Immunoglobulin normal - instructions for use, dose, side effects, contraindications

Transparent or slightly opalescent liquid, colorless or slightly yellow in color. During storage, a slight white precipitate may appear, completely disappearing when the preparation is shaken.

Pharmacotherapeutic group:Immunoglobulin

ATX: & nbsp

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

Pharmacodynamics:

Characteristics of the preparation

Concentrated solution of immunologically active protein fraction of human blood plasma, isolated by fractionation with ethyl alcohol at low temperatures. To produce a series of drugs, use human blood plasma obtained from at least 1000 healthy donors, individually tested for the absence of antibodies to HIV-1, HIV-2, to hepatitis C virus and the surface antigen of the hepatitis B virus.

Pharmacological properties

The active principle of the preparation is immunoglobulins, mainly of the class G (IgG), possessing the activity of antibodies of different specificity. Distribution of subclasses IgG corresponds to their distribution in the native plasma of human blood. The maximum concentration of antibodies in the blood is reached after 24-48 hours; the half-life of antibodies from the body is 3-4 weeks. Immunoglobulins also increase the nonspecific resistance of the body.

Indications:

Prevention of hepatitis A and measles.

Contraindications:

- Alaryngic reactions or severe systemic reactions to the administration of human blood products in anemia;

- hypersensitivity to an auxiliary substance.

Pregnancy and lactation:

The safety of the use of normal human immunoglobulin preparations during pregnancy and during breastfeeding has not been studied in controlled clinical trials, so their administration to pregnant women and women during breastfeeding should be done with caution. The experience of the clinical use of immunoglobulin allows us to conclude that there is no adverse effect on the course of pregnancy, on the fetus or on the child during breastfeeding.

Dosing and Administration:

Immunoglobulin is given intramuscularly, in the upper outer quadrant of the gluteus muscle or the external surface of the thigh. Before the injection, the ampoule with the drug is kept for several minutes at room temperature.

The drug in the opened ampoule is not subject to storage. The drug is not suitable for use in ampoules with broken integrity or marking, with changing physical properties (color change, cloudiness of solution, presence of unbreakable flakes), expired shelf life and non-observance of storage conditions.

The dose of immunoglobulin and the frequency of its administration depend on the indications for use and the age of the patient.

Prevention of hepatitis A

The drug is administered once, if less than 2 weeks have passed since the possible infection: 0.75 ml for children from 1 to 6 years, -1.5 ml for 7-10 years, 10 years for adults and 3 ml for adults.

Repeated administration of immunoglobulin in case of need of prophylaxis of hepatitis A is shown not earlier than in 2 months.

Prevention of measles

The drug is administered once from three months of age to persons who have not had measles and are not vaccinated against this infection, no later than 6 days after contact with the patient.The dose of the drug to children (1.5 or 3 ml) is determined depending on the health status and the time elapsed from the moment of contact. The adult drug is given in a dose of 3 ml.

Side effects:

Reactions to the introduction of immunoglobulin, as a rule, are absent.

Common reactions are possible: headache, dizziness, chills, nausea, vomiting, arthralgia, back pain, lowering of blood pressure, fever. In rare cases, local reactions can develop in the form of edema, soreness, redness, denseness, burning, itching, bruising, rash.

In very rare cases, the use of immunoglobulins can cause a sharp drop in blood pressure, anaphylactic shock, and therefore persons who have been injected should be under medical supervision within 30 minutes after its introduction. Vaccination sites should be provided with anti-shock therapy.

Overdose:

The effects of an overdose are not known.

Interaction:

The use of immunoglobulin may interfere with the formation of immunity in vaccination with weakened live viral vaccines from measles, rubella, mumps and varicella.In this regard, after the introduction of immunoglobulin vaccinations against these infections are carried out no earlier than 3 months.

After vaccination against these infections, immunoglobulin preparations should be administered no earlier than 2 weeks; If immunoglobulin is required before this time, vaccination should be repeated. In the case of measles, a decrease in the effectiveness of the vaccine can last for 1 year. Therefore, in patients vaccinated against measles, it is necessary to control the level of antibodies.

Vaccinations against other infections can be carried out at any time before or after the administration of the immunoglobulin.

Special instructions:

With the introduction of immunoglobulin, it is necessary to take into account the possible changes in immunological parameters.

The production of blood or human plasma drugs includes a set of measures that prevent the transmission of infections to patients. Such measures include the careful selection of blood and plasma donors to prevent the donation of people at risk, testing each unit of blood or plasma and the pool of plasma for viruses / infections. Manufacturers of such medicines also take measures to process blood or plasma, which allow inactivating or removing viruses.Despite the observance of these measures, it is impossible to completely eliminate the risk of transmission of infection, including unknown or newly discovered viruses or other types of infection, when manufacturing medicinal products from human blood or plasma.

With the introduction of each dose of the drug, it is strongly recommended that its name and series be recorded in order to retain information about it.

Precautions for use

The drug is not intended for intravenous administration; Intravenous administration can lead to shock.

Persons with allergic diseases or having a history of severe allergic reactions, on the day of administration of the immunoglobulin and for the next 3 days, the appointment of antihistamines is recommended.

Persons suffering from systemic immunopathological diseases (diseases of the blood, connective tissue, nephritis, etc.) should be administered immunoglobulin against the background of appropriate therapy.

Effect on the ability to drive transp. cf. and fur:

Some undesirable reactions associated with the action of the drug may have an effect on the ability to drive a vehicle or moving machinery.For patients who experience undesirable reactions when administering the drug, driving or moving vehicles is only possible after the symptoms of unwanted reactions have disappeared.

Form release / dosage:Solution for intramuscular injection, 1.5 ml / dose.

Packaging:

For 1.5 ml (1 dose) or 3 ml (2 doses) in ampoules with a fracture ring made of glass HC with a capacity of 3 and 5 ml, respectively.

For 10 ampoules are placed in a tray of corrugated cardboard and together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of 2 to 8 ° C. Freezing is not allowed.

Keep out of the reach of children.

Transportation conditions

Transport in accordance with SP 3.3.2.1248-03, at a temperature of 2 to 8 ° C. Freezing is not allowed.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003823

Date of registration:06.09.2016

Expiration Date:06.09.2021

The owner of the registration certificate:Chelyabinsk Regional Blood Transfusion StationChelyabinsk Regional Blood Transfusion Station Russia

Manufacturer: & nbsp

Chelyabinsk Regional Blood Transfusion Station Russia

Information update date: & nbsp07.11.2017

Illustrated instructions

Instructions

The human immunoglobulin is normal (Immunoglobulinum humanum normale)