FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 1000
English: Remove the blue cap from BAXJECT II / BAXJECT III.
Romanian: Scoateţi capacul albastru de la BAXJECT II / BAXJECT III.
English: Adjusted Incremental Recovery at Cmax (IU/dL per IU/kg)a
Romanian: ASC totală (UI*ore/dl) Recuperare incrementală corectată la Cmax (UI/dl per UI/kg)a
English: Excipient related considerations
Romanian: Consideraţii privind excipienţii
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.
Romanian: Dupǎ trecerea de la un medicament care conţine factorul VIII recombinant la altul, la pacienţii care au urmat anterior un astfel de tratament timp de peste 100 de zile şi care au dezvoltat în antecedente inhibitori față de factorul VIII, au fost observate cazuri de reapariţie a inhibitorilor (titruri scăzute).
English: INFORMATION IN BRAILLE ADVATE 500
Romanian: INFORMAŢII ÎN BRAILLE ADVATE 500
English: Prevention of bleeding
Romanian: Profilaxia hemoragiei
English: Older Children (n=18)
Romanian: Copii mari (n=18)
English: The following table 1 can be used to guide dosing in bleeding episodes and surgery:
Romanian: Tabelul 1 de mai jos poate fi folosit ca ghid de dozaj în cazul episoadele hemoragice sau intervenţiilor chirurgicale.
English: You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions:
Romanian: Prin urmare, trebuie să cunoaşteţi semnele de debut ale reacţiilor alergice.
English: Talk to your doctor before using ADVATE.
Romanian: Înainte să utilizaţi ADVATE, adresaţi-vă medicului dumneavoastră.
English: • Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration as indicated by the symbol: • Do not refrigerate the solution after preparation.
Romanian: • Nu utilizaţi dispozitivul BAXJECT II în cazul în care sistemul său de filtrare steril sau ambalajul acestuia sunt deteriorate sau prezintă semne de deteriorare indicată prin simbolul:
English: Adjusted Incremental Recovery at Cmax (IU/dL per IU/kg)
Romanian: ASC totală (UI*ore/dl) Recuperare incrementală corectată la Cmax (UI/dl per UI/kg)
English: Remove the blue cap from BAXJECT III.
Romanian: Scoateţi capacul albastru de la BAXJECT III.
English: Factor VIII inhibition
Romanian: Inhibare a factorului VIII
English: Feeling abnormal
Romanian: Stare generală de rău
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ŞI CALEA(CĂILE) DE ADMINISTRARE
English: Uncommon (PTPs)
Romanian: Mai puţin frecvente (PTA)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT II DEVICE)
Romanian: INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR CUTIE (DISPOZITIVUL BAXJECT II)
English: Powder: White to off-white friable powder.
Romanian: Pulbere friabilă, de culoare albă până la aproape albă.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 500
English: Chest discomfort
Romanian: Disconfort la nivelul toracelui
English: - rash, hives, wheals, generalised itching, - swelling of lips and tongue, - difficulty in breathing, wheezing, tightness in the chest, - general feeling of being unwell, - dizziness and loss of consciousness.
Romanian: Acestea sunt: pruritul, erupţiile cutanate, apariţia de pustule, mâncărimea generalizată, umflarea buzelor şi a limbii, dificultăţile de respiraţie, respiraţie şuierătoare, o senzaţie de presiune în piept, o stare generală de rău şi ameţeală.
English: Use in children and adolescents (from 0 to 18 years of age) For the treatment of bleeding the dosing in children does not differ from adult patients.
Romanian: Pentru tratamentul sângerărilor, dozele la copii şi adolescenţi nu sunt diferite faţă de cele la adulţi.
English: Remove the blue cap from BAXJECT II.
Romanian: Scoateţi capacul albastru de la BAXJECT II.
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).
Romanian: Fiecare ambalaj conţine un flacon cu pulbere, un flacon ce conţine 2 ml cu solvent şi un dispozitiv pentru reconstituire (BAXJECT II).
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).
