FrancophonIA/ELRC3.0 huggingface dataset:
English: The desired blood glucose levels, the type of Insuman to be used, and the dose and timing of injections are determined by the doctor for each patient individually, and are adjusted to suit the patient's diet, physical activity and lifestyle.
Slovenian: Zdravnik za vsakega posameznika posebej določi zaželene koncentracije glukoze v krvi, vrsto zdravila Insuman, ki ga je treba uporabiti ter odmerek in čas uporabe injekcij ter jih prilagodi, da najbolje ustrezajo prehrani, telesni aktivnosti in življenjskemu slogu bolnika.
English: In one of the studies, Insuman was given to patients with type 1 diabetes using an external insulin pump.
Slovenian: V eni od študij so zdravilo Insuman dajali bolnikom s sladkorno boleznijo tipa 1 z uporabo zunanje insulinske črpalke.
English: Insuman Implantable is given only by infusion into the abdominal cavity using a pump (Medtronic MiniMed implantable pump) that is implanted under the skin of the abdomen.
Slovenian: Zdravilo Insuman Implantable se daje le z infundiranjem v trebušno votlino z uporabo črpalke (vsajene črpalke Medtronic MiniMed), ki je vsajena pod kožo trebuha.
English: • Insuman Rapid, Insuman Infusat and Insuman Implantable, which are fast-acting insulin solutions containing soluble insulin;
Slovenian: • Insuman Rapid, Insuman Infusat in Insuman Implantable, tj. raztopine insulinov s hitrim delovanjem, ki vsebujejo topni insulin;
English: Insuman Implantable must not be used in any other way and can only be used in centres where staff have received adequate training in the use of the implantable pump.
Slovenian: Uporablja se lahko le na ta način in to le v centrih, kjer so zaposleni ustrezno usposobljeni za uporabo vsajene črpalke.
English: Insuman led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with semi-synthetic human insulin.
Slovenian: Zdravilo Insuman je privedlo do znižanja koncentracije HbA1c, kar kaže, da so bile koncentracije glukoze v krvi vzdrževane na podobni ravni kot pri polsintetičnem humanem insulinu.
English: The CHMP decided that Insuman's benefits are greater than its risks for the treatment of type 1 and type 2 diabetes.
Slovenian: CHMP je zaključil, da so koristi zdravila Insuman pri zdravljenju sladkorne bolezni tipa 1 in tipa 2 večje od z njim povezanih tveganj.
English: • Insuman Basal, an intermediate-acting insulin suspension containing isophane insulin;
Slovenian: • Insuman Basal, suspenzijo insulinov s srednje dolgim delovanjem, ki vsebuje insulin izofan;
English: What is Insuman used for?
Slovenian: Za kaj se zdravilo Insuman uporablja?
English: The patient's blood glucose should be tested regularly to find the lowest effective dose.
Slovenian: Za določitev najmanjšega učinkovitega odmerka je potrebno redno spremljati koncentracijo glukoze v krvi bolnika.
English: Insuman is a range of insulin-containing solutions and suspensions for injection.
Slovenian: Zdravilo Insuman obsega različne raztopine in suspenzije za injiciranje, ki vsebujejo insulin.
English: How does Insuman work?
Slovenian: Kako zdravilo Insuman deluje?
English: In addition, Insuman Implantable must not be used any other way than as a continuous infusion using the Medtronic MiniMed Implantable Pump.
Slovenian: Pole tega se zdravilo Insuman Implantable lahko uporablja le kot kontinuirana infuzija z uporabo vsajene črpalke Medtronic MiniMed.
English: In another study, Insuman Comb 25 was compared with semi-synthetic human insulin in patients with type 1 and type 2 diabetes.
Slovenian: V drugi pa so zdravilo Insuman Comb 25 pri bolnikih s sladkorno boleznijo tipa 1 in tipa 2 primerjali s polsintetičnim humanim insulinom.
English: It is supplied in vials, cartridges, or pre-filled disposable pens.
Slovenian: Na voljo je v vialah, injekcijskih vložkih ali napolnjenih injekcijskih peresnikih za enkratno uporabo.
English: How is Insuman used?
Slovenian: Kako se zdravilo Insuman uporablja?
English: What is Insuman?
Slovenian: Kaj je zdravilo Insuman?
