Active substanceThe human immunoglobulin is normalThe human immunoglobulin is normal
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  • Dosage form: & nbspsolution for infusions
    Composition:

    1 ml contains:

    The human immunoglobulin is normal

    - 100 mg

    Glycine

    - 15 mg

    Water for injections

    - up to 1 ml

    Description:Transparent or slightly opalescent colorless or light yellow liquid.
    Pharmacotherapeutic group:MIBP - globulin
    ATX: & nbsp

    J.06.B.A.02   Immunoglobulin normal human for intravenous administration

    Pharmacodynamics:

    Gamunex® C (The human immunoglobulin is normal), treated with caprylate, purified chromatography is ready for use by a human immunoglobulin for intravenous administration. The gamunex® C contains 9-11% protein and 0.16-0.24 M glycine. At least 98% of proteins have electrophoretic mobility of gamma-globulin. The gamunex® C contains trace amounts of fragments and IgA (mean 0.046 mg / ml), levels IgM are equal to or below the limits of quantitation (0.002 g / l). Distribution of subclasses IgG similar to that in normal serum. The buffer capacity of the preparation is 35 mEq/ l, osmolality 258 mOsmol/ kg of the solvent. pH 4.0-4.5. Does not contain preservatives. Gamunex® C is made from a pool of blood plasma from healthy donors. Individual portions of plasma used for the production of Gamunex® C are monitored for the absence of antibodies to HIV-1 and HIV-2, hepatitis C virus, and hepatitis B surface antigen (HBsAg).

    Gamunex® C contains valuable opsonizing and neutralizing antibodies against infectious agents of various infectious diseases. Has immunomodulatory properties.

    Indications:

    Primary humoral immunodeficiency (PGI) (congenital agammaglobulinemia, general variable immunodeficiency, immunodeficiency with hyperproduction Ig M, associated with the X-chromosome, Wiskott Aldridge syndrome and severe combined immunodeficiencies).

    Idiopathic thrombocytopenic purpura (ITP).

    Chronic inflammatory demyelinating polyneuropathy (CVD)
    Contraindications:

    Anaphylactic or severe systemic reactions to the administration of human immunoglobulin.

    Patients with severe selective deficiency IgA (whey IgA<0.05 g / l), in the presence of antibodies to immunoglobulin A, can receive Gamunex with exceptional precautions in view of the risk of developing an immediate hypersensitivity reaction, including anaphylaxis.

    Carefully:

    There is evidence that intravenous administration of human immunoglobulin can lead to renal dysfunction, acute renal failure, osmotic nephrosis, and death.For patients predisposed to acute renal failure include patients with any degree of renal failure in history, diabetes, over 65 years, with a reduced amount of urine, sepsis, paraproteinemia or patients receiving known nephrotoxic drugs. In these patients, intravenous immunoglobulins should be used in minimal concentrations and with a minimum rate of administration.

    Dosing and Administration:

    Recommended administered Gamuneks® C initially at a rate of 0.01 ml / kg / min (1 mg / kg / min) during the first 30 min. With good tolerability, the rate can be gradually increased to a maximum of 0.08 ml / kg / min (8 mg / kg / min). If side effects are observed, the rate may be reduced or the infusion is interrupted until the symptoms disappear. Infusions can then be resumed at a rate optimal for the patient.

    Patients with increased risk for renal dysfunction may be advised to decrease the amount of administered drug in unit time is less than 8 mg / kg / min (0.08 ml / kg / min). Data on the maximum safe dose, concentration and rate of administration for patients at risk of developing renal dysfunction are absent. In these conditions, all parameters should be at the lowest level of the practiced indicators.

    Before administration, the drug should be visually inspected for absence of foreign particles, turbidity and discoloration.

    To puncture the plug when taking the drug from a vial containing 10 ml of the drug, only size 18 needles should be used. Needles of size 16 or distributing piercers should be used only for vials containing 25 ml or more of the preparation. The needle should pierce the plug perpendicular to the plane only within the designated circle.

    The contents of the vials can be connected under aseptic conditions to sterile packets and used within 8 hours after combining.

    Primary humoral immunodeficiency (PGI)

    A single dose of Gamunex® C is 300 to 600 mg / kg (3 and 6 ml / kg). Doses should be individualized taking into account the intervals between infusions (3 or 4 weeks).

    Idiopathic thrombocytopenic purpura (ITP)

    The gamunex® C can be used in a total dose of 2 g / kg divided into two doses of 1 g / kg (10 ml / kg) administered two consecutive days or 5 doses of 0.4 g / kg (4 ml / kg) administered for 5 consecutive days. If after introduction of one of two doses of 1 g / kg (10 ml / kg) there is an adequate increase in platelets by 24 h, the second dose can not be administered.The dose of 1 g / kg (10.0 ml / kg) is not recommended for dehydrated patients.

    Chronic inflammatory demyelinating polyneuropathy (CVD)

    The initial total dose of Gamunex® C is 2 g / kg (20 ml / kg) and is administered in 2 or 4 consecutive daily doses. The maintenance total dose of the drug is 1 g / kg (10 ml / kg), which is administered simultaneously or for 2 consecutive days at 0.5 g / kg (5 ml / kg). The interval between doses is 3 weeks. The duration of treatment is determined by positive manifestations during the course of the disease.

