Antirabies immunoglobulin from blood serum
human 150 IU / ml
Measurement unit: fl.
Country: PRC
Manufacturer: FC Sichuan Yuanda Shuyan LLC
Release form: Bottle 2 ml
Instructions for the use of antirabies immunoglobulin from human blood serum,
solution for injection 150 IU / ml Registration number: LSR-010494 / 08-241208.
GROUP NAME Rabies immunoglobulin. Anti-rabies immunoglobulin
from human blood serum, solution for injection, is a concentrated
solution of purified human serum gamma-globulin fraction isolated by method
Cold extraction with ethanol and ultrafiltered, purified and viral
Inactivation at a pH of 4.0 and a temperature of 23-25 ° C for 21 days.
COMPOSITION (per 1 ml) Specific antibodies to rabies virus, not less than 150 IU; stabilizer glycine (glycol)
20 to 25 mg; sodium chloride 7 mg; water for injections. The product does not contain antibiotics. HBsAg,
antibodies to HIV-1, HIV-2 and hepatitis C virus are absent.
DESCRIPTION Transparent or slightly opalescent liquid, colorless or light yellow in color.
IMMUNOLOGICAL PROPERTIES The drug contains specific antibodies capable of
neutralize the rabies virus.
PHARMACOKINETICS The maximum concentration of antibodies is reached 2-3 days after
intramuscular administration of an antirabic immunoglobulin. Antibody half-life
is 3 to 4 weeks.
PURPOSE Used in combination with rabies vaccine to prevent disease
people with hydrophobia with severe multiple bites rabid or suspicious of rabies
animals. With repeated multiple bites by a patient with rabies or suspected rabies
to animals, rabies immunoglobulin is not assigned if at the first bite the victim received
DOSAGE AND METHOD OF APPLICATION Immediately or as soon as possible after a bite or injury
carry out compulsory local treatment of the wound. Wounds are washed abundantly with soap and water or any
Detergent and treated with 40-70% alcohol or iodine tincture. In cases where there is evidence,
carry out surgical treatment of the wound. After local treatment of the wound, it begins immediately
specific treatment. Before injection, check the integrity of the vial and the presence of markings on it.
The drug is unsuitable for use in vials with impaired integrity, labeling, as well as
change in its physical properties (color, transparency, etc.), with an expired shelf life, with
Violations of the storage regime. The opening of the vials and the procedure for the introduction of the drug are carried out
With strict adherence to the rules of asepsis and antiseptics. Pre-injection skin test
not required. The drug is administered as early as possible after treatment, once in a dose
20 IU / kg body weight of an adult or child. An example of calculating the dose of immunoglobulin Body weight
the victim - 60 kg. For example, the actual activity of a given series of immunoglobulin indicated
on the bottle label or on the package, is 200 IU / ml. In order to determine the necessary
to administer the dose of immunoglobulin in ml, the weight of the victim (60 kg) must be multiplied by 20 ME and
divide the resulting number by the activity of the drug (200 IU / ml), i.e.: 60x20 / 200 = 6 ml As possible
most of the calculated dose should be infiltrated around the wound, if possible
anatomically. The rest should be injected intramuscularly into the outer superior gluteal
area for adults, or in the anterolateral area of the thigh for children. In children (especially those who have
multiple injuries) a dose of anti-rabies immunoglobulin from human serum can
be diluted 2-3 times with 0.9% sodium chloride solution for injection to a volume that provides
full infiltration of the affected areas of the body. The introduction of antirabies immunoglobulin from
human serum should be carried out 10-15 minutes before the anti-rabies vaccine.
It is necessary to strictly observe the sequence of administration of anti-rabies drugs.
In cases of late treatment of the victim for anti-rabies help, anti-rabies
immunoglobulin from human serum can be administered no later than 7 days after contact
with rabies sick or suspicious of rabies animals. The introduction of antirabies
Immunoglobulin at a later date, as well as after the introduction of the rabies vaccine is not allowed.
The dosage of immunoglobulin should not be exceeded under any circumstances, since the administration
an increased dose of immunoglobulin can partially suppress the production of antibodies. Immunoglobulin
Rabies vaccine and rabies vaccine should be given to different parts of the body using
various syringes. If emergency prophylaxis of tetanus is necessary, the latter is carried out
after the introduction of rabies immunoglobulin and the first vaccination of the rabies vaccine.