Romanian: Fiecare ambalaj conţine un flacon cu pulbere, un flacon ce conţine 5 ml cu solvent şi un dispozitiv pentru reconstituire (BAXJECT II).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU octocog alfa
Romanian: CONŢINUTUL PE MASĂ, VOLUM SAU UNITATEA DE DOZĂ Octocog alfa 2000 UI
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT III SYSTEM)
Romanian: INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR CUTIE (SISTEMUL BAXJECT III)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 2000 IU octocog alfa, approx. 400 IU/ml after reconstitution.
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE 1 flacon: octocog alfa 2000 UI, aproximativ 400 UI/ml după reconstituire.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU octocog alfa
Romanian: CONŢINUTUL PE MASĂ, VOLUM SAU UNITATEA DE DOZĂ Octocog alfa 250 UI
English: Pallor
Romanian: Paloare
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection.
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 3000 UI pulbere şi solvent pentru soluţie injectabilă.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 3000 IU octocog alfa, approx. 600 IU/ml after reconstitution.
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE 1 flacon: octocog alfa 3000 UI, aproximativ 600 UI/ml după reconstituire.
English: How to store ADVATE
Romanian: Cum se administrează ADVATE
English: IV use
Romanian: Administrare IV
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)
Romanian: ETICHETA BLISTERULUI (SISTEMUL BAXJECT III)
English: Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Romanian: De aceea, după trecerea de la un medicament care conţine factorul VIII recombinant la altul, se recomandă monitorizarea cu atenţie a tuturor pacienţilor, pentru a depista dezvoltarea inhibitorilor.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 125 IU/ml after reconstitution.
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE 1 flacon: octocog alfa 250 UI, aproximativ 125 UI/ml după reconstituire.
English: End of 6 month period, if stored at room temperature: Do not use after the expiry date.
Romanian: La sfârşitul perioadei de 6 luni, dacă este păstrat la temperatura camerei.
English: - If you get any side effects talk to your doctor.
Romanian: - Dacă manifestaţi orice reacţii adverse, adresaţi-vă medicului dumneavoastră.
English: Can be stored at room temperature (up to 25 °C) for a single period up to 6 months.
Romanian: Poate fi păstrat la temperatura camerei (până la 25°C) pentru o singură perioadă ce nu va depăşi 6 luni.
English: Trehalose
Romanian: Bufeuri
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU octocog alfa
Romanian: CONŢINUTUL PE MASĂ, VOLUM SAU UNITATEA DE DOZĂ Octocog alfa 3000 UI
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 750 IU/ml after reconstitution.
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE 1 flacon: octocog alfa 1500 UI, aproximativ 750 UI/ml după reconstituire.
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.
Romanian: Pe parcursul perioadei de valabilitate, medicamentul poate fi păstrat la temperatura camerei (până la 25°C) pentru o singură perioadă care nu va depăşi 6 luni.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU octocog alfa
Romanian: CONŢINUTUL PE MASĂ, VOLUM SAU UNITATEA DE DOZĂ Octocog alfa 500 UI
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU octocog alfa
Romanian: CONŢINUTUL PE MASĂ, VOLUM SAU UNITATEA DE DOZĂ Octocog alfa 1000 UI
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 200 IU/ml after reconstitution.
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE 1 flacon: octocog alfa 1000 UI, aproximativ 200 UI/ml după reconstituire.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection.
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 1500 UI pulbere şi solvent pentru soluţie injectabilă.
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.
Romanian: Pe parcursul perioadei de valabilitate, blisterul cu medicament poate fi păstrat la temperatura camerei (până la 25°C) pentru o singură perioadă care nu va depăşi 6 luni.
English: Reconstitution with the BAXJECT II device - For reconstitution use only the sterilised water for injections and the reconstitution device provided in the pack.
Romanian: Pentru reconstituire trebuie utilizate numai apa sterilă pentru preparate injectabile şi dispozitivul de reconstituire furnizate în ambalaj.Cu Baxject II ataşat la flaconul cu solvent, răsuciţi sistemul astfel încât flaconul cu solvent să ajungă deasupra dispozitivului.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 300 IU/ml after reconstitution.
