DTaP Vaccine(WuSheng)
Date：2023-06-07
- COMPOSITION AND DESCRIPTION
This vaccine is a kind of opalescent suspension absorbed by aluminium after the combination of acellular pertussis, refined diphtheria and Tetanus toxoid. The product, containing preservative, will become a kind of symmetrical suspension when it is shaked well. Deposition will precipitate its adjuvant.
OBJECT OF INOCULATION
Children from 3 months to 6 years of age.
FUNCTION
This vaccine can induce body to generate immunoreaction against diphtheria, tetanus and pertussis, thus can be used for the prevention of infection caused by diphtheria, tetanus and pertussis.
FORMULATION
1 dose (0.5ml) is intended for use in adult, containing at least 4.0IU potency of pertussis, 30IU diphtheria and 40IU tetanus.
QUALITY CRITERION
The manufacture and identification of this product comply with China Requirements for Biologics, 2000 edition.
ADMINISTRATION AND DOSEAGE
ADMINISTRATION: Inject the vaccine into upperarm deltoid muscle by intramuscular route.
PROCESS AND DOSEAGE: The primary vaccination is performed with 3 doses of vaccine from 3 to 12 months of age. The interval is expected to 4 or 6 weeks. And 18 to 24 months later, the booster injection for vaccination should be performed. Either primary or booster vaccination is injected with 0.5 ml.
SIDE EFFECTS AND TREATMENT
The side effect is very slight after the vaccination. Some local reactions, such as slight redness, itch or fever, are self-limited. Expectant treatment should be performed immediately if severe side effect occurs.
CONTRAINDICTION
· This vaccine is contra-indicated in subjects with a past illness history of epilepsy, convulsions or neural disease.
· This vaccine should be postponed in subjects suffering from acute infectious disease (including convalescence) or fever heat.
PRECAUTIONS
· Shake up well before use. Do not use in case that there is any crack in the container, the vaccine has ever been frozen or there is big masses that can not be dispersed by shaking.
· Nodule may be observed, which is self-limited. The next injection should be performed on the other side of the former site of injection.
· As in the case of all injectable vaccines, it is advisable to have a solution of epinephrine available in the case of anaphylactics. It is strongly recommended that the vaccinee should take a rest on the spot after vaccinating.
· The second dose is prohibited if sever fever or eclampsia occurs followed by the first dose.
· Do not freeze.
STORAGE
Store or transport between 2oC and 8oC, protect from light.
PACKAGE
Small-sized package, containing 3 doses, is provided for 1 person to use.
Middle-sized package is provided for 15 persons to use.
Bin-sized package is provided for 15 persons to use.
SHELF-LIFE
2 years.
EXECUTIVE CRITERION
The registration criterion of the manufacturer.
AUTHORIZED NUMBER
Guo Yao Zhun Zi S19980016
MANUFACTURER
WUHAN INSTITUTE OF BIOLOGICAL PRODUCTS
