Tetraxim vaccine (diphtheria, tetanus, whooping cough, polio)

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Tetraxim is a French vaccine, produced by the famous company Sanofi Pasteur S.A.

Tetraxim is a vaccine designed to prevent diphtheria, whooping cough, tetanus and polio. Accordingly, this suspension is used in cases where primary immunization of children or their revaccination against the listed ailments is required.

The vaccine contains antigens of diphtheria and tetanus toxoid, components of the cell wall of the causative agent of whooping cough and inactivated polio virus types 1,2,3. The antigenic composition and manufacturer are the same as the Pentaxim® vaccine. Compared to whole cell vaccines (DTP), acellular vaccines contain 30 times fewer protein molecules and are more immunogenic. This means that there are fewer reactions to the vaccine, tolerability improves, and effectiveness is maintained.

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Compound

The composition of 1 immunizing vaccine (0.5 ml of suspension for intramuscular administration) includes the following active ingredients:

• at least 30 IU of diphtheria toxoid;
• at least 40 IU of tetanus toxoid;
• 25 mcg pertussis toxoid;
• 25 μg filamentous hemagglutinin (FHA);
• 40 D-units of antigen - inactivated polio virus type 1;
• 8 D-units of antigen - inactivated polio virus type 2;
• 32 D-units of antigen - inactivated poliovirus type 3.

In addition, there are constituent auxiliary substances:

• 0.3 mg aluminum hydroxide;
• 0.05 ml Hanks' medium 199 (without phenol red);
• 12.5 mg formaldehyde;
• 2.5 µl phenoxyethanol 2;
• d/i water – to bring to 0.5 ml;
• ethanoic acid or sodium hydroxide - to achieve a pH value of 6.8-7.3.

Release forms

The average cost in the pharmacy chain of the Russian Federation is 1150 – 1300 rubles.

The medicine is produced in the form of a homogeneous white suspension for intramuscular use.

The manufacturer includes a 0.5 ml dosing syringe with a fixed needle, which reduces pain during injection. This option is convenient and safe to use, since one syringe dose of the drug is used once, eliminating the overdose and the possibility of reusing the syringe.

Packaging: syringe dispenser with suspension, instructions in a cardboard box.

Pharmacodynamics and pharmacokinetics

Immune response after primary vaccination

As a result of immunogenicity studies, it was found that the entire group of newborns (100%) vaccinated with 3 doses of the vaccine, starting at the age of 2 months, developed a seroprotective antibody titer (more than 0.01 IU/ml) against diphtheria and tetanus .

More than 87% of children younger than 1-2 months. after the completion of the primary course of immunization, an increase in the titer of antibodies against pertussis toxoid and PHA by 4 times.

99.5% of children after primary vaccination had a protective antibody titer against polio types 1,2,3.

After the first dose of revaccination at 16-18 months. all children had protective antibodies against diphtheria (more than 0.1 IU/ml), tetanus (more than 0.1 IU/ml) and 87.5% against the polio .

Seroconversion rates for pertussis (titers are 4 times higher compared to titers for vaccination) are 92.6% for pertussis toxoid and 89.7% for PHA .

Immune response after revaccination

As a result of revaccination, all children aged 5-13 years had protective antibody titers against tetanus (more than 0.1 IU/ml) and polio . Of these, at least 99.6% had protective antibody titers against diphtheria (more than 0.1 IU/ml). Seroconversion rates for pertussis (titers 4 times higher than pre-vaccination titers) ranged from 89.1% to 98% for pertussis toxoid and from 78.7% to 91% for PHA .

Contraindications

• A hypersensitivity reaction to one of the components or an allergic reaction to residues from the manufacturing process that may be present in trace amounts, for example, gutaraldehyde , neomycin , streptomycin , polymyxin B , or to the pertussis acellular or whole-cell component .
• A life-threatening reaction to a previous dose of this vaccine or a vaccine containing similar components.
• In cases of chronic or acute diseases, while receiving immunosuppressive therapy, vaccination should be postponed in an immunosuppressed state.
• Progressive encephalopathy (cerebral lesions) or that occurred 7 days after vaccination with any vaccine with a pertussis component (acellular or whole-cell).

The vaccine is used only in pediatrics!

Can be used with caution

• children with thrombocytopenia or bleeding disorders;
• a history of febrile seizures not associated with previous vaccination requires temperature control for 2 days after vaccination, as well as the use of antipyretics .

Precautionary measures

Therapy with medications that suppress the immune system often causes a weak immune response to Tetraxim. In such cases, the medicine is used later - after the end of treatment or during remission.

If there is a low platelet count or blood thinning, the injection is given with caution to avoid bleeding.

