains 1.08 mL of solution.
Slovenian: En vložek vsebuje 1,08 ml raztopine.
English: The patients should be advised of the potential risk of multiple births before starting treatment.
Slovenian: Pred začetkom zdravljenja morajo biti bolnice seznanjenez možnim tveganjem večplodnih porodov.
English: See “Giving a split-dose of REKOVELLE“ at Page 22 to 231 for examples of how to calculate and record your split dose.
Slovenian: Glejte razdelek »Dajanje deljenega odmerka zdravila REKOVELLE« na straneh 22 do 231 s primeri,
English: • you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus
Slovenian: • če imate tumor na maternici, jajčnikih, dojkah, hipofizi ali hipotalamusu;
English: There have been reports of ovarian and other reproductive system tumours in women who had undergone infertility treatment.
Slovenian: Tumorji jajčnikov in drugih organov reprodukcijskega sistema Pri ženskah, ki so se zdravile zaradi neplodnosti, so poročali o tumorjih jajčnikov in drugih organov reprodukcijskega sistema.
English: The pharmacokinetic profile of follitropin delta has been investigated in healthy female subjects and in IVF/ICSI patients undergoing COS.
Slovenian: 5.2 Farmakokinetične lastnosti Farmakokinetični profil folitropina delta je bil preučevan pri zdravih preiskovankah in pri bolnicah,
English: Do not use this medicine after the expiry date which is stated on the cartridge label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki vložka in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Replace pen cap - (Step 14)
Slovenian: Ponovna namestitev pokrovčka peresnika - (14. korak)
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.
Slovenian: da od številke v stolpcu A odštejete številko v stolpcu B. S kalkulatorjem lahko preverite, ali je vaš izračun pravilen.
English: Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki napolnjenega injekcijskega peresnika in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Do not use the pen if it is damaged.
Slovenian: Poškodovanega peresnika ne uporabljajte.
English: Split-dosing:
Slovenian: Deljeni odmerki:
English: Read this booklet completely before using your REKOVELLE pre-filled pen and each time you get a new pen.
Slovenian: Prav tako preberite to knjižico vsakič, ko dobite nov injekcijski peresnik.
English: • Do not throw the outer needle cap away.
Slovenian: • Zunanjega zaščitnega pokrovčka igle ne zavrzite.
English: • Do not store the pen with the needle attached.
Slovenian: • Injekcijskega peresnika ne shranjujte z nameščeno iglo.
English: • Turn the dose knob clockwise until a symbol of a droplet lines up with the dose indicator.
Slovenian: • Obračajte gumb za odmerjanje v smeri urinega kazalca, dokler se simbol kapljice ne poravna s kazalnikom odmerka.
English: EU/1/16/1150/002
Slovenian: EU/1/16/1150/001 EU/1/16/1150/002 EU/1/16/1150/003
English: PHARMACEUTICAL FORM Solution for injection in a pre-filled pen (injection).
Slovenian: Raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcija).
English: This medicine does not affect your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo ne vpliva na sposobnost upravljanja voozil in strojev.
English: The cartridge is designed to be used in conjunction with the REKOVELLE injection pen.
Slovenian: Vložki so zasnovani za uporabo skupaj z injekcijskim peresnikom REKOVELLE.
English: When undergoing assisted reproductive technology treatment the possibility of having a multiple pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the quality of the embryos, and your age.
Slovenian: (npr. dvojčki) povezana predvsem s številom zarodkov, vstavljenih v vašo maternico, njihovo kakovostjo in vašo starostjo.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 9 pen injection needles
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za injiciranje v napolnjenem injekcijskem peresniku 1 večodmerni napolnjen injekcijski peresnik z 9 injekcijskimi iglami za peresnik
English: Each cartridge contains 0.36 mL of solution.
Slovenian: En vložek vsebuje 0,36 ml raztopine.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 3 pen injection needles
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za injiciranje v napolnjenem injekcijskem peresniku 1 večodmerni napolnjen injekcijski peresnik s 3 injekcijskimi iglami za peresnik
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 6 pen injection needles
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za injiciranje v napolnjenem injekcijskem peresniku 1 večodmerni napolnjen injekcijski peresnik s 6 injekcijskimi iglami za peresnik
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Phenol
Slovenian: 6.1 Seznam pomožnih snovi fenol polisorbat 20
English: Throw away (dispose of) the pen if it has not been used after 3 months.
Slovenian: Če peresnika niste uporabili, ga po 3 mesecih zavrzite (odstranite med odpadke).
English: REKOVELLE is a clear and colourless solution for injection in a pre-filled pen (injection).
Slovenian: Izgled zdravila REKOVELLE in vsebina pakiranja Zdravilo REKOVELLE je bistra in brezbarvna raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcija).
English: There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive technology treatment.
Slovenian: Po zdravljenju s postopki oploditve z biomedicinsko pomočjo so poročali o zasuku (torziji) jajčnikov.
English: There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility treatment.
Slovenian: Pri ženskah, ki so bile vključene v več režimov zdravljenja neplodnosti, so poročali o benignih in malignih novotvorbah na jajčnikih in drugih organih reprodukcijskega sistema.
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).
Slovenian: REKOVELLE 72 mikrogramov/2,16 ml raztopina za injiciranje 3 ml večodmerni vložek (steklo tipa I) z batom (halobutilna guma) in objemno zaporko (aluminij) z notranjo prevleko (guma).
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk SHSJ
English: REKOVELLE contains sodium
Slovenian: Vsebnost natrija