    Bone marrow transplantation

    Although no clinical trials of Gamunex® C have been performed in this category of patients, the data obtained with the analogue of this drug Gamimun indicate the advisability of using Hamunex in adult patients in bone marrow transplantation.

    The recommended dose of Gamunex® C in individuals over the age of 20 is 500 mg / kg (5 ml / kg). The drug is administered 7 and 2 days before transplantation and then weekly for 3 months.

    HIV infection in children

    There were no clinical trials of Gamunex® C in HIV-infected children. However, the analogue of Gamunex® C, an intravenous human immunoglobulin Gamimun, is recommended at a dose of 400 mg / kg (4 ml / kg). The drug is administered at intervals of 28 days.

    Side effects:

    With the administration of the drug Gamunex ® C, the same reactions can develop as after the intramuscular and intravenous administration of other human immunoglobulin preparations. These include: vomiting, nausea, urticaria, restlessness, hot flashes, shortness of breath, abdominal pain, myalgia, arthralgia, dizziness, fainting, chills, fever, headache, very rarely rash. These reactions are associated with the rate of administration of the drug, therefore, it is necessary to strictly follow the recommendations for its use. In individuals with kidney disease, the administration of Gamunex® C can lead to the development of renal failure.

    There may be side effects not identified after the administration of Gamunex® C, but previously observed with other IVIG preparations for intramuscular injection.

    Rare adverse reactions include: bronchospasm, cyanosis, liver dysfunction, hypoxemia, pulmonary edema, convulsions, thromboembolism, tremor, dyspnea, hypotension, pyrexia, hemolysis, positive direct antiglobulin test (Coombs), back and stomach pain.

    There are reports of rare cases of aseptic meningitis (AMS) syndrome with intravenous injection of human immunoglobulin.The syndrome usually develops in a few hours (up to two days) after administration and is characterized by severe headache, neck stiffness, drowsiness, fever, photophobia, painful movement of eyeballs, nausea and vomiting. CAM is more common at high doses (2 g / kg) and / or rapid infusion. Termination of IVIG treatment results in remission of CAM within a few days without consequences.

    Typical anaphylactic reactions to Gamunex ® C can be observed in patients with severe allergic reactions to intramuscular IgG, but some patients can tolerate IVIG injected cautiously without adverse reactions. Very rarely, anaphylactic reactions can occur in persons who did not have any history of allergic reactions to intramuscular or intravenous immunoglobulins.

    In rare cases, treatment with immunoglobulin preparations can cause a drop in blood pressure and a clinical picture of anaphylaxis, even in cases when the patient's sensitivity to immunoglobulin preparations was previously absent. In this regard, with the introduction of the drug should be available in the form of antishock therapy, primarily adrenaline.

    Interaction:

    Gamunex® C not compatible with saline solutions. If necessary, gamunex® C can be diluted with 5% aqueous solution of sucrose.

    The compatibility or interaction of gamunex® with other drugs has not been determined.

    It is recommended that gamunex® C be administered using an independent system, without mixing it with other fluids or drugs that are simultaneously receiving the patient.

    Special instructions:

    The contents of each opened vial should be used immediately. Partially used vial should be discarded. Each bottle is scanned before use. The drug is not to be used if the contents of the vial are cloudy or frozen.

    Before starting IVG infusion, you need to make sure that the patient does not have a decrease in urine output. Periodic monitoring of kidney function and urinary excretion is especially important in patients predisposed to develop acute renal failure. Control of kidney function, including measurement of urea nitrogen in the blood and serum creatinine, should be performed prior to the commencement of Gamunex® C treatment and be performed during treatment. If renal dysfunction should be considered, discontinue further treatment.In patients at risk of developing renal dysfunction, it is justified to administer Gamunex® C in an amount of less than 8 mg IG / kg / min (0.08 ml / kg / min).

    Form release / dosage:

    Solution for infusions, 10%.

    Packaging:

    10 ml, 25 ml, 50 ml, 100 ml or 200 ml in bottles of colorless transparent neutral glass (Class II in USP) capped with chlorobutyl stoppers.

    The bottle is crimped with an aluminum cap with a plastic lid sealed with a hot-melt film.

    For 1 bottle in a cardboard box with instructions for use.

    Storage conditions:

    Store and transport at a temperature of 2-8 ° C.

    Do not freeze.

    Shelf life:

    36 months.

    It is possible to store the drug at a temperature of up to 25 ° C for 6 months at any time during the 36-month shelf life, after which the drug should be immediately used or discarded.

    The drug with expired shelf life is not subject to application.

    When the drug is withdrawn from the refrigerator, the date of withdrawal should be recorded in the appropriate box of the outer packaging.

    Keep out of the reach of children.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002531/08
    Date of registration:04.04.2008
    The owner of the registration certificate:Grifols Therapyutics Inc.Grifols Therapyutics Inc. USA
    Manufacturer: & nbsp
    Representation: & nbspR-PHARM, JSC R-PHARM, JSC Russia
    Information update date: & nbsp15.10.2015
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