Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
ANTI-D IMMUNOGLOBULINS
KAMADA LTD, ISRAEL
J06BB01
SOLUTION FOR INJECTION
ANTI-D IMMUNOGLOBULINS 150 MCG/ML
I.M
Required
KAMADA LTD, ISRAEL
ANTI-D (RH) IMMUNOGLOBULIN
ANTI-D (RH) IMMUNOGLOBULIN
Pregnancy/other obstetric conditions, Suppression of Rh immunization in non-sensitized Rh0 (D) negative women delivering an Rh0 positive baby or when the baby's Rh type is unknown. Suppression of Rh immunization after spontaneous or induced abortions threatened abortion associated with maternal bleeding amniocentesis chorionic villus sampling ruptured tubal pregnancy and significant abdominal trauma. Kam Rh0 -D IM should be given within 72 hours of the event. It may be given even after up to one month although efficacy may be somewhat reduced.Transfusion: Suppression of Rh isoimmunization in Rh0 (D) antigen-negative patients transfused with Rh0 (D) antigen-positive RBCs of blood components containing Rh0 (D) antigen-positive RBCs . Initate treatment within 72 hours of exposure.
2022-01-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת __________ 14-7-13 _____________ םש רישכת תילגנאב רפסמו םושירה KAM-RHO D I.M., 108-73-28991 םש לעב םושירה __________ KAMADA LTD ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח WARNINGS RECOMMENDATIONS REGARDING THROMBOSIS Care should be used when immune globulin products are given to individuals determined to be at increased risk of thrombosis. Patients at increased risk of thrombosis include those with acquired or hereditary hypercoagulable states, prolonged immobilization, in-dwelling vascular catheters, advanced age, estrogen use, a history of venous or arterial thrombosis, cardiovascular risk factors (including history of atherosclerosis and/or impaired cardiac output), and hyperviscosity (including cryoglobulins, fasting chylomicronemia and/or high triglyceride levels, and monoclonal gammopathies). As noted in product labeling, patients at risk for thrombosis should receive immune globulin products at the slowest rate practicable, and these individuals should be monitored for thrombotic complications. Consideration should also be given to measurement of baseline blood viscosity in individuals at risk for hyperviscosity. RECOMMENDATIONS REGARDING HEMOLYSIS Heightened awareness of the potential for hemolysis is recommended in individuals receiving immune globulin products, particularly those who are determined to be at increased risk. Patients at increased risk for hemolysis following treatment with immune globulins include those with non-O blood group types, those who have underlying associated inflammatory conditions, and those receiving high cumulative doses of immune globulins over the course of several days. As noted in product labeling, p Przeczytaj cały dokument
Rh o (D) Immune Globulin (Human) for intramuscular use only. DESCRIPTION KAMRH O -D I.M. is a sterile non-pyrogenic aqueous solution, containing 150 µ g/ml of immune globulin anti-D. It is prepared from pooled Human venous plasma with a high content of anti-D antibodies. Each unit of plasma and each plasma pool used in the manufacture of this product has been tested and found to be non- reactive to Hepatitis B Surface Antigen (HBsAg), anti HIV I-II and anti-HCV. Kamada’s manufacturing process includes a Solvent/Detergent step, that is, treatment with tri-(n-butyl) phosphate and Triton X-100, a step designed to increase the safety of the product by eliminating the risk of transmission of lipid enveloped viruses. In addition the process includes heat- treatment at 60°C for 10 hours, a process long-known to inactivate viruses. Finally the purification process itself has been found to be capable of reducing the concentration of a non-enveloped type virus by several logs. The product is stabilized with 0.3 M Glycine and is preservative free. COMPOSITION Each vial of KAMRH O -D I.M. contains: Rh o (D) Immune Globulin 150 µ g/ml Glycine 2.25% W/V = 0.3 M. ACTIONS AND CLINICAL PHARMACOLOGY PHARMACOLOGY KAMRH O -D I.M. is a sterile non-pyrogenic purified gamma globulin (IgG) solution, manufactured from human plasma containing high titers of anti-Rh o (D). The manufacturing process includes a solvent/detergent treatment and heat - treatment at 60°C for 10 hours, steps that are effective in inactivating viruses such as hepatitis B, hepatitis C, HIV and others. These steps are designed to increase product safety by reducing the risk of virus transmission. KAMRH O -D immune globulin is prepared from human plasma by an ion-exchange column chromatography method. KAMRH O -D I.M. is used to suppress the immune response of non-sensitized Rh o (D) antigen-negative individuals following Rh o (D) antigen-positive red blood cell exposure by fetomaternal hemorrhage during delivery of a Rh o (D) antigen-positive infant, abortion ( Przeczytaj cały dokument