FrancophonIA/ELRC3.0 huggingface dataset:
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA II A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: It must be discarded if not used after these 30 days.
Slovenian: Raztopino morate zavreči, če je ne uporabite v teh 30 dneh.
English: OHSS due to excessive ovarian response can be avoided by withholding hCG administration.
Slovenian: OHSS zaradi čezmernega odziva jajčnikov se je mogoče izogniti z opustitvijo dajanja hCG.
English: If you do not see any liquid, you may try a second time (you may do this a maximum of two times) starting from step 1 of section “If you do not see a tiny drop(s) of fluid at or near the tip” above.
Slovenian: Če ne vidite tekočine, lahko poskusite še drugič (to lahko naredite največ dvakrat), pri čemer začnete s korakom 1 poglavja "Če prvič ne opazite drobnih kapelj na ali blizu konice igle" zgoraj.
English: • The dose number shown in the dose display will turn back to ‘0'.
Slovenian: • Številka, ki označuje nastavljeni odmerek v prikazu odmerka, se bo povrnila na "0".
English: Severe OHSS was reported in less than 0.5% of patients (see section 4.4).
Slovenian: O hudem OHSS so poročali pri manj kot 0,5 % bolnic (glejte poglavje 4.4).
English: • Local reactions at the injection site, such as pain, redness or swelling.
Slovenian: • lokalne reakcije na mestu injiciranja kot so bolečina, pordelost ali oteklina
English: Use each needle and pen only once.
Slovenian: Vsako iglo in peresnik uporabite samo enkrat.
English: • The dose display should show “250”, shown in the figure below.
Slovenian: • Prikaz odmerka mora kazati »250«, kot je prikazano na sliki spodaj.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 February 2001
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 02. februar 2001 Datum zadnjega podaljšanja: 02. februar 2006
English: Children and adolescents Ovitrelle is not for use in children and adolescents.
Slovenian: Otroci in mladostniki Zdravilo Ovitrelle ni primerno za uporabo pri otrocih in mladostnikih.
English: • Allergic reactions such as fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing, or serious breathing difficulty are very rare (may affect up to 1 in 10,000 people).
Slovenian: • Alergijske reakcije, kot so hiter ali neenakomeren utrip, oteklost jezika in grla, kihanje, sopenje ali resne težave z dihanjem so zelo redke (pojavijo se lahko pri največ 1 od 10.000 bolnikov).
English: Stop using Ovitrelle and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Slovenian: Takoj prenehajte uporabljati zdravilo Ovitrelle in pojdite k zdravniku, če opazite katerega koli od naslednjih resnih neželenih učinkov, saj morda potrebujete nujno medicinsko zdravljenje:
English: The effects of an overdose of Ovitrelle are unknown.
Slovenian: Učinki prevelikega odmerka zdravila Ovitrelle niso znani.
English: • Serious blood clotting complications (thromboembolic events) sometimes independent of OHSS may be found very rarely.
Slovenian: • Resni zapleti zaradi krvnih strdkov (trombembolični dogodki), ki so včasih neodvisni od OHSS, so zelo redki.
English: These are considered concomitant effects related to assisted reproductive techniques.
Slovenian: Te smatrajo za spremljajoči učinek, povezan s postopki asistirane reprodukcije.
English: 5.3 Verify once more that the number in the dose display reads ‘250'.
Slovenian: 5.3 Znova preverite, da kaže številka v prikazu odmerka "250".
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Slovenian: • preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
English: Please note that alcohol swabs are not contained in the package.
Slovenian: Prosimo upoštevajte, da alkoholni blazinici nista priložena v pakiranju.
English: If you pass this position, simply turn the dose setting knob back to the dot (●).
Slovenian: Če ta položaj presežete, preprosto zasukajte gumb za nastavitev odmerka nazaj na piko (●).
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 nedavno ali obstoječo trombembolično boleznijo ali pri ženskah s splošno znanimi dejavniki tveganja za trombembolične dogodke, kot so osebna ali družinska anamneza, zdravljenje z gonadotropini lahko še bolj povečajo tveganje za poslabšanje ali pojav teh dogodkov.
English: • Gather everything you need and lay it out:
Slovenian: • Pripravite in razvrstite vse, kar potrebujete:
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and the higher incidence of multiple pregnancies.
Slovenian: Menijo, da je vzrok v razlikah v značilnostih staršev (npr. starost matere, značilnosti sperme) in višji incidenci večplodnih nosečnosti.
English: “Instructions for use” provided in the carton.
Slovenian: »navodila za uporabo«, priložena v škatli.
