FrancophonIA/ELRC3.0 huggingface dataset:
English: • The injection button is firmly pushed in all the way until it stops.
Slovenian: • Gumb za injiciranje je trdno pritisnjen do konca.
English: Patients must be educated on how to use the REKOVELLE injection pen and to perform injections.
Slovenian: Bolnice je treba poučiti o uporabi injekcijskega peresnika REKOVELLE in injiciranju.
English: How to use REKOVELLE
Slovenian: Kako uporabljati zdravilo REKOVELLE
English: There are no data from the inadvertent exposure to REKOVELLE in pregnant women.
Slovenian: Podatkov o nenamerni izpostavljenosti zdravilu REKOVELLE pri nosečnicah ni.
English: • Do not use a pen if it has been dropped or hit against hard surfaces.
Slovenian: • Injekcijskega peresnika ne uporabljajte, če vam je padel na tla ali ste z njim udarili ob trdne površine.
English: • ovarian, uterine or mammary carcinoma (see section 4.4)
Slovenian: • karcinom jajčnikov, maternice ali dojk (glejte poglavje 4.4)
English: Following repeated daily subcutaneous administrations, REKOVELLE reaches steady-state within 6 to 7 days with a threefold higher concentration compared with the concentration after the first dose.
Slovenian: Zdravilo REKOVELLE doseže stanje dinamičnega ravnovesja v 6 do 7 dneh ponavljajoče vsakodnevne subkutane uporabe, in sicer s trikrat višjo koncentracijo v primerjavi s koncentracijo po prvem odmerku.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and local tolerance.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in lokalne tolerance ne kažejo posebnega tveganja za človeka.
English: Hormones used in the treatment of infertility such as this medicine may cause a high level of activity in the ovaries (ovarian hyperstimulation syndrome).
Slovenian: Hormoni, ki se uporabljajo za zdravljenje neplodnosti, kot je to zdravilo, lahko povzročijo visoko raven aktivnosti jajčnikov (sindrom hiperstimulacije jajčnikov).
English: • Breast complaints (include breast pain, breast tenderness)
Slovenian: • težave z dojkami (vključno z bolečino v dojkah, občutljivost dojk).
English: • Inject the remaining dose of medicine (the number in column C) using your new pen to complete your prescribed dose.
Slovenian: • Injicirajte preostali odmerek zdravila (vrednost v stolpcu C) z uporabo novega injekcijskega peresnika, da dokončate dajanje predpisanega odmerka.
English: Subcutanous use
Slovenian: subkutana uporaba
English: Do not use REKOVELLE if:
Slovenian: Ne uporabljajte zdravila REKOVELLE:
English: If you are not able to dial the full prescribed dose in your pen, this means that there is not enough medicine left in the pen to give the full dose.
Slovenian: Če na injekcijskem peresniku ne morete izbrati celotnega predpisanega odmerka, to pomeni, da v peresniku ni ostalo dovolj zdravila, da bi lahko uporabili celotni odmerek.
English: Self-administration should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Slovenian: Samo dobro motivirane in ustrezno usposobljene bolnice, z dostopom do strokovnega svetovanja, si lahko zdravilo injicirajo same.
English: • When turning the dial to your dose, you will hear a click sound and feel resistance on the dial for each increment to help you dial the correct dose.
Slovenian: • Med nastavljanjem želenega odmerka, boste pri vsakem koraku zaslišali klik in začutili upor na gumbu za odmerjanje, kar vam bo pomagalo pri izbiri pravilnega odmerka.
English: The trial compared the individualised dosing regimen of REKOVELLE where the daily dose is established for each patient and fixed throughout stimulation with no adjustments (see section 4.2) to follitropin alfa filled-by-mass at a starting dose of 11 micrograms (150 IU) for the first five days followed by dose adjustments from day 6 of stimulation based on follicular development in a GnRH antagonist protocol.
