FrancophonIA/ELRC3.0 huggingface dataset:
English: The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay.
Slovenian: Jakost zdravila (v mednarodnih enotah) je določena s pomočjo kromogenega testa po evropski farmakopeji.
English: In this case, this medicine expires at the end of this 6 month period or the expiration date printed on the product vial, whichever is earlier.
Slovenian: V tem primeru se rok uporabe zdravila izteče na koncu tega šestmesečnega obdobja ali po preteku roka uporabnosti, natisnjenega na viali zdravila, kar se zgodi prej.
English: Do not remove the blue cap until instructed in a later step.
Slovenian: Modrega pokrovčka ne smete sneti do koraka z navodilom za odstranitev.
English: Uncommon (PTPs)d Very common (PUPs)
Slovenian: občasni (PZB)d zelo pogosti (PNB)d
English: Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development.
Slovenian: Opazili so primere ponovnega pojava zaviralcev (nizek titer) po prehodu z enega zdravila s faktorjem VIII na drugega pri predhodno zdravljenih bolnikih z izpostavljenostjo, daljšo od 100 dni, ki imajo v anamnezi nastanek zaviralcev.
English: The end of the 6 months storage at room temperature should be recorded on the product carton.
Slovenian: Konec 6-mesečnega obdobja shranjevanja pri sobni temperaturi zapišite na škatlo zdravila.
English: Disconnect the syringe.
Slovenian: Snemite brizgo.
English: Solvent Sterilised water for injections
Slovenian: Vehikel sterilna voda za injekcije
English: Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids.
Slovenian: Oktokog alfa (humani koagulacijski faktor VIII (rDNA)) je očiščena beljakovina z 2.332 aminokislinami.
English: Each pack also contains a device for reconstitution (BAXJECT II).
Slovenian: V vsakem pakiranju je tudi pripomoček za raztapljanje (BAXJECT II).
English: Place the ADVATE on a flat surface with the solvent vial on top (Fig. 1).
Slovenian: Zdravilo ADVATE položite na ravno površino tako, da je viala z vehiklom zgoraj (slika 1).
English: Dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal) x 0.5
Slovenian: Odmerek (i.e.) = telesna masa (kg) x želeno zvišanje faktorja VIII (v % normalne vrednosti) x 0,5
English: The dose of octocog alfa is calculated depending on your body weight and the factor VIII levels to be achieved.
Slovenian: Odmerek oktokoga alfa izračunamo glede na bolnikovo telesno maso in koncentracijo faktorja VIII, ki jo želimo doseči.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Sterilised water for injections
Slovenian: IME ZDRAVILA IN POT(I) UPORABE sterilna voda za injekcije
English: The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines.
Slovenian: Bolniki, pri katerih se pojavijo zaviralci faktorja VIII Nastanek zaviralcev (protiteles) je znan zaplet, ki se lahko pojavi med zdravljenjem z vsemi zdravili s faktorjem VIII.
English: Repeat injections every 8 to 24 hours (6 to 24 hours for patients under the age of 6) until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Slovenian: Injekcije ponavljajte na vsakih 8 do 24 ur (6 do 24 ur za bolnike, mlajše od 6 let), dokler se rana zadostno ne zapre, nato nadaljujte s terapijo še najmanj 7 dni za vzdrževanje aktivnosti faktorja VIII med 30% do 60% (i.e./dl).
English: Driving and using machines ADVATE has no influence on your ability to drive or to use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo ADVATE ne vpliva na sposobnost vožnje in upravljanja s stroji.
English: Do not use ADVATE if the solution is not fully clear or not completely dissolved.
Slovenian: • Zdravila ADVATE ne smete uporabiti, če raztopina ni popolnoma bistra ali če zdravilo ni popolnoma raztopljeno.
English: All pharmacokinetic studies with ADVATE were conducted in previously treated patients with severe to moderately severe haemophilia A (baseline factor VIII ≤ 2%).
Slovenian: Vse farmakokinetične študije z zdravilom ADVATE so bile izvedene pri predhodno že zdravljenih bolnikih s hudo do srednje hudo obliko hemofilije A (osnovna vrednost faktorja VIII ≤ 2%).
English: ADVATE must not be mixed with other medicinal products or solvents.
Slovenian: Zdravila ADVATE ne smemo mešati z drugimi zdravili ali vehikli.
English: Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).
