Tetanus toxoid purified adsorbed liquid - AS

Doctors often forget to provide tetanus prophylaxis to patients, which then serves as a reason for litigation. The rules for performing prophylaxis are regulated in Russia by order of the Ministry of Health of the Russian Federation dated May 17, 1999 N 174 “On measures to further improve the prevention of tetanus.” The order is quite voluminous; only extracts that relate to issues of emergency prophylaxis are listed below.

• Emergency prophylaxis of tetanus
• Immunological control for emergency prophylaxis of tetanus
• Prescription of drugs
• Active-passive prophylaxis of tetanus
• Contraindications

Emergency prophylaxis of tetanus

Emergency prevention of tetanus begins with primary surgical treatment of the wound and simultaneous specific immunoprophylaxis. Emergency immunoprophylaxis for tetanus should be carried out as early as possible and up to 20 days after the injury, taking into account the length of the incubation period for tetanus.

Emergency prophylaxis of tetanus is carried out when:

• frostbite and burns (chemical, thermal, radiation) of the 2nd, third and fourth degree;
• injuries in which there was a violation of the integrity of the skin and mucous membranes;
• abortions performed outside of hospitals;
• penetrating injuries of the gastrointestinal tract;
• gangrene or tissue necrosis of any type, long-term carbuncles, abscesses;
• childbirth outside of medical institutions (for example, at home);
• animal bites.

Note

<1> Instead of 0.5 ml of adsorbed tetanus toxoid, ADS-M can be used if vaccination against diphtheria with this drug is necessary. If the localization of the wound allows, it is preferable to introduce AS into the area where it is located by subcutaneous injection.

<2> Use one of the following drugs: PSCHI or PSS (it is preferable to administer PSCHI).

<3> For “infected” wounds, 0.5 ml of AS is administered if 5 or more years have passed since the last revaccination.

<4> The full course of AS immunization for adults consists of two vaccinations of 0.5 ml each with an interval of 30-40 days and revaccination after 6-12 months. the same dose. According to the abbreviated scheme, the full course of immunization includes a single vaccination with AC in a double dose (1 ml) and revaccination after 1-2 years with a dose of 0.5 ml of AC.

<5> Two vaccinations according to the regular immunization schedule (for adults and children) or one vaccination according to the abbreviated immunization schedule for adults.

<6> For “infected” wounds, PSCH or PSS is administered.

<7> All people who received active-passive prophylaxis to complete the course of immunization after 6 months. - 2 years old should be vaccinated again with 0.5 ml of AC.

<8> After the post-traumatic state has normalized, children should be vaccinated with the DTP vaccine.

Tetanus toxoid purified adsorbed liquid (AS-anatoxin) (Anatoxinum tetanicum purificatum adsorptum fluidum) Active ingredient: Tetanus toxoid (Anatoxin tetanus)

Instructions for medical use Dosage form Suspension for subcutaneous administration. Composition A single dose of the drug (0.5 ml) contains: 10 binding units (EC) of tetanus toxoid, no more than 1.25 mg of aluminum hydroxide in terms of aluminum (sorbent), from 42.5 to 57.5 mcg thiomersal (preservative) .

Description of the dosage form A suspension of grayish-white color, which separates when standing into a loose grayish-white sediment that breaks up when shaken, and a transparent colorless supernatant liquid.

Characteristics Tetanus toxoid purified, adsorbed, liquid is a tetanus toxin neutralized by formaldehyde and heat, purified from ballast proteins, adsorbed on aluminum hydroxide.

Pharmacological group MIBP-anatoxin

Indications The drug is intended for active immunization against tetanus (for persons who have not previously been vaccinated against tetanus), as well as for emergency specific prevention of tetanus.

