ANTI-RABIC IMMUNOGLOBULIN FROM HUMAN BLOOD SERUM
Registration number: LSR-010494/08 dated 241208.
grouping name. Anti-rabies immunoglobulin.
Rabies immunoglobulin from human blood serum, solution for injection, is a concentrated solution of purified gamma globulin fraction of human blood serum, isolated by cold extraction with ethanol and subjected to the process of ultrafiltration, purification and viral inactivation at a pH value of 4.0 and a temperature of 23-25 ° C within 21 days.
Composition (per 1 ml).
Specific antibodies to the rabies virus, at least 150 IU; stabilizer glycine (glycocol) from 20 to 25 mg; sodium chloride 7 mg; water for injections.
The drug does not contain antibiotics.
HBsAg, antibodies to HIV-1, HIV-2 and hepatitis C virus are absent.
Description.
Clear or slightly opalescent liquid, colorless or light yellow.
immunological properties.
The drug contains specific antibodies that can neutralize the rabies virus.
Pharmacokinetics. The maximum concentration of antibodies is reached 2-3 days after intramuscular injection of anti-rabies immunoglobulin. The half-life of antibodies is 3 to 4 weeks.
Appointment.
It is used in combination with an anti-rabies vaccine to prevent hydrophobia in people with severe multiple bites by rabid or suspected rabies animals.
Rabies immunoglobulin is not prescribed for repeated multiple bites by patients with rabies or animals suspected of having rabies if the victim received a full combined course of treatment with rabies immunoglobulin and the rabies vaccine at the first bite.
Method of application and dosage.
Immediately or as soon as possible after a bite or injury, a mandatory local treatment of the wound is carried out. Wounds are washed abundantly with soap and water or any detergent and treated with 40-70% alcohol or tincture of iodine. In cases where there are indications, 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, if the expiration date has expired, or if the storage regime has been violated.
The opening of the vials and the procedure for administering the drug are carried out with strict observance of the rules of asepsis and antisepsis.
A skin test is not required prior to administration.
The drug is administered as much as possible early dates after treatment, a single dose of 20 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 an immunoglobulin of this series, 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, you need to multiply the weight of the victim (60 kg) by 20 IU and divide the resulting number 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 anatomically possible. The rest should be injected intramuscularly into the outer upper gluteal region for adults, or into the anterolateral thigh region for children. In children (especially those with multiple injuries), 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 provides complete infiltration of the affected areas of the body.
The introduction of rabies immunoglobulin from human blood serum should be carried out 10-15 minutes before the 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 blood serum can be administered no later than 7 days after contact with a rabies patient or an animal suspected of rabies.
The introduction of rabies 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 introduction of an increased dose of immunoglobulin may partially suppress the production of antibodies.
Rabies immunoglobulin and rabies vaccine must be administered to different parts of the body using different syringes.
If necessary, emergency tetanus prophylaxis is carried out after the introduction of rabies immunoglobulin and the first vaccination of the rabies vaccine.
Interaction with drugs.
The introduction of anti-rabies immunoglobulin can be carried out simultaneously with emergency tetanus prophylaxis. The introduction of other prophylactic drugs is allowed no earlier than 3 months after the completion of the course of combined anti-rabies treatment.
Contraindications.
Since immunoglobulin from human blood serum is used for vital (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.
Side effect.
In some individuals, in the first few days at the injection site, hyperemia and swelling may develop, which do not require treatment, as well as subfebrile temperature. In extremely rare cases, an immediate allergic reaction may develop (urticaria, Quincke's edema, anaphylactic shock), and therefore persons who have received anti-rabies human immunoglobulin should be under medical supervision for at least 30 minutes.
Precautionary measures.
1. It is forbidden to administer the drug intravenously.
2. It is not allowed to use the drug in case of presence of a precipitate that does not disappear when shaken, foreign formations, cracks on the vial, not tightly closed vial cap.
3. After opening the vial, the prescribed dose should be used immediately.
The rest of the drug in the vial should not be used.
Release form.