Slovenian: V študiji so individualno prilagojeni režim odmerjanja zdravila REKOVELLE, kjer je bil dnevni odmerek določen za vsako bolnico posebej in stalen v celotnem obdobju spodbujanja brez prilagoditev (glejte poglavje 4.2), primerjali s folitropinom alfa odmerjenim glede na maso, z začetnim odmerkom 11 mikrogramov (150 i.e.) prvih pet dni, čemur sledi prilagoditev odmerka od šestega dne spodbujanja na podlagi razvoja foliklov v protokolu antagonistov GnRH.
English: • If you will use a new pen to give your full prescribed dose instead of giving a split-dose injection, throw away (dispose of) your pen when there is not enough medicine in the pen for a full dose.
Slovenian: • Če boste namesto injiciranja deljenega odmerka uporabili nov peresnik za dajanje celotnega predpisanega odmerka, injekcijski peresnik zavrzite (odstranite med odpadke), ko v njem ni več dovolj zdravila za celotni odmerek.
English: • Do not try to repair a damaged pen.
Slovenian: • Ne popravljajte poškodovanega injekcijskega peresnika.
English: No interaction studies have been performed with REKOVELLE.
Slovenian: Študij medsebojnega delovanja z zdravilom REKOVELLE niso izvedli.
English: There may be a degree of interpatient variability in response to FSH administration, with poor response to FSH in some patients and exaggerated response in others.
Slovenian: Odziv na zdravljenje s FSH se lahko med bolnicami razlikuje; pri nekaterih je odziv na FSH zelo šibek in pri drugih pretiran.
English: In the following situations, treatment outcome is unlikely to be favourable, and therefore REKOVELLE should not be administered:
Slovenian: Zdravilo REKOVELLE naj se ne uporablja v naslednjih primerih, saj rezultat zdravljenja najverjetneje ne bi bil ugoden:
English: • Check that a droplet of liquid appears at the tip of the needle.
Slovenian: • Prepričajte se, da se je na vrhu igle pojavila kapljica tekočine.
English: • Do not press the injection button when dialing the dose to avoid loss of medicine.
Slovenian: • Med nastavljanjem odmerka ne pritiskajte gumba za injiciranje, da se izognete izgubi zdravila.
English: Dialing the dose - (Step 10)
Slovenian: Nastavitev odmerka - (10. korak)
English: • If you are not able to dial your complete dose, this means there is not enough medicine left in the pen.
Slovenian: • Če ne morete izbrati celotnega odmerka, pomeni, da v injekcijskem peresniku ni ostalo dovolj zdravila.
English: Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Slovenian: Pred začetkom zdravljenja je treba neplodnost para oceniti kot primerno za zdravljenje ter ovrednotiti domnevne kontraindikacije za nosečnost.
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Slovenian: V zelo redkih primerih je lahko pri hudi obliki SHSJ zaplet tudi torzija jajčnikov ali trombembolični dogodki, kot so pljučna embolija, ishemična možganska kap ali miokardni infarkt.
English: Using the pen incorrectly could result in receiving an incorrect dose of medicine.
Slovenian: nepravilno uporabo injekcijskega peresnika si lahko odmerite nepravilni odmerek zdravila.
English: Following subcutaneous administration, the apparent clearance of follitropin delta is 0.6 L/h and the clearance after intravenous is 0.3 L/h.
Slovenian: Navidezni očistek folitropina delta po subkutani uporabi znaša 0,6 l/h, očistek po intravenski uporabi pa 0,3 l/h.
English: REKOVELLE has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo REKOVELLE nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: • you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian disease)
Slovenian: • če imate povečane jajčnike ali ciste na jajčnikih (ki niso posledica sindroma policističnih jajčnikov);
English: • Check the pen (cartridge) to see that the medicine is clear and does not contain particles.
Slovenian: • Preverite, ali je zdravilo v injekcijskem peresniku (vložku) bistro in ne vsebuje delcev.
English: • If blood appears at the injection site, press a gauze pad or cotton ball lightly to the injection site.