Contraindications Permanent contraindications are a strong reaction or post-vaccination complication to a previous administration of AC-toxoid. The use of routine vaccinations is not recommended for pregnant women and during difficult feeding. Persons who have suffered acute diseases are vaccinated no earlier than 1 month after clinical recovery. Patients with chronic diseases are vaccinated no earlier than 1 month after achieving remission. Children with neurological disorders (reflex muscle rigidity, facial asymmetry, hand tremors, neuralgia) are vaccinated after progression of the process has been ruled out. For patients with allergic diseases, vaccinations are carried out 2-4 weeks after the end of the exacerbation, while stable manifestations of the disease (localized skin phenomena, hidden bronchospasm, etc.) are not contraindications to vaccination, which can be carried out against the background of appropriate therapy. Immunodeficiencies, HIV infection, as well as maintenance course therapy, including steroid hormones and anticonvulsants, are not contraindications to vaccination. In order to identify contraindications, the doctor (paramedic at the medical and obstetric station) on the day of vaccination conducts a survey of parents and an examination of the vaccinated with mandatory thermometry. When vaccinating adults, preliminary selection of persons to be vaccinated is allowed, with their interview by the medical worker conducting the vaccination on the day of vaccination. Persons temporarily exempt from vaccination must be monitored and registered and vaccinated in a timely manner.

Use during pregnancy and breastfeeding Use during pregnancy and breastfeeding is possible only for absolute epidemiological indications, taking into account the risk/benefit ratio, i.e. when the expected benefit to the mother outweighs the expected risk to the fetus or infant. Use by children and adults with chronic diseases is given in the “Contraindications for use” section.

Directions for use and doses

AC-toxoid is injected deep subcutaneously into the subscapular region in a dose of 0.5 ml (single dose). Before vaccination, the ampoule must be thoroughly shaken until a homogeneous suspension is obtained. The administration of the drug is registered in the established accounting forms, indicating the batch number, expiration date, manufacturer, and date of administration. Active immunization: The full course of vaccination with AC-toxoid (for persons not previously vaccinated against tetanus) consists of two 0.5 ml vaccinations with an interval of 30-40 days. And revaccinations after 6-12 months once at the same dose (as an exception, the interval can be extended to 2 years). Subsequent revaccinations are carried out every 10 years with AS or ADS-M toxoid once in the same dose. Immunization of some hard-to-reach populations (elderly people, unorganized population), taking into account specific conditions in certain areas, by decision of the Ministry of Health and Social Development of the Russian Federation, can be carried out according to an abbreviated scheme, providing for a single administration of AC-anatoxin in a double dose (1.0 ml) with the first revaccination in the period from 6 months to 2 years and subsequent revaccinations every 10 years with the usual doses of the drug (0.5 ml).

Emergency prevention of tetanus: Emergency specific prevention of tetanus is carried out for: • Injuries with violation of the integrity of the skin and mucous membranes; • Frostbite and burns (thermal, chemical, radiation) of the second, third and fourth degree; • Out-of-hospital abortions; • Childbirth outside medical institutions; • Gangrene or tissue necrosis of any type, long-term abscesses; • Animal bites; • Penetrating injuries of the gastrointestinal tract. Emergency prevention of tetanus involves primary surgical treatment of the wound and the creation, if necessary, of specific immunity against tetanus. Emergency immunoprophylaxis of tetanus should be carried out as early as possible from the moment of injury, up to 20 days, taking into account the length of the incubation period for tetanus disease. For emergency specific prevention of tetanus, the following is used: • AS-toxoid; • antitetanus human immunoglobulin (PSHI); • in the absence of PSCI, purified concentrated liquid antitetanus serum (PSS). The choice of prophylactic agents for emergency specific prophylaxis of tetanus is presented in Table 1. PSCH is administered in a dose of 250 IU intramuscularly into the upper outer quadrant of the buttock (see instructions for use of antitetanus human immunoglobulin). PSS is administered in a dose of 3000 IU subcutaneously (see instructions for use of antitetanus serum).

