Adsorbed Td Vaccine Bio Farma

Adsorbed Td Vaccine Bio Farma

vaccine, diphtheria and tetanus toxoid

Manufacturer:

Bio Farma

Distributor:

Biovalys

Marketer:

Biovalys
Full Prescribing Info
Contents
Purified tetanus toxoid, purified diphtheria toxoid.
Description
The vaccine contains purified tetanus and diphtheria toxoids, with a reduced dose of the diphtheria component. One dose of 0.5 ml has a potency of less than 30 IU of diphtheria toxoid and not less than 40 IU of tetanus toxoids. The toxoids are adsorbed onto 3 mg/ml aluminum phosphate. Thimerosal 0.1 mg/ml is used as a preservative (vial only). The vaccine is used for the active immunization of adult and children 7 years of age and older against diphtheria and tetanus.
Composition: Volume 0.5 ml, Purified Diphtheria Toxoid 2 Lf, Purified Tetanus Toxoid 7.5 Lf, Aluminum phosphate 1.5 mg, Thimerosal 0.05 mg.
Action
Challenge the body to produce antibody against tetanus and diphtheria.
Indications/Uses
Booster immunization against tetanus and diphtheria of individuals aged 7 years onwards.
Dosage/Direction for Use
The vaccine vial should be shaken to homogenize the suspension. The vaccination should be injected intramuscular in the upper arm. A sterile needle and sterile syringe should be used for each injection.
Immunization Schedule: A single 0.5 ml dose of the vaccine is recommended. The use of Td vaccine to replace other Diphtheria and Tetanus containing vaccines should be in accordance with official recommendation due to the low dose of diphtheria toxoid in this vaccine. The use of vaccine for primary immunization and in pregnancy has not been evaluated. It may be given at the same time as measles, polio (OPV and IPV), hepatitis B, yellow fever vaccines and vitamin A supplementation.
Contraindications
A second or subsequent dose of Td should not be given to an individual who suffers a severe reaction to the previous dose.
Immune deficiency: Individuals infected with human immunodeficiency virus (HIV), both asymptomatic and symptomatic, should be immunized with Adsorbed Td vaccine according to standard schedules.
Special Precautions
The ACIP (Advisory Committee on Immunization Practices) has published recommendation for use of Tetanus and Diphtheria Toxoids Adsorbed, for adult use in pregnant women. Td vaccine may be used as a primary immunization for persons contraindicated for DTP Vaccine, from 7 years of age. According to ACIP (Advisory Committee on Immunization Practices), they should receive two doses of 0.5 ml of adsorbed Td with reduced dose of diphtheria for adults at an interval of at least four-eight weeks. A third dose recommended at least 6 months after the second dose.
Vial: According to WHO insert model, "Td vaccine may be used as a primary immunization for persons from 7 years of age. They should receive two doses of 0.5 ml of adsorbed Td with reduced dose of diphtheria for adult at an interval of at least four weeks. A third dose is recommended at least 6 months after the second dose. After a primary immunization course of either DTP or Td, adsorbed Td for adults may be used as a booster at intervals of approximately 10 years, but with a minimum of at least one year between doses. It can be safely replace monovalent tetanus toxoid (TT) vaccine, including during pregnancy".
Side Effects
Amp: Some transitional local pain (20-30%) and fever (4.7%) were reported during the clinical trial.
Vial: Some transitional tenderness and redness at the site of the injection and occasional fever may occur. It is safe to give during pregnancy.
Drug Interactions
There is no drug interaction.
Storage
Td Vaccine should be protected from light and stored and transported between +2°C and +8°C. It must not be frozen.
Vial: Once opened, multi-dose vials should be kept between +2°C and +8°C.
Multi-dose vials of Td from with one or more dose of vaccine have been removed during an immunization session may be used in subsequent immunization session 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 dose; The vaccine vial monitor (VVM), if attached, has not reached the discard point.
ATC Classification
J07AM51 - tetanus toxoid, combinations with diphtheria toxoid ; Belongs to the class of tetanus bacterial vaccines.
Presentation/Packing
Vaccine inj (whitish colloidal suspension) (amp) 0.5 mL x 10's, (vial) 5 mL x 10's.
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