FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin and subcutaneous tissue disorders Very common Urticariab, rashb, eczemab, pruritis, rash maculo-papular
Slovenian: Bolezni kože in podkožja zelo pogosti urtikarija b, izpuščaj b, ekcem b, pruritus,
English: Reproductive system and breast disorders
Slovenian: Infekcijske in parazitske bolezni pogosti okužba sečil
English: Anxietyc, insomnia
Slovenian: Psihiatrične motnje pogosti tesnobnost c, nespečnost
English: Skin and subcutaneous tissue disorders Common
Slovenian: Srčne bolezni pogosti tahikardija
English: Laryngeal oedema e, dyspnoea b,c,e
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti laringealni edeme, dispnejab,c,e
English: Store in a refrigerator Do not freeze.
Slovenian: DRUGI PODATKI Shranjujte v hladilniku.
English: Each vial contains 33 mg sodium.
Slovenian: Pomožne snovi z znanim učinkom: ena viala vsebuje 33 mg natrija.
English: The medicine will be diluted before being given to you or your child.
Slovenian: Zdravilo je treba pred dajanjem razredčiti.
English: ● Risk Management Plan (RMP)
Slovenian: ● Načrt za obvladovanje tveganj (RMP)
English: Your doctor will decide how much medicine you will take and how often.
Slovenian: Vaš zdravnik se bo odločil, koliko zdravila boste uporabljali in kako pogosto.
English: • you have difficulty in breathing.
Slovenian: • imate težave z dihanjem.
English: It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Slovenian: Sprejemljivo je podaljšanje trajanja stimulacije v kateremkoli ciklusu do 5 tednov.
English: Children and adolescents This medicine is not indicated for use in children and adolescents less than 18 years of age.
Slovenian: Otroci in mladostniki To zdravilo ni indicirano za uporabo pri otrocih in mladostnikih, starih manj kot 18 let.
English: • This medicine is usually given every day.
Slovenian: • To zdravilo se običajno daje vsak dan.
English: Benzyl alcohol may cause allergic reactions.
Slovenian: Benzilalkohol lahko povzroči alergijske reakcije.
English: The doses described below are stated in International Units (IU).
Slovenian: Spodaj opisani odmerki so navedeni v mednarodnih enotah (i.e.).
English: All strengths listed above contain the other ingredients.
Slovenian: Vse jakosti, navedene zgoraj, vsebujejo druge sestavine.
English: Alternatively, IUI may be performed.
Slovenian: Alternativno se lahko izvede IUI.
English: Proper treatment of your condition, however, requires close and constant co-operation with your doctor.
Slovenian: Zaradi pravilnega zdravljenja vašega stanja morate tesno in stalno sodelovati s svojim zdravnikom.
English: This usually takes about 10 days but can take any time between 5 and 20 days.
Slovenian: To običajno traja približno 10 dni, vendar je razpon kadar koli med 5 in 20 dni.
English: urinary FSH (n = 116)
Slovenian: urinarni FSH (n = 116)
English: • The dose may be increased, depending on your response.
Slovenian: • Odmerek se lahko zviša glede na vaš odziv.
English: The majority of multiple conceptions are twins.
Slovenian: Večino večplodnih zanositev predstavljajo dvojčki.
English: OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event.
Slovenian: Ker se lahko OHSS razvije hitro (v 24 urah) ali v nekaj dneh v resen zdravstven zaplet.
English: However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
Slovenian: Vendar pa je treba upoštevati, da so razlike med rezultati meritev LH, ki so izvedene v različnih laboratorijih.
English: Following subcutaneous administration, the absolute bioavailability is about 70 %.
Slovenian: Po subkutani uporabi je absolutna biološka razpoložljivost 70 %.
English: Do not use this medicine if any of the above applies to you.
Slovenian: Ne uporabljajte tega zdravila, če kar koli od zgoraj naštetega velja za vas.
English: • Treatment is continued until your eggs have developed to a desired point.
Slovenian: • Zdravljenje se nadaljuje, dokler se jajčeca ne razvijejo do želene stopnje.
English: It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about 7 to 10 days following treatment.
