CARIMUNE NANOFILTERED- human immunoglobulin g injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)

Available from:

CSL Behring AG

INN (International Name):

HUMAN IMMUNOGLOBULIN G

Composition:

HUMAN IMMUNOGLOBULIN G 6 g

Administration route:

INTRAVENOUS

Therapeutic indications:

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

Product summary:

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:

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

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