FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Emadine (which may affect between 1 and 2 patients in 100) are eye pain, eye pruritus (itchy eye) and conjunctival hyperaemia (increased blood flow to the eye, leading to redness).
Slovenian: Najpogostejši neželeni učinki pri zdravilu Emadine (opaženi pri 1 do 2 bolnikih od 100) so bolečine v očeh, očesni pruritus (srbenje v očesu) in konjunktivna hiperemija (zvišan dotok krvi v oko, kar povzroči njegovo pordelost).
English: In both groups of patients, itching scores fell from around 5.1 at the start of the study, to around 3.8 after five minutes and around 2.7 after two hours.
Slovenian: Pri obeh skupinah bolnikov se je ocena srbenja znižala s približno 5,1 na začetku študije na približno 3,8 po petih minutah in 2,7 po dveh urah.
English: For the full list of all side effects and restrictions with Emadine, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Emadine glejte navodilo za uporabo.
English: For redness, the scores fell from around 2.7 to 0.5 for Emadine and to 1.1 for levocabastine.
Slovenian: Ocene pordelosti so z 2,7 padle na 0,5 za zdravilo Emadine in na 1,1 za levokabastin.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Emadine's benefits are greater than its risks for the symptomatic treatment of seasonal allergic conjunctivitis.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Emadine pri simptomatskem zdravljenju sezonskega alergijskega konjunktivitisa večje od z njim povezanih tveganj.
English: What is the risk associated with Emadine?
Slovenian: Kakšna tveganja so povezana z zdravilom Emadine?
English: Emadine is used to treat the symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Slovenian: Zdravilo Emadine se uporablja za zdravljenje simptomov sezonskega alergijskega konjunktivitisa (vnetja oči, ki ga pri bolnikih s senenim nahodom povzroča cvetni prah).
English: Similar reductions in redness scores were seen, falling from 4.5 to 3.7 after five minutes and 2.7 after two hours.
Slovenian: Podobno zmanjšanje je bilo opaziti pri pordelosti, ki je bila na začetku ocenjena s 4,5, po petih minutah s 3,7 in po dveh urah 2,7.
English: In the long term, the itching scores fell from an average of around 3.9 on the first day, falling to 0.8 for Emadine and 2.0 for levocabastine after six weeks.
Slovenian: Dolgoročno se je povprečna ocena srbenja, ki je v prvem dnevu znašala 3,9, po šestih tednih znižala na 0.8 pri uporabi zdravila Emadine in na 2,0 pri uporabi levokabastina.
English: Emadine was as effective as levocabastine in reducing symptoms of seasonal conjunctivitis.
Slovenian: Zdravilo Emadine se je pri zmanjševanju simptomov sezonskega konjunktivitisa izkazalo kot enako učinkovito kot levokabastin.
English: Why has Emadine been approved?
Slovenian: Zakaj je bilo zdravilo Emadine odobreno?
English: Emadine is available in a bottle and in single-dose containers.
Slovenian: Na voljo je v stekleničkah in vsebnikih z enim odmerkom.
English: Emadine is a clear eye drop solution.
Slovenian: Zdravilo Emadine je bistra raztopina za kapljice za oči.
English: What is Emadine used for?
Slovenian: Za kaj se zdravilo Emadine uporablja?
English: How has Emadine been studied?
Slovenian: Kako je bilo zdravilo Emadine raziskano?
English: What is Emadine?
Slovenian: Kaj je zdravilo Emadine?
English: How is Emadine used?
Slovenian: Kako se zdravilo Emadine uporablja?
English: It works by blocking the receptors that histamine normally attaches to. Histamine is a substance in the body that causes allergic symptoms.
Slovenian: Histamin je snov v telesu, ki povzroča alergijske simptome.
English: Emadine has been compared with levocabastine (another antihistamine) in one main study involving 222 patients with seasonal conjunctivitis aged four years and over.
Slovenian: V glavni študiji, v katero je bilo vključenih 222 bolnikov, starejših od štirih let, s sezonskim konjunktivitisom, so zdravilo Emadine primerjali z levokabastinom (drugi antihistaminik).