Notes: 1. Instead of 0.5 ml AC, ADS-M can be used if vaccination against diphtheria is necessary. 2. For “infected” wounds, 0.5 ml of AS is administered if 5 or more years have passed since the last revaccination. 3. The full course of AS immunization for adults consists of two vaccinations of 0.5 ml each with an interval of 30-40 days and revaccination after 6-12 months with the same dose. According to the abbreviated scheme, the full course of immunization includes a single vaccination with AC in a double dose (1.0 ml) and revaccination after 1-2 years with a dose of 0.5 ml of AC. 4. Two vaccinations according to the regular immunization schedule (for adults and children) or one vaccination with an abbreviated immunization schedule for adults. 5. All persons who received active-passive prophylaxis must be revaccinated with 0.5 ml of AC in 6 months to 2 years to complete the course of immunization. 6. After normalization of the post-traumatic state, children should be vaccinated with the DTP vaccine. Side effects AC-anatoxin is a weakly reactogenic drug. Some vaccinated people may develop short-term general (fever, malaise) and local soreness, hyperemia, swelling at the injection site in the first two days. Allergic reactions may develop (Quincke's edema, urticaria, polymorphic rash), exacerbation of allergic diseases. Considering the possibility of developing immediate allergic reactions in particularly sensitive individuals, vaccinated individuals must be provided with medical supervision for 30 minutes. Vaccination sites must be provided with anti-shock therapy. For persons who have suffered severe forms of allergic reactions to the administration of AC-anatoxin, further routine vaccinations with the drug are stopped. Overdose

No overdose symptoms were identified. Interaction

Interactions with other drugs have not been established. Precautions AC-toxoid is a grayish-white suspension. During storage, a grayish-white precipitate and a clear supernatant may form. Before use, the vaccine must be shaken thoroughly until a homogeneous, grayish-white suspension is obtained and checked visually for the absence of foreign particles and/or changes in appearance. If foreign particles or changes in appearance are detected, the vaccine should not be used. The drug is also not suitable for use in ampoules with damaged integrity, lack of labeling, or improper storage. The opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antiseptics. The drug cannot be stored in an opened ampoule. Vaccination is carried out with caution in patients with chronic diseases, neurological disorders and allergic reactions. special instructions

Effect on the ability to drive vehicles and machinery: The drug does not affect the ability to drive vehicles. Release form

AC-toxoid is produced in the form of a suspension for subcutaneous administration in ampoules containing 0.5 ml (one vaccination dose) or 1.0 ml (two vaccination doses). 5 ampoules in a blister pack. Two contour blister packs along with instructions for use or 10 ampoules with a separating snake and instructions for use and an ampoule scarifier in a cardboard pack. When using ampoules with a break ring or break point, do not insert an ampoule scarifier. Storage conditions

Should be stored in a dry place, protected from light, at a temperature of 4 to 8 °C. Do not freeze. The drug that has been frozen cannot be used. Keep out of the reach of children. Best before date

3 years. Do not use after the expiration date. Conditions for dispensing from pharmacies

Vacation only for medical institutions.

Manufacturer: SERUM INSTITUTE OF INDIA PVT. LTD. 212/2, Hadapsar, Pune 411 028, INDIA

Immunological control for emergency prophylaxis of tetanus

In the absence of reliable information about vaccinations, the state of tetanus immunity is assessed immediately at the time of the patient’s treatment for injury. The scheme for choosing emergency prophylaxis is based on the results of determining the level of a specific antitoxin in the blood serum of a patient with trauma or on indirect criteria for the fact of vaccination against tetanus (age, gender, absence of contraindications, military service, etc.)

A blood volume of 0.2 ml sufficient for research can be obtained from a wound or simultaneously with taking blood from a finger for any clinical analysis. Blood is collected into a capillary or test tube, which is left at room temperature or in a household refrigerator for 15-20 minutes, after which the supernatant liquid over the red blood cells (serum) is used for serological studies.

When taking blood from a vein, a standard method of separating blood serum is used. The determination of tetanus antitoxin in the patient’s blood serum is carried out in the RPGA in accordance with the instructions for the use of diagnosticums. The minimum titer of tetanus antitoxin, indicating immunization, is 1:20.

