GAMUNEKS

Active material: Human normal immunoglobulin
When ATH: J06BA02
CCF: Preparation, affecting the immune system. Immunoglobulin
ICD-10 codes (testimony): B24, D69.3, D80, D81, D82.0, (D) 51.2, D83, M30.3, Z94
When CSF: 14.05
Manufacturer: TALECRIS BIOTHERAPEUTICS Inc. (United States)

Pharmaceutical form, composition and packaging

Solution for infusion 10% clear or slightly Opalescent colourless or light yellow in colour.

Excipients: glycine (15 mg), water d / and.

10 ml – colorless glass vials (1) – packs cardboard.
25 ml – colorless glass vials (1) – packs cardboard.
50 ml – colorless glass vials (1) – packs cardboard.
100 ml – colorless glass vials (1) – packs cardboard.
200 ml – colorless glass vials (1) – packs cardboard.

Pharmacological action

Human immunoglobulin for on/in the introduction, processed kaprilatom, chromatographically purified.

The preparation contains 9-11% protein and 0.16-0.24 M glycine. No less 98% proteins have electrophoretic mobility of the gamma-globulin. Gamuneks contains a trace amount of fragments of IgA (average 0.046 mg / ml), Igm levels equal to or below limits of quantification (0.002 g / l). Distribution of IgG subclasses similar to those in normal serum.

Gamuneks are made from the pool of blood plasma in healthy donors. Individual portions of plasma, used for the production of Gamuneksa, control on the absence of antibodies to human immunodeficiency virus (HIV-1 and HIV-2), hepatitis c virus and hepatitis b virus surface antigen (HBsAg).

The product contains full opsonirujushhie and nejtralizirujushhie antibodies against pathogens of various infectious diseases. Possesses immunomodulatory properties.

No preservatives.

Pharmacokinetics

The farmakokinetike drug Gamuneks not available.

Testimony

is the primary humoral immunodeficiency (congenital agammaglobulinemia, common variable immunodeficiency, immunodeficiency with overproduction of IgM, associated with x-linked, Wiskott Aldridge novel, severe combined immunodeficiency);

-Idiopathic Thrombocytopenic Purpura.

Dosage regimen

We recommend that you enter Gamuneks with speed 0.01 ml / kg / min (1 mg / kg / min) during the first 30 m. With good endurance speed can be gradually increased to a maximum of 0.08 ml / kg / min (8 mg / kg / min). If you notice side effects, speed can be reduced or infusion interrupted until symptoms disappear. Infusion can then be resumed with speed, best for a given patient.

For patients with a high risk of violations of the kidney are encouraged to lower infusion rate less 8 mg / kg / min (0.08 ml / kg / min). Data on the maximum safe dose, concentration and speed of for patients at risk of developing kidney is missing. In these circumstances, all options must be on the lower level practised indicators.

At the primary humoral immunodeficiency a single dose of the drug Gamuneks is from 300 to 600 mg / kg (3 and 6 ml / kg). Dose should be chosen individually, taking into account the spacing between infuzyami more (3 or 4 of the week).

At idiopathic thrombocytopenic purpura Gamuneks should be added to the total dose 2 g / kg body weight, razdelennoy of 2 dose on 1 g / kg (10 ml / kg), entered in two consecutive days or 5 doses of 0.4 g / kg (4 ml / kg), input for 5 consecutive days. If after entering one of two doses of 1 g / kg (10 ml / kg) There is an adequate increase in the platelet 24 no, the second dose can not enter. Application doses 1 g / kg (10 ml / kg) not recommended for dehydrated patients.

Although clinical trial application in patients with Gamuneksa bone marrow transplantation not performed, data, obtained from the analogue of this drug Gamimunom, indicate the usefulness of Gamuneksa in adult patients with bone marrow transplantation.

The recommended dose of Gamuneksa at older patients 20 years is 500 mg / kg (5 ml / kg). The drug was administered 7 and 2 days before the transplant and then weekly during 3 Months.

Clinical trials at Gamuneksa HIV-infected children not performed. However, an analogue of the drug Gamimun, recommended dose 400 mg / kg (4 ml / kg). The drug is injected at intervals 28 d.

Terms of preparation of the solution

We recommend that you enter Gamuneks, using an independent system, not mixing it with other liquids or medications, who gets sick.

Prior to the introduction of the drug should be visually checked for the absence of foreign particles, turbidity and discoloration.

To pierce the Cork when taking the drug from a vial, contains 10 ml of the product, should only be used needle size 18. Needle size 16 or distributing punches should only be used for bottles, containing 25 ML and more of the drug. The needle should pierce the Cork perpendicular to the plane only in terms of.

