Composition, form of production and packaging
Solution for infusions 10% transparent or slightly opalescent colorless or light yellow in color.
1 ml
human immunoglobulin 100 mg
buffer capacity - 35 mEq / l theoretical osmolality - 258 mOsmol / kg pH 4.0-4.5
Excipients: glycine (15 mg), water d / and.
10 ml - vials of colorless glass (1) - packs cardboard.
25 ml - vials of colorless glass (1) - packs cardboard.
50 ml - vials of colorless glass (1) - packs cardboard.
100 ml - vials of colorless glass (1) - packs cardboard.
200 ml - vials of colorless glass (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Human immunoglobulin for intravenous administration, treated with caprylate, purified chromatographically.
The preparation contains 9-11% protein and 0.16-0.24 M glycine. At least 98% of proteins have electrophoretic mobility of gamma globulin. The gamunex contains trace amounts of IgA fragments (average 0.046 mg / ml), IgM levels are equal to or below the limits of quantitation (0.002 g / l). The distribution of subclasses of IgG is similar to that of normal serum.
Gamuneks are made from a pool of blood plasma from healthy donors. Individual plasma portions used for the production of Hamunex are monitored for the absence of antibodies to human immunodeficiency virus (HIV-1 and HIV-2), hepatitis C virus, and hepatitis B surface antigen (HBsAg).
The preparation contains valuable opsonizing and neutralizing antibodies against the causative agents of various infectious diseases. Has immunomodulatory properties.
Does not contain preservatives.
PHARMACOKINETICS
Data on the pharmacokinetics of the drug Gamuneks are not available.
INDICATIONS
- Primary humoral immunodeficiency (congenital agammaglobulinemia, general variable immunodeficiency, immunodeficiency with hyperproduction of IgM, associated with the X-chromosome, Wiskott-Aldridge syndrome, severe combined immunodeficiency);
idiopathic thrombocytopenic purpura.
DOSING MODE
It is recommended that gamunex be administered at a rate of 0.01 ml / kg / min (1 mg / kg / min) for 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 the optimal rate for a particular patient.
For patients with an increased risk of developing renal dysfunction, a reduction in the infusion rate of less than 8 mg / kg / min (0.08 ml / kg / min) is recommended.Data on the maximum safe dose, concentration and rate of administration for patients at risk of developing renal dysfunction are not available. In these conditions, all parameters should be at the lowest level of the practiced indicators.
In the case of primary humoral immunodeficiency, a single dose of Gamuneks is 300 to 600 mg / kg (3 and 6 ml / kg). Dose should be selected individually, taking into account the intervals between infusions (3 or 4 weeks).
In idiopathic thrombocytopenic purpura, Gamuneks should be administered at a total dose of 2 g / kg body weight divided into 2 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 ml / kg) is not recommended for dehydrated patients.
Although clinical trials of the application of gamunex in patients with bone marrow transplantation have not been performed, the data obtained with the analogue of this drug Gamimun indicate the advisability of using Hamunex in adult patients with bone marrow transplantation.
The recommended dose of Gamuneks in patients older than 20 years is 500 mg / kg (5 ml / kg). The drug is administered 7 and 2 days before transplantation and then weekly for 3 months.
There were no clinical trials of Gamunex in HIV-infected children . However, the analogue of this drug Gamimun, is recommended in a dose of 400 mg / kg (4 ml / kg). The drug is administered at intervals of 28 days.
Rules for the preparation of solution
It is recommended to administer Hamunex using an independent system, without mixing it with other fluids or drugs that are simultaneously receiving the patient.
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.
SIDE EFFECT
With the introduction of the drug Gamuneks, the same adverse reactions can develop as with the IM and / or the administration of other human immunoglobulin preparations. These include:
On the part of the digestive system: vomiting, nausea, abdominal pain.
Allergic reactions: urticaria; very rarely - a rash.
From the side of the central nervous system: anxiety, dizziness, fainting.
From the musculoskeletal system: myalgia, arthralgia.
On the part of the body as a whole: hot flashes, shortness of breath, chills, fever, headache.
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 predisposed patients, the administration of Gamunex can lead to the development of renal failure.
