Prevenar 13 suspension for injection

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Upplýsingar fylgiseðill (PIL)

07-07-2023

Vara einkenni (SPC)

07-07-2023

Virkt innihaldsefni:

pneumococcal polysaccharide conjugate vaccine (pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6A, pneumococcal polysaccharide serotype 6B, pneumococcal polysaccharide serotype 7F, pneumococcal polysaccharide serotype 9V, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18C, pneumococcal polysaccharide serotype 19A, pneumococcal polysaccharide serotype 19F, pneumococcal polysaccharide serotype 23F)

Fáanlegur frá:

Pfizer Manufacturing Belgium N.V.

ATC númer:

J07AL02

INN (Alþjóðlegt nafn):

Skammtar:

2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 4.4mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose

Lyfjaform:

suspension for injection

Einingar í pakka:

(50) vials 0,5ml

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2019-12-27

Upplýsingar fylgiseðill

PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE
(ADSORBED), 13-VALENT
PREVENAR 13*
DESCRIPTION
PREVENAR 13 (pneumococcal 13-valent conjugate vaccine) is a sterile
suspension. The
vaccine is composed of saccharides of the capsular antigen of
_Streptococcus pneumoniae _
(_S. pneumoniae_), serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,
19F, and 23F,
individually conjugated to diphtheria CRM
197
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 CRM
197
~32

g
Aluminum as aluminum phosphate adjuvant
0.125 mg
Other ingredients:
Polysorbate 80
Succinic acid
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, children, and adolescents from 6 weeks
through 17 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, aged 18 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 to infants and children 6 weeks to 5 years of
age at the
same time as diphtheria, tetanus, acellular

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Vara einkenni

1
1.
NAME OF THE MEDICINAL PRODUCT
Prevenar 13 suspension for injection in single dose vial
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 CRM
197
carrier protein, adsorbed on aluminium phosphate.
1 dose (0.5 ml) contains a
pproximately 32 µg CRM
197
carrier protein and 0.125 mg aluminium.
Excipients with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in single dose vial.
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 17 years of age.
Active immunisation for the prevention of invasive disease and
pneumonia caused by_ Streptococcus _
_pneumoniae _in adults ≥ 18 years of age and the elderly.
See sections 4.4 and 5.1 for information on protection against
specific pneumococcal serotypes.
2
The use of Prevenar 13 should be determined on the basis of official
recommendations taking into
consideration the risk of invasive disease and pneumonia in different
age groups, underlying
comorbidities as well as the variability of serotype epidemiology in
different geographical areas.
4.2

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