FrancophonIA/ELRC3.0 huggingface dataset:
English: Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for at least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved.
Estonian: Korrata injektsioone iga 12...24 tunni järel (alla kuueaastaste patsientide puhul 8...24 tunni järel) vähemalt 1 ööpäeva vältel, kuni veritsusega kaasnev valu on kadunud või on toimunud paranemine.
English: Monocyte Count increased
Estonian: Monotsüütide arvu tõus
English: Distribution at Steady State (dl/kg) Clearance (ml/kg*h)
Estonian: Maksimaalne kontsentratsioon plasmas pärast infusiooni (RÜ/dl) Keskmine toimimisaeg (h) Jaotusruumala püsiolekus (dl/kg) Kliirens (ml/kg*h)
English: Feeling abnormal
Estonian: Halb enesetunne
English: Remove caps from powder and solvent vials.
Estonian: Eemaldada pulbri- ja lahustiviaalilt korgid.
English: Major
Estonian: Suur
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Estonian: Need inhibiitorid on tavaliselt VIII hüübimisfaktori prokoaguleeriva toime vastu suunatud IgG immuniglobuliinid, mille hulka väljendatakse Bethesda ühikutes (BÜ) vereplasma ühe ml kohta, kasutades modifitseeritud testi.
English: Table 2 Frequency of adverse drug reactions (ADRs) in clinical trials and from spontaneous reports MedDRA Standard System Organ Class
Estonian: Tabel 2 Ravimi kõrvaltoimete esinemissagedus (ADR) kliinilistes uuringutes ja vabatahtlikes aruannetes
English: Therefore, caution is advised during injection of ADVATE reconstituted in 2 ml sterilised water for injections, especially in children.
Estonian: Seetõttu peab olema 2 ml steriilses süstevees lahjendatud ADVATE süste ajal ettevaatlik, eriti laste puhul.
English: INFORMATION IN BRAILLE ADVATE 1500
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) ADVATE 1500
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use, after reconstitution.
Estonian: MANUSTAMISVIIS JA -TEE Lahustamise järel intravenoosne.
English: INFORMATION IN BRAILLE ADVATE 3000
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) ADVATE 3000
English: Can be stored at room temperature (up to 25 °C) for a single period up to 6 months.
Estonian: Võib hoida toatemperatuuril (kuni 25 °C) ühekordse kuni 6-kuulise perioodi vältel.
English: Connect the syringe to BAXJECT II / BAXJECT III.
Estonian: Ühendada süstal ja BAXJECT II/BAXJECT III.
English: ADVATE 250 IU powder and solvent for solution for injection ADVATE 500 IU powder and solvent for solution for injection ADVATE 1000 IU powder and solvent for solution for injection ADVATE 1500 IU powder and solvent for solution for injection
Estonian: ADVATE 250 IU süstelahuse pulber ja lahusti ADVATE 500 IU süstelahuse pulber ja lahusti ADVATE 1000 IU süstelahuse pulber ja lahusti ADVATE 1500 IU süstelahuse pulber ja lahusti
English: How ADVATE is given
Estonian: Kuidas ADVATE't manustatakse
English: ADVATE 250 IU powder and solvent for solution for injection
Estonian: ADVATE 250 IU süstelahuse pulber ja lahusti
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 2000
English: Misapplication of ADVATE
Estonian: ADVATE valesti manustamine
English: Both the powder vial and the vial containing 2 ml solvent are of type I glass closed with chlorobutyl rubber stoppers.
Estonian: Nii pulbri viaal kui ka 2 ml lahustiviaal on I tüüpi klaasist ja suletud klorobutüül-kummikorgiga.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 250
English: Allergic type reactions include anaphylaxis and have been manifested by dizziness, paresthesias, rash, flushing, face swelling, urticaria, and pruritus.
Estonian: Allergilist tüüpi reaktsioonide alla kuulub anafülaksia; teateid on ka pearinglusest, paresteesiatest, lööbest, punetusest, näopaistetusest, urtikaariast ja kihelusest.