Slovenian: • Če se na mestu injiciranja pojavi kri, narahlo pritisnite gazo ali kos vate.
English: If you have any of these symptoms you should contact a doctor immediately.
Slovenian: Če opazite katerega koli izmed teh neželenih učinkov, se nemudoma posvetujte z zdravnikom.
English: • Each number is separated by two lines, each line is equal to one increment of 0.33 micrograms.
Slovenian: • Vsaka številka je ločena z dvema črticama, pri čemer vsaka črtica predstavlja en korak v višini
English: The cartridge may be used for several injections.
Slovenian: Vložek lahko uporabite za več injekcij.
English: • Tap with your finger on the cartridge holder to make any air bubbles in the cartridge rise to the top of the cartridge.
Slovenian: • S prstom narahlo potrkajte po držalu vložka, da se morebitni zračni mehurčki v vložku dvignejo na vrh vložka.
English: Known gastrointestinal symptoms associated with OHSS include abdominal pain, discomfort, and distension, nausea, vomiting and diarrhoea.
Slovenian: Znani gastrointestinalni simptomi, povezani s SHSJ, vključujejo bolečino v trebuhu, nelagodje in napihnjenost, navzejo, bruhanje in drisko.
English: Ovarian hyperstimulation syndrome
Slovenian: Sindrom hiperstimulacije jajčnikov
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.
Slovenian: Morali si boste injicirati deljeni odmerek ali zavreči (odstraniti med odpadke) trenutni injekcijski peresnik in za injiciranje uporabiti novega.
English: • Always use a new needle for each injection.
Slovenian: • Ob vsakem injiciranju uporabite novo iglo.
English: Paediatric population There is no relevant use of REKOVELLE in the paediatric population.
Slovenian: Pediatrična populacija Zdravilo REKOVELLE ni namenjeno za uporabo pri pediatrični populaciji
English: • you have kidney or liver disease
Slovenian: • če imate bolezen ledvic ali jeter.
English: After daily subcutaneous administration of REKOVELLE, the time to maximum serum concentration is 10 hours.
Slovenian: Čas do najvišje serumske koncentracije znaša po dnevni subkutani uporabi zdravila REKOVELLE 10 ur.
English: • With the needle still pointing upwards (away from the face) press in the injection button all the way in until you see the number ‘0' lined up with the dose indicator.
Slovenian: • Z navzgor obrnjeno iglo (stran od obraza) do konca pritisnite na gumb za injiciranje, dokler se številka »0« ne poravna s kazalnikom odmerka.
English: REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of hormones called gonadotropins.
Slovenian: Kaj je zdravilo REKOVELLE in za kaj ga uporabljamo Zdravilo REKOVELLE vsebuje folitropin delta, folikle stimulirajoči hormon iz družine hormonov, imenovanih gonadotropini.
English: Repeated treatment with REKOVELLE of patients with pre-existing or treatment-induced anti-FSH antibodies did not increase the antibody titre, was not associated with decreased ovarian response, and did not induce immune-related adverse events.
Slovenian: se titri protiteles niso povečali, ponavljajočega zdravljenja niso povezali z zmanjšanim odzivom jajčnikov, prav tako pa ni sprožilo neželenih učinkov, povezanih z imunostjo.
English: • The dose can be corrected either up or down without loss of medicine by turning the dose knob in either direction until the correct dose lines up with the dose indicator.
Slovenian: • Odmerek lahko brez izgube zdravila povečate ali zmanjšate tako, da gumb za odmerjanje obračate v kateri koli smeri, dokler se pravilni odmerek ne poravna s kazalnikom odmerka.
English: • 72 micrograms/2.16 mL
Slovenian: • 72 mikrogramov/2,16 ml
English: • After pressing in the injection button for 5 seconds, release the injection button.
Slovenian: • Gumb za injiciranje po 5 sekundah pritiskanja spustite.
