Bio-TT

Bio-TT

Manufacturer:

Bio Farma

Distributor:

Shwin Chan Trading
Full Prescribing Info
Contents
Purified tetanus toxoid.
Description
Each dose (0.5 mL) contains: Purified tetanus toxoid 10 Lf, Aluminum phosphate (as adsorbent) 1.5 mg, Thimerosal (as preservative) 0.05 mg.
Bio-TT is a TT (Tetanus Toxoid) vaccine, containing purified tetanus toxoid adsorbed onto 3 mg/ml aluminum phosphate. Thimerosal 0.1 mg/ml is used as a preservative. One dose of 0.5 ml has a potency of at least 40 IU.
Bio-TT fulfills WHO requirements for Biological Substances and Indonesian Pharmacopoeia.
Indications/Uses
For active immunization to produce antibody against tetanus and used in the prevention of neonatal tetanus by immunizing women of child-bearing age.
Dosage/Direction for Use
ADMINISTRATION: The vaccine should be shaken before use to homogenize the suspension. It should be injected intramuscularly.
A sterile needle and a sterile syringe should be used for each injection.
IMMUNIZATION SCHEDULE: Bio-TT immunization for the prevention of tetanus/neonatal 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.
To maintain the immunity of women against tetanus through the child-bearing period, a total of five doses are recommended.
A fourth dose should be given at least one year after the third dose, and a fifth dose at least one year after the fourth dose.
Bio-TT can be administered safely during pregnancy, preferably after reaching the second trimester. In previously non-immunized women, two doses of Bio-TT are recommended in pregnancy, at least 4 weeks apart, the second dose should be given at least two weeks before childbirth, in order to prevent maternal and neonatal tetanus.
Bio-TT should also be given in situation where a risk of developing tetanus from any other source exists (e.g. Injuries). 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 over time. National immunization schedules will provide more details.
Bio-TT may be given at the same time as BCG, measles, rubella, mumps, polio (OPV or IPV), hepatitis B, Haemophilus influenzae type b, and yellow fever vaccines and vitamin A supplementation.
Contraindications
A severe reaction to previous dose of tetanus toxoid immunization.
Hypersensitive to one of the components in the vaccine.
Should not be given to those having fever or acute infection. Can be administered to those having minor febrile illness such as mild infection on the upper respiratory tracts.
Special Precautions
Immune deficiency: Persons infected with human immunodeficiency virus (HIV), whether asymptomatic or symptomatic, should be immunized with Bio-TT vaccine according to standard schedules.
Side Effects
Rare and mild. Some temporary tenderness and redness at the site of the injection and occasional fever. It is safe to be given during pregnancy.
Drug Interactions
Not Reported.
Storage
Bio-TT should be stored between +2°C and +8°C. DO NOT FREEZE.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AM01 - tetanus toxoid ; Belongs to the class of tetanus bacterial vaccines.
Presentation/Packing
Susp for inj (amp) 10 Lf/0.5 mL x 10’s.
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