Slovenian: Pomožne snovi: manitol, natrijev klorid, histidin, trehaloza, kalcijev klorid, trometamol, polisorbat 80, glutation (reduciran)
English: A MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: ADVATE is used for the treatment and prevention of bleeding in patients of all age groups with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Slovenian: Zdravilo ADVATE se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih vseh starostnih skupin s hemofilijo A (prirojeno motnjo strjevanja krvi zaradi pomanjkanja faktorja VIII).
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly.
Slovenian: Posesajte rekonstituirano raztopino v brizgo s počasnim vlečenjem bata nazaj.
English: How to use ADVATE
Slovenian: Kako uporabljati zdravilo ADVATE
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Slovenian: Preobčutljivost ali alergijske reakcije (med katere sodijo angioedem, pekoč in zbadajoč občutek na mestu infundiranja, mrzlica, pordelost, generalizirana urtikarija, glavobol, koprivnica, hipotenzija, letargija, navzea, nemir, tahikardija, tiščanje v prsih, ščemenje, bruhanje, piskanje) so opazili le redko, vendar v nekaterih primerih lahko napredujejo do hude anafilakse (vključno s šokom).
English: In this case, this medicine expires at the end of this 6 month period or the expiration date printed on the blister, whichever is earlier.
Slovenian: V tem primeru se rok uporabe zdravila izteče na koncu tega šestmesečnega obdobja ali po preteku roka uporabnosti, natisnjenega na pretisnem omotu z zdravilom, kar se zgodi prej.
English: ADVATE contains recombinant coagulation factor VIII (octocog alfa), a glycoprotein that is biologically equivalent to the factor VIII glycoprotein found in human plasma.
Slovenian: Zdravilo ADVATE vsebuje rekombinantni koagulacijski faktor VIII (oktokog alfa), t. j. glikoprotein, ki je biološko enakovreden glikoproteinu faktorja VIII, ki ga najdemo v človeški plazmi.
English: Fig. c
Slovenian: Slika c
English: Please record the end of the 6 months storage at room temperature on the product carton.
Slovenian: Na škatlo zdravila zapišite konec šestmesečnega obdobja shranjevanja pri sobni temperaturi.
English: After reconstitution the solution should be clear, colourless and free from foreign particles.
Slovenian: Po rekonstituciji mora biti raztopina bistra, brezbarvna in brez tujih delcev.
English: Only a clear and colourless solution should be used.
Slovenian: Uporabite lahko samo bistro in brezbarvno raztopino.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use, after reconstitution.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA intravenska uporaba po rekonstituciji Samo za enkratno uporabo.
English: Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding.
Slovenian: Zgodnja hemartroza, krvavitev v mišico oziroma krvavitev v ustni votlini
English: Procedural site reaction a) Calculated based on total number of patients who received ADVATE (418).
Slovenian: Izračunana na osnovi skupnega števila bolnikov, ki so prejeli zdravilo ADVATE (418)
English: Reconstitution with the BAXJECT II device - For reconstitution use only the sterilised water for injections and the reconstitution device provided in the pack.
Slovenian: Rekonstitucija s pripomočkom BAXJECT II - Za rekonstitucijo uporabite samo sterilno vodo za injekcije in pripomoček za rekonstitucijo, ki je priložen v pakiranju.
English: Common side effects (may affect up to 1 in 10 people) headache and fever.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) Glavobol in zvišana telesna temperatura.
English: Calculated as (Cmax - baseline Factor VIII) divided by the dose in IU/kg, where Cmax is the maximal post-infusion Factor VIII measurement.
Slovenian: Izračunano kot (Cmax - osnovna vrednost faktorja VIII), deljeno z odmerkom v i.e./kg, kjer je Cmax najvišja izmerjena vrednost faktorja VIII po infuziji.
English: Each powder vial contains nominally 250, 500, 1000, 1500, 2000, or 3000 IU octocog alfa.
Slovenian: Ena viala s praškom nominalno vsebuje 250, 500, 1000, 1500, 2000 ali 3000 i.e. oktokoga alfa.
English: Infants (n=5)
Slovenian: Dojenčki (n = 5)
English: With one hand holding the ADVATE in the BAXJECT III system, press down firmly on the solvent vial with the other hand until the system is fully collapsed and the solvent flows down into the ADVATE vial (Fig. 2).
Slovenian: Z eno roko primite zdravilo ADVATE v sistemu BAXJECT III, z drugo roko pa odločno potisnite na vialo z vehiklom, da se sistem stisne in vehikel začne teči v vialo z zdravilom ADVATE (slika 2).
English: Grip the package at its edge and pull the package off BAXJECT II (Fig. b).
