Td Vax

Adsorbed diphtheria and tetanus vaccine (with reduced antigen content).

1 dose (0.5 ml) contains: Tetanus toxoid¹ not less than 40 IU, Diphtheria toxoid¹ not less than 5 IU.
¹ adsorbed on aluminium hydroxide, hydrated not more than 0.5 mg Al ³⁺.
Excipients/Inactive Ingredients: Sodium chloride, Water for injections, Adjuvant.

Pharmacotherapeutic Group: Tetanus toxoid, combinations with diphtheria toxoid. ATC Code: J07AM51.
Pharmacology: Pharmacodynamics: Td Vax induces or enhances active immunity against tetanus and diphtheria. The vaccine contains reduced dose of diphtheria toxoid in comparison to: DTP, DTaP and DT (vaccines used in children before the end of the sixth year of life).
The active substances of the vaccine are: tetanus toxoid (T) and diphtheria toxoid (d) adsorbed on aluminium hydroxide. Toxoids are obtained by formaldehyde inactivation of bacterial toxins derived from Clostridium tetani and Corynebacterium diphtheriae cultures. Toxoids are subsequently concentrated and purified.
Toxoids retain antigenic properties of native toxins. Devoid of their pathogenicity they induce immune system response consisting in production of specific antibodies, and trigger mechanisms of immune memory. Immunizing properties of the vaccine are enhanced by aluminium hydroxide (adjuvant).
Studies on the level of immunity against diphtheria and tetanus in various age groups justify booster vaccination, especially in people aged 30-60 years who are the poorly immunized group. Results of studies confirm both safety and high immunogenicity of Td Vax.
An appropriate level of protective antibodies against tetanus and diphtheria is achieved after the completion of the full course of vaccination (basic and booster), according to the National Immunization Program.
Td Vax complies with the requirements of the European Pharmacopoeia and WHO.
Pharmacokinetics: Not applicable.
Toxicology: Preclinical safety data: Prior to release, each production lot is a subject to specific toxicity analyses performed according to European Pharmacopoeia requirements.

Td Vax is indicated for active immunisation of children over 7 years of age, adolescents and adults against tetanus and diphtheria.
Basic vaccination: Individuals over 7 years of age who were not vaccinated against diphtheria and tetanus (DTP or DT vaccine).
Booster vaccination: Children over 7 years of age who have not received booster dose of DTP (in case of contraindication to pertussis vaccination); adolescents at the age of 14 and 19; adults who received a full course of basic vaccination against tetanus and diphtheria (booster dose every 10 years).
Vaccinations against tetanus in injured individuals: In case of injury, Td Vax may be used instead of vaccine containing tetanus toxoid (T), if a booster dose of a vaccine against diphtheria is recommended in the same time.

Basic vaccination: The basic vaccination schedule consists of three doses of the vaccine: Two doses of the vaccine with an interval of 4 weeks (primary vaccination); the third dose of the vaccine 6-12 months after the second dose (supplementary vaccination).
Booster vaccination: One dose of the vaccine: Children over 7 years of age who have not received booster dose of DTP (in case of contraindication to pertussis vaccination); adolescents at the age of 14 (the second booster dose); adolescents at the age of 19 (the third booster dose); adults with basic vaccination, every 10 years. (See table.)

Click on icon to see table/diagram/image

Posology during pregnancy: Unvaccinated women or those with incomplete basic vaccination should be vaccinated. Women, who received one or two doses of the vaccine before the pregnancy, should complete the vaccination during the pregnancy.
Pregnant women who were vaccinated more than 10 years ago should receive a booster dose.
Method of administration: A dose of 0.5 ml should be administered intramuscularly into deltoid muscle.

Overdose is unlikely, because the packaging contains single dose only.

Hypersensitivity to the active substances or to any of the excipients listed in Description.
Acute febrile illnesses. Mild infections are not contraindications to the vaccine administration.
Exacerbation of chronic diseases. In such cases, the vaccination should be postponed until the exacerbation subsides.
Thrombocytopenia or neurological disorders after previous administration of vaccines containing T, DT, Td, D or d antigens. If the contraindications for administration of diphtheria vaccine exist, the vaccine containing only tetanus toxoid (T) should be administered.
If there are any contraindications for vaccination with Td Vax, it is necessary to assess the risk associated with vaccine administration in relation to the risk of infection.
In case of injury and existing contraindications for using Td or T, tetanus immunoglobulin should be administered immediately.