Detailed description of the study

Tetanus is an acute infectious disease that causes muscle hypertonicity and seizures. These symptoms are caused by the action of a toxin from the causative agent of the disease, the bacterium Clostridium tetani. This microorganism has the shape of a rod with rounded ends and can only live in an environment deprived of oxygen. Upon contact with air, it forms a spore that is resistant to various physical and chemical factors.

Tetanus is most often found in children and agricultural workers. A person becomes infected through injuries, scratches and other, even minor, damage to the skin when bacterial spores found in the soil enter the wound. There is also a possibility of infection during childbirth outside a medical facility.

This infection is divided into general and local tetanus, which is rare. The main role in the development of the clinical picture is played by tetanus toxin (exotoxin), consisting of tetanospasmin. It is a neurotoxin, its effect on the body is expressed mainly by damage to the nervous system and is characterized by the development of tonic (tension) and convulsive contractions of striated muscles, while in the intervals between convulsions the skeletal muscles do not relax, causing severe pain in the patient. The infection can occur in mild, moderate, severe and very severe forms. In most cases, the disease begins acutely. Specific manifestations of tetanus are:

1. Trismus - tension in the masticatory muscles;
2. Spasm of facial muscles, which causes a characteristic facial expression - a “sardonic smile”;
3. Dysphagia is a swallowing disorder that occurs due to overstrain of the muscular layer of the pharynx;
4. Stiffness - tension - in the neck muscles.

Symptoms of tetanus may also include:

1. Dull nagging pain and muscle twitching at the site of skin injury;
2. Sweating, irritability;
3. Tension of the muscles of the whole body, with severe infection, opisthotonus develops - a characteristic position of the patient’s body when the lumbar part is raised above the bed and the head is thrown back;
4. Disorders of defecation and urination;
5. Temperature rise to 41-42 °C;
6. Dyspnea.

Immunity after an illness is unstable, so re-infection is possible. However, the incidence of tetanus in our country is minimal. This is facilitated by the implementation of preventive measures to prevent the occurrence of this disease.

Prevention of tetanus can be specific and nonspecific. The latter involves preventing injuries at home and at work, eliminating the possibility of infection of wounds in medical institutions, as well as treating areas of skin damage. Specific prevention or immunoprophylaxis is human immunization, which includes vaccination.

The most effective way to prevent tetanus infection is vaccination. The DPT vaccine contains tetanus and diphtheria toxoids, as well as killed whole pertussis bacillus, which makes it possible to prevent these diseases in children. Adolescents and adults are vaccinated with diphtheria-tetanus toxoid (ADS-M toxoid).

Vaccination of children is carried out in accordance with the National Calendar of Preventive Vaccinations adopted in the Russian Federation from 3 months to 14 years at certain intervals. Further, to maintain tetanus immunity, it is necessary to be vaccinated at intervals of 10 years and, if necessary, undergo a study to determine the strength of post-vaccination immunity.

Antitetanus antibodies.

After vaccination, the body produces special molecules - antibodies, aimed at preventing the development of the disease in case of infection. This study serves to determine IgG antibodies (responsible for the immune response) to tetanus toxoid in the blood serum and decide on the need for vaccination and revaccination.

Prescription of drugs

The prescription of drugs for emergency immunoprophylaxis of tetanus is carried out differentially depending on the availability of documentary evidence of preventive vaccination or data from immunological monitoring of the intensity of tetanus immunity, as well as taking into account the nature of the injury.

No medications are administered

• children and adolescents who have documented evidence of routine preventive vaccinations, which are due to them by age, regardless of the time that has passed since the next vaccination;
• adults who have documented evidence of a full course of immunization no more than five years ago;
• people who have a titer of tetanus antitoxin in the blood serum above 1:160 according to RPGA (according to emergency immunological control), which corresponds to a titer above 0.1 IU/ml according to the biological neutralization reaction - PH (protective titer).

