Pneumococcal conj.vacc,13-val.,1 ds vial

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General Description:
PREVENAR - Pneumococcal conjugate vaccine, 13-valent

PREVENAR 13 (pneumococcal 13-valent conjugate vaccine) is a sterile suspension. The vaccine is composed of saccharides of the capsular antigen of Streptococcus pneumonia (S. pneumoniae), serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually conjugated to diphtheria CRM197 protein, a nontoxic variant of diphtheria toxin.
PREVENAR 13 is manufactured as a liquid preparation. After shaking, the vaccine is a homogenous, white suspension.

COMPOSITION Paediatric Dose
Volume per dose 0.5 mL
Pneumococcal polysaccharide for serotypes
1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F & 23F 2.2 g of each
Pneumococcal polysaccharide for serotype 6B 4.4 g
Diphtheria protein CRM197 ~34 g
Aluminum as aluminum phosphate adjuvant 0.125 mg
Other ingredients:
Polysorbate 80
Sodium chloride
Water-for-injection

ADMINISTRATION
Shake well before use to homogenize the suspension, and only use if the vaccine is a homogenous, white suspension. Use a sterile syringe and a sterile needle for each injection.
The dose is 0.5 mL given intramuscularly, with care to avoid injection into or near nerves and blood vessels. The preferred sites are the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in older children and adults. The vaccine should not be injected in the gluteal area.

IMMUNIZATION SCHEDULE
Active immunization of infants and children from 6 weeks through 5 years of age against invasive disease, pneumonia and otitis media caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Active immunization of adults, 50 years and older, against pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Infants and Children
PREVENAR 13 may be given at the same time as diphtheria, tetanus, acellular or whole-cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, meningococcal serogroup C, measles, mumps, rubella and varicella vaccines. When rotavirus or hepatitis A vaccines were given with PREVENAR 13, the safety profiles were similar, but immunogenicity was not measured.
The use of PREVENAR 13 should be based on official recommendations, taking into consideration the impact of invasive disease in different age groups, as well as variability of serotype epidemiology in different geographical areas.

Primary Immunization
For infants, the immunization series of PREVENAR 13 consists of three primary doses of 0.5 mL each. The first dose may be given as early as 6 weeks of age, with a minimum of 4 weeks between doses. A fourth, booster dose is recommended after the first birthday.
Alternatively, when PREVENAR 13 is given as part of a routine infant immunization programme, a three-dose schedule may be considered. The first dose may be given from the age of 2 months, with a second dose 2 months later, and a third (booster) dose is recommended between 11-15 months of age.
PREVENAR 13 may be given to infants with sickle cell disease or HIV infection.

For Previously Unvaccinated Older Children
For previously unvaccinated, older infants and children who are beyond the age of routine infant immunization, other schedules are recommended:
·Infants 7 to 11 months of age at first dose: three doses total (two doses at least 4 weeks apart, third dose after the first birthday and at least 2 months after the second dose)
·Children 12 to 23 months of age at first dose: two doses at least 2 months apart
·Children 24 months through 5 years of age at first dose: one dose
Alternatively, when PREVENAR 13 is routinely given as part of a generalized infant immunization programme, a single dose may be considered in previously unvaccinated children aged 12 to 23 months.

For Children Previously Vaccinated with PREVENAR
PREVENAR 13 contains the same 7 serotypes contained in pneumococcal 7-valent conjugate vaccine and is manufactured based on the same conjugate technology, using the same carrier protein CRM197. Children who have begun immunization with pneumococcal 7-valent conjugate vaccine may complete immunization by switching to PREVENAR 13 at any point in the schedule. In clinical trials, immunogenicity and safety profiles were comparable. A single dose of PREVENAR 13 in children 12-59 months of
age has been shown to induce immunity to the six additional serotypes.

Adults aged 50 years and older
One single dose.
The need for revaccination with a subsequent dose of PREVENAR 13 has not been established. Regardless of prior pneumococcal vaccination status, if the use of 23-valent polysaccharide vaccine is considered appropriate, PREVENAR 13 should be given first.

SIDE EFFECTS
Infants and Children
The most frequently reported adverse reactions included injection site reaction, fever (
≥ 39ºC), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash. Risks are associated with all vaccines.
Adults 50 years and older
The most frequently reported adverse reactions included pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite, injection site redness, injection site swelling, limitation of arm movement, chills and rash.
PREVENAR 13 does not provide 100% protection against vaccine serotypes or protect against non-vaccine serotypes.

CONTRAINDICATIONS
Hypersensitivity to any component of the vaccine, including diphtheria toxoid.

STORAGE
Transport and store refrigerated at +2ºC to +8ºC.
DO NOT FREEZE. Discard if the vaccine has been frozen.

PRESENTATION
Vial, 1 Dose (50 per package)
Vial, 1 Dose (25 per package)
VVM:
Vaccine Vial Monitors (VVMs) have been applied to the flip cap on all PREVENAR 13 Single Dose Vials manufactured by Wyeth Pharmaceuticals Inc. The colour dot which appears on the flip cap of the vial is the VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond
an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour willchange progressively. As long as the colour of this square is lighter than the colour of thering, then the vaccine can be used. As soon as the colour of the central square is the same colour as the ring or of a darker colour than the ring, then the vial should be discarded.