Stablix immunization for the prevention of tetanus consists of two primary doses of 0.5 ml given intramuscularly at least four weeks apart followed by the third dose at least 6 months later.

Stablix is used for 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. At least two doses with at least one-month interval will be required to provide basic protection in a previously unimmunized person, and additional booster doses will be required to maintain protection overtime. National immunization schedules will provide more details.

Stablix may be given at the same time as BCG, measles, rubella, mumps, polio (OPV and IPV), hepatitis B, Haemophillus influenzae type b, yellow fever vaccines and vitamin A supplementation.

a) Do not use Stablix vaccine if you have:

A severe reaction to a previous dose of Stablix.

b) Take special care with Stablix vaccine if you have:

Immunodeficiency Person infected with Human immunodefi ciency virus (HIV), whatever asymptomatic or symptomatic, should be immunized with Stablix vaccine according to standard schedules.

c) Using other medicines and Stablix vaccine

No interaction studies have been performed.

d) Pregnancy and breast-feeding

There is no evidence that Stablix administered safely during pregnancy even during the first trimester.

e) Driving and using machines

There is no evidence that Stablix Vaccine effect on the ability to drive and use machines.

Important information about some of the ingredients of Stablix Vaccine.

Stablix Vaccine contains purified tetanus toxoid. The toxoid is adsorbed onto 3 mg/ml, aluminum phosphate.

Stablix Vaccine will be given to you by a doctor or nurse.

- Shake well before use.

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

- Multi-dose vials of Stablix from which one or more doses of vaccine have been removed during an immunization session may be used in subsequent immunization session for up to a maximum 4 weeks, provided that all of following conditions are met (as described in the WHO policy statement:

The use of opened multi-dose vials in subsequent immunization session, WHO/V&B/00.09):

• The expiry date has not passed.

• The vaccine is stored under appropriate cold chain conditions.

• The vaccine vial septum has not been submerged in water.

• Aseptic technique has been used to withdraw all doses.

If you have any further questions on the use of this product, ask your doctor or

health care provider or pharmacist.

Like all medicine, Stablix can cause side effects, although not everybody gets them.

Rare and mild. Some temporary tenderness and redness at the site of the injection and occasional fever.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

- Keep out of the reach and sight of children.

- Do not use Stablix vaccine after the expiry date which is stated on the outer carton after EXP. The expiry date refers to the last day of that month.

- Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light.

- Once opened, multi-dose vials should be kept between 2°C to 8°C. Multidose vials of Stablix from which one or more doses of vaccine have been removed during an immunization session may be used in subsequent immunization sessions for up to a maximum of 4 weeks, provided that all of the following conditions are met (as described in the WHO policy statement:

The use of opened multi-dose vials in subsequent immunization sessions.

WHO/V&B/00.09):

• The expiry date has not passed.

• The vaccines are stored under appropriate cold chain conditions.

• The vaccine vial septum has not been submerged in water.

• Aseptic technique has been used to withdraw all doses.

- Medicines should not be disposed of via wastewater or household waste.

Your doctor or nurse will dispose of this medicine. These measures will help to protect the environment.