English: Connect the syringe to BAXJECT III.
Estonian: Ühendada süstal ja BAXJECT III.
English: Malaise
Estonian: Düspnoe
English: Adjusted Incremental Recovery at Cmax (IU/dL per IU/kg)a
Estonian: Kogu AUC (RÜ*·h/dl) Kohandatud taseme astmeline tõus Cmaxi juures (RÜ/dl RÜ/kg kohta)a
English: d) Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients
Estonian: PTP = previously treated patients, varem ravitud patsiendid, PUP = previously untreated patients, varem ravimata patsiendid
English: Reconstitution with the BAXJECT II device - For reconstitution use only the sterilised water for injections and the reconstitution device provided in the pack.
Estonian: Lahustamine BAXJECT II seadmega - Lahustamiseks kasutada ainult pakendis olevat steriilset süstevett ja seadet pulbri lahustamiseks.
English: Slight transient reddening at the administration site was observed after intraarterial application and after paravenous administration.
Estonian: Pärast intraarteriaalset ja paravenoosset manustamist täheldati vähest mööduvat punetust manustamiskohal.
English: Both the powder vial and the vial containing 5 ml solvent are of type I glass closed with chlorobutyl rubber stoppers.
Estonian: Nii pulbri viaal kui ka 5 ml lahustiviaal on I tüüpi klaasist ja suletud klorobutüül-kummikorgiga.
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.
Estonian: Korrata injektsioone iga 12...24 tunni järel (alla kuueaastaste patsientide puhul 8...24 tunni järel) 3...4 ööpäeva vältel või kauem, kuni valu ja äge funktsioonihäire on kadunud.
English: INFORMATION IN BRAILLE ADVATE 250
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) ADVATE 250
English: Aseptic technique is required during administration.
Estonian: Manustamisel tuleb järgida aseptikanõudeid.
English: With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device.
Estonian: Pöörata lahustiviaal ja selle külge kinnitatud BAXJECT II süsteem ümber, nii et lahustiviaal jääb ülespoole.
English: Administration Use Aseptic Technique
Estonian: Manustamine Tuleb järgida aseptikanõudeid
English: Vessel puncture site haematoma
Estonian: Hematoom veresoone punktsioonikohas
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 1500
English: INFORMATION IN BRAILLE ADVATE 2000
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) ADVATE 2000
English: INFORMATION IN BRAILLE ADVATE 500
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) ADVATE 500
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 3000
English: Chest pain
Estonian: Valu rinnus
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)
Estonian: MINIMAALSED NÕUDED, MIS ON BLISTERITEL VÕI RIBADEL BLISTERI ETIKETT (BAXJECT III SÜSTEEM)
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 1000
English: - Aseptic Technique should be used
Estonian: - Tuleb järgida aseptikanõudeid:
English: INFORMATION IN BRAILLE ADVATE 1000
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) ADVATE 1000
English: Post procedural complication
Estonian: Reaktsioon protseduurikohal
English: Attach a butterfly needle to the syringe.
Estonian: Kinnitada libliknõel süstla külge.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 500
English: Lymphangitis
Estonian: Lümfangiit
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.
Estonian: Inhibiitorite tekkerisk on vastavuses haiguse raskusastme ja VIII hüübimisfaktori toimeajaga.
English: Adjusted Incremental
Estonian: Suurenenud higistamine
English: For reconstitution only the sterilised water for injections and the reconstitution device provided in the pack should be used.
Estonian: Lahustamiseks kasutada ainult pakendis olevat steriilset süstevett ja süsteemi pulbri lahustamiseks.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)
Estonian: MINIMAALSED NÕUDED, MIS ON BLISTERITEL VÕI RIBADEL KOMPLEKTI SILT (BAXJEXT III SÜSTEEM)
English: Discard any unused solution appropriately.