DRUG INTERACTIONS Administration of rabies immunoglobulin can
be carried out simultaneously with the emergency prophylaxis of tetanus. Introducing others
combined antirabies treatment.
CONTRAINDICATIONS Since immunoglobulin from human blood serum is used for vital
(vital) indications, there are no contraindications to its use.
Persons with hypersensitivity to human blood preparations and pregnant women
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Rabies vaccine preparations.
What is the choice of drugs based on?
For rabies vaccinations (rabies immunization), two drugs are used:
These drugs have a different principle of action.
The rabies vaccine by itself is unable to kill the virus. The job of a vaccine is to provide the body with antigenic information about the virus. The immune system is presented with a seemingly inanimate model of a real virus, devoid of its harmful power, but retaining its identification marks - antigens.
By reading and memorizing information about these identification marks, the immune system acquires the ability to produce specific proteins - antibodies. Antibodies recognize the virus by familiar antigens and neutralize it. With the help of the vaccine, they acquire the so-called "active immunity" for a period of at least 1 year.
However, this process takes about two weeks. All this time, the body remains defenseless against the virus.
What to do? Provide temporary "crutches" - inject ready-made antibodies.
Where to get them from? In another organism. The preparation containing concentrated antibodies is called "immunoglobulin" (the previously used prerarate, unrefined from foreign protein fractions, was called "serum"). Immunoglobulin is obtained from donated blood. The donor can be a person (homologous immunoglobulin) or an animal, in practice a horse (heterologous immunoglobulin). In order for the donor to have enough antibodies, he is preliminarily immunized with an anti-rabies vaccine. Human immunoglobulin is more effective than equine immunoglobulin, therefore the dose is 2 times less. Plus it's safer.
Immunoglobulin, like any protein molecule, itself contains antigens. The more foreign the introduced protein, the more hostile it is perceived by the immune system. Within a few weeks after administration, the immunoglobulin is completely destroyed in the body. This type of immunity is called "passive".
Thus, immunoglobulin provides passive immunity immediately, but for a short time, and the vaccine provides active immunity after two to three weeks, for a long time.
The choice of drugs mainly depends on the expected length of the incubation period. Its duration is influenced primarily by the localization of the bite, as well as the number, depth and extent of the bites.
If there is confidence that the vaccinations will have time to create sufficient immunity before the onset of the development of the disease (light bites), they are vaccinated
If it is impossible to wait until active immunity appears (severe and moderate bites, as well as belated - more than 10 days - treatment with bites of any severity inflicted by an unknown or suspicious animal) - a combined course of treatment is carried out - in addition to the vaccine, they also introduce
Rabies vaccine.
The first rabies vaccine was proposed in 1885 by Louis Pasteur. He obtained an attenuated (so-called "fixed") strain of the virus by 90 successive passages of the virus through the rabbit brain. The Pasteur strain has been provided to various countries for the production of vaccines. Since then, a large number of vaccines have been developed. For a long time, live vaccines were used (they contained live viruses of a fixed strain).
For inoculations against rabies, inactivated (ie, containing a killed virus) vaccines produced "in vitro" on tissue cultures are now used.
Doses and vaccination schedules are the same for children and adults.
Once the vaccine is dissolved, it should be used for no more than 5 minutes. The vaccine is injected intramuscularly into the deltoid muscle of the shoulder, and for children under 5 years old - into the upper part of the antero-lateral surface of the thigh. The introduction of the vaccine into the gluteal region is unacceptable.
The vaccinated person must be under medical supervision for at least 30 minutes.
Indications for vaccine administration:
- acute infectious and non-infectious diseases, chronic diseases in the stage of exacerbation or decompensation - vaccinations are carried out no earlier than one month after recovery (remission)
- local and systemic allergic reactions to the previous vaccine administration (generalized rash, Quincke's edema, etc.)
- pregnancy
Therapeutic and prophylactic immunization - carried out in connection with an already held bite
There are no contraindications in this case.
Preventive immunization - vaccinate "just in case and in advance" people at increased risk - hunters, veterinarians, gamekeepers, laboratory staff working with the "wild" rabies virus, etc.
Contraindications for prophylactic immunization:
Side effects of the vaccine:
- local reactions - short-term edema, redness, edema, itching, induration at the injection site
- general reactions - moderate fever, tremors in the limbs, weakness, dizziness, headache, arthralgia (joint pain), myalgia (muscle pain), gastroenterological disorders (abdominal pain, vomiting)
- possible development of immediate allergic reactions (urticaria, Quincke's edema)
Rabies immunoglobulin.