In low borosilicate glass bottles of 1 ml (not less than 150 IU), 2 ml (not less than 300 IU), 5 ml (not less than 750 IU), sealed with a stopper made of bromobutyl rubber with an aluminum-plastic cap. One vial with instructions for
application in a cardboard box. A self-adhesive label is attached to the bottle.
Conditions of storage and transportation.
At a temperature of 2 to 8 ° C in a place protected from light. Do not freeze. Keep out of the reach of children.
Best before date.
2 years. Expired drug should not be used.
Holiday conditions.
For medical institutions.
Manufacturer. LLC "FK Sichuan Yuanda Shuyan", China.
Rabies is an unusually contagious natural focal infectious disease characterized by rapid damage to the central nervous system. Without adequate treatment, it inevitably ends in death. Rabies affects all kinds of animals, as well as humans. People become infected through a bite when saliva enters the wound.
The incubation period ranges from 8 days to 3 months, but cases of latent rabies have been recorded, when the first signs of the disease appear only after 6 months and even after a year. It depends on the virulence of the virus, viral load, bite site and personal immunity.
Therapeutic and preventive measures are effective only before the onset of clinical symptoms. Prevention when bitten by an animal with suspected rabies includes a number of comprehensive measures: treatment, cleaning and disinfection of wounds and damaged areas.
A course of anti-rabies vaccination and passive immunization with anti-rabies immunoglobulin, which is effective, is also immediately prescribed. The method and scheme of treatment are selected individually and depend on the site of the bite, the degree of contamination with saliva and the patient's condition.
Obtaining anti-rabies immunoglobulin from human and horse blood serum
In the event of a risk that after vaccination, intense immunity may not have time to form, anti-rabies immunoglobulin is used. It inactivates viral antigens and creates a fast, but short-acting passive immunity that has a virus-neutralizing effect.
Rabies immunoglobulin from horse blood serum
Anti-rabies liquid immunoglobulin registered in Russia. It is a protein fraction of gamma globulins isolated by the rivanol-alcohol method from the blood serum of horses immunized with the rabies virus. For the purpose of immunization of animals, a fixed strain of the rabies virus "Moscow" is used.
The drug has proven itself well, but there is a problem. Since equine rabies immunoglobulin contains a foreign protein, severe complications are possible in humans after injection. Therefore, before the introduction, it is necessary to make an intradermal allergic test for sensitivity to a foreign protein.
Immunoglobulin anti-rabies Rebinolin
There is a human serum immunoglobulin on the market, manufactured in China. Manufacturers get it by cold extraction with ethyl alcohol, followed by purification and ultrafiltration. In the manufacture of the drug, the blood of donors immunized with the corresponding one is used.
Chinese rabies immunoglobulin contains human homologous antibodies. Therefore, the development of allergic reactions to this drug is excluded, and the use of antihistamine drugs, as well as setting up a skin allergic reaction, is not required.
Rabies immunoglobulin must be administered strictly before vaccination, 10-15 minutes before vaccination.
Composition and mechanism of action of Rebinolin
Rebinoline is the most common drug for the prevention and treatment of rabies. He contains:
- anti-rabies human immunoglobulin (150 IU in 1 ml of solution);
- glycine (filler, excipient);
- water for injection.
The mechanism of action of Rebinoline is simple. The drug is an isotonic buffer solution of human rabies immunoglobulin obtained from donors immunized with the rabies vaccine. It contains specific antibodies from this virus.
Once in the body, Rebinolin forms a rapid passive immunity to rabies and increases the incubation period.
Immunity is developed more effectively if Rebinolin is administered to a person who has undergone immunoprophylactic vaccination against rabies.
Indications for the introduction of AIH
Immunoglobulin is indicated in combination with the rabies vaccine. It is used to prevent and prevent rabies in humans when bitten by animals that are obviously sick or suspicious.
Upon repeated contact with an infected animal, rabies immunoglobulin is no longer used.
If the victim received the entire course of complex treatment for AIH and the rabies vaccine for the first time, then additional injections are not necessary.
Instructions for use of human rabies immunoglobulin
In order for the immunoglobulin to have a positive effect, it must be administered immediately, preferably immediately after the bite. But first you need to treat the wound. Simply rinse with water and wipe with alcohol or iodine.
