Rebinolin, also known as rabies immunoglobulin from human blood serum: instructions for use and reviews. Anti-rabies immunoglobulins

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Active ingredient:

Instructions for medical use

Instructions for medical use- RU No.

Date last change: 18.12.2015

Dosage form

Solution for injection.

Compound

Composition per 1 ml of the drug:

Active ingredient:

Specific antibodies - at least 150 IU;

Excipients:

Sodium chloride - 9 mg, glycine (glycocol) - 22.5 mg, water for injection up to 1 ml.

Produced complete with anti-rabies immunoglobulin from horse blood serum diluted 1:100.

Description of the dosage form

Rabies immunoglobulin is a clear or slightly opalescent liquid from colorless to slightly yellow in color.

Rabies immunoglobulin diluted 1:100 is a transparent or slightly opalescent liquid from colorless to slightly yellow in color.

Characteristic

Rabies immunoglobulin from serum, blood, horse liquid is a gamma globulin fraction of horse blood immune serum obtained by the rivanol-alcohol method.

Pharmacological group

MIBP-globulin.

Indications

Used in combination with rabies vaccine (on the same day as the first dose of rabies vaccine) to prevent people from developing hydrophobia after severe bites from rabies or suspected rabies

animals.

Contraindications

There are no contraindications. If the test for intradermal administration of rabies immunoglobulin diluted 1:100 is positive, as well as if the victim has a history of strong allergic reactions for the administration of antitetanus serum or other drugs horse serum, the administration of rabies immunoglobulin is recommended to be carried out in a hospital environment equipped with resuscitation facilities.

Directions for use and doses

Immediately or as soon as possible after a bite or injury, local wound treatment is carried out: the wound surface is washed generously with soap and water (or detergent), and the edges of the wound are treated with 70% alcohol or 5% alcohol solution Yoda. Immediate suturing of the wound is contraindicated; if necessary, a simple connection of its edges is permissible. Suturing is indicated exclusively in following cases: for extensive wounds - several guiding skin sutures after preliminary treatment of the wound; for cosmetic indications - (skin sutures on facial wounds); suturing of bleeding vessels to stop external bleeding. After local treatment of the wound, therapeutic and prophylactic immunization is immediately started. AIH must be administered no later than three days after being bitten or injured by a rabid or suspected rabid animal. The most effective administration of the drug is on the first day after injury. Before injection, check the integrity of the ampoules and the presence of markings on them. The drug is not suitable for use: in ampoules with damaged integrity, markings, as well as when there is a change in its physical properties (color, transparency, etc.), when expired expiration date if stored incorrectly.

The opening of the ampoules and the procedure for administering the drug is carried out when strict adherence rules of asepsis and antiseptics.

AIH should be administered exclusively in combination with rabies vaccine, the first administration of which is carried out no more than 30 minutes after administration of AIH in a dose of 1 ml. The treatment regimen for AIH and rabies vaccine is shown in Table 1.

AIH is administered at a dose of 40 IU per 1 kg of body weight of an adult or child. The volume of administered AIH should not exceed 20 ml.

Example: the victim’s body weight is 60 kg; AIH activity (indicated on ampoules and packs of the drug), for example, 200 IU in 1 ml. In order to determine the dose of AIH required for administration, you need to multiply the weight of the victim (60 kg) by 40 IU and divide the resulting number by the activity of the drug (200 IU), that is:

Before the introduction of AIH, to identify sensitivity to a foreign protein, it is mandatory to carry out internal skin test with anti-rabies immunoglobulin diluted 1:100 (ampoules are marked in red), which is in a box with undiluted drug (ampoules are marked in blue).

Immunoglobulin diluted 1:100 is injected in a volume of 0.1 ml intradermally into the flexor surface of the forearm.

The test is considered negative if after 20-30 minutes there is no swelling or redness at the injection site or less than 1 cm. The test is considered positive if swelling or redness reaches 1 cm or more.

If the reaction is negative, 0.7 ml of rabies immunoglobulin diluted 1:100 is injected subcutaneously into the shoulder area. If there is no reaction, after 30 minutes, the entire calculated dose of AIH, heated to (37±0.5) °C, is administered in 3 divided doses with an interval of 10-15 minutes, taking the drug for each portion from previously unopened ampoules.

The calculated dose of AIH should be infiltrated around the wounds and deep into the wound. If the anatomical location of the injury (fingertips, etc.) does not allow the entire dose to be administered around the wounds, then the remainder of the AIH is injected intramuscularly into a location other than. vaccine administration (buttock muscles, upper outer thigh, shoulder).

Administration of AIH and rabies vaccine should not be administered to the same shoulder.

