FrancophonIA/ELRC3.0 huggingface dataset:
English: Olanzapine Glenmark 5 mg: yellow coloured circular flat bevelled edge tablets with ‘B' debossed on one side.
Slovenian: Olanzapin Glenmark 5 mg: rumena, okrogla, ploščata tableta z zaobljenim robom in oznako 'B' na eni strani.
English: Excipient with known effect: Each tablet contains 0.69 mg of aspartame For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,69 mg aspartama.
English: Olanzapine Glenmark 2.5 mg tablets
Slovenian: Olanzapin Glenmark 2,5 mg tablete
English: Excipient with known effect: Each tablet contains 0.46 mg of aspartame For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,46 mg aspartama.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg olanzapine.
Slovenian: Ena tableta vsebuje 7,5 mg olanzapina.
English: 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Slovenian: 7Pri nenadni prekinitvi zdravljenja z olanzapinom so poročali o akutnih simptomih kot so znojenje, nespečnost, tresenje, tesnoba, slabost in bruhanje.
English: Seizures
Slovenian: DisartrijaJecljanje
English: NAME OF THE MARKETING AUTHORISATION HOLDER Glenmark Arzneimittel GmbH
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Glenmark Arzneimittel GmbH
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥0.01% and < 0.1%) when olanzapine is stopped abruptly.
Slovenian: Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
English: Olanzapine Glenmark 10 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on other side.
Slovenian: Olanzapin Glenmark 10 mg: rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'D' na drugi strani.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA Načrt za obvladovanje tveganja (RMP) Navedba smiselno ni potrebna.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 7.5 mg tablets Olanzapine
Slovenian: IME ZDRAVILA Olanzapin Glenmark 7,5 mg tablete olanzapin
English: EU/1/09/587/013 EU/1/09/587/014 EU/1/09/587/015 EU/1/09/587/024
Slovenian: EU/1/09/587/016 EU/1/09/587/017 EU/1/09/587/018 EU/1/09/587/019 EU/1/09/587/025
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg olanzapine.
Slovenian: Ena tableta vsebuje 2,5 mg olanzapina.
English: Magnesium stearate
Slovenian: Aluminijast pretisni omot
English: Excipient with known effect: Each tablet contains 0.35 mg of aspartame For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,35 mg aspartama.
English: MARKETING AUTHORISATION HOLDER Glenmark Arzneimittel GmbH Industriestr.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Glenmark Arzneimittel GmbH Industriestr.
English: Olanzapine Glenmark 15 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Slovenian: Olanzapin Glenmark 15 mg: rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'E' na drugi strani.
English: Keep this medicine out of sight and reach of children
Slovenian: Zdravilo shranjujte nedosegljivo otrokom!
English: Excipient with known effect: Each tablet contains 0.23 mg of aspartame For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,23 mg aspartama.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 20 mg tablets Olanzapine
Slovenian: IME ZDRAVILA Olanzapin Glenmark 20 mg tablete olanzapin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg olanzapine.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 10 mg olanzapina.
English: Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).
Slovenian: Občasno ( ≥ 0.1% in < 1%) so poročali o občasnih povezavah med zdravljenjem z olanzapinom in vensko tromboembolijo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 7.5 mg olanzapine.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 7,5 mg olanzapina.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg olanzapine.
Slovenian: Ena tableta vsebuje 15 mg olanzapina.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 10 mg tablets Olanzapine
Slovenian: IME ZDRAVILA Olanzapin Glenmark 10 mg tablete olanzapin
English: Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on other side.
Slovenian: Rumene, okrogle, ploščate tablete z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'D' na drugi strani.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 2.5 mg tablets
Slovenian: IME ZDRAVILA Olanzapin Glenmark 2,5 mg tablete olanzapin
English: Oedema
Slovenian: Alopecija
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg olanzapine Excipient with known effect: Each tablet contains 0.92 mg of aspartame For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,92 mg aspartama.