Only 0.5 ml of AC toxoid is administered

• adults who have documented evidence of a full course of immunization more than 5 years ago;
• children and adolescents who have documentary evidence of a course of scheduled preventive vaccinations without the last age-specific revaccination, regardless of the date of the last vaccination;
• persons who, according to emergency immunological control, have a tetanus toxoid titer in the range of 1:20-1:80 according to RPGA data or in the range of 0.01-0.1 IU/ml according to RN data;
• persons of all ages who received two vaccinations no more than 5 years ago, or one vaccination no more than 2 years ago; children from 5 months of age, adolescents, conscripts and those who have served a specified period in the army, whose vaccination history is unknown, and there were no contraindications to vaccinations.

Instead of 0.5 ml of AC, 0.5 ml of ADS-M can be administered if immunization with this drug is necessary.

Emergency prevention of tetanus is carried out in compliance with the following rules:

• Before administration, the ampoule with the drug is carefully examined. The drug should not be used in the following cases:
• – if there is no complete information about the drug on the label;

– if there is no label on the ampoule;

– in the presence of unbreakable flakes, sediment or foreign inclusions (fibers, burnt marks, etc.);

– if there are cracks on the ampoule;

– in case of improper storage of the drug;

– in case of expired medicinal product;

• immediately before administering the AS, the ampoule is shaken until a homogeneous suspension is obtained;
• When opening the ampoule, before and after the incision with a file, wipe it with sterile cotton wool moistened with alcohol. An opened ampoule of AS or PSS can be stored, covered with a sterile napkin, for no more than 30 minutes;
• drugs are drawn into a syringe from an ampoule using a long needle with a wide lumen. A different needle must be used for injection;
• the skin at the injection site is disinfected with 70% alcohol;
• After administering the drug, the injection site is lubricated with iodine or alcohol.

Tetanus toxoid purified adsorbed liquid - AS

FSUE NPO Microgen, Ministry of Health of the Russian Federation, JSC Biomed, Russia

Release form: 1 ampoule / 2 doses No. 10.

Vaccination schedule: the vaccination course for persons who have not previously been vaccinated against tetanus consists of two vaccinations with an interval of 30-40 days and revaccination after 6-12 months. Subsequent revaccinations are carried out every 10 years.

INSTRUCTIONS FOR USE Tetanus toxoid purified adsorbed liquid for donors (AS-anatoxin for donors), suspension for subcutaneous administration

The drug is a tetanus toxin neutralized by formaldehyde and heating, purified from ballast proteins and adsorbed on aluminum hydroxide gel. The drug contains in 1 ml (1 dose) 40 binding units (EC) of tetanus toxoid, no more than 1.1 mg of aluminum hydroxide (sorbent), from 80 to 120 mcg of merthiolate (preservative) and no more than 200 mcg of formaldehyde. A yellowish-white suspension without foreign inclusions, which separates upon settling into a clear supernatant liquid and a loose sediment, which completely breaks up when shaken.

BIOLOGICAL PROPERTIES. The drug causes the formation of specific antitoxic antibodies in people who have been immunized.

PURPOSE. Immunization of donors to obtain antitetanus plasma and antitetanus immunoglobulin.

METHOD OF APPLICATION AND DOSAGE. AC toxoid for donors is injected deep subcutaneously into the subscapular region. Before vaccination, the ampoule must be thoroughly shaken until a homogeneous suspension is obtained. The opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antiseptics. The drug cannot be stored in an opened ampoule. The drug is not suitable for use in ampoules with damaged integrity, lack of labeling, changes in physical properties (change in color, presence of unbreakable flakes), expired expiration dates, or improper storage. AS-toxoid for donors is used in accordance with the current “Instructions for immunization of donors for the purpose of producing tetanus immunoglobulin”.

The drug is administered in the following cases: 1. For the first revaccination of donors who have received two injections of AC toxoid containing 20 EU/ml. 2. For subsequent revaccinations of donors with a known vaccination history after 5 years after the previous administration of drugs containing tetanus toxoid. For revaccination of donors with an unknown vaccination history, in whose blood serum, during the initial background examination, the content of tetanus antitoxin (by ELISA) was found to be in the range of 0.01-4 IU per 1 ml. Note: Donors with serum levels of 8 or 16 IU should be given tetanus toxoid containing 20 EU/ml. When selecting donors for immunization and plasmapheresis, it is necessary to be guided by the general provisions provided for by the “Instructions for medical examination of blood, plasma and blood cell donors”, approved by the Ministry of Health of the Russian Federation on November 16, 1998.

