Abbreviated prescribing information

Prevenar (CDS 10.0)

Prevenar©

Sterile  solution of saccharides of  capsular antigen of Strep. pneumoniae serotypes 4, 6B, 9V, 14, 18C 19F and 23F individually  conjugated. to diphtheria CRM 197  protein. Each 0.5 ml dose contains. 2mg of saccharide  for serotypes 4, 9V, 14, 18C 19F & 23F, 4mg serotype 6B per dose & approx. 20mg of CRM197 carrier protein.

Ind. act. immuniz. infan. & childr. from 6 wks. until. 9 yrs. against. invasive disease, pneumonia & otitis media caused  Strep. pneumoniae. serotypes 4, 6B, 9V, 14, 18C, 19F,& 23F.

Inf. prim. vacc. sched: 3 doses, usually at 2 mnths. (can be giv. at 6 wks),  Interv. of 4-8 wks betw. doses. Fourth dose recommend. 2nd yr. of life (12-15 mnths).
Previously. unvaccinated Infan. : 7-11 mnths. should rec. 2 doses approx. 1 mnth. apart. foll.
by 3rd dose aft. 1st birthd., interv. bet. 2nd and 3rd dose 2 mnths. apart.
12-23 mnths: 2 doses, 2 mnths. apart
24 mnths. or older: rec. single dose.
IM use only.

Side effects: Inj. site erythema, induration/swell., pain/tendern., diarrh., vom., fever, decr. appetite, drowsiness, restless., sleep, irritabil., rash.

Precautions: admin. should be postponed in subjects suffering. from acute severe. febrile. illness., approp. medical. treatment. always avail. in case of rare anaphylactic. event. foll. admin. Should be given with caution to children on anticoagulant therapy. Immunization does not substitute for routine  diphtheria immunization. Children with impaired. responsiveness. whether due to use of immunosup. therapy., a genetic.defect, HIV infect. or other causes may have reduced antibody response to active immunization. Vaccine not recommended. for use in adults.

Contraindications: hypersensitivity to any component of vaccine, incl. diphtheria toxoid.

Warnings: approp. med. treatment & supervision should always be readily available in case of  rare anaphylactic event foll. admin. of vaccine. Safety & efficacy. in childr. below age of 6 wks or aft. 10th birthd. have not been establ. Not  to be given to infan. or childr. with thrombocytopenia or any coagulation disorder. Latex sensitivity.

S2, A.30.1 Biological antigens

35/30.1/0239, Wyeth South Africa, Thornhill Office Park, 94 Bekker Road, Vorna Valley Ext 60, Midrand, 1685, É (011) 655-2600

Further information is available on request from Wyeth South Africa, or can be found in the currently approved package insert.

Further Notes:

Prevenar does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.