English: This is justified, given the proteinous nature of the active substance and the negative outcome of the genotoxicity testing.
Slovenian: To je upravičeno glede na beljakovinsko naravo zdravilne učinkovine in negativen izid testiranja genotoksičnosti.
English: Very rare (may affect up to 1 in 10,000 people) • Mild skin allergic reactions such as rash.
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) • blaga kožna alergijska reakcija, kot je izpuščaj
English: Setting the dose to 250”).
Slovenian: Nastavitev odmerka na 250").
English: • To help release an egg from the ovary (ovulation induction) in women who cannot produce eggs (‘anovulation'), or women who produce too few eggs (‘oligo-ovulation').
Slovenian: • Kot pomoč pri sproščanju jajčeca iz jajčnika (induciranje ovulacije) pri ženskah, pri katerih jajčeca ne nastajajo ("anovulacija") ali ženskah, pri katerih nastaja premalo jajčec ("oligoovulacija").
English: Safety, efficacy and pharmacokinetics of Ovitrelle in patients with renal or hepatic impairment have not been established.
Slovenian: Varnosti, učinkovitosti in farmakokinetike zdravila Ovitrelle pri bolnikih z okvarjenim delovanjem ledvic ali jeter niso ugotavljali.
English: Clear, colourless to slightly yellow solution.
Slovenian: Bistra in brezbarvna do rahlo rumena raztopina.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins, ATC code: G03GA08
Slovenian: Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, gonadotropini, oznaka ATC: G03GA08
English: This is when your follicles develop too much and become large cysts.
Slovenian: Do tega pride, ko se jajčniki preveč razvijejo in postanejo velike ciste.
English: CAUTION: If you do not see a tiny drop(s) at or near the needle tip, you must perform the steps on the next page.
Slovenian: POZOR: Če prvič ne opazite drobnih kapelj na ali blizu konice igle, morate izvesti korake na naslednji strani.
English: If you are developing OHSS, you may be told not to have sex or to use a barrier contraceptive method for at least four days.
Slovenian: Če se pri vas razvija OHSS, vam bodo morda povedali, da se vsaj 4 dni vzdržite spolnih odnosov ali uporabljajte mehansko kontracepcijsko zaščito.
English: Treatment with Ovitrelle should be performed under the supervision of a physician experienced in the treatment of fertility problems.
Slovenian: Zdravljenje z zdravilom Ovitrelle mora potekati pod nadzorom zdravnika, izkušenega v zdravljenju težav s plodnostjo.
English: This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2. under “Blood clotting problems”).
Slovenian: Povzročijo lahko bolečino v prsih, zasoplost, kap ali srčni napad (glejte tudi v poglavju 2 "Težave s strjevanjem").
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).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: • Be careful not to prick yourself with the needle.
Slovenian: • Pazite, da se ne zbodete z iglo.
English: Find a clean area and lay out everything: two alcohol swabs, one pre-filled syringe containing the medicinal product.
Slovenian: Poiščite čisto površino in vse razpostavite: dve alkoholni blazinici napolnjeno injekcijsko brizgo z zdravilom.
English: Following subcutaneous administration, choriogonadotropin alfa is eliminated from the body with a terminal half-life of about 30 hours, and the absolute bioavailability is about 40%.
Slovenian: Po subkutani uporabi se horiogonadotropin alfa izloča iz telesa s končnim razpolovnim časom približno 30 ur, absolutna biološka razpoložljivost pa je približno 40 %.
English: Via delle Magnolie 15 70026 Modugno (Bari) Italy
Slovenian: Via delle Magnolie 15 70026 Modugno (Bari) Italija
English: • Get a new needle - only use the ‘single use' needle supplied.
Slovenian: • Vzemite novo iglo - uporabljajte samo iglo za "enkratno uporabo", ki je priložena.
English: • if you have a tumour in a part of your brain called the ‘hypothalamus' or ‘pituitary gland'.
Slovenian: • če imate tumor v delu možganov, imenovanem "hipotalamus" ali "žleza hipofiza"
English: No specific interaction studies with Ovitrelle and other medicinal products have been performed; however, no clinically significant medicinal product interactions have been reported during hCG therapy.
Slovenian: Specifičnih študij medsebojnega delovanja zdravila Ovitrelle z drugimi zdravili niso izvedli, vendar pa ni poročil o klinično pomembnih interakcijah z drugimi zdravili med zdravljenjem s hCG.
English: If you do a pregnancy test with serum or urine after use of Ovitrelle, and up to ten days later, it may happen that you get a false positive test result.