English: How does Emadine work?
Slovenian: Kako zdravilo Emadine deluje?
English: The bottles are packed individually in a carton box.
Slovenian: Stekleničke so pakirane posamezno v zloženkah.
English: The duration of protection is 6 months.
Slovenian: Zaščita traja 6 mesecev.
English: 4.8 Interaction with other medicinal product and other forms of interaction
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council, Member States prohibit or/ may prohibit the import, sale, supply and/or use of Porcilis Pesti on the whole or part of their territory if it is established that:
Slovenian: V skladu z 71. členom Direktive 2001/82/ES evropskega parlamenta in Sveta države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo Porcilisa Pesti na celotnem svojem ozemlju ali delu ozemlja, če se ugotovi, da:
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMA) http://www.ema.europa.eu/.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: Zdravilna učinkovina, ki je biološkega izvora in je namenjena za vzbujanje aktivne imunosti, ni zajeta v Uredbi (ES) št. 470/2009.
English: If you notice any serious side effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
English: Avoid the introduction of contamination.
Slovenian: Pazite, da ne bi prišlo do kontaminacije.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Za pomožne snovi (vključno z dodatki), navedene v poglavju 6.1 SPC, tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo (ES) št. 470/2009.
English: However, the use of vaccines may be authorised in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordance with Community Legislation on control and eradication of classical swine fever;
Slovenian: Vendar se uporaba cepiv lahko odobri v sklopu načrta za cepljenje v izrednih razmerah, ki ga po potrditvi bolezni izvede pristojni organ v državi članici v skladu z zakonodajo Skupnosti o nadzoru in izkoreninjenju klasične prašičje kuge;
English: The onset of protection is 2 weeks.
Slovenian: Zaščita se razvije v 2 tednih.
English: After administration of an overdose, local reactions at the injection site may be more pronounced.
Slovenian: Po vnosu prevelikega odmerka so lahko lokalne reakcije na mestu vboda izrazitejše.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C to 8°C).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C do 8 °C).
English: Manufacturer of the biological active substance:
Slovenian: Izdelovalec biološke zdravilne učinkovine:
English: Shelf-life after first broaching the bottle: 3 hours.
Slovenian: Rok uporabnosti po prvem odpiranju stekleničke: 3 ure.
English: b) The storage, supply, distribution and sale of classical swine fever vaccines must be carried out under the control of and in accordance with the eventual instructions established by the competent authority of the Member State;
Slovenian: b) Skladiščenje, oskrbo, distribucijo in prodajo cepiv proti klasični prašičji kugi je treba izvajati pod nadzorstvom pristojnega organa v državi članici in v skladu z morebitnimi navodili, ki jih ta organ uvede;
English: According to Community Legislation on Classical swine fever (Council Directive 80/217/EEC, as amended), in the European Union:
Slovenian: Zakonodaja Skupnosti, ki obravnava klasično prašičjo kugo (Direktiva Sveta 80/217/EEG, z vsemi spremembami) v Evropski uniji določa:
English: Excipients: For a full list of excipients, see section 6.1
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.,
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International B.V.
English: Administer one dose (2 ml) by deep intramuscular injection in the neck area behind the ear.
Slovenian: Injicirajte en odmerek (2 ml)globoko intramuskularno v vrat v predel za ušesom
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/016/001 - EU/2/99/016/006
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/99/016/001 - EU/2/99/016/006
English: Any person intending to import, sell, supply and/or use the veterinary medicinal product must be authorised by the competent authority of the Member State.
Slovenian: Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati zdravilo za uporabo v veterinarski medicini, mora imeti pooblastilo pristojnega organa v državi članici.
English: SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous
Slovenian: POSEBNA OPOZORILA, ČE SO POTREBNA Nenamerno injiciranje je nevarno.
English: Shelf life of the veterinary medicinal product as packaged for sale: 12 months Shelf life after first broaching the bottle: 3 hours.