The entire dose of AIH is administered within one hour.

The most effective administration of the drug is on the first day after injury, but no later than three days.

If the intradermal test is positive (swelling or redness of 1 cm or more) or if an allergic reaction occurs to subcutaneous injection, AIH is administered with special precautions. First, it is recommended to administer immunoglobulin diluted 1:100 in subcutaneous tissue shoulder in doses of 0.5 ml, 2.0 ml, 5.0 ml with an interval of 15-20 minutes, then 0.1 ml of undiluted immunoglobulin is administered and after 30-60 minutes the entire prescribed dose of the drug, heated to (37 ± 0.5) °C, divided into 3 doses with an interval of 10-15 minutes. Before the first injection, parenteral administration of antihistamines (suprastin, diphenhydramine, etc.) is recommended. In order to prevent shock simultaneously with the administration of AIH, subcutaneous administration of a 0.1% solution of adrenaline or a 5% solution of ephedrine in an age-specific dosage is recommended.

When administering AIH, solutions of adrenaline, ephedrine, diphenhydramine or suprastin should always be ready.

After the administration of AIH, the patient must be under medical supervision for at least 1 hour. The first vaccination with rabies vaccine is carried out on the day of administration of AIH after the administration of the last one. The vaccination performed is registered in the established accounting forms, indicating the dose, date, manufacturer of the drug, batch number, reaction to administration.

Table 1. Scheme of therapeutic and prophylactic vaccinations with rabies vaccine (AV) and rabies immunoglobulin (RAI)

	Nature of contact	Animal details
	No damage skin, no drooling of the skin and mucous membranes.	Rabies patient.	Not assigned.
	Salivation of intact skin, abrasions, scratches, single superficial bites of the torso, upper and lower limbs(except for bites of dangerous localization: head, face, neck, hand, fingers and toes) caused by domestic and farm animals	If within 10 days of observation of the animal it remains healthy, then treatment is stopped (i.e. after the 3rd injection). If the absence of rabies in an animal is laboratory proven, then treatment is stopped from the moment the absence of rabies is established. In all other cases, when it is impossible to monitor the animal for 10 days (killed, died, ran away, etc.), continue treatment according to the specified scheme.	Start treatment immediately: AB 1.0 ml on days 0.3, 7, 14, 30, 90.
	Any drooling of the mucous membranes, any bites of the head, face, neck, hand, fingers and toes, genitals; single or multiple deep lacerations caused by domestic and farm animals. Any drooling or damage caused by wild carnivores is bats and rodents.	If it is possible to monitor the animal and it remains healthy for 10 days, then treatment is stopped (i.e. after the 3rd injection). If the absence of rabies in an animal is laboratory proven, then treatment is stopped from the moment establishing the absence of rabies. In all other cases, when it is impossible to monitor the animal, continue treatment according to the specified regimen.	Start immediately combined treatment with rabies immunoglobulin: AIH on day 0 and rabies vaccine: AB 1.0 ml on days 0, 3, 7, 14,30 and 90.

Side effects

The administration of AIH may be accompanied by the development of allergic reactions, including anaphylactic shock and serum sickness, and therefore vaccination sites must be equipped with means antishock therapy.

Interaction:

It is possible to administer it on the same day as emergency tetanus prophylaxis, with AIH administered before antitetanus serum. Compatible with antibiotics Use of immunosuppressive drugs medicines during the subsequent course of vaccination is permissible for health reasons.

Special instructions

The drug should not be administered after the start of a course of rabies vaccine. In case of hypersensitivity to heterologous immunoglobulins and serums (history), it should be prescribed orally antihistamines V age dosage 2 times a day for 7-10 days (careful monitoring of the patient is necessary). Intravenous administration AIH is contraindicated (due to the risk of shock), so when injecting you need to make sure that the needle does not penetrate into blood vessel.

To avoid possible interactions between multiple various drugs, you must inform your doctor about any other therapy you are undergoing.

A victim who, for any reason, received during the previous 24 hours antitetanus serum, AIH is administered without prior intradermal testing.

Release form

Rabies immunoglobulin - 3 ml, 5 ml or 10 ml in an ampoule.

Rabies immunoglobulin diluted 1:100 - 1 ml per ampoule.

Available as a set: 1 ampoule of immunoglobulin and 1 ampoule of immunoglobulin diluted 1:100.

5 sets are packed in a pack of cardboard for consumer packaging. The pack contains instructions for use and an ampoule knife or ceramic ampoule knife.

Storage conditions

Storage - at temperatures from 2 to. 8°C in a place inaccessible to showers of children. Do not freeze.

