Antirabies immunoglobulin from human serum (Solution) Instructions for Use

Marketing Authorization Holder

Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd (China)

ATC Code

J06BB05 (Human antirabies immunoglobulin)

Dosage Form

Rabies immunoglobulin from human serum

Solution for injection 150 IU/ml: 1 ml, 2 ml, or 5 ml fl. 1 pc.

Dosage Form, Packaging, and Composition

Solution for injection transparent, slightly opalescent, colorless or light yellow in color.

	1 ml
Rabies immunoglobulin	150 IU

Excipients: glycine (stabilizer) – 20-25 mg, sodium chloride – 7 mg, water for injections.

The preparation does not contain antibiotics.
HBsAg, antibodies to HIV-1, HIV-2 and hepatitis C virus are absent.

1 ml (not less than 150 IU) – vials (1) – cardboard boxes.
2 ml (not less than 300 IU) – vials (1) – cardboard boxes.
5 ml (not less than 750 IU) – vials (1) – cardboard boxes.

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

MIBP-globulin

Pharmacological Action

Rabies immunoglobulin from human serum is a concentrated solution of the purified gamma-globulin fraction of human serum, isolated by cold ethanol extraction and subjected to ultrafiltration, purification and viral inactivation at pH 4.0 and a temperature of 23-25°C (73-77°F) for 21 days.

The preparation contains specific antibodies capable of neutralizing the rabies virus.

Pharmacokinetics

The maximum concentration of antibodies is reached 2-3 days after intramuscular administration of antirabies immunoglobulin. The half-life of antibodies is from 3 to 4 weeks.

Indications

In combination with antirabies vaccine for the prevention of rabies in humans in cases of severe multiple bites by rabid or rabies-suspected animals.

Repeated administration in case of repeated multiple bites by a rabid or rabies-suspected animal, antirabies immunoglobulin is not prescribed if the victim received a full combined course of antirabies treatment at the first bite, and a full course is carried out with the prescription of only the antirabies vaccine.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
Z24.2	Need for immunization against rabies
Z29.1	Prophylactic immunotherapy (administration of immunoglobulin)

ICD-11 code	Indication
QC01.2	Need for immunization against rabies
QC05.1	Prophylactic immunotherapy

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Immediately or as soon as possible after a bite or injury, mandatory local wound treatment is performed. Wounds are washed abundantly with water and soap or any detergent and treated with 40-70% alcohol or a 5% alcohol solution of iodine. In cases where there are indications, surgical treatment of the wound is performed.

After local wound treatment, specific treatment begins immediately. Before injection, the integrity of the vial and the presence of labeling on it are checked. The preparation in vials with damaged integrity, labeling, as well as with changes in its physical properties (color, transparency, etc.), with an expired shelf life, or with violations of storage conditions is not suitable for use.

Opening of vials and the procedure for administering the preparation are carried out in strict compliance with the rules of asepsis and antisepsis. A skin test before administration is not required.

The preparation is administered as early as possible after treatment, once, at a dose of 20 IU/kg of body weight for an adult or child.

Example of immunoglobulin dose calculation

Victim’s body weight – 60 kg;

For example, the actual activity of the immunoglobulin of this batch, indicated on the vial label or on the packaging, is 200 IU/ml.

To determine the required dose of immunoglobulin in ml, multiply the victim’s weight (60 kg) by 20 IU and divide the resulting number by the activity of the preparation (200 IU/ml), i.e., 60×20/200 = 6 ml

As much as possible of the calculated dose should be infiltrated around and into the depth of the wound, if anatomically possible.

The remainder should be administered intramuscularly

For adults into the upper outer quadrant of the gluteal muscle;

For children into the anterolateral surface of the thigh.

For children (especially those with multiple wounds) the dose of antirabies immunoglobulin from human serum can be diluted 2-3 times with sterile 0.9% sodium chloride solution to a volume that ensures complete infiltration of the affected areas of the body. Antirabies immunoglobulin from human serum is administered no later than 7 days after contact with a rabid or rabies-suspected animal.

