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Pre-filled Syringe (solution for injection)
– For routine booster injections, a single dose of 0.5 ml should be administrated every 10 years is recommended.
– For the primary vaccination consists of 3 successive 0.5 ml should be administrated doses at monthly intervals.
– The post–tetanus exposure prophylaxis recommendations are summarized in the attached doctor’s leaflet.
Given the adsorbed nature of the vaccine, it is preferable to administer it by the intramuscular route in order to minimize local reactions. The recommended sites are the antero-lateral face of the thigh or arm.
The deep sub-cutaneous route may also be used. However, the intradermal route must not be used.
This vaccine is indicated for adults over 18 years of age in the following cases:
– routine booster vaccinations against diphtheria and tetanus. The diphtheria toxoid content is reduced to one tenth of the normal dose to minimize the risks of a severe hypersensitivity reaction.
– primary vaccination.
– post-exposure prophylaxis following a tetanus-prone wound, if a booster diphtheria injection is required.
This adsorbed diphtheria and tetanus vaccine (Imovax dT) may be administered as a booster vaccination in children over 10 years of age in whom poliomyelitis is prevented by separate administration of poliomyelitis vaccine.
Hypersensitivity to the active substances or to any of the excipients, or to
formaldehyde (which may be present as traces owing to its use during the manufacturing process).
It is preferable to postpone vaccination in the event of fever, acute disease in particular with an infection cause or chronic progressive illness unless it is absolutely indicated e.g. if there is a lethal risk associated with a tetanus-prone wound.
Hypersensitivity reaction or neurological disorder after a previous injection of vaccine.
As with all injectable vaccines appropriate medical treatment should always be readily available and supervision provided in case of an anaphylactic reaction following administration of the vaccine.
An immunosuppressive treatment or an immunodeficiency condition may induce a decrease in the immune response to the vaccine. It is therefore recommended to wait for the end of the treatment for the vaccination or to make sure that the subject is well protected. However, the vaccination of subjects with chronic immunodepression, such as HIV infection, is recommended if the underlying disease allows an antibody response even if limited.
In order to prevent hypersensitivity reactions, avoid administering the vaccine to persons who have received a complete primary vaccination or a booster dose in the previous 5 years.
If Guillain-Barre syndrome or brachial neuritis has occurred following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. Vaccination is usually justified when primary immunization schedules are incomplete (i.e. fewer than three doses have been received).
Do not inject by the intravascular route. Make sure the needle does not penetrate a blood vessel .
Based on spontaneous reporting the following adverse events have been reported during the commercial use of Imovax dT. These events have been rarely (<0.01%) reported, however exact incidence rates cannot precisely be calculated.
Blood and lymphatic system disorders: Lymphadenopathy
Immune system disorders: Immediate hypersensitivity reactions such as face oedema, angioedema, Quincke’s oedema and anaphylactic reactions.
Nervous system disorders: cephalagia, malaise
Vascular disorders: hypotension
Skin and subcutaneous tissue disorders: Generalised pruritus and urticaria
Erythema or oedema.
Musculoskeletal and connective tissue disorders: myalgia, arthralgia
General disorders and administration site condition: Injection site reactions such as pain, rash, induration or oedema, which can occur within 48 hours and persist for one or two days. The formation of a sub-cutaneous nodule can sometimes accompany these reactions. Cases of aseptic abscesses have exceptionally been reported.
All these reactions have been observed more frequently in hyper immunized subjects, particularly in case of over-frequent boosters.
Potential adverse events (i/.e. adverse events which have not been reported directly with Imovax dT, but with other vaccines containing one or more of the constituents of Imovax dT): Brachial neuritis and Gullian-Barre Syndrome after administration of a tetanus toxoid containing vaccine.
There is no evidence of any interaction with other medicinal products.
There is no contraindication to the administration of this vaccine during a vaccination session with other common vaccines.
Pregnancy and Lactation
Diphtheria vaccine: No reliable animal teratogenesis data are available.
Clinically, no deformity or fetotoxic effects have been reported to date. However follow up of pregnant women exposed to the diphtheria vaccine is insufficient to rule out all risk. Since this vaccine may induce hyperthermia, a vaccine with a reduced dose should be used in pregnant women who have been vaccinated previously.
Tetanus vaccine: Considering the experimental and clinical data this vaccine may be prescribed at any stage of pregnancy.
Consequently and as a precaution, this combination is to be avoided during pregnancy unless the subject is living in or traveling to an endemic area. Should one of the vaccines be needed, a monovalent vaccine should be preferred.
There is no contraindication to vaccination during lactation.
Incompatibilities: As no compatibility studies are available, this medicinal product must not be mixed with other medicinal products.
Shelf life: After opening: the product should be used immediately.
Storage: Store in a refrigerator (2°C-8°C). Do not freeze.