After treating the wound, you can inject:
- First you need to check the integrity of the ampoule. If it is damaged, immunoglobulin cannot be used;
- you also need to pay attention to the labeling. It must be whole;
- Finally, you need to make sure that physical properties the contents of the ampoule have not changed. Immunoglobulin is a clear liquid, colorless or yellowish. The drug may become cloudy or precipitate. This usually happens if the expiration date has passed or if storage rules are violated.
The medicine is administered only once. The dosage depends on the weight of the victim and is calculated individually. It is important that the largest possible proportion of immunoglobulin be infiltrated directly into the wound.
The rest is administered intramuscularly:
- for an adult, an injection is made in the upper part of the buttock;
- the child is given an injection in the anterolateral part of the thigh.
The drug should only be administered by a doctor, self-medication in case of suspected rabies is unacceptable.
Contraindications for use
Rabies is a 100% fatal disease. Therefore, if there is a risk of infection, there are no contraindications. The drug is administered to a person in any case. Patients with an identified allergic reaction to the components of anti-rabies immunoglobulin should be used in a hospital, strictly under medical supervision.
Side effects and complications after vaccination
Most patients do not experience any complications after vaccination. But in some cases, the injection causes pain, a feeling of discomfort appears, the injection site may turn red.
Systemic reactions are manifested in the form of nausea and vomiting, hypotension, palpitations, as well as in the form of allergic reactions and anaphylactic shock. But such cases are extremely rare.
With caution and strictly under the supervision of a physician, the vaccine is used in patients with immunodeficiency and.
In order to avoid the manifestation of negative reactions and serious complications, vaccination should be carried out in a hospital.
Price and analogues of the vaccine
After a bite by an animal that is sick or suspected of carrying the rabies virus, WHO and the Ministry of Health of the Russian Federation recommend the immediate use of an inactivated anti-rabies vaccine. There are several of them, but the effectiveness of all is approximately the same.
Vaccine anti-rabies Rabipur
The average price for 1 dose is 0.5-6 thousand rubles. Wherein:
- the cheapest is, the cost of which is about 500 rubles;
- belongs to the middle price category, it is sold for 2-2.5 thousand rubles;
- the most expensive vaccine is Rabivak-Vnukovo, but it is difficult to find it on the open market.
Any of the listed drugs is administered six times. The choice of vaccination scheme is selected individually by the doctor. The effectiveness of treatment and, accordingly, the life of a person depends on this.
If there is a risk of infection (by being bitten by a sick animal), the person is entitled to a free vaccination.
The preparation contains rabies immunoglobulin , as well as additional components of glycine glycocol as a stabilizer, water, sodium chloride. does not contain the product. It also does not contain antibodies to HIV, hepatitis C virus, HBsAg.
Release form
Immunoglobulin anti-rabies is produced in the form of a solution for injection. It can be transparent or slightly opalescent. The liquid is colorless or light yellow. The drug is packaged in vials of 1, 2, 5 ml.
pharmachologic effect
Immunoglobulin anti-rabies is a concentrated solution of purified gamma globulin fraction of serum. It is isolated from the blood using the method of cold extraction with ethanol. Next, the substance goes through the process of ultrafiltration, it is purified and inactivated to ensure purification from viruses. The preparation 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 given in combination with the 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.
With repeated multiple bites of rabid or suspected 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 an anti-rabies vaccine.
Contraindications
Considering the fact that this remedy is prescribed in the presence of vital signs. There are no contraindications to its use. People who are noted for human blood products, as well as pregnant women, should only be given immunoglobulin in a hospital.
Side effects
Some people in the first time after receiving the funds (in the first few days) may develop hyperemia , appears puffiness . It is possible to increase body temperature to subfebrile indicators.
Very rarely, severe allergic reactions can develop:, manifestations,. Therefore, after the introduction of the drug, a person must necessarily remain under the supervision of a specialist for at least thirty minutes.
Instructions for use (Method and dosage)
If a person has been bitten by an animal, the surface of the wound should be treated immediately. It is recommended to wash the wounds and treat them with alcohol or alcohol. If necessary, the wound is treated surgically.
