Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
HUMAN FIBRINOGEN
CSL BEHRING LTD., ISRAEL
B02BC10
POWDER FOR SOLUTION FOR INJ/INF
HUMAN FIBRINOGEN 1800 - 2600 MG / 1 VIALS
I.V
Required
CSL BEHRING GmbH, GERMANY
FIBRINOGEN, HUMAN
FIBRINOGEN, HUMAN
Haemocomplettan P 1g/2g, Fibrinogen Concentrate (Human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.Haemocomplettan P 1g/2g is not indicated for dysfibrinogenemia.
2014-07-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת 09/09/2014 םש רישכת תילגנאב רפסמו :םושירה HAEMOCOMPLETTAN P 1 G ( 141 35 31819 00 ), HAEMOCOMPLETTAN P 2 G ( 141 36 31820 00 ) םש לעב םושירה GENMEDIX דבלב תורמחהה טורפל דעוימ הז ספוט ! תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY_ Before administration of Haemocomplettan P 1g/2g_ _ the fibrinogen level should be determined using the method of Clauss. Furthermore, the amount to be administered and the frequency of application of Haemocomplettan P 1g/2g_ _ should always be oriented to the degree of bleeding and the clinical efficacy in the individual case. Generally, 1 to 2 g Fibrinogen is administered initially, with subsequent infusions as required. The critical plasma fibrinogen level below which haemorrhages may occur is 100 mg/dl Normal values are in the range of 200 to 450 mg/dl. The circulating fibrinogen level should not be raised Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders . _POSOLOGY_ The dosage and duration of the substitution therapy depend on the severity of the disorder, location and extent of bleeding and the patient’s clinical condition . The (functional) fibrinogen level should be determined in order to calculate individual dosage and the amount and frequency of administration should be determined on an individual patient basis by regular measurement of plasma fibrinogen level and continuous monitoring of the clinical condition of the patient and other replacement therapies used . Normal plasma fibrinogen level is in the range of 1.5 – 4.5 g/l. The critical plasma fibrinogen level below which haemorrhages may occur is approximately 0.5 – 1.0 g/l. In case of m Lesen Sie das vollständige Dokument
1. NAME OF THE MEDICINAL PRODUCT HAEMOCOMPLETTAN ® P 1G HAEMOCOMPLETTAN ® P 2G Powder for solution for injection / infusion_ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Haemocomplettan is presented as a powder for solution for injection or infusion for intravenous administration containing 1g or 2g human fibrinogen per vial. The product contains approx. 20 mg/ml human fibrinogen after reconstitution with 50 or 100 ml water for injections. The content of clottable fibrinogen is determined according to Ph. Eur. monograph for human fibrinogen. Excipients with known effect: Sodium up to 164 mg (7.1 mmol) per 1g fibrinogen. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder for solution for injection_/_infusion. White powder 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Haemocomplettan P 1g/2g, Fibrinogen Concentrate (Human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Haemocomplettan P 1g/2g is not indicated for dysfibrinogenemia. 4.2 Posology and method of administration Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders. _POSOLOGY_ The dosage and duration of the substitution therapy depend on the severity of the disorder, location and extent of bleeding and the patient’s clinical condition. The (functional) fibrinogen level should be determined in order to calculate individual dosage and the amount and frequency of administration should be determined on an individual patient basis by regular measurement of plasma fibrinogen level and continuous monitoring of the clinical condition of the patient and other replacement therapies used. Normal plasma fibrinogen level is in the range of 1.5 – 4.5 g/l. The critical plasma fibrinogen level below which haemorrhages may occur is approximately 0.5 – 1.0 g/l. In case of major surgical intervention, precise monitoring of replacement therapy by coagulati Lesen Sie das vollständige Dokument