Estonian: Kasutamata lahus hävitage nõetekohaselt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 250
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) ADVATE 250
English: - For administration the use of a luer-lock syringe is required.
Estonian: - Manustamiseks on vaja luer-lock süstalt.
English: Do not remove the blue cap from the BAXJECT II device.
Estonian: Mitte võtta BAXJECT II pealt sinist katet.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ADVATE.
Estonian: A-hemofiiliaga patsientidel, keda ravitakse VIII hüübimisfaktoriga, sealhulgas ADVATE-ga, võivad tekkida neutraliseerivad antikehad (inhibiitorid).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 125 IU/ml after reconstitution.
Estonian: 1 viaal: 250 RÜ oktokog alfat, pärast lahustamist u 125 RÜ/ml.
English: - ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 5 ml solvent are preassembled with the system for reconstitution).
Estonian: - ADVATE süsteemis BAXJECT III: igas pakendis on suletud blisteris kasutusvalmis süsteem BAXJECT III (pulbri viaal ja 5 ml lahustiviaal on lahustamiseks eelnevalt süsteemiga kokku pandud).
English: - ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 2 ml solvent are preassembled with the system for reconstitution).
Estonian: - ADVATE süsteemis BAXJECT III: igas pakendis on suletud blisteris kasutusvalmis süsteem BAXJECT III (pulbri viaal ja 2 ml lahustiviaal on lahustamiseks eelnevalt süsteemiga kokku pandud).
English: Instructions for reconstitution
Estonian: Lahuse valmistamise juhend
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 500
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) ADVATE 500
English: Memory impairment
Estonian: Mälu halvenemine
English: Infusion (IU/dl)
Estonian: TOIMEAINE(TE) SISALDUS
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU octocog alfa
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 250 RÜ oktokog alfat
English: - If you get any side effects talk to your doctor.
Estonian: - Kui teil tekib ükskõik milline kõrvaltoimete, pidage nõu oma arstiga.
English: Tabulated summary of adverse reactions
Estonian: Vastureaktsioonide tabelkokkuvõte
English: Calcium chloride Trometamol Polysorbate 80
Estonian: Pulber: mannitool naatriumkloriid histidiin trehaloos kaltsiumkloriid trometamool polüsorbaat 80 glutatioon (redutseeritud).
English: Do not use solutions that are cloudy or have deposits.
Estonian: Lahust ei tohi kasutada, kui see on hägune või selles on tahkeid osakesi.
English: It is strongly recommended that every time ADVATE is administered, the name and batch number of the product are recorded.
Estonian: On rangelt soovitatav panna kirja ravimi nimi ja partii number ADVATE igal kasutuskorral,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ADVATE 2000
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 2000 IU octocog alfa, approx. 400 IU/ml after reconstitution.
Estonian: 1 viaal: 2000 RÜ oktokog alfat, pärast lahustamist u 400 RÜ/ml.
English: Instructions for preparation and administration Aseptic technique is required during preparation of the solution and administration.
Estonian: Lahuse valmistamisel ja manustamisel tuleb järgida aseptikanõudeid
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU octocog alfa
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 3000 RÜ oktokog alfat
English: - ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 2 ml solvent and a device for reconstitution (BAXJECT II).
Estonian: - ADVATE koos seadmega BAXJECT II: igas pakendis on pulbri viaal, 2 ml lahustiviaal ja seade pulbri lahustamiseks (BAXJECT II).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 3000 IU octocog alfa, approx. 600 IU/ml after reconstitution.
Estonian: 1 viaal: 3000 RÜ oktokog alfat, pärast lahustamist u 600 RÜ/ml.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1500 IU octocog alfa
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 1500 RÜ oktokog alfat
English: - ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 5 ml solvent and a device for reconstitution (BAXJECT II).
Estonian: - ADVATE koos seadmega BAXJECT II: igas pakendis on pulbri viaal, 5 ml lahustiviaal ja seade pulbri lahustamiseks (BAXJECT II).
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection.