English: • If you dial the incorrect priming dose, the priming dose can be corrected either up or down without loss of medicine by turning the dose knob in either direction until the symbol of a droplet lines up with the dose indicator.
Slovenian: • Če ste nastavili nepravilni pripravljalni odmerek, ga lahko brez izgube zdravila povečate ali zmanjšate tako, da gumb za odmerjanje obračate v kateri koli smeri, dokler se simbol kapljice ne poravna s kazalnikom odmerka.
English: REKOVELLE pre-filled pen and its parts
Slovenian: Napolnjen injekcijski peresnik REKOVELLE in njegovi deli
English: • Prepare and prime a new pen (Step 1 to 9).
Slovenian: • Pripravite nov injekcijski peresnik in iz njega odstranite zračne mehurčke (koraki 1 do 9).
English: Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Slovenian: Nadzorovano spodbujanje jajčnikov za razvoj več foliklov pri ženskah, ki so v postopku asistirane reprodukcije (ART, assisted reproductive technologies), kot sta zunajtelesna oploditev (IVF, in vitro fertilisation) ali neposredni vnos semenčice v citoplazmo jajčne celice (ICSI, intracytoplasmic sperm injection).
English: • You may need more than one pen to complete your prescribed dose.
Slovenian: • Za odmero celotnega predpisanega odmerka boste morda potrebovali več kot en injekcijski peresnik.
English: • You can inject the medicine left in the pen and complete the prescribed dose with a new pen (split-dose) or use a new pen to give the full prescribed dose.
Slovenian: • Lahko injicirate zdravilo, ki je še preostalo v injekcijskem peresniku in preostanek celotnega predpisanega odmerka injicirate z novim peresnikom (deljeni odmerek) ali uporabite novi injekcijski peresnik za dajanje celotnega predpisanega odmerka.
English: Use only needles that come with your REKOVELLE pre-filled pen or that your healthcare provider prescribes.
Slovenian: Uporabljajte samo igle, ki so bile priložene napolnjenemu injekcijskemu peresniku REKOVELLE ali take, ki vam jih je predpisal zdravstveni delavec.
English: If you decide to give a split-dose injection, follow these instructions and write down how much medicine to give using the split-dose diary on Page 231.
Slovenian: sledite tem navodilom in si v dnevnik deljenih odmerkov na strani 231 zabeležite, koliko zdravila morate uporabiti.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Slovenian: Zdravilo REKOVELLE vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
English: Fixed daily dose of REKOVELLE
Slovenian: Stalen dnevni odmerek zdravila REKOVELLE
English: 20 (Dial to 20)
Slovenian: (obrnite do 20)
English: Use of results obtained with other assays than the ELECSYS AMH Plus immunoassay from Roche for REKOVELLE dose determination is not recommended, as there currently is no standardisation of available AMH assays.
Slovenian: Roche, za določitev odmerka zdravila REKOVELLE ni priporočljiva, saj trenutno razpoložljivi testi za določanje AMH niso standardizirani.
English: Store in a refrigerator.
Slovenian: Ne smete ga znova shranjevati v hladilniku.
English: Store at or below 25 °C.
Slovenian: Shranjujte pri temperaturi do 25 °C.
English: Other medical conditions
Slovenian: Druga zdravstvena stanja
English: You will need to give part of your prescribed dose using your current pen and the remainder of the dose using a new pen (split-dose injection) or you may throw away (dispose of) the pen you are using and use a new pen to give your full prescribed dose in 1 injection.
Slovenian: Del predpisanega odmerka si boste morali dati z injekcijskim peresnikom, ki ga trenutno uporabljate in za preostanek odmerka uporabiti nov injekcijski peresnik (injiciranje deljenega odmerka) ali pa zavreči (odstraniti med odpadke) peresnik, ki ga trenutno uporabljate, in uporabiti nov injekcijski peresnik, s katerim si boste dali celotni predpisani odmerek z 1 injiciranjem.