If previously - after the previous vaccination - there were febrile convulsions caused by high temperature, it is necessary to monitor its dynamics for 2 days. When the temperature rises, antipyretic drugs for children are used (Paracetamol in suspensions, Ibuprofen).

If you have any suspicions when observing the baby’s condition or strange behavior, you should urgently call a doctor.

It is not recommended to bathe children on the first or second day after vaccination; you should not allow the baby to rub or scratch the injection site to avoid infection through damaged skin.

Side effects

Local reactions

On the third day, pain, redness, and hardness may occur at the injection sites. Such reactions resolve spontaneously without treatment. In some cases, thickening and redness may occur, exceeding 5 cm in diameter and accompanied by swelling, spreading to one or two joints over 2-3 days, which also disappears spontaneously after 3-5 days without additional treatment.

General reactions

With a frequency of 1-10%, an increase in temperature to 38°-39°C is observed. In rare cases (less than 1%), the rectal temperature rose above 40°C.

Other reactions

• irritability, sleep disturbances, drowsiness;
• loss of appetite, vomiting, diarrhea;
• unusual or prolonged crying;
• rash, urticaria , Quincke's edema ;
• convulsions (febrile and afebrile);
• hypotension, hypotonic-hyporeactive syndrome , shock;
• Guillain-Barré syndrome , neuritis (inflammation) of the brachial nerve;
• prolongation of inhalation-exhalation intervals in very premature (≤28 weeks) children (requires monitoring of respiratory function for 48-72 hours).

pharmachologic effect

Prevention of the following diseases:

• whooping cough: an infection of the respiratory tract, relieved by a spasmodic cough. Can provoke pulmonary edema, emphysema, purulent otitis, pneumonia, bronchitis;
• polio: affects the spinal cord, causing pathology of the central nervous system. Can lead to disability, paralysis and even death;
• diphtheria: acute infection, affects the mucous membranes of the oral cavity and nasopharynx, provokes intoxication of the cardiovascular and excretory systems. Possible complications: damage to the adrenal glands, otitis media, pneumonia, respiratory failure, toxic nephrosis;
• tetanus: affects the central nervous system, limb cramps, muscle spasms. Due to possible asphyxia or cardiac arrest, death.

All of these diseases are quickly transmitted by airborne droplets, so it is easy to become infected with them. A child's fragile body may not be able to cope with the virus, and then the consequences will be irreversible. Therefore, it is worth seriously considering vaccination with the drug Tetraxim, which forms specific immunity for the rest of life. The main thing is to follow the doctor's recommendations and carry out injections when the child is healthy.

Tetraxim, instructions for use (method and dosage)

Vaccination should be carried out by medical personnel in preventive vaccination rooms of medical institutions, where all the necessary medications are available to provide emergency medical care in the event of the development of serious allergic reactions, including anaphylactic shock .

Immediately before vaccination, shake the vaccine to form a homogeneous whitish cloudy suspension. The drug should be administered in a dose of 0.5 ml intramuscularly, making sure that the needle does not enter the vessel.

The recommended injection site for children under 1 year of age is the anterolateral surface of the thigh (middle third), for older children - the densest part of the deltoid muscle of the shoulder.

Immunization schedule

Must be observed in accordance with the preventive vaccination calendar:

• 3 injections with an interval of 1.5 months, starting at 3 months of age 3, and then at 4.5 and 6 months. respectively;
• revaccination after 12 months. by administering a single dose of the vaccine.

Attention!

If the vaccination schedule has been violated, then the intervals between subsequent administrations of subsequent doses of the vaccine should not change, including before the fourth revaccination dose, and be at least 12 months.

Special conditions

The vaccine should be shaken well before administration. It is administered intramuscularly in a dosage of 0.5 ml. For children under 2 years of age, the injection is given in the middle third of the anterolateral thigh, and for older children - in the deltoid muscle of the shoulder. This drug is not administered intradermally or intravenously.

The state of immunodeficiency and immunosuppressive therapy may cause the immune response to this vaccine to be weak. However, this vaccine is recommended for children with HIV. In case of immunosuppressive therapy, it is recommended to postpone vaccination until recovery or remission occurs.

Interaction

• Tetraxim can be administered simultaneously with the measles , mumps and rubella or with the hepatitis B , provided that it is administered to different parts of the body.
• For primary immunization as a booster, Tetraxim vaccine can be used as a vaccine diluent to prevent infections associated with Haemophilus influenzae type b (Act-HIB), or simultaneously in different places on the body.

Before vaccination, tell your doctor if you are using any medications.