Transportation - at temperatures from 2 to 8°C. Do not freeze.

Best before date

2 years. A drug that has expired cannot be used.

Conditions for dispensing from pharmacies

For medical and preventive institutions.

P N016002/01 dated 2009-09-28
Rabies immunoglobulin from horse blood serum liquid - instructions for medical use - RU No. P N016002/01 dated 2015-12-18
Rabies immunoglobulin from horse blood serum liquid - instructions for medical use - RU No.

(Ministry of Health of the Chelyabinsk region 19.VII.1993)

Rabies immunoglobulin from horse blood serum, liquid, is a protein fraction of horse immune serum obtained by the rivanol-alcohol method.

Titer specific antibodies- not less than 150 IU/ml.

Stabilizer- glycol.

The drug is a transparent or slightly opalescent liquid, colorless or slightly yellow in color. Pink coloring of the drug is not allowed.

Immunological properties

Rabies immunoglobulin has the ability to neutralize the rabies virus both in vitro and in vivo.

Purpose

Used in combination with an anti-rabies vaccine to prevent people from developing hydrophobia due to severe bites from rabid or suspected rabid animals.

Directions for use and dosage

Immediately or as soon as possible after a bite or injury, local wound treatment is performed. Wounds are washed abundantly with soap and water (or detergent) and treated with 40-70° alcohol or tincture of iodine.

After local processing Specific treatment of the wound begins immediately. Before injection, check the integrity of the ampoules and the presence of markings on them. The drug is not suitable for use in ampoules with damaged integrity, labeling, as well as if its physical properties (color, transparency, etc.) have changed, if the expiration date has expired, or if stored improperly.

The opening of the ampoules and the procedure for administering the drug are carried out in strict compliance with the rules of asepsis and antiseptics.

Anti-rabies immunoglobulin is administered at a dose of 40 IU per 1 kg of body weight of an adult or child. Example: the victim’s body weight is 60 kg; immunoglobulin activity (indicated on the package label), for example, 200 IU in 1 ml. In order to determine the dose of immunoglobulin required for administration, you need to multiply the weight of the victim (60 kg) by 40 IU and divide the resulting number by the activity of the drug (200 IU), that is:

60x40=12ml

Instructions for use of rabies immunoglobulin

Before administering rabies immunoglobulin, to identify sensitivity to a foreign protein, an intradermal test with a diluted 1:100 immunoglobulin (ampoules marked in red), which is located in the box with the drug (ampoules marked in blue), is mandatory.

Diluted immunoglobulin is administered at a dose of 0.1 intradermally into the flexor surface of the forearm.

The test is considered negative if after 20 minutes the swelling or redness at the injection site is less than 1 cm. The test is considered positive if the swelling or redness reaches 1 cm or more.

If the reaction is negative, 0.7 ml of immunoglobulin diluted 1:100 is injected subcutaneously. If there is no reaction, after 30 minutes, the entire dose of immunoglobulin, heated to (37 ± 0.5) ° C, is administered in 3 divided doses with an interval of 10-15 minutes, taking the drug for each portion from previously unopened ampoules.

The calculated dose of immunoglobulin should be infiltrated around the wounds and deep into the wound. If the anatomical location of the injury (fingertips, etc.) does not allow the entire dose to be administered around the wounds, then the remainder of the immunoglobulin is injected intramuscularly into places other than the vaccine (muscles, buttocks, top part thighs, forearms).

The entire dose of rabies immunoglobulin is administered within one hour. Most impressive early introduction drug, in the first essence after injury.

If the intradermal test is positive (swelling or redness of 1 cm or more) or if an allergic reaction to a subcutaneous injection occurs, immunoglobulin is administered with special precautions. First, it is recommended to inject a diluted 1:100 drug into the subcutaneous tissue of the shoulder in doses of 0.5 ml, 2.0 ml, 5.0 ml with an interval of 15-20 minutes, then 0.1 ml of undiluted immunoglobulin and after 30-60 minutes injected intramuscularly the entire prescribed dose of the drug, heated to (37 + 0.5) ° C, divided into 3 doses with an interval of 10-15 minutes. Before the first injection, parenteral administration of antihistamines (suprastin, diphenhydramine, etc.) is recommended. In order to prevent shock, simultaneously with the administration of immunoglobulin, subcutaneous administration of a 0.1% solution of adrenaline or a 5% solution of ephedrine in an age-specific dosage is recommended.

When administering rabies immunoglobulin, solutions of adrenaline, ephedrine, diphenhydramine or suprastin should always be ready.

To prevent complications of an allergic nature after the administration of immunoglobulin, it is necessary to prescribe orally antihistamines (suprastin, diphenhydramine, diprazil, fenkarol, etc.) in an age-specific dosage 2 times a day for 7-10 days.