English: • 36 micrograms/1.08 mL
Slovenian: • 36 mikrogramov/1,08 ml
English: • you have malformations of the sexual organs which make a normal pregnancy impossible
Slovenian: • če imate malformacije spolnih organov, ki onemogočajo normalno nosečnost;
English: REKOVELLE pre-filled pens: • Throw away (dispose of) your used pens in accordance with local waste regulations.
Slovenian: • Uporabljene injekcijske peresnike zavrzite (odstranite med odpadke) v skladu z lokalnimi predpisi za ravnanje z odpadki.
English: REKOVELLE is intended for subcutaneous use, preferably in the abdominal wall.
Slovenian: Zdravilo REKOVELLE je namenjeno subkutani uporabi, po možnosti se injicira v trebušno steno.
English: It is not established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Slovenian: Ni dokazano, da zdravljenje z gonadotropini povečuje tveganje za pojav tovrstnih tumorjev pri neplodnih ženskah.
English: • Do not use the pen after the month of expiration (EXP) printed on the pen label.
Slovenian: • Injekcijskega peresnika ne uporabljajte po izteku roka uporabnosti (EXP), ki je naveden na nalepki injekcijskega peresnika.
English: • The cartridge in the pen may not have enough medicine left to deliver the prescribed dose.
Slovenian: • Morda v vložku injekcijskega peresnika ni več ostalo dovolj zdravila za predpisani odmerek.
English: • Always store the pen with the pen cap on and without a needle attached.
Slovenian: • Injekcijski peresnik vedno shranjujte z nameščenim pokrovčkom peresnika in brez nameščene igle.
English: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Slovenian: Prevalenca prirojenih malformacij po postopkih asistirane reprodukcije je morda nekoliko večja kot pri spontanem spočetju.
English: Instructions for use - REKOVELLE (follitropin delta) pre-filled pen
Slovenian: Navodila za uporabo - napolnjen injekcijski peresnik REKOVELLE (folitropin delta)
English: The frequency of these adverse reactions might decrease with repeated treatment cycles, as this has been observed in clinical trials.
Slovenian: V kliničnih študijah so opazili, da se lahko pogostnost teh neželenih učinkov zmanjšuje s ponavljajočimi cikli zdravljenja.
English: The pre-filled pen may be used for several injections.
Slovenian: Napolnjen injekcijski peresnik lahko uporabite za več injekcij.
English: In case of ovarian hyperresponse in the previous cycle, the daily dose in the subsequent cycle should be decreased by 20% or 33%, according to the extent of response observed.
Slovenian: V primeru pretiranega odziva jajčnikov v prejšnjem ciklu je treba v naslednjem ciklu dnevni odmerek zmanjšati za 20 % ali 33 % glede na obseg opaženega odziva.
English: In case of ovarian hypo-response in the previous cycle, the daily dose in the subsequent cycle should be increased by 25% or 50%, according to the extent of response observed.
Slovenian: V primeru nezadostnega odziva jajčnikov v prejšnjem ciklu je treba v naslednjem ciklu dnevni odmerek povečati za 25 % ali 50 % glede na obseg opaženega odziva.
English: • Store the pen in a refrigerator at 2 °C to 8 °C.
Slovenian: • Injekcijski peresnik shranjujte v hladilniku pri temperaturi od 2 °C do 8 °C.
English: Ovarian Hyperstimulation Syndrome (OHSS)
Slovenian: Sindrom hiperstimulacije jajčnikov (SHSJ)
English: Ovarian and other reproductive system tumours
Slovenian: Tumorji jajčnikov in drugih organov reprodukcijskega sistema
English: In the overall trial population, the mean number of oocytes retrieved was 10.0 ± 5.6 with REKOVELLE (N=636) in the individualised dosing regimen and 10.4 ± 6.5 with follitropin alfa (N=643) at a starting dose of 150 IU followed by dose adjustments.