Tetraxim vaccine (diphtheria, tetanus, whooping cough, polio)

Tetraxim (SANOFI PASTEUR, SA, France) is a combination vaccine containing adsorbed acellular pertussis-diphtheria-tetanus vaccine and inactivated polio vaccine. This vaccine is similar to the Pentaxim vaccine, but does not contain a hemophilus influenzae component (the package does not contain a bottle of lyophilized (specially dried) hemophilus influenzae vaccine). The use of the Tetraxim vaccine allows you to immunize a child against whooping cough, diphtheria, tetanus and polio with one injection, and not overpay for the unused hemophilic component. Compared to the DTP vaccine, the Tetraxim vaccine contains 30 times fewer protein molecules and has a higher immunogenicity. This means that there are fewer reactions to the vaccine, tolerability improves, and effectiveness is maintained.

Indications for use.

Prevention in children from 3 months to 5 years 11 months 29 days from:

• diphtheria;
• tetanus;
• whooping cough;
• polio;

Dosage regimen
. A single dose is 0.5 ml. The pertussis-diphtheria-tetanus and polio part of the vaccine is in a specially designed syringe dose. This syringe dose of the Tetraxim® vaccine is aseptically packaged and adapted for convenient transportation and storage, equipped with a special needle that minimizes pain from the injection. The use of such a syringe eliminates overdose and reuse.

Mode of application

. The Tetraxim vaccine is administered intramuscularly. In children, usually in the quadriceps femoris muscle (middle third of the thigh), and in older children in the deltoid muscle (shoulder). Injection into the buttock is not currently practiced. Subcutaneous administration is acceptable.

Vaccination scheme

The use of the Tetraxim Vaccine is possible both as a monovaccine (for the entire vaccination course) and instead of the Pentaxim vaccine. A competent combination of these two drugs makes it possible to reduce the cost of the vaccination course and does not lead to overuse of the Pentaxim vaccine

The course of primary vaccination consists of 3 doses of vaccine and revaccination. Immunization schedule: first administration, then the second after 45 days from the first, then the third after 45 days from the second and revaccination a year after the third is completed. The use of the vaccine is not clearly related to age. It is important to comply with vaccination dates. If the deadlines are extended, vaccination will not be resumed. Violation of the vaccination schedule can lead to a decrease in the intensity of immunity to the components of the vaccine.

For example, the Tetraxim vaccine will be the drug of choice for continuing vaccination of children over one year old, after they have been given the first Pentaxim vaccine with a hemophilic component.

Use of Tetraxim in combination with other vaccines

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The Tetraxim vaccine can be administered simultaneously with all drugs from the national calendar of preventive vaccinations on the same day, in different parts of the body, with the exception of the BCG vaccine.

The use of the Tetraxim vaccine together with other vaccinations does not affect their immunogenicity (ability to develop immunity). Tolerability of vaccines does not deteriorate, and the number of adverse reactions does not increase. The use of Tetraxim and Pentaxim vaccines during the course of vaccination against whooping cough, diphtheria, tetanus and polio is a competent approach to the health of your child and does not in any way affect the tolerability of vaccination and the development of immunity (subject to the timing of vaccination).

Administering several vaccines on the same day does not place an excessive burden on the immune system.

Tetraxim can be used to continue and complete a vaccination course started with other vaccines against whooping cough, diphtheria, tetanus, and polio. Adverse reactions.

Reactions to the Tetraxim vaccine are divided into local and general.

Local reactions to the drug are rare and, as a rule, are represented by redness, swelling, pain at the injection site (10% of vaccinated people). General reactions are mainly expressed by fever. Most often subfebrile (1-10% of vaccinated people), less often febrile (0.1-1% of vaccinated people).

General complications are extremely rare and may include lymphadenopathy, irritability, sleep disturbance, headache, itching, hardness at the injection site (0.01 to 1%).

additional information

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The use of the Tetraxim vaccine is possible only in healthy children who have passed a general blood and urine test before vaccination. The interpretation of the tests is carried out by a pediatrician who decides on the child’s admission to vaccination.

License holder to sell the drug

Sanofi Pasteur SA 2, Avenue Pont Pasteur, 69007 Lyon, France

Analogs

Level 4 ATX code matches:
Pentaxim

Infanrix Hexa

Infanrix

• Pentaxim (additionally immunization against Hib infection ).
• Boostrix Polio - used only in children over 4 years of age.
• Hexaxim - immunization differs in the vaccine administration schedule: it starts at 6 weeks of age, the interval between the next three doses of vaccines is 4 weeks, 1 month or 2 months.

Reviews of Tetraxim

Reviews about this vaccine are positive: many mothers report that vaccination and revaccination were successful; some children experienced a slight increase in temperature on the second day, which went away on its own.

Parents just planning immunization are interested in the differences between Tetraxim and Pentaxim , as well as Infanrix , which, although they are analogues, differ in the number of components they contain for protection and are tolerated differently by children. All necessary protection components can be obtained in the form of separate injections. Pentaxim has the largest number of them (additionally for Hib infection ), but this provokes a more frequent development of undesirable reactions.