Vaccination should be preceded by accurate review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
As with all injectable vaccines, appropriate immediate treatment should be readily available in case of an anaphylactic shock following the administration of the vaccine.
In patients undergoing immunosuppressive treatment or with immune deficiency immunological response may be reduced. In such cases vaccination should be postponed until the end of therapy and anti-diphtheria and anti-tetanus antibodies level should be assessed after vaccination.
Thiomersal (an organomercuric compound) has been used in the manufacturing process of Td Vax and residues of it are present in the final product. Therefore, sensitization reactions may occur.
Precaution should be taken during the use of the vaccine in individuals who have experienced or have known allergic reactions and have experienced health disorders following previous vaccine administration.
Do not administer intravascularly.
Make sure that the needle is not introduced into a blood vessel.
Following injection, vaccinated person should remain under medical supervision for 30 minutes.
Effects on ability to drive and use machines: Td Vax has no or negligible influence on the ability to drive and use machines.
Fertility: Td Vax has not been evaluated in fertility studies.

Pregnancy: The vaccine can be used during pregnancy, if recommended (see Dosage & Administration).
Breastfeeding: Breast-feeding is not a contraindication for vaccination with Td Vax.

Frequencies of adverse reactions are defined as follows: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Adverse reactions observed in clinical trials: General disorders and administration site conditions: Very common: Fever, malaise, injection site reaction and/or injection site pain.
Adverse reactions from post-marketing spontaneous monitoring (frequency not known): Blood and lymphatic system disorders: Thrombocytopenia; enlargement, painfulness of local lymph nodes.
Immune system disorders: Hypersensitivity (including generalized rash or local rash, itching, swelling of face and laryngospasm) the occurrence of anaphylactic shock inclusive.
Nervous system disorders: Headache; dizziness; central and peripheral nervous system disorders; afebrile convulsions; fainting, loss of consciousness, hypotonia; paresis of the limb in which vaccination was administered, which may be a sign of palsy or brachial plexus neuritis; Guillain-Barre syndrome.
Gastrointestinal disorders: Digestive system disorders (nausea, vomiting, abdominal pain).
Musculoskeletal and connective tissue disorders: Injected limb mobility decreased, pain in extremity, swelling and warmth of the joint of the limb, in which vaccination was administered; muscle pain.
Renal and urinary disorders: Renal failure.
General disorders and administration site conditions: General adverse reactions: Fever, chills, hyperhidrosis, malaise, these symptoms usually subside within 24-48 hours.
Adverse reactions at the administration site: Redness, pain, swelling and itching. Itchy lymphatic infiltration can also appear. These kinds of reactions occur most commonly in repeatedly vaccinated patients. Subcutaneous nodules - granulomas may occur, which sometimes develop into aseptic abscesses (1:100 000). Granulomas which fail to subside within 6 weeks may be the result of developing hypersensitivity to aluminium.

Td Vax may be administered simultaneously with other vaccines, according to the National Immunization Program and with immunoglobulins, if necessary.
Different vaccines and immunoglobulins used at the same time should be administered into different injection sites and with separate syringes and needles.

Special precautions for disposal and other handling: After shaking Td Vax is a milky, homogeneous, cream shade, suspension.
Upon storage, white sediment with a clear supernatant above can be observed.
Before use, the ampoule should be well shaken in order to obtain a homogeneous suspension. The vaccine should be visually inspected for any foreign particulate matter and/or abnormal change in physical appearance. In the event of any change, the vaccine should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Store in an upright position in a refrigerator (+2°C to +8°C).
Do not freeze. In case of freezing, discard the vaccine.
Protect from light.
Shelf-Life: 36 months.

Vaccines, Antisera & Immunologicals

J07AM51 - tetanus toxoid, combinations with diphtheria toxoid ; Belongs to the class of tetanus bacterial vaccines.

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