Slovenian: Če opravite test nosečnosti na serumu ali urinu po uporabi zdravila Ovitrelle in še do deset dni po tem, se lahko pojavijo lažni pozitivni rezultati testa.
English: • Check that the peel-off seal on the outer needle cap is not damaged or loose.
Slovenian: • Preverite, da jeziček, ki se odlepi na zunanjem pokrovčku igle, ni poškodovan ali razrahljan.
English: • Breast pain.
Slovenian: • bolečina v prsih
English: There are no indications that choriogonadotropin alfa is metabolised and excreted differently than endogenous hCG.
Slovenian: Ni znakov, da bi se horiogonadotropin alfa presnavljal in izločal drugače kot endogeni hCG.
English: • Feeling depressed, irritable or restless.
Slovenian: • občutek depresivnosti, razdražljivosti ali nemirnosti
English: Posology The maximum dose is 250 micrograms.
Slovenian: Odmerjanje Največji odmerek je 250 mikrogramov.
English: For instructions on the administration with the pre-filled pen, see section 6.6 and the “Instructions for use” provided in the carton.
Slovenian: Za navodila o dajanju zdravila z napolnjenim injekcijskim peresnikom glejte poglavje 6.6 in „Navodila za uporabo“, priložena v škatli.
English: Take as much time as you need to inject all the solution.
Slovenian: Vzemite si dovolj časa, da boste injicirali vso raztopino.
English: • Postmenopausal women
Slovenian: • ženske po menopavzi
English: • if you have severe inflammation of your veins or blood clotting in your veins (active thromboembolic disorders).
Slovenian: • če imate hudo vnetje ven ali krvne strdke v venah (aktivno trombembolično bolezen)
English: Ovitrelle is expected to have no or negligible influence on the ability to drive and use machines.
Slovenian: Pričakuje se, da zdravilo Ovitrelle nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Studies on reproduction were not performed in animals.
Slovenian: Študij o vplivu na sposobnost razmnoževanja pri živalih niso izvedli.
English: Repeated exposure to Ovitrelle was investigated in male patients only.
Slovenian: Večkratno izpostavljanje zdravilu Ovitrelle so proučevali samo pri moških bolnikih.
English: • if you have unexplained vaginal bleeding
Slovenian: • če imate nepojasnjeno krvavitev iz nožnice
English: It should be noted, however, that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Slovenian: Vendar pa je treba opomniti, da nosečnost sama po sebi in OHSS zvečujeta tveganje za trombembolične dogodke kot so pljučna embolija, ishemična kap ali miokardni infarkt.
English: • If you see a tiny drop(s) of fluid proceed to Section 4: Setting the dose to 250.
Slovenian: • Če vidite majhne kaplje tekočine, nadaljujte s poglavjem 4: Nastavitev odmerka na 250
English: No reproduction studies with choriogonadotropin alfa in animals were performed (see section 5.3).
Slovenian: Študij o vplivu horiogonadotropina alfa na sposobnost razmnoževanja pri živalih niso izvedli (glejte poglavje 5.3).
English: • To help develop and ripen several follicles (each containing an egg) in women undergoing Assisted Reproductive Techniques (procedure that may help you to become pregnant) such as ‘in vitro fertilisation'.
Slovenian: • Kot pomoč pri razvoju in zorenju več foliklov (od katerih vsako vsebuje jajčece) pri ženskah v postopku asistirane reprodukcije (postopek, ki vam lahko pomaga zanositi) kot je "in vitro oploditev".
English: Paediatric population There is no relevant use of Ovitrelle in the paediatric population.
Slovenian: Pediatrična populacija Zdravilo Ovitrelle ni primerno za uporabo pri pediatrični populaciji.
English: • Gynaecological haemorrhages of unknown aetiology
Slovenian: • ginekološke krvavitve neznane etiologije
English: The steady-state volume of distribution and the total clearance are 6 l and 0.2 L/h, respectively.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnotežja in celokupni očistek sta 6 l oziroma 0,2 l/uro.
English: It is important to have early ultrasound confirmation that a pregnancy is intrauterine, and to exclude the possibility of extrauterine pregnancy.
Slovenian: Pomembno je, da se z zgodnjim ultrazvokom potrdi, da je nosečnost maternična in izključi možnost zunajmaternične nosečnosti.
English: • if you have any condition that usually makes a normal pregnancy impossible, such as menopause or early menopause (ovarian failure), or malformations of sexual organs
Slovenian: • če imate katero koli stanje, ki običajno onemogoča normalno nosečnost, kot so menopavza ali zgodnja menopavza (odpoved jajčnikov), ali malformacijo spolnih organov
English: A comparative study between the freeze-dried and the liquid formulation showed bioequivalence between the two formulations.