Slovenian: Primite škatlo ob straneh in jo s potegom snemite z BAXJECT-a II (slika b).
English: Every 24 hours (12 to 24 hours for patients under the age of 6), at least 1 day, until healing is achieved.
Slovenian: Na vsakih 24 ur (12 do 24 ur za bolnike, mlajše od 6 let), najmanj en dan, dokler se ne začne celjenje.
English: Table 3 Summary of Pharmacokinetic Parameters of ADVATE per Age Group with severe haemophilia A (baseline factor VIII < 1%)
Slovenian: Povzetek farmakokinetičnih parametrov zdravila ADVATE po starostnih skupinah bolnikov s hudo obliko hemofilije A (osnovna vrednost faktorja VIII < 1 %)
English: - The other ingredients are mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, and glutathione (reduced).
Slovenian: - Pomožne snovi so manitol, natrijev klorid, histidin, trehaloza, kalcijev klorid, trometamol, polisorbat 80 in glutation (reduciran).
English: Table 1 Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/type of surgical procedure
Slovenian: Vodilo za odmerjanje zdravila pri krvavitvah in kirurških posegih Stopnja krvavitve/Vrsta kirurškega posega
English: The solution should be administered slowly, at a rate as determined by the patient's comfort level, not to exceed 10 ml per minute.
Slovenian: Raztopino injicirajte intravensko in počasi, s hitrostjo, ki naj bo odvisna od bolnikovega počutja, vendar ne sme preseči 10 ml na minuto.
English: Do not tilt the system until the transfer is complete.
Slovenian: Sistem mora ostati v pokončnem položaju, dokler se ne pretoči vsa tekočina.
English: A central venous access device (CVAD) may become necessary to allow frequent infusions of factor VIII products.
Slovenian: Za pogosto infundiranje pripravkov faktorja VIII bo morda potreben centralni venski dostop (CVAD).
English: The product is provided in one of the following configurations:
Slovenian: Zdravilo je na voljo v naslednjih dveh oblikah:
English: Four of these patients reported isolated events of urticaria, pruritus, rash, and slightly elevated eosinophil counts amongst repeated exposures to the study product.
Slovenian: Štirje od teh bolnikov so pri ponovljenih izpostavitvah preučevanemu zdravilu prijavili posamezne pojave urtikarije, pruritusa, izpuščaje in rahlo zvišanje števila eozinofilcev.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ADVATE ne smemo mešati z drugimi zdravili ali vehikli.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Slovenian: Bolniki morajo biti poučeni o zgodnjih znakih preobčutljivostnih reakcij, med katere sodijo koprivnica, generalizirana urtikarija, tiščanje v prsih, piskanje, hipotenzija in anafilaksa.
English: Turn the package over and insert the clear plastic spike through the solvent stopper.
Slovenian: Obrnite škatlo s pripomočkom in vstavite prozorno plastično konico skozi zamašek vehikla.
English: Adolescents (n=33)
Slovenian: Mladostniki (n = 33)
English: For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days.
Slovenian: Za dolgoročno preventivo krvavitev pri bolnikih s hudo hemofilijo A znašajo običajni odmerki od 20 do 40 i.e. faktorja VIII na kg telesne mase na vsake 2 do 3 dni.
English: Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a).
Slovenian: Odstranite papirnati pokrov s škatle pripomočka BAXJECT II, ne da bi se pri tem dotaknili vsebine škatle (slika a).
English: The target factor VIII levels will depend on the severity and location of the bleeding.
Slovenian: Ciljna koncentracija faktorja VIII je odvisna od jakosti in mesta krvavitve.
English: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Slovenian: Za zdravljenje in profilakso krvavitev pri bolnikih s hemofilijo A (prirojeno pomanjkanje faktorja VIII).
English: Children (n=30)
Slovenian: Otroci (n = 30)
English: For the prevention of bleeding in children under the age of 6, doses of 20 to 50 IU per kg body weight 3 to 4 times weekly are recommended.
Slovenian: Pri preprečevanju krvavitev pri otrocih, mlajših od šest let, priporočamo odmerke od 20 do 50 i.e. na kg telesne mase, 3- do 4-krat tedensko.
English: A local tolerance study in rabbits showed that ADVATE reconstituted with 2 ml of sterilised water for injections is well tolerated after intravenous administration.
Slovenian: Študija lokalne tolerance pri kuncih je pokazala dobro prenašanje zdravila ADVATE, rekonstituiranega v 2 ml sterilne vode za injekcije in uporabljenega intravensko.
English: After reconstitution this medicinal product contains 0.45 mmol sodium (10 mg) per vial.