Slovenian: Najpogosteje se pojavi po prekinitvi hormonskega zdravljenja in doseže maksimum približno 7 do 10 dni po zdravljenju.
English: What the recommended dose is
Slovenian: Priporočeni odmerek je
English: Multiple pregnancy may lead to medical complications for you and your babies.
Slovenian: Večplodne nosečnosti lahko vodijo v zdravstvene zaplete pri vas in vaših otrocih.
English: The pH of the solution is 6.8-7.2.
Slovenian: pH raztopine je 6,8-7,2.
English: Differences between the 2 groups were statistically significant (p < 0.05) for all criteria listed.
Slovenian: Razlike med obema skupinama so bile po vseh navedenih merilih statistično značilne (p < 0,05).
English: • if you are a man with: - testicular failure that is not treatable.
Slovenian: • če ste moški: - z odpovedjo testisov, ki je ni mogoče zdraviti.
English: • malformations of sexual organs incompatible with pregnancy;
Slovenian: • malformacije spolnih organov, ki niso združljive z nosečnostjo
English: • If you have not responded to treatment after 4 months, your doctor may suggest that you continue using these two medicines for at least 18 months.
Slovenian: • Če se po 4 mesecih ne odzovete na zdravljenje, vam bo zdravnik morda predlagal, da nadaljujete z uporabo teh dveh zdravil vsaj 18 mesecev.
English: • You will use these two medicines three times a week for at least 4 months.
Slovenian: • Ti dve zdravili boste uporabili trikrat na teden vsaj 4 mesece.
English: You may be told not to have sex or to use a barrier contraceptive method for at least 4 days.
Slovenian: Morda vam bo povedal, da ne smete imeti spolnih odnosov ali da morate uporabljati mehanska kontracepcijska sredstva najmanj 4 dni.
English: Self-administration should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Slovenian: Sami si jih lahko dajejo samo bolniki, ki so dobro motivirani, ustrezno poučeni in imajo dostop do strokovnega nasveta.
English: The first injection should be performed under direct medical supervision.
Slovenian: Injiciranje prve injekcije se mora izvesti pod neposrednim zdravniškim nadzorom.
English: Tell your doctor straight away if:
Slovenian: Svojemu zdravniku takoj povejte, če:
English: You can reduce the risk of multiple pregnancy by using the right dose of this medicine at the right times.
Slovenian: Tveganje večplodne nosečnosti lahko zmanjšate tako, da ob pravem času uporabite pravi odmerek tega zdravila.
English: If you are a man, having too much natural FSH in your blood can be a sign of damaged testicles.
Slovenian: Če ste moški in imate previsoko raven naravnega FSH v krvi, je morda to znak za poškodbo testisov.
English: Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Slovenian: Celokupne izkušnje z IVF kažejo, da je na splošno uspeh zdravljenja v prvih štirih poskusih konstanten, nato pa se postopno zmanjšuje.
English: No teratogenic effect has been observed in animal studies (see section 5.3).
Slovenian: V študijah na živalih niso opazili nobenega teratogenega učinka (glejte poglavje 5.3).
English: • you get pain in the lower part of the abdomen (belly),
Slovenian: • imate bolečine v spodnjem delu abdomna (trebuha),
English: It should be noted however that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.
Slovenian: Vendar pa moramo upoštevati, da nosečnost sama kot tudi OHSS prinašata povečano tveganje za trombembolične dogodke.
English: The adverse reactions are ranked under heading of frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so razvrščeni po pogostnosti v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: FSH is a gonadotropin, a type of hormone that plays an important role in human fertility and reproduction.
Slovenian: FSH je gonadotropin, vrsta hormona, ki ima pomembno vlogo pri plodnosti in razmnoževanju ljudi.
English: You can also report side effects directly via the national reporting system listed in Appendix V.. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: This is a condition that may be passed on from parents to children which means that you have an inability to break down porphyrins (organic compounds).
Slovenian: To je stanje, ki se lahko prenaša s staršev na otroke, in pomeni nezmožnost razgradnje porfirinov (organskih spojin).
English: If you administer this medicine to yourself, please carefully read and follow the “Instructions for Use” of the pen.
Slovenian: Če si boste to zdravilo dajali sami, skrbno preberite in upoštevajte "Navodila za uporabo" peresnika.
