Ap vaccine / tt vaccine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AP VACCINE / TT VACCINE

Composition:

Active substance: purified tetanus toxoid (purified tetanus toxoid);

1 dose (0.5 mL) contains purified tetanus toxoid 10 Lf (not less than 40 IU);

Excipients: aluminium phosphate – 1.5 mg, thiomersal – 0.05 mg, water for injections – up to 0.5 mL.

Pharmaceutical form. Injectable suspension.

Main physicochemical properties: white homogeneous suspension after shaking.

Pharmacotherapeutic group. Bacterial vaccines. Tetanus toxoid.

ATC code. J07AM01.

Immunological and biological properties.

Pharmacodynamics.

AP VACCINE / TT VACCINE, when used for primary and booster vaccination, induces the formation of specific immunity against tetanus.

According to clinical study results, AP VACCINE / TT VACCINE is safe and effective for preventive immunization against tetanus in children and adults, including women of reproductive age and pregnant women.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

The vaccine is intended for active immunization against tetanus and emergency specific prophylaxis of tetanus in children and adults.

Contraindications.

Vaccination should not be performed in individuals with an acute illness during prophylactic vaccination. Vaccination is also contraindicated in individuals with hypersensitivity to any component of the vaccine or with a severe generalized reaction to a previous dose of the vaccine.

For emergency tetanus immunoprophylaxis, hypersensitivity to any component of the product is a contraindication.

Regarding contraindications for immunization conducted in Ukraine, current orders of the Ministry of Health of Ukraine on preventive vaccinations should be followed.

Special safety measures.

Before use, the vial must be thoroughly shaken to homogenize the suspension.

A sterile needle and sterile syringe should be used for each injection.

Multi-dose vials of AP VACCINE / TT VACCINE, from which one or more vaccine doses have been withdrawn for immunization, may be used in subsequent immunization sessions for up to 4 weeks, provided all the following requirements are met (as described in the WHO position: "Use of opened multi-dose vials in subsequent immunization sessions, WHO/V&B/00.09"):

• the expiry date has not been reached;
• the vaccine has been stored under appropriate cold chain conditions;
• the vaccine vial stopper has not been submerged in water;
• each dose withdrawal from the vial is performed under aseptic conditions;
• the vial's vaccine vial monitor (VVM), if attached, has not reached its discard point.

Unused medicinal product or waste material should be disposed of in accordance with the requirements of current regulatory documents of the Ministry of Health of Ukraine.

Interaction with other medicinal products and other forms of interaction.

The medicinal product AP VACCINE / TT VACCINE can be administered simultaneously with human tetanus immunoglobulin or tetanus antitoxin, administered at different body sites.

Concomitant use of immunosuppressive agents may reduce the immune response.

Special precautions for use.

The vaccine should be administered intramuscularly.

If, after a previous vaccination with a vaccine containing tetanus toxoid, the vaccinated individual developed Guillain-Barré syndrome or brachial neuritis, careful consideration should be given to the possibility of further use of any vaccine containing tetanus toxoid, taking into account the potential benefit and the potential risk. Generally, vaccination is administered to such patients only if the patient has not completed the vaccination course (i.e., has received fewer than three doses).

Vaccination should not be performed in adults who have documented evidence of completed immunization against tetanus and whose last dose was administered less than 5 years ago.

Inactivated vaccines should not be administered earlier than 2 months after organ transplantation.

The vaccine may have reduced immunogenicity and efficacy in individuals with immunodeficiency or those receiving immunosuppressive therapy (e.g., corticosteroids, cytostatic agents, etc.). In such cases, vaccination is recommended to be postponed until completion of treatment or until adequate protection is ensured. However, vaccination of individuals with chronic immunosuppression, such as HIV-infected patients, is recommended if there is a reasonable expectation of antibody response, even if limited. If such a patient sustains an injury, passive immunization with human tetanus immunoglobulin should be administered simultaneously.

Syncope (fainting) may occur during or immediately before vaccination as a psychogenic reaction to needle injection. To prevent injury, it is recommended that vaccination be performed with the patient in a sitting or lying position, and the patient should remain in that position for 15 minutes after vaccination.

After vaccination, the patient should remain under medical supervision for at least 30 minutes in case of an allergic reaction. The vaccination room must be equipped with an emergency medical kit to manage potential anaphylactic reactions.

In the event of anaphylactic shock, management should follow the protocol for medical care in anaphylactic shock.

This medicinal product contains thiomersal (an organic mercury compound) as a preservative and may cause an allergic reaction. It is necessary to inform the physician if the individual has had or develops allergic reactions.

