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13-valent Pneumococcal Polysaccharide Conjugate Vaccine (Prefilled syringe)

Product Name
Generic name: 13-valent Pneumococcal Polysaccharide Conjugate Vaccine


Active Substances
Capsular polysaccharides of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F conjugated to tetanus toxoid carrier protein.


Indication
The vaccine is indicated for use in infants and children 6 weeks through 5 years of age (before the 6th birthday).
The vaccine elicits immune responses in recipients following immunization, and is indicated for the prevention of invasive diseases caused by 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) of Streptococcus pneumoniae.
The vaccine does not protect against diseases caused by Streptococcus pneumoniae serotypes that are not contained in the vaccine.


Dosage and Administration
Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container. This product is for intramuscular injection only. The preferred sites for injection are the anterolateral aspect of the thigh in infants and the deltoid muscle of the upper arm in toddlers and children.
The injection volume is 0.5 mL for each single human dose. The vaccine should not be injected in and/or near the areas where nerve trunks and/or blood vessels may locate.


Vaccination Schedules
The product is to be administered as a four-dose series at 2, 4, 6, and 12-15 months of age or 3, 4, 5, and 12-15 months of age, respectively, as described in Table 1 and Table 2.


Table 1 Vaccination Schedule for Infants 2 Months of Age

Dose

Dose 1a,b

Dose 2b

Dose 3b

Dose 4c

Age at Dose

2 months

4 months

6 months

12-15 months

 

a. Dose 1 may be given as early as 6 weeks of age.
b. The recommended dosing interval is 8 weeks.
c. The fourth dose should be administered at approximately 12-15 months of age, and at least 2 months after the third dose.

 

Table 2 Vaccination Schedule for Infants 3 Months of Age

Dose

Dose 1a

Dose 2a

Dose 3a

Dose 4b

Age at Dose

3 months

4 months

5 months

12-15 months

 

a. The recommended dosing interval is 4 weeks.
b. The fourth dose should be administered at approximately 12-15 months of age, and at least 2 months after the third dose.
For children 7 months through 5 years of age who have not received the product, the catch-up schedule in Table 3 applies.


Table 3 Vaccination Schedule for Infants and Toddlers 7 Months through 5 Years of Age

Age at First Dose

Total Number of 0.5 mL Doses

7-11 months of age

3a

12-23 months of age

2b

24 months through 5 years of age
(prior to the 6th birthday)

1

 

a. The first 2 doses at least 4 weeks apart; the third dose after the one-year birthday, separated from the second dose by at least 2 months.
b. Two doses at least 2 months apart.


Contraindications
Hypersensitivity to any component of the product, including active substances, excipients, or tetanus toxoid, etc.

 

Storage and Transportation
Transport and store refrigerated at 2ºC to 8ºC, protect from light.
DO NOT FREEZE. Discard if the vaccine is frozen.
Keep the product in places out of children’s reach.


Shelf Life
The shelf life of the vaccine is 24 months. Please use before the expiration date printed on the label or small box.