To a victim who has received anti-tetanus serum within the next 24 hours, rabies immunoglobulin is administered without prior intradermal testing. After administration of rabies immunoglobulin, the patient should be under medical supervision for at least 1 hour. The vaccination performed is registered in the established registration forms, indicating the dose, date, manufacturer of the drug, batch number, reaction to administration.

The drug contains rabies immunoglobulin , as well as additional components glycine glycocol as a stabilizer, water, sodium chloride. does not contain the product. It also does not contain antibodies to HIV, hepatitis C virus, or HBsAg.

Release form

Rabies immunoglobulin is produced in the form of an injection solution. It can be transparent or slightly opalescent. Colorless or light-colored liquid yellow. The drug is packaged in bottles of 1, 2, 5 ml.

Pharmacological action

Rabies immunoglobulin is a concentrated solution of purified gamma globulin fraction of whey. It is isolated from the blood using a cold ethanol extraction method. Next, the substance goes through an ultrafiltration process, it is purified and inactivated to ensure purification from viruses. The drug contains specific antibodies that can neutralize the virus .

Pharmacokinetics and pharmacodynamics

The highest level of antibodies in the blood is observed 2-3 days after the drug was administered to the patient intramuscularly. The half-life of antibodies is three to four weeks.

Indications for use

Rabies immunoglobulin is prescribed in combination with rabies vaccine to prevent the development of hydrophobia in people who have received multiple or severe bites from animals with rabies or those animals that are suspected of having rabies.

In case of repeated multiple bites of rabid or suspected rabid animals, the drug is not administered if after the first bite the patient has completed a full course of combined anti-rabies therapy. In this case, it is only necessary to prescribe the rabies vaccine.

Contraindications

Considering the fact that this drug is prescribed in the presence of vital signs. There are no contraindications to its use. People who are sensitive to human blood products, as well as pregnant women, should be administered immunoglobulin only in a hospital setting.

Side effects

Some people may develop hyperemia , appears swelling . Possible increase in body temperature to low-grade levels.

Very rarely, severe allergic reactions may develop: , manifestations , . Therefore, after administering the drug, a person must remain under the supervision of a specialist for at least thirty minutes.

Instructions for use (Method and dosage)

If a person has suffered from an animal bite, the surface of the wound should be treated immediately. It is recommended to wash the wounds and treat them with alcohol or rubbing alcohol. If necessary, the wound is treated surgically.

Next you should apply specific therapy. Before administration, the bottle containing Anti-Rabies Immunoglobulin must be carefully checked for integrity, determine whether it has the necessary markings, whether all physical properties solution.

The instructions for rabies immunoglobulin stipulate that the drug is administered in strict compliance with all aseptic and antiseptic standards. There is no need to perform a skin test before administering the drug. It is advisable to administer the medicine as soon as possible after receiving a wound, and its dose is 20 IU per 1 kg of weight of an adult or child. The exact dose of the drug is calculated by the doctor immediately before administration.

Most of the dose should be infiltrated around the wound and into the depth of the wound. The rest of the drug is administered intramuscularly.

Adults receive an injection into the gluteal muscle; for children, the drug is injected into the anterolateral surface of the thigh.

If it is necessary to administer the drug to children, especially those who have multiple wounds, Rabies Immunoglobulin can be diluted with a 0.9% sodium chloride solution to a volume that will allow complete infiltration of the wounds. The drug must be administered no later than 7 days after the person has been in contact with an animal with rabies or suspected of having this disease.

Combination therapy must be carried out in such a way as to strictly adhere to a number of conditions. Initially, the patient needs to be administered rabies immunoglobulin, after which, after 30 minutes, the rabies vaccine must be administered. This sequence of administration of these drugs must be strictly followed. Administration of immunoglobulin after rabies vaccine is not allowed.

The above two agents must be administered in different areas body and use different syringes.

In no case should the dosage of immunoglobulin be exceeded, since if the dose is exceeded, the production of antibodies may be partially suppressed.

If the patient needs emergency prophylaxis, then it can be carried out only after rabies immunoglobulin has been administered and the first vaccination of rabies vaccine has been administered.

Overdose

There is no data on an overdose of the drug.

Interaction

You can inject rabies immunoglobulin at the same time as emergency prevention tetanus. Other drugs can be administered only three months after the end of combination anti-rabies therapy.

Terms of sale

The drug is intended only for medical institutions.

Storage conditions

It is necessary to store and transport the product, maintaining a temperature of 2° to 8°C; the medicine should be protected from light and should not be frozen. Keep out of reach of children.