English: phosphatase10
Slovenian: Oteklina Pireksija10
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 15 mg tablets Olanzapine
Slovenian: IME ZDRAVILA Olanzapin Glenmark 15 mg tablete olanzapin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/016
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/587/016
English: Yellow coloured circular flat bevelled edge tablets with ‘B' debossed on one side.
Slovenian: tableta Rumene, okrogle, ploščate tablete z zaobljenim robom in oznako 'B' na eni strani.
English: Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Slovenian: Rumene, okrogle, ploščate tablete z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'E' na drugi strani.
English: Patients should be advised not to breast- feed an infant if they are taking olanzapine.
Slovenian: Če jemljejo olanzapin, naj se bolnicam dojenje dojenčka odsvetuje.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 5 mg tablets Olanzapine
Slovenian: IME ZDRAVILA Olanzapin Glenmark 5 mg tablete olanzapin
English: Gastrointestinal disorders Mild, transient anticholinergic
Slovenian: Bolezni jeter, žolčnika in žolčevodov Prehodna asimptomatska zvišanja jetrnih aminotransferaz
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/013
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/587/013
English: Tablet Yellow coloured circular flat bevelled edge tablets with ‘A' debossed on one side.
Slovenian: tableta Rumene, okrogle, ploščate tablete z zaobljenim robom in oznako 'A' na eni strani.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/010
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/587/010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/004
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/587/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/587/001
English: How to store Olanzapine Glenmark
Slovenian: Kaj vsebuje zdravilo Olanzapin Glenmark
English: INFORMATION IN BRAILLE Olanzapine Glenmark 5 mg tablets 17.
Slovenian: PODATKI V BRAILLOVI PISAVI Olanzapin Glenmark 15 mg tablete
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg olanzapine
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 20 mg olanzapina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/007
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/587/007
English: Yellow coloured circular flat bevelled edge with ‘OL' debossed on one side and ‘F' debossed on other side.
Slovenian: Rumene, okrogle, ploščate tablete z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'F' na drugi strani.
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do
English: Amnesia 9
Slovenian: Tardivne diskinezije11 Amnezija9
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: DODATEK II A. IZDELOVALCI ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE 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: Date of first authorisation: 13 April 1999 Date of latest renewal: 15 April 2014
Slovenian: Datum prve odobritve: 13. april 1999 Datum zadnjega podaljšanja: 15. april 2014
English: If you have not used it within 3 hours, throw it away.
Slovenian: Če je niste uporabili v 3 urah, jo zavrzite.
English: Repeat every 12-24 hours.
Slovenian: Ponovimo vsakih 12-24 ur.
English: SE-11276 Stockholm Sweden
Slovenian: SE-11276 Stockholm Švedska
English: No long-term outcome is available.
Slovenian: Podatki o dolgotrajnih izidih niso na voljo.
English: Additional Instructions:
Slovenian: Dodatna navodila:
English: This is of importance particularly when changing the laboratory and/or reagents used.
Slovenian: To je zlasti pomembno pri zamenjavi laboratorija in/ali uporabljenih reagentov.
English: You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions:
Slovenian: Nemudoma obvestite zdravnika, če imate katerega od naslednjih zgodnjih simptomov alergijskih reakcij:
English: The required dose is determined using the following formula:
Slovenian: Odmerek določimo z uporabo naslednje formule:
English: Date removed from the refrigerator:
Slovenian: Datum premestitve iz hladilnika:
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: Immune Tolerance Induction
Slovenian: Indukcija imunske tolerance
English: Clinical studies did not include subjects aged 65 and over.
Slovenian: Klinične študije niso vključevale preskušancev, starih 65 let in več.
English: It is important that the recommendations in section 6.3 be followed closely.
Slovenian: Pomembno je, da dosledno sledite navodilom v poglavju 6.3.
English: Consumption and efficacy results in paediatric population
Slovenian: Rezultati o porabi in učinkovitosti pri pediatrični populaciji
English: SD Median
Slovenian: SD mediana
English: Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25°C.