English: Tell your doctor before you start treatment, if you or any member of your family have porphyria.
Slovenian: Pred začetkom zdravljenja povejte zdravniku, če imate vi ali kdo v družini porfirijo.
English: 6.6 Special precautions for disposal and other handling No special requirements for disposal.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev za odstranjevanje.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: ● Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file.
Slovenian: Za izboljšanje sledljivosti biološkega zdravila je treba tržno ime in številko serije uporabljenega zdravila jasno zabeležiti v bolnikovo kartoteko.
English: If you think you are having this type of reaction, you must stop your Ovaleap injection and get medical help immediately.
Slovenian: Če menite, da imate to vrsto reakcije, morate prenehati z injiciranjem zdravila Ovaleap in takoj poiskati zdravniško pomoč.
English: Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Slovenian: Ker so te bolnice amenoreične in imajo nizko sekrecijo endogenega estrogena, se lahko zdravljenje začne kadarkoli.
English: Talk to your doctor straight away if:
Slovenian: Takoj povejte svojemu zdravniku, če:
English: Ovaleap must not be used when an effective response cannot be obtained, such as:
Slovenian: Zdravila Ovaleap ne smete uporabljati, kadar ni mogoče doseči učinkovitega odziva, kot je npr.:
English: • your skin becomes fragile and easily blistered, especially skin that has been frequently in the sun, and/or
Slovenian: • postane vaša koža krhka in se na koži hitro tvorijo mehurji, zlasti na tistih delih, ki so pogosto izpostavljeni soncu, in/ali
English: Follitropin alfa should not be used when an effective response cannot be obtained.
Slovenian: Folitropina alfa se ne sme uporabiti, če ni mogoče doseči učinkovitega odziva.
English: In men, FSH is needed for the production of sperm.
Slovenian: Pri moških je FSH potreben za nastajanje sperme.
English: If you are not ovulating, have no periods and have been diagnosed with very low levels of FSH and LH hormones
Slovenian: Če nimate ovulacije, nimate menstruacije in imate diagnozo zelo nizkih ravni hormonov FSH in LH
English: Your doctor or nurse will show you how to inject the medicine.
Slovenian: Vaš zdravnik ali medicinska sestra vam bosta pokazala, kako se injicira zdravilo.
English: Therefore, patients should be followed for at least 2 weeks after hCG administration.
Slovenian: Zato je treba bolnice spremljati najmanj 2 tedna po dajanju hCG.
English: In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
Slovenian: Pri ženskah z nedavnimi ali potekajočimi trombemboličnimi boleznimi ali pri ženskah s splošno znanimi dejavniki tveganja za trombembolične dogodke, kot so osebna ali družinska anamneza, lahko zdravljenje z gonadotropini še poveča tveganje za poslabšanje ali pojav teh dogodkov.
English: Empty cartridges must not be refilled.
Slovenian: Praznih vložkov ni dovoljeno ponovno napolniti.
English: This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Slovenian: Večje količine benzilalkohola se namreč lahko kopičijo v vašem telesu in povzročajo neželene učinke (imenovane »metabolična acidoza«).
English: The very first injection of this medicine should only be given in the presence of a doctor or nurse.
Slovenian: Prvo injekcijo tega zdravila si morate dati v prisotnosti zdravnika ali medicinske sestre.
English: Each cartridge must be used by a single patient only.
Slovenian: Vsak vložek se lahko uporablja samo pri enem bolniku.
English: • If you have irregular periods, start using this medicine within the first 7 days of your menstrual cycle.
Slovenian: • Če imate neredne menstruacije, začnite uporabljati to zdravilo v roku prvih 7 dni vašega menstrualnega ciklusa.
English: As the multidose cartridge is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the medicine.
Slovenian: Ker je večodmerni vložek namenjen dajanju več injekcij, mora dobiti bolnik jasna navodila za uporabo, v izogib napačni uporabi zdravila.
English: If you do not have periods, you can start using the medicine on any convenient day.
Slovenian: Če nimate menstruacij, lahko začnete zdravilo uporabljati kateri koli dan, kot vam ustreza.