Best before date

Shelf life - 2 years.

Special instructions

Rabies immunoglobulin should not be administered intravenously.

The solution should be used immediately after opening the bottle. The remaining solution cannot be used later.

The medicine should not be administered after the course of administration has been started. rabies vaccine .

If the patient has increased sensitivity to heterologous immunoglobulins and serums, then during the administration of the drug it is necessary to prescribe antihistamines for 1 to 10 days. It is important to carefully monitor the person. Intravenous administration is contraindicated, so it is important to ensure during the injection process that the needle does not enter a blood vessel.

Before starting treatment, you should tell your doctor if you are taking any other medications.

For children

For children, the drug is prescribed according to indications and is administered in the dosage specified in the instructions into the anterolateral part of the thigh.

During pregnancy and lactation

It is practiced to administer the drug in the presence of vital indications.

INSTRUCTIONS*

on the use of rabies vaccine culture concentrated purified inactivated dry, lyophilisate for preparing a solution for intramuscular injection and rabies immunoglobulin

The anti-rabies vaccine, cultural concentrated, purified, inactivated, dry, lyophilisate for preparing a solution for intramuscular administration, is a vaccine rabies virus strain Vnukovo-32, grown in a primary culture of Syrian hamster kidney cells, inactivated by ultraviolet rays and formaldehyde, concentrated by ultrafiltration followed by purification by gel chromatography.

Rabies vaccine – porous mass white, hygroscopic.

One dose (1.0 ml) of the vaccine contains: specific antigen of the rabies virus strain “Vnukovo-32” - at least 2.5 IU (International Units) - active ingredient, albumin – 5.0 mg (solution for infusion) – stabilizer, sucrose – 75.0 mg – stabilizer, gelatin – 10.0 mg – forming agent. The drug does not contain preservatives or antibiotics.

^ Immunological properties. The vaccine induces the development of immunity against the rabies virus.

Purpose: therapeutic and prophylactic or prophylactic immunization of humans against rabies.

^ Method of application. The contents of the vaccine ampoule must be dissolved in 1.0 ml of water for injection. Dissolution time should not exceed 5 minutes. The dissolved vaccine is a clear or slightly opalescent liquid from colorless to light yellow.

The dissolved vaccine is administered slowly intramuscularly into the deltoid muscle of the shoulder, for children under 5 years old - into the upper part of the anterolateral surface of the thigh.

^ Injection of the vaccine into the gluteal region is not allowed.

The drug is not suitable for use in ampoules with damaged integrity, labeling, as well as changes in color and transparency, expired or improperly stored.

* Instead of instructions approved by the Chief State Sanitary Doctor

Russian Federation 02/07/2008 No. 01-11/7-08

The opening of the ampoules and the vaccination procedure are carried out under strict adherence to the rules of asepsis.

Storage of the dissolved vaccine for more than 5 minutes is not allowed.

The vaccinated person must be under medical supervision for at least 30 minutes.

Vaccination sites must be equipped with anti-shock therapy.

^ Providing anti-rabies assistance

Anti-rabies care consists of local treatment of wounds, scratches, abrasions, salivation sites and subsequent administration of an anti-rabies vaccine or, if indicated, a combined administration of rabies immunoglobulin (RAI) and rabies vaccine. The interval between the administration of AIH and rabies vaccine is no more than 30 minutes.

^ Local wound treatment

Local treatment of wounds (bites, scratches, abrasions) and drooling areas should begin immediately or as soon as possible after the bite or injury. It consists of abundantly washing the wound surface for several minutes (up to 15 minutes) with soap and water or other detergent(detergent) or in the absence of soap or detergent, the damaged area is washed with a stream of water. After this, the edges of the wound should be treated with 70% alcohol or 5% aqueous-alcohol solution Yoda.

Sutures should be avoided whenever possible.

Suturing is indicated only in the following cases:

For extensive wounds - several guiding skin sutures after pre-treatment of the wound;

For cosmetic reasons (skin sutures on facial wounds);

Stitching of bleeding vessels to stop external bleeding.

If there are indications for the use of rabies immunoglobulin, it is used immediately before suturing (see section Rabies immunoglobulin (RAI) dose).

After local treatment of wounds (damages), therapeutic and prophylactic immunization is immediately started.

^ Therapeutic and preventive immunization

Indications. Contact and bites of people by animals with rabies, animals suspected of having rabies, wild or unknown animals.

Contraindications. None. Pregnancy is not a contraindication.

A detailed scheme of therapeutic and prophylactic immunization and notes to the scheme are presented in the table (Scheme of therapeutic and prophylactic vaccinations with rabies vaccine and rabies immunoglobulin (RAI).

