Human immunoglobulin normal, 100 mg/ml 1.5 ml 10 pcs

Prevention of hepatitis A and measles.

Active ingredient

Human immunoglobulin normal

Composition

In 1 ml of the drug contains:

Active ingredients:
-human plasma proteins of which immunoglobulin G is at least 97% – 100 mg.

Additives:
– glycine (aminoacetic acid) – 22.5 mg;
– water for injection – up to 1 ml.

The drug contains no preservatives or antibiotics.

How to take, the dosage

The drug is injected intramuscularly into the upper outer quadrant of the gluteal muscle or the outer surface of the thigh.

The drug must not be administered intravenously.

The temperature of the drug must be brought to room temperature or body temperature before administration. The opening of the ampoule and the procedure of injection are performed in strict compliance with the rules of asepsis and antisepsis.

The dosage of immunoglobulin and the frequency of its administration depend on the indication for use.

Hepatitis A prophylaxis. The preparation is administered singly in doses: 0.75 ml in children of 1-6 years old, 1.5 ml in children 7-10 years old and 3.0 ml in adults over 10 years old. Repeated administration of immunoglobulin if it is necessary to prevent hepatitis A is indicated not earlier than in 2 months.

Prevention of measles. The drug is administered once from the age of 3 months to persons who have not had measles and who have not been vaccinated against this infection, not later than 6 days after contact with a sick person. The dose of the drug in children (1.5 or 3.0 ml) is set depending on the state of health and the time elapsed since exposure. In adults as well as in children exposed to mixed infections the drug is administered in a dose of 3.0 ml.

The drug in the opened ampoule must not be stored. The drug is not suitable for use in ampoules with compromised integrity, labeling, as well as with changes in physical properties (color change, clouding of the solution, the presence of unbreakable flakes), if the expiration date has expired, if the storage conditions have not been observed.

Cautions for use

Cautiously.
Inmunoglobulin is used only if prescribed by the doctor.
Allergic patients (bronchial asthma, atopic dermatitis, recurrent urticaria) or those prone to allergic reactions should take antihistamines on the day of immunoglobulin administration and for the following 8 days. In the period of allergic process aggravation the drug is administered upon the opinion of an allergologist.
Persons suffering from diseases with the leading immunopathological mechanisms (collagenosis, immune blood diseases, nephritis and others) the drug is prescribed after consultation with the corresponding specialist.

With caution the drug should be used:
– in patients older than 65 years;
– in patients with severe heart failure;
– in patients with renal failure.

Interaction

The drug can be used in combination with other drugs, in particular with antibiotics, in complex therapy of the disease. At the same time it is not allowed to mix the drug with other drugs in one syringe. Do not use simultaneously with calcium gluconate in infants. Immunoglobulin administration may reduce the effectiveness of active immunization, so weakened live virus vaccines (against measles, mumps, rubella, varicella) should not be administered earlier than 3 months after immunoglobulin administration. After vaccination against these infections immunoglobulin should not be administered earlier than 2 weeks; if immunoglobulin needs to be administered earlier, the vaccination against measles, mumps, rubella, varicella should be repeated. In the case of measles vaccination, the effectiveness of the vaccine may decrease within 1 year after immunoglobulin administration. Therefore, patients vaccinated with measles vaccine should have their antibody levels monitored. Vaccinations against other infections can be performed at any time before or after immunoglobulin administration.

Special Instructions

In order to avoid the formation of foam, the drug is taken into the syringe with a needle with a wide clearance, for injection use another needle.
The drug must not be used after the expiration date.

The patient’s condition should be carefully monitored during the administration of the drug.

Persons to whom the drug is administered should be under medical supervision for 30 minutes after administration. The injection sites should be provided with antishock therapy. If symptoms of an allergic reaction occur, appropriate therapy is immediately administered.

Unused drug and consumables should be disposed of in a suitable way.

The administration of immunoglobulin can lead to a transient increase of various passively transferred antibodies in the patient’s blood and to false positive serological tests (e.g., Coombs test).

Safety information regarding infectious agents

The product is produced from human plasma. Standard measures to prevent transmission of infections arising from drugs made from human blood or plasma include selecting donors, screening individual donations and plasma pools for specific infection markers, and incorporating effective manufacturing steps to inactivate and/or remove viruses. Notwithstanding this, the possibility of transmission of infectious agents cannot be completely excluded when using preparations made from human blood or plasma. This provision also applies to unknown or new viruses and other infectious agents. Measures taken to ensure antiviral safety are considered effective for enveloped viruses such as HIV, hepatitis B and C viruses, as well as for nonenveloped viruses such as hepatitis A virus and parvovirus B19. There is encouraging clinical experience indicating no transmission of hepatitis A virus and parvovirus B19 with human immunoglobulin preparations, and it is also suggested that the presence of antibodies contributes significantly to viral safety.
Injection of the drug should be recorded on established record forms with the name of the drug, series number, date of manufacture, expiration date, manufacturing company, date of administration, dose and adverse reactions to the drug.

Injection of the drug should be recorded on the established record forms.

Synopsis

A colorless or light yellow colored, transparent or slightly opalescent solution. During storage a slight precipitate may appear which disappears after slight shaking.

The drug is a concentrated solution of purified immunoglobulin fraction isolated by ethanol fractionation from the blood plasma of healthy donors. The immunoglobulin fraction is at least 97% of the total protein content. The technology of immunoglobulin isolation includes procedures for virus inactivation and/or removal: cold fractionation with ethanol, incubation at pH 4.0-4.5 at 37 °C for 48 h and filtration using filters to reduce virus concentration, which has been proven in virus inactivation validation. Each immunoglobulin series is made from a pool of plasma from at least 1000 healthy donors individually tested for the absence of hepatitis B virus surface antigen (HBsAg), antibodies to hepatitis C virus, antibodies to human immunodeficiency virus HIV-1 and HIV-2 and p24 HIV-1 antigen, antibodies to syphilis pathogen (Treponema pallidum). Donor plasma pooled in minipools and the production pool is additionally tested for the absence of hepatitis C virus RNA, human immunodeficiency virus RNA and hepatitis B virus DNA by polymerase chain reaction (PCR). Only plasma with negative test results is used in production.

Contraindications

History of allergic reactions or severe systemic reactions to human blood products. Hypersensitivity to the excipient.

Side effects

Frequency of side effects is defined as follows: very frequently (≥ 1/10), frequently (≥ 1/100 and < 1/10), infrequently (≥ 1/1,000 and < 1/100), rarely (≥ 1/10,000 and < 1/1,000), very rarely (< 1/10,000, including individual cases).

Possible side effects:

General disorders and disorders at the injection site:
Frequently: soreness at the injection site.
Rarely: chills, hyperthermia, weakness, hyperemia at the injection site.

Immune system disorders:
very rarely: allergic reactions (urticaria, itching, rash), anaphylactic shock.

Nervous system disorders:
very rarely: headache, dizziness.

Disorders of the digestive system:
Very rare: nausea, vomiting.

Motor system disorders:
Very rare: back pain, joint pain.

Cardiovascular system disorders:
Rarely: decreased blood pressure.

Overdose

No cases of drug overdose have been reported.

Pregnancy use

The safety of using the drug during pregnancy and breastfeeding has not been studied in controlled clinical trials. Administration of the drug during pregnancy and breastfeeding is possible only in cases when the potential benefit to the mother exceeds the potential risk to the fetus and child. Immunoglobulins penetrate into the breast milk and protective antibodies during breastfeeding may be transmitted from mother to child.