Slovenian: Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 12 mesecev Rok uporabnosti po prvem odpiranju stekleničke: 3 ure.
English: The product contains Classical Swine Fever virus E2 immunogen incorporated in an emulsion in order to prolong stimulation of the immune system of the target species.
Slovenian: Izdelek vsebuje imunogen E2 virusa klasične prašičje kuge, vgrajen v emulzijo, kar podaljša stimulativni učinek na imunski sistem ciljne živalske vrste.
English: Classical Swine Fever vaccine, ATC vet code: QI09AA06
Slovenian: Cepivo proti klasični prašičji kugi, oznaka ATCvet: QI09AA06
English: a) The use of classical swine fever vaccines is prohibited.
Slovenian: a) Uporaba cepiv proti klasični prašičji kugi je prepovedana.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJE, ČE STA RAZLIČNA
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/016/001-006
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/99/016/001-006
English: The active substance stimulates active immunity against Classical Swine Fever (CSF).
Slovenian: Zdravilna učinkovina spodbudi aktivno imunost proti klasični prašičji kugi (KPK).
English: c) Special provisions regulate the movement of pigs from areas where classical swine fever vaccine is being or has been used and the marking of pig meat from vaccinated pigs.
Slovenian: c) Premike prašičev z območij, kjer uporabljajo ali so uporabljali cepivo proti klasični prašičji kugi, ter označevanje mesa cepljenih prašičev urejajo posebne določbe.
English: Re-vaccination: Every 6 months, using a single dose.
Slovenian: Revakcinacija: enkratni odmerek vsakih 6 mesecev.
English: a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and elimination of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the product is intended to confer immunity is largely absent from the territory.
Slovenian: a) bi uporaba izdelka pri živalih ovirala izvajanje nacionalnih programov diagnosticiranja, nadzora ali zatiranja živalskih bolezni ali da bi povzročila težave pri zagotavljanju, da ne bi prišlo do okužbe živih živali, živil ali drugih proizvodov, ki izvirajo iz zdravljenih živali.
English: Basic vaccination: Inject one dose per pig followed by a second injection 4 weeks after the first injection.
Slovenian: Osnovno cepljenje: en odmerek za enega prašiča, nato drugi odmerek 4 tedne po prvem.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Slovenian: Zato se je treba odločiti za uporabo tega cepiva pred nekim drugim zdravilom za uporabo v veterinarski medicini ali po njem v vsakem primeru posebej.
English: Before use, allow the vaccine to reach room temperature.
Slovenian: Cepivo naj se pred uporabo ogreje na sobno temperaturo.
English: The import, sale, supply and/or use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended).
Slovenian: Uvoz, prodaja, oskrba ali uporaba tega zdravila za uporabo v veterinarski medicini so dovoljeni samo pod določenimi pogoji, ki jih predpisuje zakonodaja Evropske skupnosti za nadzor nad KPK (Direktiva Sveta 80/217/EGS, z vsemi spremembami).
English: Since safety after giving both inoculations at the same site has not been examined, it is advised to carry out the second vaccination at a different site than the first vaccination.
Slovenian: Varnost dajanja obeh odmerkov na isto mesto ni raziskana, zato je pri drugem cepljenju odmerek priporočljivo dati na drugo mesto kot prvič.
English: The import, sale, supply and/or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended).
Slovenian: Uvoz, prodaja, oskrba in/ali uporaba zdravila Porcilis Pesti je dovoljena samo pod določenimi pogoji, ki jih predpisuje zakonodaja Evropske skupnosti za nadzor nad KPK (Direktiva Sveta 80/217/EGS, z vsemi spremembami).
English: As a consequence of the subunit nature of the vaccine, vaccination does not induce production of antibodies against CSF virus antigen, other than E2.
Slovenian: Ker je uporabljena podenota, cepljenje ne povzroči nastanka protiteles proti drugim antigenom virusa KPK, razen proti E2.
English: Transient hyperthermia may occur post the second dose.