Rabies immunoglobulin is indicated for a combined course of rabies immunization in conjunction with rabies vaccine:
- with late treatment (more than 10 days) with bites of any severity inflicted by an unknown or suspicious animal
Two types of immunoglobulin are used:
- heterologous (equine) immunoglobulin
- homologous (human) immunoglobulin obtained from donated blood.
Homologous (human) rabies immunoglobulin is prescribed at a dose of 20 IU per 1 kg of body weight.
Heterologous (equine) rabies immunoglobulin is prescribed at a dose of 40 IU per 1 kg of body weight.
Example: the patient's body weight is 60 kg, the immunoglobulin activity is bitten on the package (for example, 200 IU in 1 ml)
60 * 40/200 = 12 ml must be administered to this patient, after determining the sensitivity to a foreign protein.
As much of the calculated dose as possible should be infiltrated near the wound and into the depth of the wound. If the anatomical location (fingertips, etc.) does not allow the entire dose of rabies immunoglobulin to be injected into the tissue near the wound, then the remainder is injected intramuscularly (into the upper thigh or deltoid muscle, on the side of the body opposite the vaccine injection site).
The administration of rabies immunoglobulin is most effective on the first day after the bite. The entire dose of the drug is administered on one day. Only with especially wide and multiple bites inflicted by a rabid wolf or other carnivore, the introduction of rabies immunoglobulin can be repeated, in the same dose, after which a course of vaccination is carried out with the mandatory introduction of an additional dose of vaccine on the 60th day from the start of treatment (see) ...
Test for sensitivity to a foreign protein.
20 minutes before the administration of the drug, test for sensitivity to a foreign protein- 0.1 ml of diluted (1: 100) immunoglobulin is injected intradermally into the anterior surface of the forearm. An ampoule with diluted (1: 100) immunoglobulin is attached to each dose of the undiluted drug and is in the same package.
| Diluted (1: 100) immunoglobulin in a dose of 0.1 ml is injected intradermally into the anterior surface of the forearm. | ||
| after 20 minutes - sample evaluation ⇓ |
||
|
||
| sample negative ⇓ |
test positive ⇓ |
|
| 0.7 ml of diluted (1: 100) immunoglobulin is injected subcutaneously to reveal general sensitivity to a foreign protein. | when general reactions appear after 30 minutes ⇒ |
Diluted immunoglobulin (1: 100) is injected in doses of 0.5 ml, 2.0 ml, 5.0 ml injected at intervals of 20 minutes into the subcutaneous tissue of the shoulder |
| in the absence of general reactions after 30 minutes ⇓ |
in 20 minutes ⇓ |
|
| 0.1 ml of undiluted immunoglobulin is injected subcutaneously | ||
| in 30-60 minutes ⇓ |
||
| Before the first injection of immunoglobulin, antihistamines are prescribed (diphenhydramine, suprastin, etc.) and are recommended to be taken orally for 10 days. In order to prevent shock, subcutaneous administration of 0.1% adrenaline solution or 5% ephedrine solution at an age-specific dose is recommended. | ||
| ⇓ | ||
| Introduce fractionally (in 3 doses at intervals of 15 minutes) the entire dose of immunoglobulin heated to 37 ° C, collecting the drug for each portion from an unopened ampoule. The entire dose should be infiltrated around and deep into the wound. If anatomical damage precludes this (fingertips, etc.), then the drug can be injected intramuscularly in other places (muscles of the buttocks, thighs, shoulder, etc.). The entire dose is administered within an hour. | ||
Filterable list
Active substance:
Instructions for medical use
Instructions for medical use - RU No.
Last modified date: 18.12.2015
Dosage form
Injection.
Composition
Composition for 1 ml of the preparation:
Active ingredient:
Specific antibodies - not less than 150 IU;
Excipients:
Sodium chloride - 9 mg, glycine (glycocol) - 22.5 mg, water for injection up to 1 ml.
Produced complete with rabies immunoglobulin from horse blood serum diluted 1: 100.
Description of the dosage form
Antirabies immunoglobulin is a clear or slightly opalescent liquid from colorless to slightly yellow in color.
Immunoglobulin antirabies diluted 1: 100 - transparent or slightly, opalescent liquid from colorless to slightly yellow color.