Slovenian: Kemijsko in fizikalno stabilnost med uporabo so dokazali za 3 ure pri temperaturah do 25 ºC.
English: Frequency of doses (hours)/ Duration of therapy (days)
Slovenian: Pogostnost odmerkov (ure) / Trajanje zdravljenja (dnevi)
English: • swelling of lips and tongue
Slovenian: • otekanje ustnic in jezika
English: Other in-use storage times and conditions are the responsibility of the user.
Slovenian: Za druge čase shranjevanja in pogoje med uporabo je odgovoren uporabnik.
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Slovenian: Upoštevajte, da letna stopnja krvavitev (ABR - Annualized Bleeding Rate) ni primerljiva med različnimi koncentrati faktorja in med različnimi kliničnimi študijami.
English: (pre- and post-operative)
Slovenian: (pred operacijo in po operaciji)
English: The amount of drug product left in the infusion set will not affect your treatment.
Slovenian: Količina zdravila, ki ostane v infuzijskem sistemu, ne bo vplivala na vaše zdravljenje.
English: Do not stop using ReFacto AF without consulting your doctor.
Slovenian: Ne prenehajte uporabljati zdravila ReFacto AF, ne da bi se posvetovali z zdravnikom.
English: • certain blood tests may show an increase in antibodies to factor VIII
Slovenian: • nekatere preiskave krvi lahko pokažejo zvišanje ravni protiteles proti faktorju VIII
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Pogostnosti so ocenjene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).
English: Inform your doctor if you are on a controlled sodium diet.
Slovenian: Obvestite zdravnika, če ste na dieti z nadzorovanim vnosom natrija.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije danega zdravila.
English: Repeat infusion every 8-24 hours until threat is resolved.
Slovenian: Infuzijo ponavljamo vsakih 8-24 ur, dokler ogroženost ne mine.
English: The ReFacto AF laboratory standard can be used to correct for this discrepancy (see section 5.2).
Slovenian: Za odpravljanje tega neskladja se lahko uporabi laboratorijski standard zdravila ReFacto AF (glejte poglavje 5.2).
English: Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.
Slovenian: Ob hudih simptomih, vključno z oteženim dihanjem in (skoraj) omedlevico, je potrebno takojšnje nujno zdravljenje.
English: Factor VIII level required (% or IU/dl)
Slovenian: Potrebna aktivnost faktorja VIII (% ali i.e./dl)
English: - if you are allergic to moroctocog alfa or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na moroktokog alfa ali katerokoli sestavino tega zdravila (navedeno v poglavju
English: Your doctor or other healthcare professional should teach you how to infuse ReFacto AF.
Slovenian: Vaš zdravnik ali drug zdravstveni delavec vas mora naučiti, kako si dati infuzijo zdravila ReFacto AF.
English: The manufacturing process for ReFacto was modified to eliminate any exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation; and at the same time the invented name was changed to ReFacto AF.
Slovenian: Postopek izdelave zdravila ReFacto je bil spremenjen tako, da se iz postopka gojenja celičnih kultur, čiščenja in končnega pripravka odstranijo vse eksogene beljakovine človeškega ali živalskega izvora; hkrati je bilo izmišljeno ime spremenjeno v ReFacto AF.
English: Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately.
Slovenian: Bolniki ali njihovi skrbniki lahko dajejo injekcije zdravila ReFacto AF, če so bili o tem ustrezno podučeni.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: All components used in the reconstitution and administration of this product should be used as soon as possible after opening their sterile containers, to minimise unnecessary exposure to the air.
Slovenian: Vse predmete, uporabljene pri pripravi in dajanju tega zdravila, je treba po odprtju sterilnih vsebnikov uporabiti kakor hitro je mogoče, da tako kar najbolj zmanjšamo nepotrebno izpostavljanje zraku.