There may be side effects not detected after the administration of the drug Gamunex, but previously observed with the use of other immunoglobulin preparations for the / m administration.
Rarely: 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 the development in rare cases of the syndrome of aseptic meningitis with IV injection of human immunoglobulin. The syndrome usually develops in a few hours (up to two days) after administration and is characterized by severe headache, stiff neck muscles, drowsiness, fever, photophobia, painful movement of eyeballs, nausea and vomiting. The syndrome of aseptic meningitis is more common when the drug is used in high doses (2 g / kg) and / or high speed of intravenous infusion. Termination of intravenous immunoglobulin leads to regression of the syndrome of aseptic meningitis for several days without consequences.
Typical anaphylactic reactions to administration of Gamunex can be observed in patients who have a history of severe allergic reactions to the / m introduction of IgG, but in some cases, with cautious in / in the introduction of immunoglobulin, adverse reactions may not occur. Very rarely, anaphylactic reactions can occur in persons who have not had an allergic reaction to the / m or IV injection of immunoglobulins in the anamnesis.
CONTRAINDICATIONS
- Anaphylactic or severe systemic reactions to the administration of human immunoglobulin.
With exceptional caution , gamunex should be administered to patients with severe selective IgA deficiency (serum IgA <0.05 g / l) in the presence of antibodies to immunoglobulin A (due to the risk of developing an immediate hypersensitivity reaction, including anaphylaxis).
PREGNANCY AND LACTATION
There is no evidence of the possibility and safety of the use of the drug Gamunex during pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Periodic monitoring of kidney function and diuresis is especially important in patients with an increased risk of developing acute renal failure. Control of kidney function, including measurement of urea nitrogen in the blood and serum creatinine, should be performed before the beginning of treatment with Gamuneks and be carried out during treatment. If renal dysfunction should be considered, discontinue further treatment. In patients at risk of developing renal dysfunction, the administration of gamuneux at a dose of less than 8 mg / kg / min (0.08 ml / kg / min) is justified.
APPLICATION FOR CHILDREN
There were no clinical trials of Gamunex in HIV-infected children . However, the analogue of this drug Gamimun, is recommended in a dose of 400 mg / kg (4 ml / kg). The drug is administered at intervals of 28 days.
SPECIAL INSTRUCTIONS
There is evidence that IV administration of human immunoglobulin can lead to impaired renal function, acute renal failure, osmotic nephrosis, and death. An increased risk of developing acute renal failure exists in the presence of a history of kidney failure of any severity, in diabetes mellitus, in patients over the age of 65, with reduced urine output, sepsis, paraproteinemia, as well as in patients receiving nephrotoxic drugs simultaneously. In all of the above situations, intravenous immunoglobulin should be administered in minimal concentrations and at a minimal rate of administration.
In rare cases, the use of immunoglobulin preparations can cause a pronounced decrease in blood pressure and a clinical picture of anaphylaxis, even in cases where the patient previously had no hypersensitivity to immunoglobulin preparations. In this regard, with / in the introduction of Gamuneks should be available means of anti-shock therapy, primarily epinephrine (adrenaline).
Prior to the onset of an intravenous infusion of Gamunex, one should make sure that the patient does not have a decrease in the volume of urine output.
Periodic monitoring of kidney function and diuresis is especially important in patients with an increased risk of developing acute renal failure. Control of kidney function, including measurement of urea nitrogen in the blood and serum creatinine, should be performed before the beginning of treatment with Gamuneks and be carried out during treatment. If renal dysfunction should be considered, discontinue further treatment. In patients at risk of developing renal dysfunction, the administration of gamuneux at a dose of less than 8 mg / kg / min (0.08 ml / kg / min) is justified.
The contents of each opened vial of Hamunex 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.
OVERDOSE
Cases of an overdose of the drug Gamuneks are not described.
DRUG INTERACTION
Gamunex is not compatible with saline solutions. If necessary, the Gamunex can be diluted with 5% aqueous solution of sucrose.
The compatibility or interaction of gamunex with other drugs has not been determined.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored and transported at a temperature of 2 В° to 8 В° C; Do not freeze. Shelf life - 36 months.
It is possible to store the drug at a temperature of up to 25 В° 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.