English: Insuman was effective for both type 1 and type 2 diabetes.
Slovenian: Zdravilo Insuman je bilo učinkovito tako pri sladkorni bolezni tipa 1 kot tipa 2.
English: How has Insuman been studied?
Slovenian: Kako je bilo zdravilo Insuman raziskano?
English: Data show that immune tolerance may be achieved.
Slovenian: Podatki kažejo, da se imunska toleranca lahko doseže.
English: However, in some cases, especially in younger patients, more frequent injections or higher doses may be necessary.
Slovenian: Vendar pa so v nekaterih primerih, še posebej pri mlajših bolnikih, lahko potrebne pogostejše injekcije ali večji odmerki.
English: Tel: +44(0)1256 894 959 e-mail: medinfoEMEA@shire.com
Slovenian: Tel: +44(0)1256 894 959 e-pošta: medinfoEMEA@shire.com
English: Wash your hands thoroughly using soap and warm water.
Slovenian: Temeljito si umijte roke z milom in toplo vodo.
English: This is particularly important if you are having major surgery.
Slovenian: To je še posebej pomembno pri večjih operacijah.
English: The product dissolves rapidly (usually in less than 1 minute).
Slovenian: Prašek se hitro raztaplja (ponavadi prej kot v 1 minuti).
English: Important note:
Slovenian: Pomembno opozorilo:
English: This product is for single use only.
Slovenian: Ta izdelek je samo za enkratno uporabo.
English: Frequency of doses (hours)/duration of therapy (days)
Slovenian: Pogostnost odmerjanja (ure)/Trajanje zdravljenja (dni)
English: Parameter (mean ± standard deviation)
Slovenian: Parameter (srednja vrednost ± standardni odklon)
English: ATC code: B02BD02.
Slovenian: Oznaka ATC: B02BD02
English: Additional side effects in children
Slovenian: Dodatni neželeni učinki pri otrocih
English: Date of latest renewal: 20 December 2013
Slovenian: Datum prve odobritve: 2. marec 2004 Datum zadnjega podaljšanja: 20. december 2013
English: Frequency categories are defined according to 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), not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at 25 °C.
Slovenian: Kemično in fizikalno stabilnost zdravila med uporabo so sicer dokazali za čas 3 ur pri temperaturi 25 °C.
English: The data from this study demonstrate that the two prophylactic dosing regimens are comparable in terms of reduction of bleeding rate.
Slovenian: Podatki iz te študije kažejo, da je pri obeh režimih preventivnega odmerjanja zmanjšanje hitrosti krvavitve primerljivo.
English: - Use within three hours after reconstitution.
Slovenian: - Uporabite v treh urah po rekonstituciji.
English: ANNEX II A. MANUFACTURERS 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. IZDELOVALCI BIOLOŠKE ZDRAVILNE 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: Use immediately or within 3 hours of reconstitution.
Slovenian: Po rekonstituciji uporabite takoj ali v 3 urah.
English: A non-interventional prospective registry (PASS-INT-004) documented ITI in 44 paediatric and adult subjects of whom 36 completed ITI therapy.
Slovenian: V neintervencijskem prospektivnem registru (PASS-INT-004) se je ITI zabeležil pri 44 pediatričnih in odraslih preiskovancih, od tega jih je 36 zaključilo zdravljenje ITI.
English: Do not draw air into the syringe.
Slovenian: Pri tem ne smete posesati zraka v brizgo.
English: Catheter-related complications in treatment
Slovenian: S katetri povezani zapleti zdravljenja
English: In case of shock, standard medical treatment for shock should be implemented.
Slovenian: V primeru šoka uvedite standardno medicinsko zdravljenje za zdravljenje šoka.
English: The safety and haemostatic efficacy of ADVATE in the paediatric population are similar to that of adult patients.
Slovenian: Varnost in hemostatska učinkovitost zdravila ADVATE pri pediatrični populaciji sta podobni kot pri odraslih bolnikih.
English: The dose and frequency of administration should be adapted to the clinical response in the individual case.
Slovenian: Odmerek in pogostnost dajanja zdravila morata biti prilagojena kliničnemu odzivu v posameznem primeru.
English: Rarely, inhibitors may develop after the first 100 exposure days.