Use during pregnancy or breastfeeding.

Vaccination of pregnant women should be performed in accordance with current orders of the Ministry of Health of Ukraine. Vaccination during pregnancy ensures the development of adequate immunity against tetanus in the mother and prevents tetanus in both the mother and the newborn. If laboratory evidence of protection against tetanus is present, administration of a toxoid dose may be postponed.

There is no evidence of risk to the fetus from vaccination of pregnant women with inactivated vaccines, including tetanus toxoid.

Breastfeeding is not a contraindication, although tetanus antibodies are present in breast milk and may thus be transferred to the newborn.

Ability to influence reaction rate while driving or operating machinery.

The vaccine has no effect or has a negligible effect on the ability to drive vehicles or operate other machinery.

Method of Administration and Dosage

Dosing

The single dose of the vaccine is 0.5 mL and is the same for both children and adults.

Active Tetanus Immunization

Immunization with tetanus toxoid in individuals who have not previously been vaccinated against tetanus consists of three primary doses of 0.5 mL each, administered intramuscularly. The first two doses should be given at an interval of at least 1 month. The third dose of tetanus toxoid is administered 6 to 12 months after the second dose. Booster vaccinations should be repeated every 10 years.

Booster vaccination in adults who were previously fully immunized with combination vaccines containing tetanus toxoid should be performed every 10 years with adsorbed tetanus toxoid (AP) or adsorbed tetanus-diphtheria toxoid (ADT-M), 0.5 mL dose.

Emergency Tetanus Prophylaxis

Tetanus toxoid should also be administered whenever there is a risk of developing tetanus for any reason (e.g., trauma, burns, frostbite, animal bites, home deliveries, etc.). At least two doses, given at an interval of not less than 1 month, are required to provide primary protection in previously unimmunized individuals; additional booster doses will be necessary to maintain long-term immune protection.

Emergency tetanus prophylaxis should be carried out in accordance with the requirements of the relevant regulatory document on emergency tetanus prophylaxis, approved by the order of the Ministry of Health of Ukraine.

Children

AP VACCINE / TT VACCINE is used for active immunization and emergency prophylaxis in children who have not completed or have not received prior preventive immunization against tetanus.

Scheduled tetanus immunization in children is also performed using vaccines containing tetanus toxoid, in accordance with the preventive vaccination calendar approved by the order of the Ministry of Health of Ukraine and the respective product instructions.

Overdose

Data are not available.

Adverse reactions.

Adverse reactions are listed based on post-marketing surveillance data.

The following criteria have been used to assess the frequency of adverse reactions:

very common – more than 10 %;

common – 1–10 %;

uncommon – 0.1–1 %;

rare – 0.01–0.1 %;

very rare – less than 0.01 %;

frequency not known – reliable data are lacking.

Injection site reactions.

Uncommon: redness, swelling, pain at the injection site.

General disorders.

Rare: increased body temperature.

Very rare: malaise, fatigue.

Immune system disorders.

Very rare: allergic reactions (in individual cases, systemic reactions such as anaphylactic shock).

Skin and subcutaneous tissue disorders.

Very rare: urticaria, polymorphic rash, pruritus.

Cardiovascular system.

Frequency not known: arterial hypotension.

Blood and lymphatic system disorders.

Frequency not known: lymphadenopathy, thrombocytopenia.

Gastrointestinal disorders.

Frequency not known: nausea.

Musculoskeletal and connective tissue disorders.

Very rare: myalgia, arthralgia.

Nervous system disorders.

Very rare: headache, syncope, shoulder neuritis, Guillain-Barré syndrome.

Respiratory, thoracic and mediastinal disorders.

Potential risk of apnoea should be considered in preterm infants (≤ 28 weeks of gestation), particularly in those with a history of respiratory immaturity.

Reporting of adverse reactions.

Reporting of adverse reactions after medicinal product registration is very important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any adverse reactions through the national reporting system.

Shelf life.

3 years.

Storage conditions.

Store and transport at a temperature of 2 to 8 °C. Do not freeze. Keep out of reach of children. After opening, multidose vials should be stored at 2 to 8 °C for up to 4 weeks.

Incompatibilities.

Do not mix with other medicinal products!

Packaging.

5 ml (10 doses) in a vial; 10 vials in a box.

Prescription category.

Prescription only.

Manufacturer.

PT Bio Farma (Persero).

Manufacturer's address and place of business.

Jalan Pasteur No. 28 Bandung, Indonesia.