SIDE EFFECTS. AS-toxoid for donors is a weakly reactogenic drug. Some donors may develop short-term general reactions (fever, malaise) and local reactions (pain, hyperemia, swelling) in the first two days. In extremely rare cases, allergic reactions may develop (Quincke's edema, urticaria, polymorphic rash), a slight exacerbation of allergic diseases. Considering the possibility of developing immediate allergic reactions in particularly sensitive individuals, vaccinated individuals must be monitored for 30 minutes. Immunization sites must be provided with anti-shock therapy.

INTERACTION WITH OTHER MEDICINES. Interaction with other drugs has not been established.

CONTRAINDICATIONS. Donors who have suffered acute illnesses are immunized no earlier than 1 month after recovery or remission.

RELEASE FORM. In ampoules of 1 ml. 10 ampoules with instructions for use, an ampoule knife or an ampoule scarifier in a pack.

VARIATION CONDITIONS. For medical and preventive institutions.

BEST BEFORE DATE. STORAGE AND TRANSPORTATION CONDITIONS. Shelf life: 3 years. The drug is stored (out of reach of children) and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 °C. Freezing is not allowed.

Complaints regarding the quality of the drug, with the obligatory indication of the batch number and date of manufacture, should be sent to the Federal State Budgetary Institution GISK named after. L.A. Tarasevich (119002, Moscow, Sivtsev-Vrazhek, 41, tel. 241-39-22, fax 241-92-38) and to the address of the enterprise, 115088, Moscow, st. 1st Dubrovskaya, 15, tel., fax 981 -62-09; (Production address: 614089, Perm, Bratskaya st., 177, tel.).

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Active-passive prophylaxis of tetanus

AC should be administered in a volume of 1 ml, having previously read the instructions for the drug. At the same time, PSCH 250 IU must be injected into another part of the body; in the absence of PSCH, 3000 IU PSS must be injected. Before administering PSS, an intradermal test with horse serum diluted in a ratio of 1:100 is required to determine sensitivity to horse serum proteins (the ampoule is marked in red). An intradermal test cannot be performed if the victim was tested with 1:100 diluted anti-rabies gammaglobulin from horse serum for 1-3 days before the administration of PSS due to the need to administer anti-rabies gammaglobulin.

To perform the test, you need to use an individual ampoule, as well as sterile syringes with 0.1 ml graduations and a thin needle. The serum diluted 1:100 is injected under the skin into the flexor surface of the forearm in an amount of 0.1 ml. The reaction is monitored after 20 minutes. The test is considered negative if the diameter of the swelling or redness at the injection site is less than 1.0 centimeters.

The test is considered positive if the swelling or redness in diameter is 1.0 cm or more. If the skin test is negative, PSS (from an ampoule marked in blue) is injected subcutaneously in a volume of 0.1 ml. If there is no reaction after half an hour, you need to inject the remaining dose of serum with a sterile syringe. During this period, the opened ampoule with PSS should be covered with a sterile napkin.

Note : For people with allergic diseases and reactions to various allergens, as well as those who have previously received drugs containing horse serum (PSS and others) or heterologous gammaglobulins (anti-rabies, anti-encephalitis, etc.), it is best to resort to the administration of antihistamines before administering the main dose of PSS.

Persons with a positive reaction to intradermal injection of 0.1 ml of horse serum diluted 1:100 or who had a reaction to subcutaneous injection of 0.1 ml of PSS cannot undergo further administration of PSS.

Considering that after the administration of PSS and drugs that contain tetanus toxoid, particularly sensitive individuals may develop shock, each vaccinated person must be monitored medically for 60 minutes after vaccination. And the institution where people are vaccinated should be provided with anti-shock therapy in case of need.

