Dosage Form       

Liquid

Specifications      

0.5ml per container. Each single human dose is 0.5ml containing not less than 4.0 IU of pertussis vaccine, not less than 30 IU of diphtheria toxoid and not less than 40 IU of tetanus toxoid.

Eligible           

Children at 3 months to 6 years of age.

Storage & Shipping 

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

Validity Period      

24 months starting from the date of adsorption and 36 months starting from the date when the acellular pertussis antigen is detoxified. The vaccine shall be used before the expiry date stated on the label of carton (or container).

Constituents and characters  

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

Contraindications  

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

(2)     Immunization shall be postponed to the subjects with acute infectious diseases (including those in convalescence period) or with fever.

(3)     Subjects with allergies.

Adverse reactions & Treatment  Generally, there is no adverse reaction. Occasionally, slight redness or itch at injection site or low fever may occur, which can be relieved spontaneously. Subjects with serious adverse reaction shall consult the doctor promptly.

Precautions       

(1)     Shake the container before use. Do not use the vaccine if any foreign matters, leakage of container, illegible label or clumps not dispersed on shaking are found, or the product has been frozen or is beyond the expiry date.

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

(3)     Adrenaline should be available for first aid in case of shock..

(4)    If abnormal conditions such as a high fever or convulsion occur after the first injection, the second injection should not be given.