Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
IMMUNOGLOBULINS, NORMAL HUMAN
TAKEDA ISRAEL LTD
J06BA02
SOLUTION FOR INFUSION
IMMUNOGLOBULINS, NORMAL HUMAN 100 MG / 1 ML
I.V
Required
BAXTER AG, AUSTRIA
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
IVIg can be used in all age ranges, unless otherwise specified below.Replacement therapy in:Primary immunodeficiency syndromes with impaired antibody production.Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed.Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation.Children and adolescents (age 0-18) with congenital AIDS and recurrent bacterial infections.Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT).ImmunomodulationPrimary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.Guillain Barré syndrome.Kawasaki disease.
2016-06-30
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ןולעב )תוחיטב אפורל אפורל אפורל יאמ ןכדועמ ,דבלב תורמחהה טורפל דעוימ הז ספוט 5102 ךיראת 2 NOV 2015 תילגנאב רישכת םש KIOVIG 100 MG/ ML SOLUTION FOR INFUSION םושירה רפסמ 641-44-55643 םושירה לעב םש TEVA MEDICAL MARKETING LTD תורמחהה קובמה ש תו ןולעב קרפ יחכונ טסקט שדח טסקט SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE In all patients, IVIg administration requires: adequate hydration prior to the initiation of the infusion of IVIg monitoring of urine output monitoring of serum creatinine levels avoidance of concomitant use of loop diuretics. […] Thromboembolism … Caution should be exercised in prescribing and infusion of IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, hypercoagulable disorders, patients with prolonged periods of immobilisation, severely hypovolemic patients, patients with diseases which increase blood viscosity). […] Acute renal failure ... In most cases, risk factors have been identified, such as pre-existing renal insufficiency, In all patients, IVIg administration requires: adequate hydration prior to the initiation of the infusion of IVIg monitoring of urine output monitoring of serum creatinine levels monitoring for signs and symptoms of thrombosis assessment of blood vicosity in patients at risk for hyperviscosity avoidance of concomitant use of loop diuretics. […] Thromboembolism … Caution should be exercised in prescribing and infus Olvassa el a teljes dokumentumot
1 1. NAME OF THE MEDICINAL PRODUCT _ _ KIOVIG 100 mg/ml _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg) One ml contains: Human normal immunoglobulin ……………...100 mg (purity of at least 98% is IgG) Each vial of 10 ml contains: 1 g of human normal immunoglobulin Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin Each vial of 300 ml contains: 30 g of human normal immunoglobulin Distribution of IgG subclasses (approx. values): IgG1 ≥ 56.9% IgG2 ≥ 26.6% IgG3 ≥ 3.4% IgG4 ≥ 1.7% The maximum IgA content is 140 micrograms/ml . Produced from the plasma of human donors. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion . The solution is clear or slightly opalescent and colourless or pale yellow. 2 4. CLINICAL PARTICULARS 4.1 Therapeutic indications IVIg can be used in all age ranges, unless otherwise specified below Replacement therapy in: • Primary immunodeficiency syndromes ( PID ) with impaired antibody production (see section 4.4). • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed. • Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation. • Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT). • Children and adolescents (age 0-18) with congenital AIDS and recurrent bacterial infections. Immunomodulation: • Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. • Guillain-Barré syndrome. • Kawasaki disease. 4.2 Posology and method of administration Replacement therapy should be initia Olvassa el a teljes dokumentumot