English: Complication of severe OHSS
Slovenian: redki zaplet resnega OHSS
English: Data on a limited number of exposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or foeto/neonatal toxicity of follitropin alfa.
Slovenian: Podatki omejenega števila izpostavljenih nosečnosti (manj kot 300 izidov nosečnosti) ne kažejo na malformacijsko ali feto/neonatalno toksičnost folitropina alfa.
English: If you need to develop several eggs for collection prior to any assisted reproductive technology
Slovenian: Če želite, da se razvije več jajčec za odvzem pred tehniko asistirane reprodukcije
English: Therefore, it is considered appropriate to give a lower total dose of follitropin alfa than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation (see section 5.1).
Slovenian: Zato je primerno, da predpišemo nižji skupni odmerek folitropina alfa kot se običajno uporablja za urinarni FSH, ne samo za optimiranje razvoja foliklov, ampak tudi zato, da čim bolj zmanjšamo tveganje za neželeno hiperstimulacijo jajčnikov (glejte poglavje 5.1).
English: For accurate interpretation of the indices of follicle development and maturation, the physician should be experienced in the interpretation of the relevant tests.
Slovenian: Za pravilno interpretacijo kazalcev folikularnega razvoja in dozorevanja mora imeti zdravnik izkušnje na področju interpretacije tovrstnih testov.
English: If you experience the above symptoms your doctor may recommend that you stop treatment.
Slovenian: Če se pojavijo zgoraj navedeni simptomi, vam lahko zdravnik priporoča, da prenehate z zdravljenjem.
English: • you gain any weight rapidly,
Slovenian: • hitro pridobite telesno maso,
English: This could cause chest pain, breathlessness, stroke or heart attack [see also section 2 under “Blood clotting problems (thromboembolic events)”].
Slovenian: Povzročijo lahko bolečino v prsih, zasoplost, kap ali srčni napad [glejte tudi poglavje 2 "Težave s strjevanjem krvi (trombembolični dogodki)"].
English: The maximal daily dose is usually not higher than 225 IU FSH.
Slovenian: Maksimalni dnevni odmerek običajno ni večji kot 225 i.e. FSH.
English: Clinical assessment of follitropin alfa indicates that its daily doses, regimens of administration and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products.
Slovenian: Klinična ocena folitropina alfa kaže, da njegovi dnevni odmerki, režim uporabe in postopki nadzorovanja zdravljenja ne bi smeli biti drugačni od tistih, ki se trenutno uporabljajo za zdravila z urinarnim FSH.
English: Pregnancy and breast-feeding You should not use this medicine if you are pregnant or breast-feeding.
Slovenian: Nosečnost in dojenje Ne uporabljajte tega zdravila, če ste noseči ali če dojite.
English: The effects of an overdose of follitropin alfa are unknown, nevertheless, there is a possibility that OHSS may occur (see section 4.4).
Slovenian: Učinki prevelikega odmerka folitropina alfa niso znani, vendar pa obstaja možnost, da se pojavi OHSS (glejte poglavje 4.4).
English: Deterioration or a first appearance of this condition may require cessation of treatment.
Slovenian: Poslabšanje ali prvi pojav porfirije lahko zahteva prekinitev zdravljenja.
English: In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and appropriate specific treatment given.
Slovenian: Bolnike je treba še posebej pregledati na hipotiroidizem, adrenokortikalno insuficienco, hiperprolaktinemijo ter jih ustrezno specifično zdraviti.
English: • Swelling of the veins above and behind the testicles (a varicocele)
Slovenian: • oteklost žil nad testisi in za njimi (varikokela)
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA05.
Slovenian: Farmakoterapevtska skupina: Spolni hormoni in zdravila za uravnavanje delovanja spolovil, gonadotropni hormoni, oznaka ATC: G03GA05.
English: Your doctor or nurse will give you instructions on how to do this and you can also find instructions in the separate instructions for use of the pen.
Slovenian: Vaš zdravnik ali medicinska sestra vas bosta o tem poučila, napotke pa najdete tudi v ločenem navodilu za uporabo injekcijskega peresnika.
English: Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
Slovenian: Zdravljenje z gonadotropinom zahteva od zdravnika in ostalega zdravstvenega osebja določen čas, kakor tudi razpoložljivost ustrezne opreme za nadzorovanje zdravljenja.