ADS-M toxoid

FSUE NPO Microgen, Ministry of Health of the Russian Federation, JSC Biomed, Russia

Release form: 1 ampoule / 2 doses No. 10.

Vaccination schedule: prevention of diphtheria and tetanus according to the National Vaccination Calendar in children from 6 years of age, adolescents and adults.

INSTRUCTIONS FOR USE of purified diphtheria-tetanus toxoid, adsorbed with a reduced content of antigens, liquid (ADS-M toxoid), suspension for injection

ADS-M toxoid consists of a mixture of purified diphtheria and tetanus toxoids adsorbed on aluminum hydroxide. The drug contains in 1 ml 10 flocculating units (LF) of diphtheria toxoid, 10 antitoxin-binding units (EU) of tetanus toxoid, 100 μg of merthiolate (preservative). A suspension of grayish-white color that separates when standing; a loose grayish-white precipitate that breaks up when shaken and a clear, colorless supernatant. IMMUNOBIOLOGICAL PROPERTIES . Administration of the drug in accordance with the approved regimen causes the formation of specific antitoxic immunity against diphtheria and tetanus. PURPOSE . Prevention of diphtheria and tetanus in children from 6 years of age, adolescents and adults. METHOD OF APPLICATION AND DOSAGE . ADS-M toxoid is administered intramuscularly into the upper outer quadrant of the buttock or the anterior outer part of the thigh, or deep subcutaneously (for adolescents and adults) into the subscapular region in a dose of 0.5 ml (single dose). Before vaccination, the ampoule must be thoroughly shaken until a homogeneous suspension is obtained. ADS-M anatoxin is used: 1. For planned age-related revaccinations at 7 and 14 years, then every subsequent 10 years without age limitation. The drug is administered once. Note. Persons vaccinated with tetanus toxoid are vaccinated with AD-M toxoid between revaccinations. 2. For vaccination of children six years of age and older who have not previously been vaccinated against diphtheria and tetanus. The vaccination course consists of two vaccinations with an interval of 30 - 45 days. Reducing the interval is not allowed. If it is necessary to increase the interval, the next vaccination should be carried out as soon as possible. The first revaccination is carried out 6 - 9 months after the completed vaccination once, the second revaccination is carried out at an interval of 5 years. Subsequent revaccinations are carried out every 10 years without age restrictions. 3. As a replacement for DTP vaccine (DTa toxoid) in children with severe general reactions (temperature up to 40 °C and above) or post-vaccination complications to these drugs. If a reaction has developed to the first vaccination with DPT (ADS), then ADS-M toxoid is administered once no earlier than 3 months later, if the reaction has developed to the second vaccination, then the course of vaccination against diphtheria and tetanus is considered completed. In both cases, the first revaccination with ADS-M toxoid is carried out after 9-12 months. If a reaction has developed to the third vaccination with DPT (ADS), the first revaccination with DPT-M toxoid is carried out after 12 - 18 months. 4. To carry out a course of vaccination for adults who have not previously been reliably vaccinated against diphtheria and tetanus, a full course of immunization is carried out (two vaccinations with ADS-M toxoid with an interval of 30 days and revaccination after 6 - 9 months). In diphtheria outbreaks, preventive vaccinations are carried out in accordance with the instructions and methodological documents of the Russian Ministry of Health. ADS-M toxoid can be administered a month later or simultaneously with the polio vaccine and other drugs in the national vaccination schedule. The drug is not suitable for use in ampoules with damaged integrity, lack of labeling, or when the physical properties have changed. ADS-M toxoid can be administered a month later or simultaneously with the polio vaccine and other drugs in the national vaccination schedule. The drug is not suitable for use in ampoules with damaged integrity, lack of labeling, changes in physical properties (change in color, presence of unbreakable flakes), or improper storage. The opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antiseptics. The drug cannot be stored in an opened ampoule. The administration of the drug is registered in the established accounting forms, indicating the batch number, expiration date, manufacturer, and date of administration. REACTION TO INTRODUCTION . ADS-M toxoid