Slovenian: Primerjalna študija zmrzovalno sušene oblike zdravila in tekoče oblike je pokazala bioekvivalenco obeh oblik zdravila.
English: • Active thromboembolic disorders
Slovenian: • aktivne trombembolične motnje
English: • Press the dose knob down as far as it will go and hold it to complete the full injection.
Slovenian: • Gumb za odmerek pritisnite navzdol, dokler gre, in držite, dokler injiciranje ni končano.
English: If you had in the past or recently blood clots in the leg or in the lung, or a heart attack or stroke, or if those happened in your family, then you might have a higher risk that these problems occur or become worse with Ovitrelle treatment.
Slovenian: Če ste imeli v preteklosti ali pred kratkim krvne strdke v nogah ali pljučih ali srčni napad ali kap, ali če se je to zgodilo komu v družini, ste morda izpostavljeni večjemu tveganju, da se bodo te težave pri zdravljenju z zdravilom Ovitrelle pri vas pojavile ali poslabšale, če jih že imate.
English: Self-administration of Ovitrelle should only be performed by patients who are adequately trained and have access to expert advice.
Slovenian: Samoinjiciranje zdravila Ovitrelle lahko izvajajo samo bolnice, ki so bile ustrezno podučene in imajo možnost nasveta strokovnjaka.
English: In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Slovenian: Bolnice moramo zlasti pregledati glede hipotiroidizma, adrenokortikalne insuficience, hiperprolaktinemije in hipofiznih ali hipotalamičnih tumorjev in jih ustrezno specifično zdraviti.
English: • if you have large ovaries or sacs of fluid within the ovaries (ovarian cysts) of unknown origin
Slovenian: • če imate povečane jajčnike ali vrečke s tekočino v jajčnikih (ciste na jajčniku) neznanega izvora
English: During Ovitrelle therapy, a minor thyroid stimulation is possible, of which the clinical relevance is unknown.
Slovenian: Med zdravljenjem z zdravilom Ovitrelle je možna manjša stimulacija ščitnice, katere klinični pomen ni znan.
English: Do not attempt to inject a second time.
Slovenian: Zdravila ne poskušajte ponovno injicirati.
English: The dose display will show a straight line and you have to keep turning until you can read the number ‘250'.
Slovenian: V prikazu odmerka boste videli ravno črto, nato pa gumb obračajte, dokler ne zagledate številke "250".
English: Blood clotting problems (thromboembolic events)
Slovenian: Težave s strjevanjem (trombembolični dogodki)
English: Setting the dose to 250
Slovenian: Nastavitev odmerka na 250
English: No clinical data on exposed pregnancies are available.
Slovenian: Ni na voljo kliničnih podatkov o izpostavljenosti zdravilu med nosečnostjo.
English: What Ovitrelle is used for Ovitrelle is used together with other medicines:
Slovenian: Za kaj uporabljamo zdravilo Ovitrelle Zdravilo Ovitrelle se uporablja skupaj z drugimi zdravili:
English: Multiple pregnancy and/or birth defects
Slovenian: Večplodna nosečnost in/ali prirojene okvare
English: Fertility Ovitrelle is indicated for use in infertility (see section 4.1).
Slovenian: Plodnost Zdravilo Ovitrelle je indicirano za uporabo ob neplodnosti (glejte poglavje 4.1).
English: If the peel-off seal is damaged or loose, do not use the needle.
Slovenian: Če je jeziček, ki se odlepi, poškodovan ali razrahljan, igle ne uporabite.
English: Nevertheless, there is a possibility that OHSS may result from an overdose of Ovitrelle (see section 4.4).
Slovenian: Kljub temu obstaja možnost, da se zaradi prevelikega odmerka zdravila Ovitrelle pojavi OHSS (glejte poglavje 4.4).
English: 6.3 Disposal
Slovenian: 6.3 Odstranjevanje
English: Warning: Medicines should not be disposed of via wastewater or household waste.
Slovenian: Opozorilo: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: • Your doctor will explain to you exactly when to give the injection.
Slovenian: • Vaš zdravnik vam bo natančno pojasnil, kdaj dati injekcijo.
English: If you use more Ovitrelle than you should
Slovenian: Če ste uporabili večji odmerek zdravila Ovitrelle, kot bi smeli
English: This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed (see also in section 2. under “Ovarian Hyperstimulation Syndrome”).
Slovenian: Lahko kažejo na to, da so se jajčniki premočno odzvali na zdravljenje in so se razvile velike ciste na jajčnikih (glejte tudi v poglavju 2 "Sindrom hiperstimulacije jajčnikov").
