PREVENAR 20 SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

CRM197 protein; Pneumococcal polysaccharide serotype 1 (conjugate); Pneumococcal polysaccharide serotype 10A (conjugate); Pneumococcal polysaccharide serotype 11A (conjugate); Pneumococcal polysaccharide serotype 12F (conjugate); Pneumococcal polysaccharide serotype 14 (conjugate); Pneumococcal polysaccharide serotype 15B (conjugate); Pneumococcal polysaccharide serotype 18C (conjugate); Pneumococcal polysaccharide serotype 19A (conjugate); Pneumococcal polysaccharide serotype 19F (conjugate); Pneumococcal polysaccharide serotype 22F (conjugate); Pneumococcal polysaccharide serotype 23F (conjugate); Pneumococcal polysaccharide serotype 3 (conjugate); Pneumococcal polysaccharide serotype 33F (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 8 (conjugate); Pneumococcal polysaccharide serotype 9V (conjugate)

Disponible depuis:

PFIZER PRIVATE LIMITED

Code ATC:

J07AL02

forme pharmaceutique:

INJECTION, SUSPENSION

Composition:

CRM197 protein Approx. 51 μg/0.5ml; Pneumococcal polysaccharide serotype 1 (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 10A (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 11A (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 12F (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 14 (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 15B (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 18C (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 19A (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 19F (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 22F (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 23F (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 3 (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 33F (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 4 (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 5 (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 6A (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 6B (conjugate) 4.4 μg/0.5ml; Pneumococcal polysaccharide serotype 7F (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 8 (conjugate) 2.2 μg/0.5ml; Pneumococcal polysaccharide serotype 9V (conjugate) 2.2 μg/0.5ml

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

Prescription Only

Fabriqué par:

Pfizer Ireland Pharmaceuticals

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2022-11-30

Résumé des caractéristiques du produit

Page 1 of 28
1. NAME OF THE MEDICINAL PRODUCT
Prevenar 20 Suspension for Injection in Pre-filled Syringe
Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)_ _
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
Pneumococcal polysaccharide serotype 1
1,2
2.2 µg
Pneumococcal polysaccharide serotype 3
1,2
2.2 µg
Pneumococcal polysaccharide serotype 4
1,2
2.2 µg
Pneumococcal polysaccharide serotype 5
1,2
2.2 µg
Pneumococcal polysaccharide serotype 6A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 6B
1,2
4.4 µg
Pneumococcal polysaccharide serotype 7F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 8
1,2
2.2 µg
Pneumococcal polysaccharide serotype 9V
1,2
2.2 µg
Pneumococcal polysaccharide serotype 10A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 11A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 12F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 14
1,2
2.2 µg
Pneumococcal polysaccharide serotype 15B
1,2
2.2 µg
Pneumococcal polysaccharide serotype 18C
1,2
2.2 µg
Pneumococcal polysaccharide serotype 19A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 19F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 22F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 23F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 33F
1,2
2.2 µg
1
Conjugated to CRM
197
carrier protein (approximately 51 µg per dose)
2
Adsorbed on aluminium phosphate (0.125 mg aluminium per dose)
For the 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
Active immunisation for the prevention of invasive disease, pneumonia,
and acute otitis
media caused by _Streptococcus pneumoniae_ in infants, children, and
adolescents from
6 weeks to less than 18 years of age.
Active immunisation for the prevention of invasive disease and
pneumonia caused by
_Streptococcus pneumoniae_ in individuals 18 years of age and older.
Page 2 of 28
See sections 4.4 and 5.1 for information on