English: 4.7 Effects on ability to drive and use machines Ovaleap has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Ovaleap nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Adherence to recommended follitropin alfa dose and regimen of administration can minimise the risk of ovarian hyperstimulation (see sections 4.2 and 4.8).
Slovenian: Upoštevanje priporočenega odmerka folitropina alfa in režima uporabe lahko zmanjšata tveganje hiperstimulacije jajčnikov (glejte poglavji 4.2 in 4.8).
English: Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure.
Slovenian: Pogosto so poročali o blagem ali zmernem OHSS, ki ga je treba obravnavati kot tveganje, značilno za postopek stimulacije.
English: • The usual dose of this medicine is 150 IU together with hCG.
Slovenian: • Običajni odmerek tega zdravila je 150 i.e. skupaj s hCG.
English: Table 3: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety of follitropin alfa with urinary FSH in ART)
Slovenian: Preglednica 3: Rezultati študije GF 8407 (randomizirana študija z vzporednima skupinama, pri kateri so primerjali učinkovitost in varnost folitropina alfa z urinarnim FSH pri ART) folitropin alfa (n = 130)
English: If you have ever had blood clots in your leg or lung, or a heart attack or stroke, or if your family have experienced these, inform your doctor.
Slovenian: Težave s strjevanjem krvi (trombembolični dogodki) Če ste kadar koli imeli krvne strdke v nogah ali v pljučih, srčni napad ali kap, ali če se je to zgodilo kakemu družinskemu članu, obvestite svojega zdravnika.
English: • you feel sick or are vomiting,
Slovenian: • vam je slabo ali bruhate,
English: Follitropin alfa should be given at a dose of 150 IU three times a week, concomitantly with hCG, for a minimum of 4 months.
Slovenian: Folitropin alfa se mora dajati v odmerku 150 i.e., trikrat na teden, sočasno s hCG, najmanj 4 mesece.
English: This could be related to multiple pregnancies or to parent characteristics such as maternal age and sperm characteristics.
Slovenian: To je lahko povezano z večplodno nosečnostjo ali lastnostmi staršev kot so materina starost in lastnosti sperme.
English: A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate, but not excessive, response.
Slovenian: Režim, ki se običajno uporablja, se prične z odmerkom 75-150 i.e. FSH na dan, in se ga, če je potrebno, povečuje za 37,5 ali 75 i.e. v 7 ali najbolje v 14 dnevnih intervalih, za doseganje zadostnega, a ne pretiranega odziva.
English: If severe OHSS occurs, it is recommended that gonadotropin treatment be stopped if still ongoing and that the patient be hospitalised and appropriate therapy be started.
Slovenian: Če se pojavi hud OHSS, je priporočljivo zdravljenje z gonadotropinom ukiniti, v kolikor še traja, in bolnico sprejeti v bolnišnico in začeti ustrezno zdravljenje OHSS.
English: You might have a higher risk of these problems occurring or becoming worse with Ovaleap treatment.
Slovenian: Morda je pri vas večje tveganje, da se te težave pri zdravljenju z zdravilom Ovaleap pojavijo ali poslabšajo.
English: The maximum daily dose is 450 IU.
Slovenian: Največji dnevni odmerek je 450 i.e..
English: PHARMACEUTICAL FORM Solution for injection (injection).
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje (injekcija).
English: This medicine contains the active substance follitropin alfa, which is almost identical to a natural hormone produced by your body called “follicle-stimulating hormone” (FSH).
Slovenian: To zdravilo vsebuje učinkovino folitropin alfa, ki je skoraj identična naravnemu hormonu, ki nastaja v telesu, imenovanim "folikle stimulirajoči hormon" (FSH).
English: • Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed in section 6.1;
Slovenian: • preobčutljivost na učinkovino folitropin alfa, FSH ali katero koli pomožno snov, navedeno v poglavju 6.1
English: The lowest effective dose in relation to the treatment objective should be used in both men and women.
Slovenian: Tako pri moških kot pri ženskah se mora uporabiti najmanjši še učinkoviti odmerek glede na namen zdravljenja.