Further, specific therapy should be applied. The vial containing anti-rabies Immunoglobulin must be carefully checked for integrity before administration, to determine whether it has the necessary markings, whether all the physical properties of the solution are preserved.
The instruction for anti-rabies immunoglobulin provides that the agent is administered with strict observance of all aseptic and antiseptic standards. It is not necessary to conduct a skin test before the administration of the drug. It is desirable to administer the drug as soon as possible after receiving a wound, while its dose is 20 IU per 1 kg of the weight of an adult or child. The exact calculation of the dose of the drug is carried out 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, Anti-rabies Immunoglobulin can be diluted with 0.9% sodium chloride solution to the volume that will allow complete wound infiltration. The drug must be administered no later than 7 days after the person has been in contact with an animal with rabies, or with suspicion of 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 injected with anti-rabies Immunoglobulin, after which, after 30 minutes, the anti-rabies vaccine should be administered. This sequence of administration of these drugs must be strictly observed. Do not administer immunoglobulin after the rabies vaccine.
The two above funds must be injected into different parts of the body and at the same time use different syringes.
In no case should the dosage of immunoglobulin be exceeded, since if the dose is exceeded, partial suppression of antibody production is possible.
If the patient needs to provide emergency prophylaxis, then it can be carried out only after anti-rabies immunoglobulin has been introduced and the first anti-rabies vaccine has been given.
Overdose
There is no data on an overdose of the drug.
Interaction
Rabies immunoglobulin injection can be given at the same time as emergency tetanus prophylaxis. Other drugs can be administered only after three months after the end of the combined 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, adhering to a temperature of 2 ° to 8 ° C, the medicine should be protected from light, it should not be frozen. Keep out of reach of children.
Best before date
Shelf life - 2 years.
special instructions
Immunoglobulin anti-rabies should not be administered intravenously.
The solution should be used immediately after opening the vial. The remaining solution can not be used later.
The drug should not be administered after the course of administration has been started. rabies vaccine .
If the patient has hypersensitivity to heterologous immunoglobulins and sera, then in the process of administering the drug, antihistamines should be prescribed medicines for 1 to 10 days. It is important to keep a close eye on the person. Intravenous administration is contraindicated, so it is important to make sure that the needle does not enter a blood vessel during the injection process.
Before starting treatment, tell your doctor if you are taking any other medications.
children
For children, the remedy is prescribed according to indications, it is administered in the dosage indicated in the instructions, in the anterolateral part of the thigh.
During pregnancy and lactation
When practicing the introduction of the drug in the presence of vital indications.
Rabies is a viral disease that affects the human nervous system. In the absence of timely treatment, it 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 from human blood serum is used to prevent rabies.
Immunoglobulin from human blood serum for the prevention of rabies: composition and form of release
Rabies immunoglobulin is produced in the People's Republic of China from the blood serum of donors who have been immunized with the rabies vaccine. The rabies vaccine contains a gamma globulin fraction of proteins. These are exactly the substances that are needed to neutralize the rabies virus. In the manufacture of the drug, cleaning methods are used. These are cold extraction with ethanol, purification, ultrafiltration. One milliliter contains:
- 150 IU (international units) of specific antibodies to the rabies virus.
- Glycine stabilizer.
- Sodium chloride.
- Water for injections.
Rabies immunoglobulin is available in vials of 300 and 150 IU. The vaccine does not contain antibiotics, which significantly reduces the risk of allergic reactions. Externally, the drug has a uniform consistency of light yellow color.
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 a protein nature. They are synthesized in the human body by special immune cells - plasma cells. Antibodies - there is a universal way to fight human body with bacterial, viral and other infections. With all infectious diseases, in response to the penetration of a foreign agent into the body, the production of immunoglobulins occurs. These proteins bind to antigens that carry pathogens 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, leading to 100% mortality without emergency immunoprophylaxis.
Important! Rabies emergency immunization should be started as soon as possible after the moment of infection.