English: Therefore, your doctor should perform an early ultrasound examination to rule out the possibility of pregnancy outside the womb.
Slovenian: Zato mora vaš zdravnik zgodaj opraviti pregled z ultrazvokom, s katerim izključi možnost zunajmaternične nosečnosti.
English: • Verify the expiration date on the pen label.
Slovenian: • Preverite datum izteka roka uporabnosti na nalepki injekcijskega peresnika.
English: 6.2 Removing the needle after injection
Slovenian: 6.2 Odstranjevanje injekcijske igle po injiciranju
English: • Lower abdominal pain together with nausea (feeling sick) or vomiting may be the symptoms of Ovarian Hyperstimulation Syndrome (OHSS).
Slovenian: • Bolečina v spodnjem delu trebuha skupaj s slabostjo ali bruhanjem so lahko simptomi sindroma hiperstimulacije jajčnikov (OHSS).
English: Wipe the chosen area with an alcohol swab.
Slovenian: Obrišite izbrano mesto z alkoholno blazinico.
English: The risk of multiple pregnancy following assisted reproductive techniques is related to the number of embryos replaced.
Slovenian: Tveganje za večplodno nosečnost po postopkih asistirane reprodukcije je povezano s številom prenesenih embrijev.
English: What Ovitrelle is and what it is used for
Slovenian: Kaj je zdravilo Ovitrelle in za kaj ga uporabljamo
English: Adherence to recommended Ovitrelle dose, regimen of administration and careful monitoring of therapy will minimise the risk of OHSS and multiple pregnancy.
Slovenian: Strogo upoštevanje predpisanega odmerjanja zdravila Ovitrelle, režima dajanja in skrbno nadzorovanje zdravljenja, zmanjšajo pogostnost tveganja OHSS in večplodnih nosečnosti.
English: In comparative trials with different doses of Ovitrelle, the following adverse reactions were found to be associated with Ovitrelle in a dose-related fashion: OHSS, vomiting and nausea.
Slovenian: V primerjalnih študijah z različnimi odmerki zdravila Ovitrelle, so ugotovili, da so naslednje neželene reakcije povezane z velikostjo odmerka zdravila Ovitrelle: OHSS, bruhanje in slabost.
English: Ovitrelle is used to trigger final follicular maturation and early luteinisation after use of medicinal products for stimulation of follicular growth.
Slovenian: Zdravilo Ovitrelle se uporablja za sprožitev dokončnega folikelskega dozorevanja in zgodnje luteinizacije po uporabi zdravil za stimulacijo folikelske rasti.
English: 5.2 Clean the skin at the injection site by wiping with an alcohol swab.
Slovenian: 5.2 Kožo na mestu injiciranja očistite z alkoholno blazinico.
English: Ovitrelle is for single use only.
Slovenian: Zdravilo Ovitrelle je samo za enkratno uporabo.
English: • Anovulatory or oligo-ovulatory women:
Slovenian: • Ženske brez ovulacije ali z oligoovulacijo:
English: • This confirms that the dose has been fully delivered.
Slovenian: • To potrjuje, da je bil odmerek v celoti injiciran.
English: The incidence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Slovenian: Incidenca kongenitalnih malformacij po postopkih asistirane reprodukcije je lahko neznatno višja kot pri spontani zanositvi.
English: Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Slovenian: Nato iglo takoj izvlecite in kožo očistite z alkoholno blazinico s krožnimi gibi.
English: Ovitrelle is not indicated during breastfeeding.
Slovenian: Zdravilo Ovitrelle ni indicirano med dojenjem.
English: Throw it away in a sharps disposal container.
Slovenian: Zavrzite jo v vsebnik za odlaganje ostrih odpadkov.
English: There are no data on the excretion of choriogonadotropin alfa in milk.
Slovenian: Podatkov o izločanju horiogonadotropina alfa v mleko ni.
English: So far, there are no signs of antibody development in humans to Ovitrelle.
Slovenian: Do sedaj ni znakov razvoja protiteles za zdravilo Ovitrelle pri človeku.
English: If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting, or have difficulty in breathing, do not give yourself the Ovitrelle injection and talk to your doctor straight away (see section 4).
Slovenian: Če se pojavijo bolečine v spodnjem delu trebuha, če hitro pridobivate telesno maso, če vam je slabo ali bruhate, če imate težave z dihanjem, si ne dajte injekcije zdravila Ovitrelle in se takoj pogovorite z zdravnikom (glejte poglavje 4).