Slovenian: Po rekonstituciji vsebuje to zdravilo 0,45 mmol natrija (10 mg) na vialo.
English: The pulse rate should be determined before and during administration of ADVATE.
Slovenian: Pred in med dajanjem zdravila ADVATE morate meriti pulz.
English: Solvent: Clea and colourless solution.
Slovenian: Vehikel: bistra in brezbarvna raztopina.
English: Influenza
Slovenian: Pogostnosta gripa
English: The following table 1 can be used to guide dosing in bleeding episodes and surgery:
Slovenian: Preglednico 1 spodaj lahko uporabljate kot vodilo za odmerjanje pri krvavitvah in kirurških posegih:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Baxter AG
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Baxter AG
English: Excipients with known effect: 0.45 mmol sodium (10 mg) per vial.
Slovenian: Pomožne snovi z znanim učinkom: 0,45 mmol natrija (10 mg) na vialo
English: No interaction studies have been performed with ADVATE.
Slovenian: Študij medsebojnega delovanja zdravila ADVATE z drugimi zdravili niso izvedli.
English: ADVATE in BAXJECT III system: Keep the sealed blister in the outer carton in order to protect from light.
Slovenian: Zdravilo ADVATE s sistemom BAXJECT III: Zapečaten pretisni omot shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Slovenian: Zdravila ne uporabljajte, če so pripomoček BAXJECT II, njegov sterilen pregradni sistem ali njegova ovojnina poškodovani ali kažejo kakršnekoli znake kvarjenja.
English: Repeat injections every 8 to 24 hours (6 to 12 hours for patients under the age of 6) until threat is resolved.
Slovenian: Injekcije ponavljajte na vsakih 8 do 24 ur (6 do 12 ur za bolnike, mlajše od 6 let), dokler ne mine ogroženost.
English: Misapplication of ADVATE
Slovenian: Napačna uporaba zdravila ADVATE
English: Fig. b
Slovenian: Slika b
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available.
Slovenian: Zaradi redkega pojavljanja hemofilije A pri ženskah ni izkušenj z uporabo faktorja VIII med nosečnostjo in dojenjem, zato smete zdravilo uporabljati med nosečnostjo in dojenjem samo, če je nujno potrebno.
English: Therefore, caution is advised during injection of ADVATE reconstituted in 2 ml sterilised water for injections, especially in children.
Slovenian: Zato je med injiciranjem zdravila ADVATE, rekonstituiranega v 2 ml sterilne vode za injekcije, potrebna previdnost, zlasti pri otrocih.
English: Therefore, caution is advised during injection of ADVATE reconstituted in 2 ml, especially in children.
Slovenian: Zato je med injiciranjem zdravila ADVATE, rekonstituiranega v 2 ml, potrebna previdnost, zlasti pri otrocih.
English: Manufacturers
Slovenian: Izdelovalca:
English: It is strongly recommended that every time ADVATE is administered, the name and batch number of the product are recorded.
Slovenian: Močno priporočamo, da ob vsakem injiciranju zdravila ADVATE zabeležite ime in serijsko številko zdravila.
English: Each powder vial contains nominally 250, 500, 1000, or 1500 IU octocog alfa.
Slovenian: Ena viala s praškom nominalno vsebuje 250, 500, 1000 ali 1500 i.e. oktokoga alfa.
English: Parenteral medicinal products should be inspected for particulate matter prior to administration, whenever solution and container permit.
Slovenian: Zdravila za parenteralno uporabo morate pred uporabo skrbno pregledati, ali vsebujejo neraztopljene delce, če to omogoča vrsta raztopine in viale.
English: ADVATE contains the active substance octocog alfa, human coagulation factor VIII produced by recombinant DNA technology.
Slovenian: ADVATE vsebuje zdravilno učinkovino oktokog alfa, humani koagulacijski faktor VIII, izdelan s tehnologijo rekombinantne DNA.
English: Older Children (n=18)
Slovenian: Starejši otroci (n = 18)
English: Major
Slovenian: Večji
English: Use only the sterilised water for injections and the reconstitution device for preparation of the solution that are provided with each package of ADVATE.
Slovenian: Za pripravo raztopine smete uporabiti samo sterilno vodo za injekcije in pripomočke za pripravo raztopine, ki so na voljo v vsakem pakiranju zdravila ADVATE.
English: This medicine contains 0.45 mmol sodium (10 mg) per vial.
Slovenian: Zdravilo vsebuje 0,45 mmol natrija (10 mg) na vialo.