All persons at risk of contracting rabies are subject to therapeutic and prophylactic immunization. If there are indications for combined treatment, then AIH is first administered and, no more than 30 minutes after it, the rabies vaccine is administered.

^ Anti-rabies immunoglobulin (AIH) is prescribed as soon as possible after contact with a rabid animal or an animal suspected of having rabies, wild or unknown animals.

Before insertion heterologous (equine) rabies immunoglobulin it is necessary to check the patient’s individual sensitivity to horse protein (see “Instructions for the use of rabies immunoglobulin from horse blood serum, liquid”). Before administration of homologous (human) rabies immunoglobulin individual sensitivity is not tested.

^ Heterologous anti-rabies immunoglobulin administered no later than 3 days after the bite, homologous anti-rabies immunoglobulin entered no later than

7 days after the bite.

^ Dose of rabies immunoglobulin (RAI). Heterologous (equine) rabies immunoglobulin is prescribed at a dose of 40 IU per 1 kg of body weight. Homologous (human) rabies immunoglobulin is prescribed at a dose of 20 IU per 1 kg of body weight. The volume of administered heterologous rabies immunoglobulin should not exceed 20 ml.

^ Administration of rabies immunoglobulin (RAI) . As much of the recommended dose of AIH as possible should be infiltrated into the tissue around the wound and deep into the wound. The unused portion of the drug dose is injected deep intramuscularly into a site other than the rabies vaccine.

^ Preventive immunization

Indications. WITH preventive purpose immunize persons at high risk of contracting rabies (laboratory employees working with street rabies virus; veterinarians; rangers, hunters, foresters; persons performing work on catching and keeping animals and other professional groups).

The vaccine is administered intramuscularly into the deltoid muscle of the shoulder, 1.0 ml on days 0, 7 and 30. Revaccination is carried out once, in a dose of 1.0 ml every year and then every three years.

^ Preventive immunization scheme

Preventive immunization of contingents increased risk infection with rabies is carried out in vaccination rooms of medical institutions, where they fill out and issue a “Certificate of preventive vaccinations", where all the necessary information is entered (names, series, doses, multiplicities and dates of receipt of the drugs).

^ Contraindications for preventive immunization

1. Acute infectious and non-communicable diseases, chronic diseases in the stage of exacerbation or decompensation - vaccinations are carried out no earlier than one month after recovery (remission).

2. Systemic allergic reactions to previous administration of rabies immunoglobulin (generalized rash, Quincke's edema, etc.).

3. Allergic reactions to antibiotics.

4. Pregnancy.

Side effects of anti-rabies drugs

1. The introduction of the vaccine may be accompanied by a local or general reaction. Local reaction characterized by slight swelling, redness, itching, pain at the injection site, and enlarged regional lymph nodes. General reaction may manifest itself in the form of malaise, headache, weakness, and increased body temperature. Recommended symptomatic therapy, the use of hyposensitizing agents and antihistamines.

IN in rare cases may develop neurological symptoms, such a patient should be hospitalized.

2. After administration of rabies immunoglobulin from horse blood serum, complications may be observed: local allergic reaction that occurs 1-2 days after administration; serum sickness, which most often occurs on days 6-8; anaphylactic shock. In the event of an anaphylactoid reaction, a solution of adrenaline or norepinephrine in an age-appropriate dosage and 0.2-1.0 ml of ephedrine 5% are administered subcutaneously.

When symptoms of serum sickness appear, parenteral administration of antihistamines, corticosteroids, and calcium supplements is recommended.

^ Interaction with other drugs

During the course of therapeutic and prophylactic vaccination, vaccination with other drugs is prohibited. After completion of vaccination against rabies, vaccinations with other vaccines are allowed no earlier than 2 months later.

Preventive vaccination is carried out no earlier than 1 month after vaccination against another infectious disease.

^ Release form

Rabies culture vaccine, concentrated, purified, inactivated, dry, lyophilisate for preparing a solution for intramuscular administration, is available as a set: 1 ampoule of vaccine, 1.0 ml (1 dose) and 1 ampoule of solvent (water for injection), 1.0 ml. The package contains 5 sets (5 ampoules with vaccine and 5 ampoules with solvent).

Rabies immunoglobulin from horse blood serum is available in ampoules of 5.0 or 10.0 ml; diluted 1:100 – 1.0 ml per ampoule. The kit contains 1 ampoule of immunoglobulin and 1 ampoule of immunoglobulin diluted 1:100. The package contains 5 sets.

^ Shelf life, storage and transportation conditions

The shelf life of the vaccine is 2 years.