The contents of the vials may be connected in aseptic conditions in sterile packages and used within 8 h after the merger.

Side effect

With the introduction of the drug Gamuneks could develop the same adverse reactions, After the/m and/in the introduction of drugs immunoglobulin rights other. These include:

From the digestive system: vomiting, nausea, stomach ache

Allergic reactions: hives; rarely – rash.

CNS: anxiety, dizziness, fainting,

On the part of the musculoskeletal system: mialgii, arthralgia.

From the body as a whole: tides, breathlessness, chills, fever, headache .

These reactions have a link with a speed of injection, Therefore, you should strictly comply with recommendations on its implementation.

Have predisposed patients introduction Gamuneksa can lead to the development of renal failure.

There may be side effects, not identified after the introduction of the drug Gamuneks, but previously observed in other immunoglobulin in/m introduction.

Rarely: bronchospasm, cyanosis, liver dysfunction, anoxemia, pulmonary edema, convulsions, thromboembolism, tremor, dyspnoea, gipotenziya, pyrexia, gemoliz, positive direct test antiglobulinovyj (Kumʙsa), back pain and stomach.

There have been reports about the development in rare cases of aseptic meningitis syndrome when in/with the introduction of human immunoglobulin. The syndrome usually develops after a few hours (up to two days) After the introduction and characterized by a strong headache, stiffness of the muscles of the neck, sleepiness, fever, photophobia, pain when moving the eyeballs, nausea and vomiting. Aseptic meningitis syndrome is more common in applying the drug in high doses (2 g / kg) and/or high speed/infusion. Ending in/with the introduction of immunoglobulin leads to regression of aseptic meningitis syndrome for several days without consequences.

Typical anaphylactic reactions to the introduction of Gamuneksa can be observed in patients, have a history of severe allergic reaction to the in/m introduction IgG, but in some cases cautious on/in the introduction of immunoglobulin adverse reactions may not occur. Very rare anaphylactic reactions may occur in persons, did not have a history of allergic reactions to the in/m or/with the introduction of immunoglobulins.

Contraindications

-anaphylactic or severe systemic reaction to the imposition of human immunoglobulin.

C extreme caution Gamuneks should be appointed patients with selective IgA deficiency heavy (serum IgA<0.05 g / l) in the presence of antibodies to immunoglobulinu and (due to the risk of immediate hypersensitivity reactions, including anaphylaxis).

Pregnancy and lactation

No data on the feasibility and safety of drugs Gamuneks in pregnancy and lactation.

Cautions

There is evidence, that in/with the introduction of human immunoglobulin may result in a violation of the kidney, Acute renal failure, Osmotic nefrozu and death. An increased risk of developing acute renal failure exists with a history of renal failure of any degree of severity, for patients with diabetes, patients aged over 65 years, When the reduced allocation of urine volume, sepsis, paraproteinaemias, and in patients, at the same time receiving nefrotoksicskie drugs. In all of these situations, in/in the introduction should be a minimum of immunoglobulin concentrations and with a minimum speed of introduction.

In rare cases, the use of immunoglobulin preparations may cause expressed lower ad and clinical picture of anaphylaxis, even in those cases, When previously there was no patient hypersensitivity to drugs immunoglobulin. In this regard, the on/in the introduction should be available Gamuneksa means protivosokova therapy, primarily epinephrine (adrenaline).

Prior to the in/in infusion Gamuneksa you should make sure, that the patient is not reduced by the amount of allocation of urine.

Periodic monitoring of kidney function and diuresis is especially important in patients with increased risk of acute renal failure. Monitoring kidney function, including measuring blood urea nitrogen and serum creatinine, to be held prior to the start of treatment Gamuneksom and implemented in the course of treatment. If any of the kidneys should consider ending further treatment. In patients at risk of developing kidney justified the introduction of Gamuneksa in a dose of less than 8 mg / kg / min (0.08 ml / kg / min).

The contents of each bottle must be Gamuneksa be used immediately. Partially used vials must be discarded. Each vial before use browsing. The drug is not subject to the application of, If the content of the vial muddy or frozen.

Overdose

The cases of drug overdose Gamuneks not documented.

Drug Interactions

Gamuneks not compatible with salt solutions. If necessary Gamuneks can be diluted 5% aqueous solution of sucrose.

There had been no definition of compatibility or interoperability with other drugs Gamuneksa.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored and transported at a temperature from 2° to 8° c; Do not freeze. Shelf life – 36 Months.

Perhaps the drug store temperatures up to 25° c for 6 months at any time during the 36-month shelf life, after which the preparation should be used immediately or throw.

The drug expired application can not be.

Withdrawal of the drug from the refrigerator retirement date should be recorded in the appropriate box outer packaging.

Keep out of the reach of children.