TETATOX 0.5 ml. 10 ampoules
Purified tetanus toxoid not less than 40 IU Purified tetanus tonoid
not more than 1,25 mg AI
Thiomersal 0,045 mg
Water for injection to a volume of 0,5 mg
Pharmaceutical form and quantity in one package:
Suspension for injection for intramuscular injection in ampoules of 0,5 ml - 1 dose vials of 5,0 ml - 10 doses, and vials of 10,0 ml-20 doses.
The purified tetanus toxoid was prepared by detoxification of tetanus toxin with formaldehyde and heat. The toxoid is adsorbed on aluminum hydroxide. As a preservative is thiomersal used. Tetatoks is a vaccine that protects against tetanus disease. Immunity is provided after the second dose and is reinforced by booster vaccination.
1. Primary and booster immunization against tetanus in adults;
2. Extra prevention of injury and burning;
3. Specific prevention of neonatal tetanus;
4. Prevention of neonatal tetanus.
Hypersensitivity to any component of the vaccine. A history of hypersensitivity to previous administration of the vaccine.
In the presence of contraindications doctor assess the risk / benefit of the application of Tetatoks.
Precautions for use
The vial (vial) with a vaccine should be well shaken to obtain a homogeneous suspension. Injection is carried out with dry needle. As with all injectable vaccines, vaccination should remain under medical observation for 30 minutes after immunization ampoule (vial) tampered with or deleted inscription is not used!
Do not administer intravenously!
Immunisation (respectively booster) with Tetatoks can be performed simultaneously with other vaccines, each injectable vaccine is administered in a different place with a different syringe and needle. Tetatoks is compatible with vaccines against tuberculosis, polio, hepatitis B, measles, rubella vaccine against influenza vaccine, vaccine against yellow fever vaccine by H influenzae type B and the addition of vitamin A. The vaccine could be administered either simultaneously and at different times with immunoglobulins. The injection site of the immunoglobulins is different from that of Tetatoks applications. In individuals receiving immunosuppressive therapy may get weaker immune response.
No evidence of interaction with other medicinal products. Tell your doctor about all other medicines you are taking at the moment.
Special warnings about the use of vaccine
Immunization is performed by a doctor after appointment. Persons infected with HIV are immunized with Tetatoks according to the approved scheme for immunization.
In individuals with immunodeficiency or undergoing treatment to suppress the immune system is recommended to postpone immunization / booster, if planned, until its completion, as the effect of immunization may be weaker. In case of coagulation disorders the vaccine may be administered subcutaneously exceptionally deep.
Pregnancy and lactation
No evidence of toxic or teratogenic effect of Tetatoks the fetus when administered during pregnancy in order to prevent neonatal tetanus.
During lactation tetanus antibodies of maternal breastfeeding broadcast via milk. No evidence of toxicity in infants from the application of Tetatoks in women nursing their children.
Effects on ability to drive and use machines
There is no evidence that the vaccine affects alertness, the ability to drive and use machines.
Dosage and method of administration
A single dose of Tetatoks is 0,5 ml. Before use, the vial (vial) with the vaccine should be well shaken to obtain a homogeneous suspension. For each individual person using a sterile syringe and needle. Injections are done with other sterile and dry needle intramuscularly into the upper part of the deltoid muscle of the arm. The air from the syringe should be expelled before placing the dry needle.
Primary immunization in adults is held in non-immunized patients found no protective titer (<0.01 Au / ml) or data incomplete immunizations. The primary immunization in adults consists of two injections of 0,5 ml Tetatoks with an interval of 30-50 days.
In making primary immunization of adults, the first booster Tetatoks one year after the second injection. After immunization are conducted through 10 years Tetatoks 1 dose (0,5 ml).
In skipping doses or failure of the intervals between injections, further behavior is determined by your doctor.
Urgent prevention of tetanus injuries and burns
1. immunized persons
In making primary immunization or incomplete information, regardless of age face injected with 0,5 ml of Tetatoks. Incompletely immunized monitored to complete the full vaccination course.
2. In non-immunized subjects
Inject Tetatoks in dose 0,5 ml, the person is traced to complete the full course of immunization. Required at the discretion of the physician applies! M a place other than the vaccine and one of the following means for passive seroprofilaktika tetanus;
1. tetanus human immunoglobulin - a single dose in children and adults is 250-500IU.
2. tetanus serum - applied only when vital signs after the test for sensitivity to horse protein! Inject a dose 1500-3000IU, consistent with the age of the person.
Specific prophylaxis of tetanus was performed in parallel with the surgical treatment of the wound and treatment with antibiotics. Recommendations for urgent prevention of tetanus in injuries and burns, according to the type of wound and the patient's immune status.
Patients suffered from tetanus are recommended primary immunization, as by disease tetanus does not lead to the formation of a sufficient amount of tetanus antibodies.
SPECIFIC PREVENTION neonatal tetanus-performed in an outpatient birth and poor sanitary conditions.
1. unimmunized mother:
1.1. The mother was immunized with 0,5 ml of Tetatoks and monitored to complete the full vaccination course.
1.2. Mother and newborn tetanus human immunoglobulin injection at a dose of 500 IU.
2. Immunised mother before pregnancy:
2.1. The mother was immunized with 0,5 ml of Tetatoks
2.2. The newborn is immunized with a tetanus human immunoglobulin in a dose 250-500 IU.
3. Immunised mother during pregnancy:
3.1. In establishing strong pollution of newborn tetanus human immunoglobulin injected dose 250-500 IU.
Simultaneously held specific prevention, the navel of the newborn is treated with antiseptics.
Neonatal tetanus prevention
It is recommended for women of childbearing age or pregnant data for missing or incomplete held immunization against tetanus. Specific prophylaxis is conducted before pregnancy or during the first three months of pregnancy and consists of two injections of 0,5 ml at Tetatoks with an interval of one month. First Tetatoks booster dose 0,5 ml is held one year after the second injection.
At the site of injection of the vaccine may occur local reactions such as pain, redness, mild swelling and seal that resolve in 1-2 days.
General effects: slight fever, allergic reactions that occur within the first 24 hours after administration of the vaccine.
The occurrence of reactions, stronger than those described, tell your GP.
Tetatoks transported and stored in the dark in a refrigerator at 2 ° C to 8 ° C in the original carton. To avoid freezing of the vaccine! Freeze vaccine is obsolete. Keep out of reach of children!
Three years under the specified conditions of storage. The vaccine in multidose vials could be used for 4 weeks after the first withdrawal, subject to the following conditions:
- The expiration date has not expired;
- The vaccine was stored in a refrigerator at 2 ° C to 8 ° C.
- The cap of the vial is not submerged in water.
- When you download all doses was observed aseptic technique. Do not use after the date of expiry date stated on the package (month and year). The product is usable until the last day of that month.