Slovenian: Po drugem cepljenju je možna prehodna hipertermija.
English: If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Slovenian: Če vam je bil ta izdelek nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodila za uporabo.
English: Abscesses may be observed at the injection site.
Slovenian: Na mestu injiciranja se lahko pojavijo abscesi.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Pesti emulsion for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Porcilis Pesti, emulzija za injiciranje za prašiče
English: DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: 120 Elisa Units Classical Swine Fever Virus-E2 subunit antigen Liquid paraffin as adjuvant: 941.4 mg
Slovenian: 120 Elisa enot antigenskih podenot E2 virusa klasične prašičje kuge Tekoči parafin kot adjuvans: 941,4 mg
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN>IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
English: INDICATION(S) Vaccine against Classical Swine Fever
Slovenian: INDIKACIJE Cepivo proti klasični prašičji kugi
English: Active substance: Classical Swine Fever Virus (CSFV) -E2 subunit antigen: 120 Elisa Units (EU)
Slovenian: Virus klasične prašičje kuge (KPK) - antigenska podenota E2: 120 Elisa enot (EU) Dodatek:
English: Manufacturer responsible for batch release
Slovenian: Izdelovalec, odgovoren za sprostitev serije:
English: A local and in most cases transient swelling at the injection site may occur up to 4 weeks after administration of each dose of the vaccine.
Slovenian: Do 4 tedne po vsakem odmerku cepiva se lahko pojavi lokalna in večinoma prehodna oteklina na mestu injiciranja.
English: METHOD AND ROUTE(S) OF ADMINISTRATION IM injection of 2 ml
Slovenian: NAČIN IN POT(I) UPORABE 2 ml i.m.
English: Can be used during pregnancy but may not prevent transplacental transmission of Classical swine fever field virus from the sow to foetuses.
Slovenian: Lahko se uporablja v obdobju brejosti, vendar pa ne prepreči transplacentarnega prenosa naravnega virusa klasične prašičje kuge z matere na zarodke.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 120 Elisa Units CSF E2 antigen/2ml.
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) 120 Elisa enot antigena KPK E2/2 ml
English: The product can be used during pregnancy but may not prevent transplacental transmission of Classical swine fever field virus from the sow to foetuses.
Slovenian: Zdravilo se lahko uporablja v obdobju brejosti, vendar pa ne prepreči transplacentarnega prenosa naravnega virusa klasične prašičje kuge z matere na zarodke.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 2 ml contains:
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Odmerek po 2 ml vsebuje:
English: PACKAGE SIZE 50 ml (25 doses) - 100 ml (50 doses) - 250 ml (125 doses)
Slovenian: VELIKOST PAKIRANJA 50 ml (25 odmerkov) - 100 ml (50 odmerkov) - 250 ml (125 odmerkov)
English: MINIMUM PARTICULARS TO APPEAR ON Bottle Label {50ml/100ml/250ml }
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA nalepki stekleničke {50 ml/100 ml/250 ml}
English: EXPIRY DATE <EXP {month/year}> Once broached, use within 3 hours.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI <EXP> {mesec/leto}
English: {DD/MM/YYYY}
Slovenian: DATUM REVIZIJE BESEDILA {DD/MM/LLLL}
English: Adjuvant: 941.4 mg liquid paraffin
Slovenian: 941,4 mg tekočega parafina Pomožne snovi:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 50 ml (25 doses) - 100 ml (50 doses) - 250 ml (125 doses)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 50 ml (25 odmerkov) - 100 ml (50 odmerkov) - 250 ml (125 odmerkov)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
English: Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi polisorbat 80 sorbitan oleat
English: 50 ml/100 ml/250 ml multidose PET bottle
Slovenian: Večodmerna steklenička po 50 ml/100 ml/250 ml Večodmerna plastenka iz PET po 50 ml/100 ml/250 ml
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: Wim de Körverstraat 35 NL-5831 AN Boxmeer Nizozemska
English: 6.5 Nature and composition of immediate packaging Bottles of type I hydrolytic glass or polyethylene terephthalate (PET) containing 50 ml for 25 doses, 100 ml for 50 doses and 250 ml for 125 doses presentation.
