Երկիր: Մալայզիա
Լեզու: անգլերեն
Աղբյուրը: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FACTOR VIII BYPASSING FRACTION
Takeda Malaysia Sdn Bhd
FACTOR VIII BYPASSING FRACTION
1 Vials
Takeda Manufacturing Austria AG
Not Applicable Կարդացեք ամբողջական փաստաթուղթը
Black Black Dieline Technical Info Item Number: Profile: Artwork Dimensions/Size: Graphics House: Date: OPTIONAL: Artwork Approver outside the Shire Management System: Role: Name: Signature: Date: Version: Technical Specification: 0752864 1 0402140_1_PIL_Drwg 480 x 328 mm 104761028 / 402166595 / SGK München 11Dec2020 0402140 752864 CODE ITF 2/5 DATAMATRIX CODE NA RSS / GS1-128 CODE NA PHARMACODE NA CODE 3 OF 9 NA GTIN / EAN-13 CODE NA BODY TEXT SIZE 9 pt FRONT BACK 1. NAME OF THE MEDICINAL PRODUCT FEIBA (FACTOR VIII INHIBITOR BYPASSING ACTIVITY) 25 U/ML POWDER AND SOLVENT FOR SOLUTION FOR INFUSION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Factor VIII Inhibitor Bypassing Activity 1 ml contains 25 U* factor VIII inhibitor bypassing activity. 1 vial FEIBA 25 U/ml contains 500 U factor VIII inhibitor bypassing activity in 200 – 600 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: 3.6 mmol sodium (80 mg) per vial. 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 B patients with inhibitors. Furthermore, FEIBA can be used for the treatment and prophylaxis of hemorrhages in non-hemophilic patients who have developed inhibitors to Factors VIII, IX and XI. Individual reports exist about the use of FEIBA in the treatment of patients with acquired i Կարդացեք ամբողջական փաստաթուղթը