The vaccine is stored and transported at temperatures from 2 to 8 0 C. It is allowed to transport the vaccine at a temperature of 25 0 C for no more than 2 days. Store out of the reach of children.

^ Scheme of therapeutic and prophylactic vaccinations with rabies vaccine

and rabies immunoglobulin (RAI)

Category- Denia	^ Nature of contact	Animal details	Treatment
1	There is no damage to the skin, no drooling of the skin, no drooling of the mucous membranes.	^ Rabies patient	Not assigned
2	drooling intact skin, abrasions, scratches, superficial bites of the torso, upper and lower extremities (except the head, face, neck, hand, fingers and toes), caused by domestic and farm animals	^ If within 10 days observation of the animal, it remains healthy, then treatment is stopped (i.e. after the 3rd injection) treatment is stopped In all other cases when 10-day observation of the animal is impossible(killed, died, ran away, disappeared Etc.), continue treatment according to the indicated regimen	Start treatment immediately: 1.0 ml vaccine at 0, 3, 7, 14, 30 and 90 days
3	Any drooling mucous membranes, any bites of the head, face, neck, hand, fingers and toes, genitals; single or multiple deep lacerations caused by domestic and farm animals. ^ Any salivation or damage caused by wild carnivores, bats and rodents	If it is possible to observe the animal and it within 10 days stays healthy then treatment is stopped (i.e. after the 3rd injection). If it is laboratory proven that the animal does not have rabies, then treatment is stopped from the moment the absence of rabies is established. In all other cases, when it is impossible to monitor the animal, continue treatment according to the specified regimen.	^ Start immediately combination treatment anti-rabies immunoglobulin: AIH on day 0 (cm. Dose of rabies immunoglobulin (RAI) rabies vaccine: KOKAV 1.0 ml at 0, 3, 7, 14, 30 and 90 days

Notes on the scheme of therapeutic and prophylactic vaccinations with rabies vaccine and rabies immunoglobulin (RAI):

1. Doses and regimens of therapeutic and prophylactic immunization are the same for children and adults.

2. A course of therapeutic and prophylactic immunization is prescribed regardless of the timing of the victim’s request for rabies treatment, even several months after contact with an animal with rabies, an animal suspected of having rabies, wild or unknown animals.

3. For persons who have previously received a full course of therapeutic and prophylactic or preventive vaccinations, from the end of which no more than 1 year has passed, three injections of rabies vaccine, 1.0 ml each, are prescribed on days 0, 3, 7; if a year or more has passed, or an incomplete course of immunization has been carried out, then vaccinations are carried out in accordance with the given “Schedule of therapeutic and prophylactic vaccinations with rabies vaccine and rabies immunoglobulin (RAI).”

4. After a course of therapeutic and prophylactic or prophylactic immunization, the vaccinated person is issued a certificate (certificate of preventive vaccinations) indicating the type and series of drugs, the course of vaccinations and the presence of post-vaccination reactions.

Rabies - viral disease which amazes nervous system person. In the absence timely treatment ends fatally. Emergency immunoprophylaxis plays a decisive role in preventing the development of the disease after contact with an infected animal. For this purpose, anti-rabies immunoglobulin is used from human blood serum to prevent rabies.

Immunoglobulin from human blood serum for the prevention of rabies: composition and release form

Rabies immunoglobulin is produced in the People's Republic of China from the blood serum of donors who have been immunized with rabies vaccine. The rabies vaccine contains the gamma globulin fraction of proteins. These are exactly the substances that are necessary to neutralize the rabies virus. In the production of the drug, purification methods are used. These are cold extraction with ethanol, purification, ultrafiltration. One milliliter of product contains:

• 150 IU (international units) of specific antibodies to the rabies virus.
• Stabilizer in the form of glycine.
• Sodium chloride.
• Water for injections.

Rabies immunoglobulin is available in bottles of 300 and 150 IU. The vaccination does not contain antibiotics, which significantly reduces the risk of allergic reactions. Externally, the drug has a uniform, light yellow consistency.

Pharmacological action of vaccination

To understand how immunoglobulin works in the human body, you need to find out what kind of substance it is and why it is needed. Immunoglobulins (antibodies) are substances of protein nature. They are synthesized in the human body by special immune cells - plasma cells. Antibodies are a universal way to fight human body with bacterial, viral and other infections. In front of everyone infectious diseases in response to the penetration of a foreign agent into the body, immunoglobulins are produced. These proteins bind to antigens carried by infectious agents and neutralize them. The time required for the production of antibodies is two to three weeks from the moment of infection. This period is quite long. Unfortunately, with rabies, complications occur much faster, which leads to 100% mortality without emergency immunoprophylaxis.