Slovenian: Le redko pa zaviralci nastanejo po prvih 100 dnevih izpostavljenosti.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Slovenian: Pri nastanku teh zaviralcev se stanje kaže kot nezadosten klinični odziv.
English: You should tell your doctor if you have been previously treated with Factor VIII products, especially if you developed inhibitors, since there might be a higher risk that it happens again.
Slovenian: Zdravniku morate povedati, če ste bili že kdaj prej zdravljeni s pripravki faktorja VIII, še posebej, če so se pri vas pojavili zaviralci, ker lahko v tem primeru obstaja povečano tveganje, da se bo to spet zgodilo.
English: ADVATE is indicated in all age groups.
Slovenian: Zdravilo ADVATE je indicirano za vse starostne skupine.
English: Within a sub-study of PUP-study 060103, ITI-treatments in 11 PUPs were documented.
Slovenian: V okviru podštudije študije PUP 060103 so opisali zdravljenje ITI pri 11 PUP.
English: Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation.
Slovenian: Pripravljeno brez dodajanja kakršnihkoli (eksogenih) beljakovin človeškega ali živalskega izvora pri postopku celične kulture, prečiščevanja ali končne formulacije zdravila.
English: Should a significant increase occur, reducing the rate of administration or temporarily interrupting the injection usually allows the symptoms to disappear promptly (see sections 4.4 and 4.8).
Slovenian: Če pride do znatnega povečanja pulza, lahko z zmanjšanjem hitrosti infuzije oziroma z začasno prekinitvijo injiciranja običajno dosežemo takojšnje izginotje simptomov (glejte poglavji 4.4 in 4.8).
English: Detailed instructions for self-administration are given at the end of this package leaflet.
Slovenian: Podrobna navodila za samoinjiciranje zdravila so podana ob koncu teh navodil.
English: The analysis of plasma samples was conducted in a central laboratory using a one-stage clotting assay.
Slovenian: Analiza vzorcev plazme je bila opravljena v enem centralnem laboratoriju z uporabo enostopenjskega strjevalnega testa.
English: Baxalta Manufacturing Sàrl Route de Pierre-à-Bot 111 CH-2000 Neuchâtel Switzerland
Slovenian: Baxalta Manufacturing Sàrl Route de Pierre-à-Bot 111 CH-2000 Neuchâtel Švica
English: It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Slovenian: Izdelan je s tehnologijo rekombinantne DNA v ovarijskih celicah kitajskega hrčka (CHO).
English: Categories of these analyses for infants (1 month to <2 years of age), children (2 to <5 years of age), older children (5 to <12 years of age), adolescents (12 to <18 years of age), and adults (18 years of age and older) were used to summarize PK parameters, where age was defined as age at time of PK infusion.
Slovenian: Kategorije teh analiz za dojenčke (stare od 1 meseca do < 2 let), otroke (stare od 2 do < 5 let), starejše otroke (stare od 5 do < 12 let), mladostnike (stare od 12 do < 18 let) in odrasle (stare 18 let in več) so bile uporabljene za oblikovanje povzetka farmakokinetičnih parametrov, kjer je bila starost opredeljena kot starost v času farmakokinetične infuzije.
English: The required dose is determined using the following formula:
Slovenian: Potrebni odmerek določimo z uporabo naslednje enačbe:
English: After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3.
Slovenian: Po rekonstituciji je raztopina bistra in brezbarvna, brez tujih delcev in ima pH od 6,7 do 7,3.
English: C OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Factor VIII level required (% or IU/dl)
Slovenian: Potrebna koncentracija faktorja VIII (% ali i.e./dl)
English: Place the vials on a flat clean surface.
Slovenian: Viale postavite na ravno čisto površino.
English: What ADVATE is and what it is used for
Slovenian: Kaj je zdravilo ADVATE in za kaj ga uporabljamo
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Slovenian: Trombin nato pretvori fibrinogen v fibrin in tako nastane krvni strdek.
English: Baxter AG Industriestrasse 67 A-1221 Vienna Austria
Slovenian: Baxter AG Industriestrasse 67 A-1221 Dunaj Avstrija
English: The table is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Preglednica je v skladu z razvrstitvijo organskih sistemov MedDRA (raven organskih sistemov in prednostnih izrazov).
