Prevenar 13 Suspension For Injection

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CRM197 protein; Pneumococcal polysaccharide serotype 1 (conjugate); Pneumococcal polysaccharide serotype 14 (conjugate); Pneumococcal polysaccharide serotype 18C (conjugate); Pneumococcal polysaccharide serotype 19A (conjugate); Pneumococcal polysaccharide serotype 19F (conjugate); Pneumococcal polysaccharide serotype 23F (conjugate); Pneumococcal polysaccharide serotype 3 (conjugate); Pneumococcal polysaccharide serotype 4 (conjugate); Pneumococcal polysaccharide serotype 5 (conjugate); Pneumococcal polysaccharide serotype 6A (conjugate); Pneumococcal polysaccharide serotype 6B (conjugate); Pneumococcal polysaccharide serotype 7F (conjugate); Pneumococcal polysaccharide serotype 9V (conjugate)

Available from:

PFIZER PRIVATE LIMITED

ATC code:

J07AL02

Dosage:

32mcg

Pharmaceutical form:

INJECTION, SUSPENSION

Composition:

CRM197 protein 32mcg; Pneumococcal polysaccharide serotype 1 (conjugate) 2.2mcg; Pneumococcal polysaccharide serotype 14 (conjugate) 2.2mcg; Pneumococcal polysaccharide serotype 18C (conjugate) 2.2mcg; Pneumococcal polysaccharide serotype 19A (conjugate) 2.2mcg; Pneumococcal polysaccharide serotype 19F (conjugate) 2.2mcg; Pneumococcal polysaccharide serotype 23F (conjugate) 2.2mcg; Pneumococcal polysaccharide serotype 3 (conjugate) 2.2mcg; Pneumococcal polysaccharide serotype 4 (conjugate) 2.2mcg; Pneumococcal polysaccharide serotype 5 (conjugate) 2.2mcg; Pneumococcal polysaccharide serotype 6A (conjugate) 2.2mcg; Pneumococcal polysaccharide serotype 6B (conjugate) 4.4mcg; Pneumococcal polysaccharide serotype 7F (conjugate) 2.2mcg; Pneumococcal polysaccharide serotype 9V (conjugate) 2.2mcg

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Pfizer Ireland Pharmaceuticals

Authorization status:

ACTIVE

Authorization date:

2010-07-02

Patient Information leaflet

1 

1. 
NAME OF THE MEDICINAL PRODUCT 

Prevenar 13 suspension for injection 
Pneumococcal polysaccharide conjugate vaccine (13-valent,
adsorbed) 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

1 dose (0.5 ml) contains: 

Pneumococcal polysaccharide serotype 1
1

2.2 µg 
Pneumococcal polysaccharide serotype 3
1

2.2 µg 
Pneumococcal polysaccharide serotype 4
1

2.2 µg 
Pneumococcal polysaccharide serotype 5
1

2.2 µg 
Pneumococcal polysaccharide serotype 6A
1

2.2 µg 
Pneumococcal polysaccharide serotype 6B
1

4.4 µg 
Pneumococcal polysaccharide serotype 7F
1

2.2 µg 
Pneumococcal polysaccharide serotype 9V
1

2.2 µg 
Pneumococcal polysaccharide serotype 14
1

2.2 µg 
Pneumococcal polysaccharide serotype 18C
1

2.2 µg 
Pneumococcal polysaccharide serotype 19A
1

2.2 µg 
Pneumococcal polysaccharide serotype 19F
1

2.2 µg 
Pneumococcal polysaccharide serotype 23F
1 

2.2 µg 

1
Conjugated to 32 µg CRM
197
 carrier protein and adsorbed on aluminium phosphate (0.125 mg 
aluminium). 

Excipients with known effect 
For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Suspension for injection. 
The vaccine is a homogeneous white suspension. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

CHILDREN 6 WEEKS THROUGH 17 YEARS OF AGE 

Active immunisation for the prevention
of invasive disease, pneumonia and acute otitis media 
caused by _Streptococcus
pneumoniae _in infants and children from 6 weeks to 17 years
of age (prior to 
18
th
 birthday) . See sections 4.4 and 5.1 for information on
protection against specific pn

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Prevenar 13 suspension for injection
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 mL) contains:
Pneumococcal polysaccharide serotype 1
1
2.2 µg
Pneumococcal polysaccharide serotype 3
1
2.2 µg
Pneumococcal polysaccharide serotype 4
1
2.2 µg
Pneumococcal polysaccharide serotype 5
1
2.2 µg
Pneumococcal polysaccharide serotype 6A
1
2.2 µg
Pneumococcal polysaccharide serotype 6B
1
4.4 µg
Pneumococcal polysaccharide serotype 7F
1
2.2 µg
Pneumococcal polysaccharide serotype 9V
1
2.2 µg
Pneumococcal polysaccharide serotype 14
1
2.2 µg
Pneumococcal polysaccharide serotype 18C
1
2.2 µg
Pneumococcal polysaccharide serotype 19A
1
2.2 µg
Pneumococcal polysaccharide serotype 19F
1
2.2 µg
Pneumococcal polysaccharide serotype 23F
1
2.2 µg
1
Conjugated to 32 µg CRM
197
carrier protein and adsorbed on aluminium phosphate (0.125 mg
aluminium).
Excipients with known effect
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
The vaccine is a homogeneous white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CHILDREN 6 WEEKS THROUGH 17 YEARS OF AGE
Active immunisation for the prevention of invasive disease, pneumonia
and acute otitis media caused
by
_Streptococcus pneumoniae _
in infants and children from 6 weeks to 17 years of age (prior to 18
th
birthday). See sections 4.4 and 5.1 for information on protection
against specific
_pneumococcal_
serotypes.
The use of Prevenar 13 should be determined on the basis of official
recommendations taking into
consideration the impact of invasive disease in different age groups
as well as the variability of
serotype epidemiology in different geographical areas.
ADULTS 18 YEARS THROUGH 49 YEARS OF AGE
Active immunisation for the prevention of invasive disease and
pneumonia caused by
_S. pneumoniae _
in adults ≥18 to 49 years of age.
ADULTS 50 YEARS OF AGE AND OLDER
Active immunisation for the prevention of pneum