Characteristic
Immunoglobulin antirabies from serum, blood, horses, liquid is a gamma-globulin fraction of the immune blood serum of a horse, obtained by the rivanol-alcohol method.
Pharmacological group
MIBP globulin.
Indications
Used in combination with rabies vaccine (on the same day with the first dose of rabies vaccine) to prevent people from becoming hydrophobic with severe rabies bites or suspicious rabies
animals.
Contraindications
There are no contraindications. With a positive test for intradermal administration of rabies immunoglobulin diluted 1: 100, as well as if the victim has a history of severe allergic reactions to the administration of tetanus toxoid or other preparations of horse serum, it is recommended to administer rabies immunoglobulin in a hospital provided with resuscitation means.
Method of administration and dosage
The opening of the ampoules and the procedure for administering the drug are carried out in strict observance of the 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 the injected AIH should not exceed 20 ml.
Example: the body weight of the victim is 60 kg; AIH activity (indicated on ampoules and packs with the drug), for example, 200 IU in 1 ml. In order to determine the dose of AIH required for administration, the weight of the victim (60 kg) f must be multiplied by 40 IU and the resulting number must be divided by the activity of the drug (200 IU), that is:
Before the introduction of AIG-to identify sensitivity to a foreign protein, an intradermal test with antirabies immunoglobulin diluted 1: 100 is mandatory (ampoules are marked in red), which is in a box with an undiluted drug (ampoules are marked in blue).
Diluted 1: 100 immunoglobulin 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 the swelling or redness reaches 1 cm or more.
If the reaction is negative, 0.7 ml of rabies immunoglobulin diluted 1: 100 is subcutaneously injected into the shoulder area. In the absence of a reaction after 30 minutes, fractionally in 3 doses with an interval of 10-15 minutes, the entire calculated dose of AIH, heated to (37 ± 0.5) ° C, is injected, taking the drug for each portion from ampoules not previously opened.
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 place other than. the introduction of the vaccine (muscles of the buttocks, upper outer thigh, shoulder).
RIH and rabies vaccine should not be given in the same shoulder.
The entire dose of AIH is administered within one hour.
The most effective administration of the drug on the first day after injury, but no later than three days.
In case of a positive intradermal test (swelling or redness of 1 cm or more) or in the event of an allergic reaction to a subcutaneous injection, AIH is administered with special precautions. First, it is recommended to inject immunoglobulin diluted 1: 100 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 is injected and after 30-60 minutes 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 introduction of AIH, subcutaneous administration of a 0.1% solution of epinephrine or a 5% solution of ephedrine in an age-specific dosage is recommended.
When introducing 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 the rabies vaccine is carried out on the day of administration of the AIH after the administration of the latter. The vaccination carried out is registered in the established registration forms with an indication of the dose, date, manufacturer of the drug, batch number, reaction to administration.
Table 1. Scheme of therapeutic and prophylactic vaccinations with rabies vaccine (AB) and rabies immunoglobulin (RIG)
|
The nature of the contact |
Animal data |
||
|
There is no damage to the skin, no salivation of the skin and mucous membranes. |
Sick with rabies. |
Not assigned. |
|
|
Salivation of intact skin, abrasions, scratches, single superficial bites of the trunk, upper and lower extremities (except for bites of a 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 the treatment is stopped (i.e. after the 3rd injection). If the absence of rabies in the animal is laboratory proven, then the 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, escaped, etc.), continue the treatment according to the indicated scheme. |
Start treatment - immediately: AB 1.0 ml at 0.3, 7.14, 30, 90 days. |
|
|
Any salivation of the mucous membranes, any bites on the head, face, neck, hand, fingers and toes, genitals; single or multiple deep lacerations caused by domestic and farm animals. Any salivation and injury caused by wild carnivores, bats and rodents. |
If it is possible to observe the animal, and it remains healthy for 10 days, then the treatment is stopped (i.e. after the 3rd injection). If the absence of rabies in the animal is laboratory proven, then the treatment is stopped from the moment establishing the absence of rabies. In all other cases, when it is impossible to observe the animal, continue the treatment according to the indicated scheme. |
Start immediately combined treatment with rabies immunoglobulin: AIH on day 0 and rabies vaccine: AB 1.0 ml at 0, 3, 7, 14, 30 and 90 days. |
Side effects
The introduction of AIH can be accompanied by the development of allergic reactions, including anaphylactic shock and serum sickness, in connection with which the vaccination sites should be equipped with anti-shock therapy.
