Tetanus prevention and, in particular:
• post-exposure tetanus prophylaxis for recent wounds that may have been contaminated with tetanus spores in subjects who have not had any primary vaccination or for whom primary vaccination is incomplete or uncertain,
• neonatal tetanus prophylaxis in non-immunised women either of childbearing age or pregnant in countries where neonatal tetanus is frequent,
• primary vaccination,
• booster injections.

Posology
Post-tetanus exposure prophylactic vaccination:
When dealing with minor wounds, the doctor must evaluate the risks of Clostridium tetani infection at the injured site.
Disinfecting, debriding the wound and administering the vaccine excepted, the subject must, in some cases, be passively immunised with a human tetanus immunoglobulin injected at a different site (See table hereafter).

Subjects who have had tetanus must have a primary immunisation because the antibody response clinically generated by this disease is not sufficient.
Neonatal tetanus prophylaxis:
Women of childbearing age or pregnant women that have not yet been immunised must have 2 successive injections at least 4 weeks apart; the first one shall preferably be administered 90 days or more before birth.
Primary immunisation:
Whenever adults must be vaccinated, the schedule includes 2 successive injections one or two months apart followed by a booster 6 to 12 months after the second injection.
Booster injection:
1 dose of 0.5 ml 10 years after primary immunisation and every 10 years thereafter.
Paediatric population
Not applicable.
Method of administration
Precautions to be taken before handling or administering the medicinal product
Given the adsorbed nature of the vaccine, it is recommended to administer it by the intramuscular route in order to minimise local reactions. The recommended sites are the antero-lateral face of the thigh or arm.
The deep sub-cutaneous route may also be used. The intradermal route must not be used.

The lethal risk associated with tetanus excludes any potential contra-indication and imposes post- wound exposure prophylaxis. In other cases: • Hypersensitivity to one of the ingredients of the vaccine or to any of the excipients listed in section 6.1. • Usual contraindications for all vaccinations: vaccination should preferably be postponed in case of fever, acute disease or chronic progressive illness. • Hypersensitivity reaction or neurological disorder after a previous injection of vaccine.

If Guillain-Barré 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 immunisation 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.
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.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

No contra-indication to the administration of this vaccine during a vaccination session with other common vaccines using different sites has been reported.

Considering the experimental and clinical data currently available, this vaccine may be prescribed at any stage of pregnancy.

Not applicable

Based on spontaneous reporting, the following adverse events have been reported during the commercial use of TETAVAX. These events have been very rarely (< 0.01%) reported, however exact incidence rates cannot precisely be calculated.
Blood and lymphatic system disorders:
Lymphadenopathy.
Immune system disorders:

Type I hypersensitivity reactions. Nervous system disorders: Cephalalgia, dizziness.
Vascular Disorders:
Hypotension (within a context of reaction of type I hypersensitivity).
Skin and subcutaneous tissue disorders:
Allergic-like symptoms, such as urticaria, generalised pruritus, or erythema.
Musculoskeletal and connective tissue disorder:
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. A subcutaneous nodule can sometimes accompany these reactions. Cases of aseptic abscesses have exceptionally been reported. The incidence and severity of local reactions may be influenced by the site, the method and route of administration as well as by the number of previous doses received.
Transient pyrexia. Malaise.
All these reactions have been observed more frequently in hyper immunised subjects; particularly in the case of over-frequent boosters.
Potential adverse events: (i.e. adverse events which have not been reported directly with TETAVAX, but with other vaccines containing one or more of the antigenic constituents of TETAVAX):
Brachial neuritis and Guillain-Barré Syndrome after administration of a tetanus toxoid containing vaccine.
Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system:
To report any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Center (NPC)
• Fax: +966-11-205-7662
• Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340
Toll free phone: 8002490000
• Email: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc
Sanofi Pharmacovigilance: KSA_Pharmacovigilance@sanofi.com

Not documented.

Pharmacotherapeutic group: vaccine against tetanus, ATC code: J07AM01: Tetanus toxoid.
This vaccine is prepared from tetanus toxin detoxified with formaldehyde and purified.
The immune response is activated as from the second injection; it is enhanced after the third one and persists for 5 to 10 years after the fourth one.

Not applicable.

Not applicable.

Buffer solution containing sodium chloride, disodium dihydrate phosphate, monopotassium phosphate and water for injections.

As no compatibility studies are available, this medicinal product must not be mixed with other medicinal products.

3 years

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

0.5 ml of suspension in prefilled syringe (glass) with a plunger-stopper (bromobutyl or chlorobutyl or bromochlorobutyl); box of 1.

Shake before injection, until a homogenous suspension is obtained.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.