English: When prescribing ReFacto AF it is important to individually titrate and monitor each patient's factor level in order to ensure an adequate therapeutic response (see section 4.8).
Slovenian: Pri predpisovanju zdravila ReFacto AF je pomembno, da posebej titriramo in spremljamo raven faktorja vsakega bolnika, ker le tako lahko zagotovimo ustrezen terapevtski odziv (glejte poglavje 4.8).
English: Every 24 hours, at least 1 day, until healing is achieved.
Slovenian: Vsakih 24 ur vsaj 1 dan, dokler se rana ne zaceli.
English: • increased liver enzymes, increased bilirubin
Slovenian: • zvišani jetrni encimi, zvišan bilirubin
English: Therefore, factor VIII should be used during pregnancy and breast-feeding only if clearly indicated.
Slovenian: Zato lahko faktor VIII uporabljamo med nosečnostjo in dojenjem le, če je to nujno potrebno.
English: Thrombin then converts fibrinogen into fibrin, and a clot is formed.
Slovenian: Trombin pa nato pretvori fibrinogen v fibrin in oblikuje se krvni strdek.
English: ReFacto AF is appropriate for use in adults and children of all ages, including newborns.
Slovenian: Zdravilo ReFacto AF je primerno za uporabo pri odraslih in otrocih vseh starosti, vključno z novorojenčki.
English: Minor surgery including tooth extraction
Slovenian: Manjše operacije, vključno z izdrtjem zoba
English: In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.
Slovenian: V nekaterih primerih, še posebej pri otrocih, so potrebni krajši intervali med odmerki oziroma večji odmerki.
English: The specific activity of ReFacto AF is 7,600-13,800 IU/mg protein.
Slovenian: Specifična aktivnost zdravila ReFacto AF je približno 7.600-13.800 i.e./mg beljakovine.
English: Once you learn how to self-infuse, you can follow the instructions in this Package Leaflet.
Slovenian: Ko se enkrat naučite, kako sami sebi dati infuzijo, lahko sledite navodilom v tem navodilu za uporabo zdravila.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered (see section 4.8).
Slovenian: Če potrebujemo pripomoček za centralni venski dostop (CVAD - Central Venous Access Device), je treba razmisliti glede tveganja z njim povezanih zapletov, vključno z lokalnimi okužbami, bakteriemijo in trombozo na mestu katetra (glejte poglavje 4.8).
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Slovenian: Na splošno je treba vse bolnike, zdravljene z zdravili s koagulacijskim faktorjem VIII, skrbno spremljati glede nastanka zaviralcev z ustreznim kliničnim opazovanjem in laboratorijskimi testi.
English: Note: To prevent the escape of fluid from the tip of the syringe, do not push the plunger rod with excessive force.
Slovenian: Opomba: Da bi preprečili uhajanje tekočine z vrha brizge, bata ne potiskajte s preveliko silo.
English: AUCinf, IU∙h/mLb t½, hb
Slovenian: AUCinf, i.e.∙h/ml t½, h
English: • severe allergic reaction
Slovenian: • huda alergijska reakcija
English: • weakness, injection site reactions including pain
Slovenian: • šibkost, reakcije na mestu injiciranja, vključno z bolečino
English: Do not attempt self-infusion unless properly trained.
Slovenian: Ne poskušajte si sami dajati infuzije, ne da bi bili o tem ustrezno poučeni.
English: This is to be considered during the preparation and administration of the product, including storage time elapsed in a PVC container following reconstitution.
Slovenian: To morate upoštevati pri pripravi in dajanju zdravila, skupaj s časom shranjevanja v vsebniku iz PVC po rekonstituciji.
English: • slight increase in heart enzymes
Slovenian: • rahlo zvišanje encimov srčne mišice
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Spodnja preglednica temelji na organskih sistemih po MedDRA (SOC - System Organ Class in ravni prednostnih izrazov).
