Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)
CSL Behring AG
HUMAN IMMUNOGLOBULIN G
HUMAN IMMUNOGLOBULIN G 6 g
INTRAVENOUS
Carimune® NF is indicated for the maintenance treatment of patients with primary immunodeficiencies (PID), e.g., common variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency.30,32-34 Carimune® NF is preferable to intramuscular Immune Globulin (Human) preparations in treating patients who require an immediate and large increase in the intravascular immunoglobulin level28 , in patients with limited muscle mass, and in patients with bleeding tendencies for whom intramuscular injections are contraindicated. The infusions must be repeated at regular intervals. Please see DOSAGE AND ADMINISTRATION section. A controlled study was performed in children in which Carimune® was compared with steroids for the treatment of acute (defined as less than 6 months duration) ITP. In this study sequential platelet levels of 30,000, 100,000, and 150,000/µL were all achieved faster with Carimune® than with steroids and without any of the side effects associated with steroids.29,35 Howeve
Carimune® NF is available as a white lyophilized powder in 6 and 12 g size vials. The only diluents which may be used to reconstitute the product are sterile (0.9%) Sodium Chloride Injection USP, 5% Dextrose, or Sterile Water. Each product presentation includes a package insert and the following components:
Biologic Licensing Application
CARIMUNE NANOFILTERED- HUMAN IMMUNOGLOBULIN G INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CSL BEHRING AG ---------- IMMUNE GLOBULIN INTRAVENOUS (HUMAN) CARIMUNE NF, NANOFILTERED CSL BEHRING LYOPHILIZED PREPARATION R ONLY WARNING: THROMBOSIS, RENAL DYSFUNCTION, OR ACUTE RENAL FAILURE THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS , INCLUDING CARIMUNE NF. RISK FACTORS MAY INCLUDE: ADVANCED AGE, PROLONGED IMMOBILIZATION, HYPERCOAGULABLE CONDITIONS, HISTORY OF VENOUS OR ARTERIAL THROMBOSIS, USE OF ESTROGENS, INDWELLING CENTRAL VASCULAR CATHETERS, HYPERVISCOSITY, AND CARDIOVASCULAR RISK FACTORS. THROMBOSIS MAY OCCUR IN THE ABSENCE OF KNOWN RISK FACTORS (SEE PRECAUTIONS: THROMBOSIS AND INFORMATION FOR PATIENTS). RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS, AND DEATH MAY OCCUR IN PREDISPOSED PATIENTS WITH IMMUNE GLOBULIN INTRAVENOUS (IGIV) PRODUCTS , INCLUDING CARIMUNE NF. PATIENTS PREDISPOSED TO RENAL DYSFUNCTION INCLUDE THOSE WITH ANY DEGREE OF PRE-EXISTING RENAL INSUFFICIENCY, DIABETES MELLITUS, AGE GREATER THAN 65, VOLUME DEPLETION, SEPSIS, PARAPROTEINEMIA, OR PATIENTS RECEIVING KNOWN NEPHROTOXIC DRUGS. RENAL DYSFUNCTION AND ACUTE RENAL FAILURE OCCUR MORE COMMONLY IN PATIENTS RECEIVING IGIV PRODUCTS CONTAINING SUCROSE. CARIMUNE NF CONTAINS SUCROSE. FOR PATIENTS AT RISK OF THROMBOSIS, RENAL DYSFUNCTION OR ACUTE RENAL FAILURE, ADMINISTER CARIMUNE NF AT THE MINIMUM DOSE AND INFUSION RATE PRACTICABLE. ENSURE ADEQUATE HYDRATION IN PATIENTS BEFORE ADMINISTRATION. MONITOR FOR SIGNS AND SYMPTOMS OF THROMBOSIS AND ASSESS BLOOD VISCOSITY IN PATIENTS AT RISK FOR HYPERVISCOSITY (SEE DOSAGE AND ADMINISTRATION, AND PRECAUTIONS: THROMBOSIS). DESCRIPTION Carimune NF, Nanofiltered, Immune Globulin Intravenous (Human), is a sterile, highly purified polyvalent antibody product containing in concentrated form all the IgG antibodies which regularly occur in the donor population. This immunoglobulin preparation is produced by cold alcohol fractionation from the plasma of US donors. Part of the fractionation may be perf Կարդացեք ամբողջական փաստաթուղթը