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE 1 flacon: octocog alfa 1500 UI, aproximativ 300 UI/ml după reconstituire.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection Octocog alfa
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 250 UI pulbere şi solvent pentru soluţie injectabilă Octocog alfa
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 2000 UI pulbere şi solvent pentru soluţie injectabilă Octocog alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 100 IU/ml after reconstitution.
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE 1 flacon: octocog alfa 500 UI, aproximativ 100 UI/ml după reconstituire.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1500 IU octocog alfa
Romanian: CONŢINUTUL PE MASĂ, VOLUM SAU UNITATEA DE DOZĂ Octocog alfa 1500 UI
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 3000 UI pulbere şi solvent pentru soluţie injectabilă Octocog alfa
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection.
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 500 UI pulbere şi solvent pentru soluţie injectabilă.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection.
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 2000 UI pulbere şi solvent pentru soluţie injectabilă.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/008
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/008
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/016
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/016
English: Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa.
Romanian: Fiecare flacon conţine factor VIII de coagulare uman (rADN), octocog alfa 250 UI.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 250 IU/ml after reconstitution.
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE 1 flacon: octocog alfa 500 UI, aproximativ 250 UI/ml după reconstituire.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 50 IU/ml after reconstitution.
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE 1 flacon: octocog alfa 250 UI, aproximativ 50 UI/ml după reconstituire.
English: Misapplication of ADVATE
Romanian: Administrarea greşită a ADVATE
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 2000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Romanian: Conţinut: 1 flacon cu octocog alfa 2000 UI, 1 flacon cu apă pentru preparate injectabile 5 ml, 1 dispozitiv BAXJECT II.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 1500 UI pulbere şi solvent pentru soluţie injectabilă Octocog alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 500 IU/ml after reconstitution.
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE 1 flacon: octocog alfa 1000 UI, aproximativ 500 UI/ml după reconstituire.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 2000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Romanian: Conţinut: 1 flacon cu octocog alfa 2000 UI şi 1 flacon cu apă pentru preparate injectabile 5 ml preasamblate într-un sistem BAXJECT III.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 500 UI pulbere şi solvent pentru soluţie injectabilă Octocog alfa
English: Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), octocog alfa.
Romanian: Fiecare flacon conţine factor VIII de coagulare uman (rADN), octocog alfa 2000 UI.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/018
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/018
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)
Romanian: ETICHETA ANSAMBLULUI (SISTEMUL BAXJECT III)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/012
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/012
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 1000 UI pulbere şi solvent pentru soluţie injectabilă Octocog alfa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/006
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/006
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection.
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 250 UI pulbere şi solvent pentru soluţie injectabilă.
English: Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), octocog alfa.
Romanian: Fiecare flacon conţine factor VIII de coagulare uman (rADN), octocog alfa 1000 UI.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/015
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/015
English: Volume of
Romanian: Frecvenţaa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/014
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/014
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/005
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/005
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 3000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Romanian: Conţinut: 1 flacon cu octocog alfa 3000 UI, 1 flacon cu apă pentru preparate injectabile 5 ml, 1 dispozitiv BAXJECT II.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/017
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/020
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/019
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/019
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/011
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/011
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 3000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Romanian: Conţinut: 1 flacon cu octocog alfa 3000 UI şi 1 flacon cu apă pentru preparate injectabile 5 ml preasamblate într-un sistem BAXJECT III.
English: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa.
Romanian: Fiecare flacon conţine factor VIII de coagulare uman (rADN), octocog alfa 500 UI.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Romanian: Conţinut: 1 flacon cu octocog alfa 1000 UI şi 1 flacon cu apă pentru preparate injectabile 2 ml preasamblate într-un sistem BAXJECT III.
English: ADVATE contains approximately 125 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Romanian: După reconstituire, ADVATE conţine factor VIII de coagulare uman (rADN), octocog alfa aproximativ 125 UI pe ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/010
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/013
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/013
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Romanian: Conţinut: 1 flacon cu octocog alfa 250 UI şi 1 flacon cu apă pentru preparate injectabile 2 ml preasamblate într-un sistem BAXJECT III.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection.