Rabies immunoglobulin from human serum is used in combination with antirabies vaccine for category 3 injury; a detailed description of the nature of contact with the animal, data about it, as well as the treatment regimen are described in the table below.

Schedule of therapeutic and prophylactic vaccinations with antirabies vaccine and Antirabies Immunoglobulin from human serum (ARIG)

Damage category	Nature of contact	Data about the animal	Treatment
1	No damage to the skin, no licking of the skin, no licking of mucous membranes	Rabid	Not prescribed
2	Licking of intact skin, abrasions, scratches, superficial bites of the trunk, upper and lower extremities (except for areas of the head, face, neck, hands, fingers and toes) inflicted by domestic and farm animals	If within 10 days of observation the animal remains healthy, then treatment is stopped (i.e., after the 3rd injection). If the absence of rabies in the animal is laboratory proven, then treatment is stopped from the moment the absence of rabies is established. In all other cases, when 10-day observation of the animal is impossible (killed, died, ran away, disappeared, etc.), treatment should be continued according to the indicated scheme	Start treatment immediately: vaccine 1.0 ml on days 0, 3, 7, 14, 30, 90
3	Any licking of mucous membranes, any bites to the head, face, neck, hands, fingers and toes, genitals; single or multiple deep lacerated wounds inflicted by domestic and farm animals. Any licking and damage inflicted by wild carnivorous animals, bats and rodents	If within 10 days it is possible to observe the animal and it remains healthy, then treatment is stopped (i.e., after the 3rd injection). If the absence of rabies in the animal is laboratory proven, then treatment is stopped from the moment the absence of rabies is established. In all other cases, when 10-day observation of the animal is impossible, treatment is continued according to the indicated scheme	Start immediate combined treatment with Antirabies Immunoglobulin from human serum on day 0 and antirabies vaccine 1.0 ml on days 0, 3, 7, 14, 30 and 90

Combined treatment with Antirabies Immunoglobulin from human serum and antirabies vaccine must be carried out under strict compliance with the following conditions.

First, Rabies immunoglobulin from human serum is administered, and no more than 30 minutes after it, the antirabies vaccine is administered.

It is necessary to strictly observe the sequence of administration of antirabies preparations!

Administration of ARIG after administration of the antirabies vaccine is not allowed.

Rabies immunoglobulin and antirabies vaccine must be administered into different parts of the body using different syringes.

The dosage of immunoglobulin must not be exceeded under any circumstances, as the administration of an increased dose of immunoglobulin may partially suppress antibody production.

If emergency tetanus prophylaxis is necessary, the latter is carried out after the administration of antirabies immunoglobulin and the first injection of antirabies vaccine.

Adverse Reactions

In some individuals, during the first few days, hyperemia and swelling may develop at the injection site, which do not require treatment, as well as subfebrile temperature. In extremely rare cases, an immediate-type allergic reaction may develop (urticaria, Quincke’s edema, anaphylactic shock), therefore, persons who have received Rabies immunoglobulin from human serum should be under medical supervision for at least 30 minutes.

Contraindications

Since immunoglobulin from human serum is used for vital indications, there are no contraindications to its use.

For persons with hypersensitivity to human blood products and pregnant women, immunoglobulin is administered in a hospital setting.

Special Precautions

Intravenous administration of the preparation is prohibited.

The use of the preparation is not allowed in case of sediment that does not disappear upon shaking, foreign formations, cracks on the vial, or a loosely closed vial cap.

After opening the vial, the prescribed dose must be used immediately. The remainder of the preparation in the vial is not subject to use.

Drug Interactions

Administration of antirabies immunoglobulin can be carried out simultaneously with emergency tetanus prophylaxis. Scheduled administration of other prophylactic preparations is allowed no earlier than 3 months after completion of the combined antirabies treatment course.

Storage Conditions

Store and transport at a temperature from 2°C (35.6°F) to 8°C (46.4°F) in a place protected from light. Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

For therapeutic and prophylactic institutions.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Medixlife (Author)

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