Slovenian: Stekleničke iz stekla 1. hidrolitične skupine ali polietilen tereftalata (PET) po 50 ml za 25 odmerkov, po 100 ml za 50 odmerkov in po 250 ml za 125 odmerkov Stekleničke so zaprte z zamaški iz nitrilne gume in zaporkami iz aluminija s šifro.
English: Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.
Slovenian: S tem se preprečuje smrtnost, zmanjšujejo pa se tudi klinični znaki klasične prašičje kuge.
English: Liquid paraffin : 941.4 mg
Slovenian: 120 Elisa enot antigena KPK-E2 Tekoči parafin: 941,4 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE {50ml Bottle/ 100ml Bottle/250ml Bottle}
Slovenian: PODATKI NA ZUNANJI OVOJNINI {steklenička po 50 ml/ steklenička po 100 ml/ steklenička po 250 ml}
English: ROUTE(S) OF ADMINISTRATION IM injection
Slovenian: POT(I) UPORABE ZDRAVILA
English: MANUFACTURER'S BATCH NUMBER <Batch> <Lot> <BN> {number}
Slovenian: ŠTEVILKA SERIJE <Serija> {številka}
English: It is important that your hands and the items you use are as clean as possible.
Slovenian: Pomembno je, da so vaše roke in predmeti, ki jih boste uporabljali, kolikor je mogoče čisti.
English: • Headache, feeling tired.
Slovenian: • glavobol, občutek utrujenosti.
English: Studies on carcinogenic potential were not performed.
Slovenian: Študij o kancerogenem potencialu niso izvedli.
English: Assemble everything you need.
Slovenian: Pripravite vse, kar potrebujete.
English: Multiple pregnancy may lead to medical complications for you and your babies.
Slovenian: Večplodna nosečnost lahko povzroči zdravstvene zaplete za vas in vašega otroka.
English: • Find a clean area and a flat surface.
Slovenian: • Poiščite čist prostor in ravno površino.
English: The following definitions apply to the frequency terminology used hereafter: 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), not known (cannot be estimated from the available data).
Slovenian: V nadaljevanju se uporabljajo naslednje definicije navedbe pogostnosti: 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: It is best to put it back into its original package.
Slovenian: Najbolje je, da ga položite nazaj v originalno ovojnino.
English: Clinical investigation in women for the indication of ART and anovulation was limited to one treatment cycle.
Slovenian: Klinične raziskave pri ženskah za indikacijo ART in anovulacijo so omejene na en ciklus zdravljenja.
English: However, the in-use stability has been demonstrated for 24 hours at + 2°C to 8°C.
Slovenian: Vendar pa je bila dokazana stabilnost pripravljene raztopine 24 ur pri +2 °C do 8 °C.
English: • Extrauterine pregnancy in the previous 3 months
Slovenian: • zunajmaternična nosečnost v zadnjih 3 mesecih
English: After opening, the medicinal product should be used immediately.
Slovenian: Po odprtju morate zdravilo takoj uporabiti.
English: OHSS was observed in approximately 4% of patients treated with Ovitrelle.
Slovenian: OHSS so opazili pri približno 4 % bolnic, zdravljenih z zdravilom Ovitrelle.
English: Dispose of all used items:
Slovenian: Odstranite vse uporabljene predmete:
English: This instructions for use was last revised in:
Slovenian: Navodilo za uporabo je bilo nazadnje revidirano:
English: In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Slovenian: Pri teh ženskah je treba prednosti dajanja gonadotropina pretehtati glede na tveganja.
English: Do not use Ovitrelle if any of the above applies to you.
Slovenian: Ne uporabljajte zdravila Ovitrelle, če kar koli od zgoraj navedenega velja za vas.
English: • Malformations of sexual organs incompatible with pregnancy
Slovenian: • malformacije spolnih organov, ki niso združljive z nosečnostjo,