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI ADVATE 1000 UI pulbere şi solvent pentru soluţie injectabilă.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Romanian: Conţinut: 1 flacon cu octocog alfa 250 UI, 1 flacon cu apă pentru preparate injectabile 5 ml, 1 dispozitiv BAXJECT II.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Romanian: Conţinut: 1 flacon cu octocog alfa 1000 UI, 1 flacon cu apă pentru preparate injectabile 2 ml, 1 dispozitiv BAXJECT II.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Romanian: Conţinut: 1 flacon cu octocog alfa 250 UI şi 1 flacon cu apă pentru preparate injectabile 5 ml, preasamblate într-un sistem BAXJECT III.
English: ADVATE contains approximately 750 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Romanian: După reconstituire, ADVATE conţine factor VIII de coagulare uman (rADN), octocog alfa aproximativ 750 UI pe ml.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Romanian: Conţinut: 1 flacon cu octocog alfa 250 UI, 1 flacon cu apă pentru preparate injectabile 2 ml, 1 dispozitiv BAXJECT II.
English: Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), octocog alfa.
Romanian: Fiecare flacon conţine factor VIII de coagulare uman (rADN), octocog alfa 3000 UI.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/009
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/009
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/004
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/004
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Romanian: Conţinut: 1 flacon cu octocog alfa 500 UI şi 1 flacon cu apă pentru preparate injectabile 2 ml preasamblate într-un sistem BAXJECT III.
English: ADVATE contains approximately 250 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Romanian: După reconstituire, ADVATE conţine factor VIII de coagulare uman (rADN), octocog alfa aproximativ 250 UI pe ml.
English: Each vial contains nominally 1500 IU human coagulation factor VIII (rDNA), octocog alfa.
Romanian: Fiecare flacon conţine factor VIII de coagulare uman (rADN), octocog alfa 1500 UI.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Romanian: Conţinut: 1 flacon cu octocog alfa 500 UI şi 1 flacon cu apă pentru preparate injectabile 5 ml, preasamblate într-un sistem BAXJECT III.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Romanian: Conţinut: 1 flacon cu octocog alfa 1500 UI şi 1 flacon cu apă pentru preparate injectabile 2 ml preasamblate într-un sistem BAXJECT III.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Romanian: Conţinut: 1 flacon cu octocog alfa 500 UI, 1 flacon cu apă pentru preparate injectabile 5 ml, 1 dispozitiv BAXJECT II.
English: ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Romanian: După reconstituire, ADVATE conţine factor VIII de coagulare uman (rADN), octocog alfa aproximativ 400 UI pe ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/002
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/002
English: Aseptic technique is required during administration.
Romanian: Instrucţiuni pentru administrarea injecţiei În timpul administrării soluţiei este necesară utilizarea tehnicii aseptice.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Romanian: Conţinut: 1 flacon cu octocog alfa 500 UI, 1 flacon cu apă pentru preparate injectabile 2 ml, 1 dispozitiv BAXJECT II.
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.
Romanian: Conţinut: 1 flacon cu octocog alfa 1500 UI şi 1 flacon cu apă pentru preparate injectabile 5 ml, preasamblate într-un sistem BAXJECT III.
English: ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Romanian: După reconstituire, ADVATE conţine factor VIII de coagulare uman (rADN), octocog alfa aproximativ 50 UI pe ml.
English: ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Romanian: După reconstituire, ADVATE conţine factor VIII de coagulare uman (rADN), octocog alfa aproximativ 200 UI pe ml.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Romanian: Conţinut: 1 flacon cu octocog alfa 1500 UI, 1 flacon cu apă pentru preparate injectabile 5 ml, 1 dispozitiv BAXJECT II.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/001
Romanian: NUMĂRUL(ELE) AUTORIZAŢIEI DE PUNERE PE PIAŢĂ EU/1/03/271/001