is one of the least reactogenic drugs. Some vaccinated people may develop short-term general (fever, malaise) and local (pain, hyperemia, swelling) reactions in the first two days. In extremely rare cases, allergic reactions may develop (Quincke's edema, urticaria, polymorphic rash), a slight exacerbation of allergic diseases. Considering the possibility of developing immediate allergic reactions in particularly sensitive individuals, vaccinated individuals must be provided with medical supervision for 30 minutes. Vaccination sites must be provided with anti-shock therapy. For persons who have suffered severe forms of allergic reactions to the administration of ADS-M toxoid, routine vaccinations with the drug are stopped. CONTRAINDICATIONS . There are no permanent contraindications to the use of ADS-M toxoid in adults and children. Vaccinations are not recommended for pregnant women. Persons who have had acute illnesses are vaccinated 2-4 weeks after recovery. In mild forms of the disease, vaccinations are allowed after the clinical symptoms disappear. Patients with chronic diseases are vaccinated upon achieving complete or partial remission. Children with neurological disorders are vaccinated after progression of the process has been ruled out. For patients with allergic diseases, vaccinations are carried out 2-4 weeks after the end of the exacerbation, while stable manifestations of the disease (localized skin phenomena, hidden bronchospasm, etc.) are not contraindications to vaccination, which can be carried out against the background of appropriate therapy. Immunodeficiencies, HIV infection, as well as maintenance course therapy, including steroid hormones and psychopharmaceuticals, are not contraindications to vaccination. In order to identify contraindications, the doctor (paramedic at the FAP) on the day of vaccination conducts a survey of parents and an examination of the vaccinated with mandatory thermometry. When vaccinating adults, preliminary selection of persons to be vaccinated is allowed, with their interview by the medical worker conducting the vaccination on the day of vaccination. Persons temporarily exempt from vaccination must be monitored and registered and vaccinated in a timely manner. VACCINATIONS ACCORDING TO INDICATIONS . If epidemiologically necessary, V\ADS-M toxoid can be administered against the background of an acute illness. In case of a strong reaction to the previous dose of this drug, a second dose is administered while using steroids (prednisolone orally 1-1.5 mg/kg/day the day before and immediately after vaccination). RELEASE FORM. In ampoules of 0.5 ml (one vaccination dose) and 1.0 ml (two vaccination doses). The package contains 10 ampoules. BEST BEFORE DATE . 3 years. A drug that has expired cannot be used. STORAGE AND TRANSPORTATION CONDITIONS . The vaccine is stored and transported in accordance with SP 3.3.2.028-95 in a dry place protected from light at a temperature of 4 to 8 °C. The drug that has been frozen cannot be used. Complaints about physical and other properties are sent to the State Research Institute for Standardization and Control of Medical Biological Preparations named after. L.A. Tarasevich, (119002, Moscow, Sivtsev Vrazhek, 41, tel/fax) and to the Biomed enterprise named after. I.I.Mechnikov. All cases of increased reactogenicity or the development of post-vaccination complications should be reported by phone or fax to the Department of the State Committee for Sanitary and Epidemiological Surveillance of the Ministry of Health of Russia and to the GISC named after. L.A. Tarasevich with the subsequent sending of medical documentation to the State Medical Inspectorate named after. L.A. Tarasevich. Manufacturer: JSC Biomed named after. I.I. Mechnikova 143422 Moscow. region, Krasnogorsk district, village. Petrovo-Dalnee Tel., fax

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Contraindications to the use of specific means of emergency prophylaxis of tetanus

The main contraindications to the use of specific tetanus prophylaxis are:

• pregnancy (in the first half, the administration of AS (ADS-M) and PSS is contraindicated, in the second half - PSS);
• increased sensitivity to the appropriate prophylactic agent;
• in persons who had contraindications to the administration of AS (ADS-M) and PSS, the possibility of emergency prophylaxis with the help of PSCI is determined by the attending physician.

Alcohol intoxication is not a contraindication to emergency prevention.