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 2000 IU süstelahuse pulber ja lahusti.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection.
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 250 IU süstelahuse pulber ja lahusti.
English: Remove the blue cap from BAXJECT III.
Estonian: Eemaldada BAXJECT III sinine kate.
English: Pallor
Estonian: Lööve
English: Remove the blue cap from BAXJECT II / BAXJECT III.
Estonian: Eemaldada BAXJECT II/BAXJECT III sinine kate.
English: Instructions for injection For administration the use of a luer-lock syringe is required.
Estonian: Süstimise juhend Manustamiseks peab kasutama luer-lock süstalt.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection.
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 1500 IU süstelahuse pulber ja lahusti.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU octocog alfa
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 1000 RÜ oktokog alfat
English: Volume of
Estonian: Esinemissagedusa
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 300 IU/ml after reconstitution.
Estonian: 1 viaal: 1500 RÜ oktokog alfat, pärast lahustamist u 300 RÜ/ml.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 750 IU/ml after reconstitution.
Estonian: 1 viaal: 1500 RÜ oktokog alfat, pärast lahustamist u 750 RÜ/ml.
English: Remove the blue cap from BAXJECT II.
Estonian: Eemaldada BAXJECT II sinine kate.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU octocog alfa
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 2000 RÜ oktokog alfat
English: Attach a butterfly needle to the syringe and inject the reconstituted solution into a vein.
Estonian: Kinnitage libliknõel süstla külge ja süstige valmislahus veeni.
English: Other than the development of inhibitors in previously untreated paediatric patients (PUPs), and catheter-related complications, no age-specific differences in ADRs were noted in the clinical studies.
Estonian: Kliinilistes uuringutes ei ole täheldatud ADR vanusespetsiifilisi eripärasid v.a. inhibiitorite kujunemine varem ravimata pediaatrilistel patsientidel (PUP) ja kateetriga seotud komplikatsioonide puhul.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection.
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 3000 IU süstelahuse pulber ja lahusti.
English: Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a).
Estonian: Avada BAXJECT II süsteemi pakend, eemaldades sellelt paberkatte.
English: During the shelf life the powder vial may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
Estonian: Ravimi kõlblikkusaja kestel võib pulbriviaali ühe perioodi vältel, mis ei ületa 6 kuud, hoida toatemperatuuril (kuni 25 °C).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT III SYSTEM)
Estonian: ANDMED, MIS PEAVAD OLEMA KIRJAS LAHUSTIVIAALIL SÜSTEVESI (BAXJECT III SÜSTEEM)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)
Estonian: MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL PULBRIVIAALI ETIKETT (BAXJECT II SEADE)
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection.
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 500 IU süstelahuse pulber ja lahusti.
English: Trehalose
Estonian: Minestus
English: ADVATE contains approximately 125 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Estonian: ADVATE sisaldab pärast lahustamist ligikaudu 125 RÜ ml kohta inimese VIII (rDNA) hüübimisfaktorit, oktokog alfat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT II DEVICE)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISPAKEND (BAXJECT II SEADE)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 250 IU/ml after reconstitution.
Estonian: 1 viaal: 500 RÜ oktokog alfat, pärast lahustamist u 250 RÜ/ml.
English: During the shelf life the blister with the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
Estonian: Ravimi kõlblikkusaja kestel võib ravimiga blistrit ühe perioodi vältel, mis ei ületa 6 kuud, hoida toatemperatuuril (kuni 25 °C).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)
Estonian: MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL PULBRIVIAALI ETIKETT (BAXJECT III SÜSTEEM)
English: During the shelf life, the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
Estonian: Ravimi kõlblikkusaja kestel võib seda ühe perioodi vältel, mis ei ületa 6 kuud, hoida toatemperatuuril (kuni 25 °C).
English: Keep the blister with the product in the outer carton in order to protect from light.
Estonian: Hoidaravimiga blistrit välispakendis, valguse eest kaitstult.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 200 IU/ml after reconstitution.