Interaction:
It is possible to administer on the same day with emergency prophylaxis of tetanus, while AIH is administered before tetanus toxoid. Compatible with antibiotics The use of immunosuppressive drugs during the subsequent course of vaccination is permissible for health reasons.
special instructions
The introduction of the drug should not be carried out after the start of the course of using the rabies vaccine. In case of hypersensitivity to heterologous immunoglobulins and sera (in history), antihistamines should be administered orally at an age-specific dosage 2 times a day for 7-10 days (with careful monitoring of the patient). Intravenous administration of AIH is contraindicated (due to the risk of shock), so when injecting, you must make sure that the needle does not enter the blood vessel.
To avoid possible interactions between several different drugs, you should inform your doctor about any other therapy you are taking.
To the victim, who for any reason received tetanus toxoid serum within the previous 24 hours, AIH is administered without preliminary setting of an intradermal test.
Release form
Antirabic immunoglobulin - 3 ml, 5 ml or 10 ml in an ampoule.
Immunoglobulin antirabies diluted 1: 100 - 1 ml in an ampoule.
Produced in a set: 1 ampoule of immunoglobulin and 1 ampoule of immunoglobulin diluted 1: 100.
5 sets are packed in a box made of cardboard box for consumer packaging. The package contains instructions for use and an ampoule knife or a ceramic ampoule knife.
Storage conditions
Storage - at a temperature from, 2 to. 8 ° C in a place inaccessible to the shower of children. Do not freeze.
Transportation - at temperatures from 2 to 8 ° C. Do not freeze.
Shelf life
2 years. The drug with an expired shelf life is not subject to use.
Conditions of dispensing from pharmacies
For medical institutions.
P N016002 / 01 from 2015-12-18
Antirabies immunoglobulin from horse blood serum, liquid - instructions for medical use - RU No.
Immediately or as soon as possible after a bite or injury, a mandatory local wound treatment is performed. Wounds are washed abundantly with soap and water or any detergent and treated with 40-70% alcohol or iodine tincture. In cases where there are indications, a surgical treatment of the wound is performed.
After local treatment of the wound, specific treatment begins immediately. Before injection, check the integrity of the vial and the presence of markings on it. The drug is unsuitable for use in vials with impaired integrity, labeling, as well as when its physical properties (color, transparency, etc.) change, when the shelf life has expired, when the storage regime is violated.
The opening of the vials and the procedure for administering the drug are carried out in strict observance of the rules of asepsis and antiseptics.
A skin test is not required prior to administration.
The drug is administered as early as possibleterms after treatment once in a dose20 IU / kg body weight of an adult or child.
An example of calculating the dose of immunoglobulin The body weight of the victim is 60 kg. For example, the actual activity of a given series of immunoglobulin, indicated on the vial label or on the package, is 200 IU / ml. In order to determine the dose of immunoglobulin required for administration in ml, the weight of the victim (60 kg) must be multiplied by 20 IU and the resulting number must be divided by the activity of the drug (200 IU / ml), i.e .:
60x20 / 200 = 6 ml
As much of the calculated dose as possible should be infiltrated around the wound, if possible anatomically. The rest should be injected intramuscularly into the outer upper gluteal region for adults, or into the anterolateral region of the thigh for children. In children (especially those with multiple wounds), the dose of anti-rabies immunoglobulin from human blood serum can be diluted 2-3 times with 0.9% sodium chloride solution for injection to a volume that ensures full infiltration of the affected areas of the body.
Administration of anti-rabies immunoglobulifrom human serum should beshould be given 10-15 minutes before the rabies vaccine. It must be strictly observedthe sequence of administration of anti-rabiesdrugs.
In cases of late treatment of the victim for anti-rabies help, anti-rabies immunoglobulin from human blood serum can be administered no later than 7 days after contact with a patient with rabies or an animal suspicious of rabies.
Administration of rabies immunoglobulinat a later date, as well as after the introductionrabies vaccine is not allowed.
The dosage of immunoglobulin should not exceedunder no circumstances, sinceadministration of an increased dose of immunoglobulincan partially suppress the production of antibodies.
Rabies immunoglobulin and rabies vaccine must be given to different parts of the body using different syringes.
If emergency prophylaxis of tetanus is necessary, the latter is carried out after the introduction of rabies immunoglobulin and the first vaccination of the rabies vaccine.