CONTENTS
Adsorbed tetanus vaccine.
PRESENTATION
Amp 1 dose x 20's. Vial 10 doses x 1's, 10's. 20 doses x 1's, 10's.
DESCRIPTION
Tetavax contains tetanus toxoid (³40 iu/0.5 mL) adsorbed on hydrated aluminium hydroxide (0.6 mg/dose). It also contains the following ingredients: Buffer solution containing sodium chloride, disodium phosphate dihydrate, monopotassium phosphate and water for injection.
INDICATIONS
Prevention of tetanus.
DOSAGE & ADMINISTRATION
Post-Exposure Tetanus Prophylaxis: The schedule is summarized in the following table.
| Type of Wound |
Patients Not Immunized |
Patients Completely Immunized |
|
| 5-10 years | >10 years | ||
| Minor – clean |
Begin or complete |
None |
Tetanus toxoid: |
|
Major – clean or |
In one arm: |
Tetanus toxoid: |
In one arm: |
|
Tetanus-prone, |
In one arm: |
Tetanus toxoid: |
In one arm: |
|
*Use different syringes, needles and injection sites. |
|||
Neonatal Tetanus Prophylaxis
Women of childbearing age or pregnant women that have not yet been immunized must receive 2 successive injections at least 4 weeks apart; the 1st injection should preferably be administered 90 days before birth, 2nd injection should be administered at least 2 weeks before the predicted date of delivery.
Primary Immunization: 2 successive injections, 1 or 2 months apart, followed by a booster dose administered 6-12 months after the 2nd injection.
Booster Dose: 1 injection 10 years after primary vaccination and every 10 years afterwards.
Persons Infected with the Human Immunodeficiency Virus (HIV): According to the WHO recommendations, any person infected with HIV, symptomatic or asymptomatic, should be immunized with Tetavax according to the usual schedule.
Administration: Shake before injection until a homogeneous suspension is obtained. It is preferable to administer the vaccine via the IM route. The vaccine may also be administered via the deep SC route. The intradermal route must be avoided.
CONTRAINDICATIONS
Hypersensitivity to any component of Tetavax; allergic reactions or neurological disorders following previous vaccine injection.
Do not inject by IM route to patients with bleeding disorders eg, hemophilia or thrombocytopenia.
PRECAUTIONS
Adverse events following immunization should be monitored, especially anaphylactic reaction. It is recommended to have adrenaline readily available.
If the treatment schedule requires to administer tetanus vaccine in association with tetanus immune globulin, it should not be administered in the same syringe as the vaccine and should be administered in another part of the body.
Inform the doctor if the patient is suffering from fever, acute infection or chronic progressive disease (it is preferable to postpone the vaccination); if suffering from immunodepression or undergoing an immunosuppressive therapy; if the patient is allergic to or have experienced an abnormal reactions following a previous administration of vaccine or if a tetanus vaccine was received in the last 5 years.
List of excipients with recognized effects: Potassium.
Use in pregnancy & lactation: If necessary, Tetavax may be administered during pregnancy and lactation.
ADVERSE REACTIONS
Local Reactions: Pain, redness, induration and swelling may occur at the site of injection and persist for 1 or 2 days. These reactions may be associated with a subcutaneous nodule.
General Reactions: Fever with or without local reaction and an increase in lymph node size; itching-type allergies, generalized urticaria or edema, dizziness, hypotension, muscle pain, joint pain, headache
Peripheral neuritis is rarely observed.
STORAGE
Store in a refrigerator (2-8°C). Do not freeze.
Shelf-Life: 36 months.