English: Your doctor will calculate your dose of ADVATE (in international units or IU) depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding.
Slovenian: Zdravnik vam bo izračunal odmerek zdravila ADVATE (v mednarodnih enotah ali i.e.) glede na vaše stanje in telesno maso ter glede na to, ali zdravilo prejemate za preprečevanje krvavitev ali za njihovo zdravljenje.
English: Swirl gently until all material is dissolved.
Slovenian: Vialo nežno obračajte, dokler se vsa vsebina ne raztopi.
English: Do not use ADVATE - if you are allergic to octocog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to mouse or hamster proteins
Slovenian: Ne uporabljajte zdravila ADVATE - če ste alergični na oktokog alfa ali katerokoli sestavino tega zdravila (navedeno v poglavju 6), - če ste alergični na mišje ali hrčkove beljakovine.
English: The factor VIII/von Willebrand Factor complex consists of two molecules (factor VIII and von Willebrand Factor) with different physiological functions.
Slovenian: Kompleks faktorja VIII in von Willebrandovega faktorja je sestavljen iz dveh molekul (faktorja VIII in von Willebrandovega faktorja), ki imata različni fiziološki funkciji.
English: You or someone else might also administer ADVATE as an injection, but only after receiving adequate training.
Slovenian: Tudi sami si lahko date zdravilo ADVATE z injekcijo oziroma vam jo da kdo drug, vendar šele po ustreznem usposabljanju.
English: Activated factor VIII acts as a Cofactor for activated Factor IX, accelerating the conversion of Factor X to activated Factor X. Activated Factor X converts prothrombin to thrombin.
Slovenian: Aktiviran faktor VIII deluje kot kofaktor aktiviranega faktorja IX in pospeši pretvorbo faktorja X v aktiviran faktor X. Aktiviran faktor X pretvori protrombin v trombin.
English: The solvent vial has a blue stripe.
Slovenian: Viala z vehiklom ima modro črto.
English: Pharmacokinetic data with ADVATE on previously untreated patients are currently not available.
Slovenian: Farmakokinetični podatki za zdravilo ADVATE pri bolnikih, ki predhodno niso bili zdravljeni, trenutno niso na voljo
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate Factor VIII levels.
Slovenian: Zdravnik bo opravil potrebne laboratorijske preiskave za zagotovitev potrebne koncentracije faktorja VIII.
English: Cleanse stoppers with alcohol swabs.
Slovenian: Očistite zamaške z alkoholnimi tamponi.
English: Do not use solutions that are cloudy or have deposits.
Slovenian: Ne uporabljajte raztopin, ki so motne ali imajo usedlino.
English: - Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: - Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: If severe, sudden allergic reactions (anaphylactic) occur, the injection must be stopped immediately.
Slovenian: Če se pojavijo hude, nenadne alergijske (anafilaktične) reakcije, morate injiciranje zdravila nemudoma ustaviti.
English: The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 20 exposure days.
Slovenian: Tveganje za nastanek zaviralcev je odvisno od resnosti bolezni in izpostavljenosti faktorju VIII - največje je v prvih 20 dneh izpostavljenosti.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije zdravila pred dajanjem, glejte poglavje 6.6.
English: Paediatric population: The listed warnings and precautions apply to both adults and children.
Slovenian: Pediatrična populacija Navedena opozorila in previdnostni ukrepi veljajo za odrasle in otroke.
English: Proceed with the next injection as scheduled and continue as advised by your doctor.
Slovenian: Nadaljujte z naslednjo predvideno injekcijo in naslednje odmerke jemljite, kot je predpisal vaš zdravnik.
English: Prevention of bleeding
Slovenian: Preprečevanje krvavitev
English: Be sure that the ADVATE powder is completely dissolved, otherwise not all reconstituted solution will pass through the device filter.
Slovenian: Prepričajte se, da se je prašek ADVATE popolnoma raztopil, sicer ne bo vsa rekonstituirana raztopina prešla skozi filter v pripomočku.
English: Adjusted recovery and terminal half-life (t½) was approximately 20% lower in young children (less than 6 years of age) than in adults, which may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Slovenian: Korigirana vrednost in končna razpolovna doba (t½) pri majhnih otrocih (mlajših od 6 let) je bila približno za 20% nižja kot pri odraslih, kar je delno lahko posledica znanega dejstva, da imajo mlajši bolniki večji volumen plazme na kilogram telesne mase.