Important! Emergency rabies immunoprophylaxis should be started as soon as possible after infection.

Indications and preparation for drug administration

Rabies vaccination is indicated for all patients suspected of being infected with the virus. It is carried out:

• For any damage to the skin or mucous membranes that was caused by wild or domestic animals with signs of rabies.
• For damage caused by animals that are under veterinary supervision.
• If the saliva of an infected animal gets on the damaged skin.

The drug is used in parallel with the rabies vaccine. In case of a repeated bite by an infected animal, the drug is not prescribed if the first time the patient received a full dose of immunoglobulin.

Doctor's advice. In case of bites from pets (cats, dogs), even if they do not have obvious symptoms of rabies, it is necessary to show the animal to a veterinarian and establish supervision. If signs of rabies appear in a pet, the patient should consult a doctor.

Method of administration of the vaccine and dose

Before using rabies immunoglobulin, you must consult a doctor and perform primary surgical treatment of the wound. It is carried out for the purpose of prevention wound infection and restoring the integrity of the skin. The surgical treatment is performed by a surgeon. It must be done as soon as possible from the moment of suspected infection. If necessary, stitches are applied.

After surgical treatment immediately begin immunoprophylaxis. To do this, the health worker takes a bottle of immunoglobulin and checks its integrity. Pays attention to color, consistency and presence of impurities. If signs of unsuitability of the drug are detected, its use is prohibited. After checking the drug under sterile conditions, open the bottle and inoculate.

Important! When administering human rabies immunoglobulin, unlike a drug made from horse blood serum, a skin test is not required

The dose of the administered drug is calculated individually. For every kilogram of the patient's body weight, 20 international units of the drug must be administered. When administering immunoglobulin, the following rule is observed: most doses should be administered at soft fabrics along the perimeter of the wound, the remainder of the drug is administered intramuscularly. For adults this is the gluteal region, for children - the front surface of the thigh.

Doctor's advice. Rabies immunoglobulin is administered strictly before the rabies vaccine (10-15 minutes before)

Prescribing the drug is possible only if no more than 7 days have passed since the bite. Administration of immunoglobulin a week after infection or after rabies vaccine is not allowed.

Side effects, complications, reactions to vaccination

The administration of the drug in some cases is accompanied by the occurrence of adverse reactions. They manifest themselves in the form of swelling and redness of the skin at the injection site. Sometimes there is a slight increase in body temperature, general weakness. These symptoms go away on their own and do not require drug treatment.

Complications associated with improper injection technique very rarely occur. The first group is purulent processes. This is the formation of an abscess at the injection site or the development of local purulent lymphadenitis. Such complications arise when the conditions of asepsis and antisepsis are violated. Purulent processes treated under the supervision of a surgeon. Treatment is often performed surgically. The abscess is opened and the purulent contents are evacuated.

Abscess - purulent complication vaccinations (photo: www.commons.wikimedia.org)

Second group: damage to the neurovascular bundle when performing an injection. A needle entering a nerve is accompanied by a characteristic acute pain along the way nerve endings. When a vessel is damaged, bleeding occurs infrequently. More often accompanied by a small hematoma.

Contraindications to drug administration

Rabies is a disease that, in the absence of treatment and immunoprophylaxis, leads to 100% mortality. In this regard, rabies immunoglobulin and vaccine are administered for health reasons. There are no contraindications to vaccination.

Interaction with other drugs for immunoprophylaxis

The drug is allowed to be administered in parallel with drugs for the prevention of tetanus. All others immunobiological preparations used only three months after the end of the rabies vaccination.

Important! Immunoglobulin and rabies vaccine must be injected into different areas of the body. A separate syringe is used for each drug

Vaccine storage conditions

The drug is stored in specially designed refrigeration equipment. Temperature ranges from two to eight degrees above zero. Freezing of the drug is not allowed. The maximum shelf life is two years.

Analogues of the drug

There are two types of rabies immunoglobulin. The first is obtained from human blood serum. To do this, immunize healthy people, and then anti-rabies antibodies are isolated from their blood. The second type is made from the blood serum of immunized horses. Antibody preparations from human blood serum have a number of advantages:

• Dosage human immunoglobulin twice as much.
• The preparation from the blood serum of immunized horses must be heated to 37⁰ C before administration.
• The introduction of antibodies obtained from humans is not accompanied by the risk of developing sensitization (allergic reactions).
• Before administering immunoglobulins obtained from horses, a skin test must be performed, and after vaccination, antihistamines must be prescribed.

A drug made from human blood serum similar in composition to rabies immunoglobulin is Rebinolin. It is produced in Israel.