Specifications

Cultivate in fermentor to improve production; extract effective ingredients to decrease adverse reaction; take place of whole-ce

Directions for Use of Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed

[Drug name]

Adopted name: Diphtheria, Tetanus .and Acellular Pertussis Combined Vaccine, Adsorbed

[Constituents and characters]

The vaccine is prepared by the adsorption of bulks of acellular pertussis vaccine, diphtheria toxoid and tetanus toxoid onto aluminum hydroxide. It is a milky-white suspension containing preservative. A precipitate may form after a long period of storage, which can be dispersed on shaking.

[Eligibles]

Children whose age is from 3 months to 6 years.

[Function and use]

The product can induce immune response in recipients following immunization. It is used to prevent diphtheria, tetanus and pertussis.

[Specifications]

0.5ml per Ampoule. Each single human dose is 0.5 ml containing not less than 4.0 IU of pertussis vaccine, not less than 30 IU of diphtheria toxoid and not less than 60 IU of tetanus toxoid.

[Administration and dosage]

(1) Inject the vaccine in buttock or in the deltoid muscle of the lateral upper arm.

(2) Primary immunization consisting of three injections which shall begin at the age of 3 months and complete at the age of 12 months; 0.5 ml per injection at intervals of 4-6 weeks. A booster of 0.5 ml shall be given at the age of 18-24 months.

[Adverse reactions]

Generally, no adverse reaction can be found. Occa­sionally, slight redness or itch at the injection site or low fever may occur, which can be relieved spontaneously. Symptomatic treatment might be given in time to the subjects with severe reactions.

[Contraindications]

(1) The vaccine shall not be administrated to the subjects with history of epilepsy, nervous system diseases or convulsion.

(2) Injection shall be postponed to the subjects with acute infectious diseases (including convalescents) or with fever.

(3) The vaccine shall not be administrated to the subjects with history of allergic reactions.

[Precautions]

(1) Shake the container fully before use. If any foreign matter, illegible label or clumps not dispersed on shaking are found or the product has been frozen, the vaccine can not be used.

(2) Indurations which may be found at the injection site can be subsided gradually. The second injection shall be given on the other side.

(3) The recipients should take a rest for a while on site following immunization. Adrenaline should be available for first aid in case of severe anaphylactic reactions.

(4) If abnormal conditions such as a high fever or convulsion occur after the first injection then there is no need for the second one.

(5) Freezing is strictly forbidden.

[Storage]

Store and ship at 2-8°C, protected from light.

[Packaging]The vaccines are packaged in ampoule. 3 ampoules (for single human dose)/ small box, 15 small boxes/ mid-box, 300 mid-box /case.

[Validity period]

24 months.

[Standard for implementation] PHARMACOPOEIA of the P. R. C Volume Ⅲ (2005)

[Product license number] GUOYAOZHUNZI S19980016.