Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
ANTI-D IMMUNOGLOBULINS
KAMADA LTD, ISRAEL
J06BB01
SOLUTION FOR INJECTION
ANTI-D IMMUNOGLOBULINS 150 MCG / 1 ML
I.V
Required
KAMADA LTD, ISRAEL
ANTI-D (RH) IMMUNOGLOBULIN
ANTI-D (RH) IMMUNOGLOBULIN
Suppression of Rh immunization in non-sensitized Rho(D) negative women delivering an Rh 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-Rho should be given within 72 hours of event. Immune thrombocytopenic purpura (ITP): Rho (d)-positive adults with chronic ITP, children with chronic or acute ITP, and patients with Thrombocytopenia secondary to HIV infection in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage.
2013-03-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת __________ 11-7-13 _____________ םש רישכת תילגנאב רפסמו םושירה _ 127-78-28761 _ KAM-RHO (D) I.V . _ םש לעב םושירה __________ KAMADA LTD ! דבלב תורמחהה טורפל דעוימ הז ספוט 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 infusion 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. For patients judged to be a risk of developing thrombotic events, administer Rh0D immune Globulins at a minimum rate of infusion. 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 infl Olvassa el a teljes dokumentumot
1 KAM_RH_ _O_ -D I.V. Rh 0 (D) Immune Globulin (Human) for intravenous use only. WARNING: INTRAVASCULAR HEMOLYSIS (IVH) INTRAVASCULAR HEMOLYSIS (IVH) LEADING TO DEATH HAS BEEN REPORTED IN PATIENTS TREATED FOR IMMUNE THROMBOCYTOPENIC PURPURA (ITP) WITH RH 0 D IMMUNE GLOBULINS. IVH CAN LEAD TO CLINICALLY COMPROMISING ANEMIA AND MULTI-SYSTEM ORGAN FAILURE INCLUDING ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). SERIOUS COMPLICATIONS INCLUDING SEVERE ANEMIA, ACUTE RENAL INSUFFICIENCY, RENAL FAILURE AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC) HAVE ALSO BEEN REPORTED. Closely monitor patients treated with KAM_RH_ _O_ -D I.V. for ITP in a health care setting for at least eight hours after administration. Perform a dipstick urinalysis at baseline, 2 hours, 4 hours after administration and prior to the end of the monitoring period. Alert patients and monitor the signs and symptoms of IVH, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently. If signs and/or symptoms of IVH are present or suspected after KAM_RH_ _O_ -D I.V. administration, post-treatment laboratory tests should be performed, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect). DESCRIPTION KAM_RH_ _O_ -D I.V. is a sterile non-pyrogenic aqueous solution, containing 150 g/mL (1500 IU/2 ml) of immune globulin anti-D. KAM_RH_ _O_ -D I.V. immune globulin is prepared from Human plasma by an ion - exchange column chromatography method, and it is manufactured from pooled Human venous plasma with a high content of anti-D antibodies. Each unit of plasma used in the manufacture of this product has been tested and found to be negative/non-reactive to Hepatitis B Surface Antigen (HBsAg), HIV-1 antigen, anti-HIV I-II and anti-HCV. In addition, the plasma has been tested by a NAT method and found to be negative for HAV, HIV, HBV and HCV and to contain < 10 4 I.U/mL Parvovirus B-19. The plasma p Olvassa el a teljes dokumentumot