Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FACTOR VIII BYPASSING FRACTION
Takeda Malaysia Sdn Bhd
FACTOR VIII BYPASSING FRACTION
1 Vials; 1 Vials
Takeda Manufacturing Austria AG
Not Applicable Прочитайте повний документ
Technical Info Dieline NA NA NA CODE 3 OF 9 DATAMATRIX CODE RSS / GS1-128 CODE BODY TEXT SIZE 9.0 pt 756232 CODE ITF 2/5 NA PHARMACODE NA GTIN / EAN-13 CODE BACK Black TECHNICAL SPECIFICATION: ARTWORK DIMENSIONS/SIZE: ITEM NUMBER: FRONT 0756232 VERSION: 1 PROFILE: 0402140_1_PIL_Drwg 0402140 480 x 328 mm GRAPHICS HOUSE: SGK Redmond DATE: 29DEC2021 OPTIONAL: Artwork Approver outside the Shire Management System: ROLE: NAME: SIGNATURE: DATE: Swatch Swatch Swatch Black Swatch Swatch Swatch 1. NAME OF THE MEDICINAL PRODUCT FEIBA (FACTOR VIII INHIBITOR BYPASSING ACTIVITY) 50 U/ML POWDER AND SOLVENT FOR SOLUTION FOR INFUSION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Factor VIII Inhibitor Bypassing Activity 1 ml contains 50 U* factor VIII inhibitor bypassing activity. FEIBA 50U/ml is available in the following presentation: - The presentation 500 U FEIBA contains 500 U factor VIII inhibitor bypassing activity in 200 – 600 mg human plasma protein, - The presentation 1000 U FEIBA contains 1000 U factor VIII inhibitor bypassing activity in 400 – 1,200 mg human plasma protein, FEIBA also contains the factors II, IX and X, mainly in non-activated form, as well as activated factor VII. Factor VIII coagulation antigen (F VIII C:Ag) is present at a concentration of up to 0.1 U./1 U. FEIBA. The factors of the kallikrein-kinin system are present in trace amounts only, if at all. * 1 unit of FEIBA shortens the activated partial thromboplastin time (aPTT) of a factor VIII inhibitor plasma by 50% of the buffer value (blank value). Excipients with known effect: 1.8 mmol sodium (40 mg) per vial with 500 U FEIBA. 3.6 mmol sodium (80 mg) per vial with 1000 U FEIBA. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for infusion. White, off-white or pale green powder. The pH value of the ready-to-use solution is between 6.8 and 7.6. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FEIBA is used for the treatment and prophylaxis of hemorrhages in hemophilia A and Прочитайте повний документ