English: Do not use this medicine if you notice that it is cloudy or contains visible particles.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je raztopina motna ali da vsebuje vidne delce.
English: If you are unsure about this, ask your doctor.
Slovenian: Če ste glede tega negotovi, se obrnite na svojega zdravnika.
English: EXP Do not use after expiry date.
Slovenian: EXP Zdravila ne smete uporabljati po datumu izteka roka uporabnosti.
English: In the presence of an inhibitor, higher doses or appropriate specific treatment may be required.
Slovenian: V prisotnosti zaviralcev so potrebni večji odmerki ali ustrezno specifično zdravljenje.
English: What ReFacto AF is and what it is used for
Slovenian: Kaj je zdravilo ReFacto AF in za kaj ga uporabljamo
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Slovenian: Če se pojavijo simptomi preobčutljivosti, je treba bolnikom svetovati, naj nemudoma prekinejo z uporabo zdravila in obvestijo zdravnika.
English: • dizziness and loss of consciousness
Slovenian: • omotica in nezavest
English: ReFacto AF does not contain von Willebrand factor, and hence is not indicated in von Willebrand's disease.
Slovenian: Zdravilo ReFacto AF ne vsebuje von Willebrandovega faktorja in zato pri von Willebrandovi bolezni ni indicirano.
English: You should bring enough of your factor VIII product for anticipated treatment when travelling.
Slovenian: S seboj morate vzeti dovolj svojega zdravila s faktorjem VIII za predvideno zdravljenje med potovanjem.
English: Any unused product or waste material is to be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: - if you are allergic to hamster proteins.
Slovenian: - če ste alergični na beljakovine hrčka.
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Slovenian: Infuzijo ponovimo vsakih 8-24 ur, dokler se rana ustrezno ne zaceli, nato še najmanj 7 dni vzdržujemo aktivnost faktorja VIII med 30 in 60 % (i.e./dl).
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanje s stroji
English: ReFacto AF has functional characteristics comparable to those of endogenous factor VIII.
Slovenian: Zdravilo ReFacto AF ima funkcijske značilnosti, primerljive z značilnostmi endogenega faktorja VIII.
English: This vented cap has tiny holes that allow air to escape in order to prevent pressure build-up.
Slovenian: Ta zaporka ima drobne luknjice, ki omogočajo izhajanje zraka, da se ne ustvarja nadtlak.
English: Of these 25 patients, 20 had a decrease in inhibitor titres to < 0.6 BU/mL, of whom initially 11 of 15 had high titres (≥ 5 BU/mL) and 9 of 10 had low titres.
Slovenian: Od teh 25 bolnikov jih je 20 imelo titre zaviralcev znižane na < 0,6 B.e./ml; od teh jih je na začetku 11 od 15 imelo visoke titre (≥ 5 B.e./ml), 9 od 10 pa nizke titre.
English: Repeat infusion every 12-24 hours for 3-4 days or more until pain and acute disability are resolved.
Slovenian: Infuzijo ponovimo vsakih 12-24 ur, 3-4 dni ali dokler bolečina oziroma akutna nezmožnost ne izzvenita.
English: In general, dose selection for an elderly patient should be individualised.
Slovenian: Na splošno je pri starejših bolnikih potrebna individualna prilagoditev odmerka.
English: ** Human coagulation factor VIII produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Slovenian: **Humani koagulacijski faktor VIII, izdelan v ovarijskih celicah kitajskega hrčka (CHO) s tehnologijo rekombinantne DNA.
English: Pack size of 1.
Slovenian: Pakiranje po 1.
English: In case of severe allergic reactions, alternative therapy must be considered.
Slovenian: V primeru hudih alergijskih reakcij je treba razmisliti o drugih možnostih zdravljenja;
English: Very rarely, development of antibodies to hamster protein has been observed, but there were no clinical sequelae.
Slovenian: Zelo redko so opazili nastanek protiteles proti beljakovinam hrčka, ni pa bilo kliničnih posledic.