Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
HUMAN PLASMA COAGULATION FACTOR VIII
KAMADA LTD, ISRAEL
B02BD02
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HUMAN PLASMA COAGULATION FACTOR VIII 100 IU/ML
I.V
Required
BIOTEST PHARMA GMBH, GERMANY
COAGULATION FACTOR VIII
COAGULATION FACTOR VIII
Treatment and prophylaxis of bleeding: in patients with haemophilia A (congenital factor VIII deficiency) in patient with acquired factor VIII deficiency.Haemoctin is not effective in controlling the bleeding of patients with Von Willebrond`s disease.
2021-09-30
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ןולעב )תוחיטב אפורל אפורל אפורל ןכדועמ( ןכדועמ( ןכדועמ( .102.50 .102.50 .102.50 ) ) ) ךיראת 74.4.5 תילגנאב רישכת םש םושירה רפסמו HAEMOCTIN SDH 250 IU םושיר רפסמ 30093 - 05 - 121 HAEMOCTIN SDH 500 IU םושיר רפסמ 4 3009 - 6 0 - 121 HAEMOCTIN SDH 1000 IU םושיר רפסמ 5 3009 - 7 0 - 121 םושירה לעב םש _ _________ KAMADA LTD ה טורפל דעוימ הז ספוט דבלב תורמחה ! תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט INDICATION CONTRAINDIC ATIONS POSOLOGY, DOSAGE & ADMINISTRAT ION Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable. Individual patients may vary in their response to factor VIII, achieving different levels of _in _ _vivo_ recovery and demonstrating different half-lives. Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. tients Previously untreated pa . No data are available Treatment monitoring During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries. Dose based on bodyweight may require adjustment in underweight or overweight patients. In the case of major surgical interventions in particular, Olvassa el a teljes dokumentumot
HAEMOCTIN SDH 250, 500 AND 1000 1. NAME OF THE MEDICINAL PRODUCT Haemoctin SDH 250 Haemoctin SDH 500 Haemoctin SDH 1000 Powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human plasma derived coagulation factor VIII One vial contains nominally 250, 500 or 1000 IU human plasma derived coagulation factor VIII. Haemoctin SDH 250 or Haemoctin SDH 500 contains approximately 50 IU/ml human coagulation factor VIII when reconstituted with 5 or 10 ml of water for injections. Haemoctin SDH 1000 contains approximately 100 IU/ml human coagulation factor VIII when reconstituted with 10 ml of water for injections. The potency (IU) is determined using the European Pharmacopoeia chromogenic factor VIII coagulation assay. The specific activity of Haemoctin SDH is approximately 100 IU/mg protein. Produced from the plasma of human donors. Excipient with known effect: One vial contains up to 32.2 mg sodium (1.4 mmol). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White powder and clear, colourless solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) In patient with acquired factor VIII deficiency. This preparation does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand´s disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be under the supervision of a physician experienced in the treatment of haemophilia. Previously untreated patients No data are available. Treatment monitoring During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries. Dose bas Olvassa el a teljes dokumentumot