Estonian: 1 viaal: 1000 RÜ oktokog alfat, pärast lahustamist u 200 RÜ/ml.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection.
Estonian: RAVIMPREPARAADI NIMETUS ADVATE 1000 IU süstelahuse pulber ja lahusti.
English: ADVATE contains approximately 750 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Estonian: ADVATE sisaldab pärast lahustamist ligikaudu 750 RÜ ml kohta inimese VIII (rDNA) hüübimisfaktorit, oktokog alfat.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 500 IU powder for solution for injection Octocog alfa
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) ADVATE 500 IU süstelahuse pulber.
English: Treatment of bleeding
Estonian: Veritsuse ravi
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU octocog alfa
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 500 RÜ oktokog alfat
English: For administration the use of a luer-lock syringe is required.
Estonian: Manustamiseks peab kasutama luer-lock süstalt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1000 IU powder for solution for injection Octocog alfa
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) ADVATE 1000 IU süstelahuse pulber.
English: • Do not refrigerate the solution after preparation.
Estonian: • Pärast lahuse valmistamist ei tohi lahust hoida külmkapis.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/016
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/016
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 500 IU/ml after reconstitution.
Estonian: 1 viaal: 1000 RÜ oktokog alfat, pärast lahustamist u 500 RÜ/ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/012
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/012
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 100 IU/ml after reconstitution.
Estonian: 1 viaal: 500 RÜ oktokog alfat, pärast lahustamist u 100 RÜ/ml.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000 IU powder for solution for injection Octocog alfa
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ADVATE 2000 IU süstelahuse pulber.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/006
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/006
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 50 IU/ml after reconstitution.
Estonian: 1 viaal: 250 RÜ oktokog alfat, pärast lahustamist u 50 RÜ/ml.
English: Each vial contains nominally 1500 IU human coagulation factor VIII (rDNA), octocog alfa.
Estonian: Igas viaalis on 1500 RÜ oktokog alfat, rekombinantset inimese VIII (rDNA) hüübimisfaktorit.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/018
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/018
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/008
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/008
English: Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), octocog alfa.
Estonian: Igas viaalis on 3000 RÜ oktokog alfat, rekombinantset inimese VIII (rDNA) hüübimisfaktorit.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/017
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/015
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/015
English: Haematocrit decreased
Estonian: Hematokriti langus
English: ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Estonian: ADVATE sisaldab pärast lahustamist ligikaudu 400 RÜ ml kohta inimese VIII (rDNA) hüübimisfaktorit, oktokog alfat.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/020
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/014
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/014
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/005
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/011
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/011
English: Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), octocog alfa.
Estonian: Igas viaalis on 1000 RÜ oktokog alfat, rekombinantset inimese VIII (rDNA) hüübimisfaktorit.
English: ADVATE contains approximately 250 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Estonian: ADVATE sisaldab pärast lahustamist ligikaudu 250 RÜ ml kohta inimese VIII (rDNA) hüübimisfaktorit, oktokog alfat.
English: ADVATE contains approximately 600 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Estonian: ADVATE sisaldab pärast lahustamist ligikaudu 600 RÜ ml kohta inimese VIII (rDNA) hüübimisfaktorit, oktokog alfat.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)
Estonian: MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL SÜSTEVEE ETIKETT (BAXJECT III SÜSTEEM)
English: ADVATE contains approximately 300 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Estonian: ADVATE sisaldab pärast lahustamist ligikaudu 300 RÜ ml kohta inimese VIII (rDNA) hüübimisfaktorit, oktokog alfat.
English: ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Estonian: ADVATE sisaldab pärast lahustamist ligikaudu 100 RÜ ml kohta inimese VIII (rDNA) hüübimisfaktorit, oktokog alfat.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Estonian: Sisu: 1 viaal 1500 RÜ oktokog alfat ja 1 viaal 5 ml steriilse süsteveega, eelnevalt kokku pandud BAXJECT III süsteemis.