Slovenian: V celotni populaciji preiskovank je bilo povprečno število pridobljenih oocitov z zdravilom REKOVELLE v individualno prilagojenem režimu odmerjanja 10,0 ± 5,6 (n = 636), s folitropinom alfa (n = 643), z začetnim odmerkom 150 i.e. in sledečimi prilagoditvami odmerka, pa 10,4 ± 6,5.
English: Pregnancy outside the uterus (ectopic pregnancy)
Slovenian: Zunajmaternična (ektopična) nosečnost
English: The instructions for use of the pen must be followed.
Slovenian: Upoštevajte navodila za uporabo peresnika.
English: Symptoms may include pain, discomfort or swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing.
Slovenian: Možni simptomi lahko vključujejo bolečino, nelagodje ali napihnjenost, slabost, bruhanje, driska, povečanje telesne mase ali oteženo dihanje.
English: Multiple pregnancy and birth defects
Slovenian: Večplodna nosečnost in prirojene okvare
English: It is important to stress the value of careful and frequent monitoring of follicular development in order to reduce the risk of OHSS.
Slovenian: Za zmanjšanje tveganja za pojav SHSJ je treba poudariti pomembnost skrbnega in rednega spremljanja razvoja foliklov.
English: Giving a split-dose of REKOVELLE
Slovenian: Dajanje deljenega odmerka zdravila REKOVELLE
English: How to store REKOVELLE 6.
Slovenian: Shranjevanje zdravila REKOVELLE 6.
English: When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy outside the uterus (ectopic pregnancy) than if you conceive naturally.
Slovenian: Pri zdravljenju s postopki oploditve z biomedicinsko pomočjo je verjetnost za zunajmaternično (ektopično) nosečnost večja kot pri naravnem spočetju.
English: After first use: 28 days when stored at or below 25 °C.
Slovenian: Po prvi uporabi: 28 dni, če se zdravilo shranjuje pri temperaturi do 25 °C.
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.
Slovenian: Informacije o napolnjenem injekcijskem peresniku REKOVELLE Na injekcijskem peresniku lahko izberete odmerek zdravila REKOVELLE od 0,33 mikrograma do 20 mikrogramov v označenih korakih po 0,33 mikrograma.
English: Ongoing pregnancy rate 30.7% Ongoing implantation rate 35.2% Population: all randomised and exposed
Slovenian: Delež trajajočih vsaditev Populacija: celotna randomizirana in izpostavljena
English: If you have any questions or problems related to the pen, contact your healthcare provider or local representative of the marketing authorisation holder (please refer to patient information leaflet for contact details).
Slovenian: Če imate kakršna koli vprašanja ali težave, povezane z injekcijskim peresnikom, se obrnite na zdravstvenega delavca ali lokalnega predstavnika imetnika dovoljenja za promet z zdravilom (kontaktni podatki so navedeni v navodilu za uporabo).
English: AMH (pmol/L)
Slovenian: Preglednica 1 Režim odmerjanja AMH (pmol/l)
English: For instructions on the administration with the pre-filled pen, see the ”Instructions for Use”.
Slovenian: Za navodila o uporabi zdravila z napolnjenim injekcijskim peresnikom glejte »Navodilo za uporabo«.
English: • Tilting the pen can cause the needle to bend or break off.
Slovenian: • Nagibanje injekcijskega peresnika bi lahko povzročilo upogibanje ali zlom igle.
English: Sodium content REKOVELLE contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Slovenian: Zdravilo REKOVELLE vsebuje natrij To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
English: • No. Priming must be performed only before giving the first injection with a new pen.
Slovenian: Odstranitev zračnih mehurčkov je treba izvesti samo pred prvim injiciranjem z novim injekcijskim peresnikom.
English: Split-dose diary
Slovenian: Dnevnik deljenih odmerkov
English: • you have fibroids of the uterus which make a normal pregnancy impossible.
Slovenian: • če imate fibroidne tumorje maternice, ki onemogočajo normalno nosečnost.