Indications and preparation for drug administration
Rabies vaccination is indicated for all patients who are suspected of being infected with the virus. It is held:
- For any damage to the skin or mucous membranes that has been inflicted by wild or domestic animals with signs of rabies.
- For injuries caused by animals under veterinary supervision.
- If the saliva of an infected animal has got on the damaged skin.
The drug is used in parallel with the rabies vaccine. In the event of a repeated bite by an infected animal, the drug is not prescribed if the patient received a full dose of immunoglobulin for the first time.
Doctor's advice. When bitten by pets (cats, dogs), even if they do not have obvious symptoms of rabies, it is necessary to show the animal to the veterinarian and establish supervision. If a pet shows signs of rabies, the patient should consult a doctor.
Route of administration of the vaccine and dose
Before using anti-rabies immunoglobulin, it is necessary to consult a doctor and perform the primary surgical treatment of the wound. It is carried out in order to prevent wound infection and restore the integrity of the skin. The surgical treatment is performed by the surgeon. It should be done as soon as possible from the moment of the alleged infection. If necessary, stitches are applied.
After surgical treatment, immediately proceed to immunoprophylaxis. To do this, the health worker takes a bottle of immunoglobulin and checks its integrity. Pays attention to color, consistency and the presence of impurities. If signs of unsuitability of the drug are detected, it is prohibited to use it. After checking the drug under sterile conditions, open the vial and inoculate.
Important! With the introduction of human rabies immunoglobulin, in contrast to the drug made from horse serum, skin testing 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 of the dose should be injected into the soft tissues along the perimeter of the wound, the remainder of the drug is administered intramuscularly. For adults, this is the gluteal region, for children, the anterior surface of the thigh.
Doctor's advice. Rabies immunoglobulin is administered strictly before the rabies vaccine (10-15 minutes before)
The appointment of the drug is possible only if no more than 7 days have passed since the bite. The introduction of immunoglobulin a week after infection or after the rabies vaccine is not allowed.
Side effects, complications, reactions to vaccination
The introduction of the drug in some cases is accompanied by the occurrence of adverse reactions. They manifest as swelling, redness of the skin at the injection site. Sometimes there is a slight increase in body temperature, general weakness. These symptoms resolve on their own and do not require medical treatment.
Very rarely there are complications associated with a violation of the injection technique. 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 are treated under the supervision of a surgeon. Often, treatment is carried out surgically. The abscess is opened and the purulent contents are evacuated.
Abscess - a purulent complication of vaccination (photo: www.commons.wikimedia.org)
The second group: damage to the neurovascular bundle during the injection. A needle entering a nerve is accompanied by a characteristic sharp pain along the nerve endings. When a vessel is damaged, bleeding occurs infrequently. Often accompanied by a small hematoma.
Contraindications to the administration of the drug
Rabies is a disease that, if left untreated and immunized, leads to 100% mortality. In this regard, anti-rabies immunoglobulin and the vaccine are administered according to vital indications. There are no contraindications to vaccination.
Interaction with other immunoprophylaxis agents
The drug is allowed to be administered in parallel with the means for the prevention of tetanus. All other immunobiological preparations are used only three months after the end of the rabies vaccination.
Important! Immunoglobulin and the rabies vaccine must be administered at different sites on the body. A separate syringe is used for each of the drugs.
Vaccine storage conditions
The drug is stored in a specially designed refrigeration equipment. Temperature regime ranges from two to eight degrees above zero. Freezing of the drug is not allowed. Maximum term storage - two years.
Drug analogues
There are two types of anti-rabies immunoglobulin. The first is obtained from human blood serum. To do this, healthy people are immunized, 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 several advantages:
- The dosage of human immunoglobulin is half that.
- The preparation from the blood serum of immunized horses must be heated to 37°C before administration.
- The introduction of antibodies obtained from a person is not accompanied by the risk of developing sensitization (allergic reactions).
- Before the introduction of immunoglobulins obtained from horses, it is necessary to conduct a skin test, and after inoculation - to prescribe antihistamines.
A drug similar in composition to anti-rabies immunoglobulin, from human blood serum, is Rebinolin. It is produced in Israel.