English: Do not throw away any medicines via waste water or household waste.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Under certain circumstances (e.g. presence of a low-titre inhibitor), doses larger than those calculated using the formula may be necessary.
Slovenian: V nekaterih okoliščinah (npr. ob prisotnosti majhnih titrov zaviralca) so lahko potrebni večji odmerki od tistih, ki jih izračunamo s pomočjo enačbe.
English: The specific activity of ADVATE is approximately 4,000-10,000 IU/mg protein.
Slovenian: Specifična aktivnost zdravila ADVATE znaša približno 4.000-10.000 i.e./mg beljakovin.
English: Usually, the replacement therapy with ADVATE is a life-long treatment.
Slovenian: Nadomestna terapija z zdravilom ADVATE običajno traja vse življenje.
English: Instructions for injection
Slovenian: Navodila za injiciranje
English: Invert the system (the vial with the reconstituted solution has to be on top).
Slovenian: Obrnite sistem narobe (viala z rekonstituirano raztopino naj bo na vrhu).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: Animal reproduction studies have not been conducted with factor VIII.
Slovenian: Študij vpliva na sposobnost razmnoževanja pri živalih ob uporabi faktorja VIII niso izvedli.
English: Boulevard René Branquart 80 B-7860 Lessines Belgium
Slovenian: Boulevard René Branquart 80 B-7860 Lessines Belgija
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 s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: ADVATE is prepared without the addition of any human- or animal-derived protein in the entire manufacturing process.
Slovenian: Zdravilo ADVATE je pripravljeno brez dodajanja kakršnihkoli (eksogenih) beljakovin človeškega ali živalskega izvora v celotnem postopku izdelave.
English: If any of these symptoms occur, stop the injection immediately and contact your doctor.
Slovenian: Če se pojavi kateri od teh simptomov, nemudoma prenehajte z injiciranjem zdravila in pokličite svojega zdravnika.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse or hamster proteins.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1, ali na mišje oz. hrčkove beljakovine.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data) potentially life-threatening reactions (anaphylaxis) and other allergic reactions (hypersensitivity), general disorders (tiredness, lack of energy).
Slovenian: Neželeni učinki z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) Smrtno nevarne reakcije (anafilaksija) in druge alergijske reakcije (preobčutljivost), splošne težave (utrujenost, pomanjkanje energije).
English: In case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
Slovenian: V primeru spodaj navedenih krvavitev aktivnost faktorja VIII ne sme pasti pod navedeno stopnjo plazemske aktivnosti (v % od normale ali i.e./dl) v ustreznem časovnem obdobju.
English: Development of antibodies to mouse and/or hamster protein with related hypersensitivity reactions may be observed.
Slovenian: Lahko pride do nastanka protiteles proti mišjim in/ali hrčkovim beljakovinam s povezanimi preobčutljivostnimi reakcijami.
English: End of 6 month period, if stored at room temperature: Do not use after the expiry date.
Slovenian: Po koncu šestmesečnega obdobja, če zdravilo hranite na sobni temperaturi: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti.
English: Do not use if packaging is opened or damaged.
Slovenian: Zdravila ne uporabljajte, če je njegova ovojnina odprta ali poškodovana.
English: If you forget to use ADVATE
Slovenian: Če ste pozabili uporabiti zdravilo ADVATE
English: Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Slovenian: Zato priporočamo, da pri vseh bolnikih po menjavi zdravila skrbno spremljate nastanek zaviralcev.
English: b) The unexpected decrease in coagulation factor VIII levels occurred in one patient during continuous infusion of ADVATE following surgery (postoperative days 10-14).
Slovenian: Nepričakovano znižanje koncentracije koagulacijskega faktorja VIII se je pojavilo pri enem bolniku med neprekinjeno infuzijo zdravila ADVATE po operaciji (pooperativni dnevi 10 - 14).
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Slovenian: Če aktivnost faktorja VIII ne doseže pričakovane ravni v plazmi ali če krvavitve z ustreznim odmerkom ne zaustavite, morate opraviti test prisotnosti zaviralca faktorja VIII.
English: • Do not use after the expiry date stated on the labels and carton.
Slovenian: • Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.