English: - Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Slovenian: - Zdravila ne uporabljajte, če so pripomoček BAXJECT II, njegov sterilen pregradni sistem ali njegova ovojnina poškodovani ali kažejo kakršnekoli znake kvarjenja.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician.
Slovenian: Bolnike poučite, naj v primeru pojava simptomov preobčutljivosti nemudoma prenehajo z jemanjem zdravila in se posvetujejo s svojim zdravnikom.
English: ADVATE with BAXJECT II device: Keep the product vial in the outer carton in order to protect from light.
Slovenian: Zdravilo ADVATE s pripomočkom BAXJECT II: Vialo z zdravilom shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Aseptic technique is required during preparation of the solution and administration.
Slovenian: Med pripravo raztopine in injiciranjem zdravila je treba uporabiti aseptično tehniko.
English: a
Slovenian: Slika a
English: For reconstitution only the sterilised water for injections and the reconstitution device provided in the pack should be used.
Slovenian: Za rekonstitucijo uporabljajte le sterilno vodo za injekcije in pripomoček za rekonstitucijo, ki je priložen v pakiranju.
English: Degree of haemorrhage/type of surgical procedure
Slovenian: Stopnja krvavitve/Vrsta kirurškega posega
English: Due to the decrease in injection volume for ADVATE reconstituted in 2 ml sterilised water for injections, if hypersensitivity reactions occur there is less time to react by stopping the injection.
Slovenian: Zaradi zmanjšanega injekcijskega volumna zdravila ADVATE, rekonstituiranega v 2 ml sterilne vode za injekcije, je na voljo manj časa za ukrepanje z zaustavitvijo injiciranja v primeru pojava preobčutljivostnih reakcij.
English: Administration Use Aseptic Technique
Slovenian: Injiciranje Uporabite aseptični postopek
English: The administration of ADVATE in children (intravenously) does not differ from the administration in adults.
Slovenian: Dajanje zdravila ADVATE pri otrocih (intravensko) je enaka kot dajanje zdravila pri odraslih.
English: Eye inflammation
Slovenian: Očesne bolezni vnetje očesa
English: Do not use this medicine after the expiry date, which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000
Slovenian: IME ZDRAVILA ADVATE 2000
English: Remove caps from powder and solvent vials.
Slovenian: Odstranite zaporki z vial s praškom in vehiklom.
English: Allergic type reactions include anaphylaxis and have been manifested by dizziness, paresthesias, rash, flushing, face swelling, urticaria, and pruritus.
Slovenian: Reakcije alergijskega tipa, vključno z anafilakso, so se izrazile v obliki omotice, parestezij, izpuščaja, navala vročine, otekanja obraza, koprivnice in srbenja.
English: Discard any unused solution appropriately.
Slovenian: Neuporabljeno raztopino zavrzite v skladu s predpisi.
English: Solvent vial: 5 ml sterilised water for injections
Slovenian: Viala z vehiklom: 5 ml sterilne vode za injekcije.
English: Remove the BAXJECT III system from the blister.
Slovenian: Sistem BAXJECT III vzemite iz pretisnega omota.
English: The following table can be used to guide dosing in bleeding episodes and surgery.
Slovenian: Spodnjo preglednico lahko uporabljate kot vodilo za odmerjanje pri krvavitvah in kirurških posegih:
English: Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for 3 - 4 days or more until pain and acute disability are resolved.
Slovenian: Injekcije ponavljajte na vsakih 12 do 24 ur (8 do 24 ur za bolnike, mlajše od 6 let) 3 do 4 dni ali več, dokler ne mineta bolečina in akutna onesposobljenost.
English: Due to the decrease in injection volume for ADVATE reconstituted in 2 ml, the time to react to hypersensitivity reactions during an injection is further reduced.
Slovenian: Zaradi zmanjšanega injekcijskega volumna zdravila ADVATE, rekonstituiranega v 2 ml, je na voljo manj časa za ukrepanje v primeru pojava preobčutljivostnih reakcij med injiciranjem.
English: Development of inhibitors is a known complication in the treatment of haemophilia A. If your bleeding is not controlled with ADVATE, tell your doctor immediately.
Slovenian: Zaviralci so protitelesa proti faktorju VIII, ki zmanjšajo učinkovitost zdravila ADVATE pri preprečevanju in obvladovanju krvavitev.Nastanek zaviralcev je znan zaplet zdravljenja hemofilije A. Če zdravilo ADVATE pri vas ni zaustavilo krvavitve, morate to nemudoma povedati svojemu zdravniku.