Imovax d.T. Adult

Each 0.5 mL dose vaccine unit contains: Purified diphtheria toxoid not less than 2 IU*; Purified tetanus toxoid not less than 20 IU^†; Aluminium hydroxide (expressed in Al) 0.6 mg.
* The lower confidence limit (p=0.95) of the estimated power is not less than 2 IU for single human dose.
^† The lower confidence limit (p=0.95) of the estimated power is not less than 20 IU for single human dose.
Excipients/Inactive Ingredients: Acetic acid and/or sodium hydroxide for pH adjustment.
Buffer solution: Sodium chloride, Disodium phosphate dihydrate, Monopotassium phosphate, Hydrochloric acid and/or sodium hydroxide for pH adjustment, Water for injection.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.

Pharmacotherapeutic group: Tetanus vaccine. ATC code: J07AM.
Pharmacology: IMOVAX d.T. Adult induces protective levels of anti-tetanus and anti-diphtheria antibodies in almost all vaccinated people.

IMOVAX d.T. Adult is indicated for active immunisation against tetanus and diphtheria in children 7 years of age and older and adults, in the following situations: As primary vaccination series in people not previously vaccinated against tetanus and diphtheria; To complete the primary vaccination series in people who did not complete it before 7 years old; As a booster dose in cases where the primary vaccination series has already been completed; In case of wounds, as prophylaxis against tetanus and as booster dose against diphtheria.

Posology: The following schedule is recommended as primary vaccination series: 1st dose in the chosen date; 2nd dose 1-2 months after the 1st dose; 3rd dose 6-12 months after the 2nd dose.
After the primary vaccination series is completed, a single dose of 0.5 mL as booster dose every five to ten years is recommended.
In case of vaccination because of wounds, it will be worth considering the need for active immunisation, with or without passive immunisation (anti-tetanus immunoglobulin) depending on the type of wound, and the patient's vaccination history. Anti-tetanus immunoglobulin should be administered in an injection site different from that used for vaccination.
Minor or clean wounds: When it is known that the person has completed his/her primary vaccination series against tetanus and has received his/her last booster dose in the last ten years, revaccination or the use of anti-tetanus immunoglobulin is not recommended. In people who have not completed their primary vaccination series, when this is unknown, or when the immunisation status is uncertain, or more than ten years have passed since the last booster dose, vaccination is recommended. In all these cases anti-tetanus immunoglobulin is not required.
Other types of wounds, such as major and contaminated: Vaccination will always be carried out, unless the person has completed his/her primary vaccination series against tetanus and has also received his/her last booster dose in the last five years. In people who have not completed their primary vaccination series against tetanus, when this is unknown, or when the immunisation status is uncertain, anti-tetanus immunoglobin should be administered in addition to the vaccine.
Method of administration: Before vaccination, the vaccine needs to be thoroughly shaken and visually observed to confirm that its appearance is as usual and that it does not contain any foreign particles.
The 0.5 mL content should be injected intramuscularly. The recommended injection site is the deltoid area (except in small children).
People who suffer from bleeding diathesis should be vaccinated by deep subcutaneous injection.
The vaccine should not be administered intradermally. It should never be administered intravenously.

Not applicable.

Hypersensitivity to the active substance or to any of the excipients listed in Description.
IMOVAX d.T. Adult administration should be postponed during the course of febrile or acute infection processes and in people, who due to a history of exposure, could be in the incubation period of an infection other than the diphtheria or tetanus, which is known, or suspected to be susceptible. However, the presence of a common infection is not a contraindication for vaccination.
IMOVAX d.T. Adult should not be administered to people with a history of thrombocytopenia, hypersensitivity reactions or neurological complications after prior vaccination against tetanus and/or diphtheria.
If there is any contraindication for diphtheria vaccine administration, only the tetanus vaccine should be administered.
When complications, such as allergic reactions and central and/or peripheral nervous system complications are present, consider the vaccination risk against the risk of getting tetanus and diphtheria.
In the cases of wounds in immunocompromised subjects, only the tetanus vaccine should be administered, and it should not be accompanied by the diphtheria component.
In case of wounds, and when there is an absolute contraindication, anti-tetanus immunoglobulin should be administered (2 x 250 IU at four-week intervals).

Do not administer by intravascular injection. Make sure that the needle does not penetrate a blood vessel.
To prevent hypersensitivity reactions, avoid the injection during the first five years after vaccination, both in people who have completed a primary vaccination series or in those who have received a booster dose.
Immunosuppressive therapy or immunodeficiency may induce a reduced antibody response to active immunisation. In such cases, it is recommended that the vaccination should be delayed until the end of treatment or check if the subject has reached protective levels. However vaccination of subjects with chronic immunosuppression, such as HIV infection is recommended if the underlying condition allows induction of an antibody response, and even if it is limited.
If Guillain-Barré syndrome or brachial neuritis occurred after having received a previous vaccine containing tetanus toxoid, the decision to administer any vaccine containing tetanus toxoid must be based on careful consideration of the benefits and potential risks, whether the primary immunization schedule has been completed or not. Vaccination is generally justified when the primary immunization schedule is incomplete (for example, those who have received less than three doses).
As with all injectable vaccines, a 1:1,000 adrenaline solution should always be prepared for immediate use, in case an anaphylactic reaction occurs.
Effects on ability to drive and use machines: No studies have been conducted on the effects on the ability to drive and use machines.

Pregnancy: For many years, clinical experience has not indicated any kind of harmful effect on embryonic and/or foetal development.
Pregnant women not immunised or insufficiently immunised may be vaccinated during the second and third trimester of pregnancy, especially in the case of travel to countries with endemic diphtheria or suspected exposure.
Breastfeeding: Breastfeeding is not a contraindication.

Based on spontaneous reporting, the following adverse reactions have been reported during marketing experience of IMOVAX d.T. Adult.
Adverse reactions have been divided by frequency groups using the following criteria: 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). (See table.)

Click on icon to see table/diagram/image

All these reactions have more frequently been observed in hyperimmunised subjects; particularly in the case of too frequent boosters.
Cases of brachial neuritis and Guillain-Barré syndrome have also been reported after the administration of other vaccines that contain tetanus toxoid.

There is no evidence of any interaction with other medicinal products; no interaction studies have been conducted with diagnostic and/or laboratory tests.
No contraindication has been reported regarding the administration of IMOVAX d.T. Adult during vaccination with other common vaccines.

Special precautions for disposal and other handling: Shake before injection to get a homogeneous suspension.
Disposal of unused medication and all the materials that have been in contact with it, will be performed in compliances with local regulations.
Incompatibilities: Not applicable.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Vaccines, Antisera & Immunologicals

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

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