PREVENAR 20

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19 F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V

Available from:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC code:

J07AL02

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19 F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 4.4 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 2.2 MCG / 0.5 ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

PFIZER INC, USA

Therapeutic area:

PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED

Therapeutic indications:

Prevenar 20 is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.

Authorization date:

2023-04-24

Patient Information leaflet

Prevenar 20 PIL CC 201223
2023-0086866
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
PREVENAR
® 20
SUSPENSION FOR INJECTION
Each dose (0.5 ml) contains:
2.2 micrograms of pneumococcal polysaccharide for serotypes 1, 3, 4,
5, 6A, 7F, 8, 9V, 10A,
11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F
4.4 micrograms of pneumococcal polysaccharide for serotype 6B
conjugated to approximately 51 micrograms CRM
197
carrier protein, adsorbed on aluminium
phosphate (0.125 mg aluminium).
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of
this medicine’s ingredients’ and section 6 'Further information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Active immunisation for the prevention of invasive disease and
pneumonia caused by
_Streptococcus pneumoniae_ in adults 18 years of age and older.
THERAPEUTIC GROUP: Pneumococcal vaccine.
Prevenar 20 helps to provide protection against infections caused by
20 types (serotypes) of
_Streptococcus pneumoniae_ bacteria.
Prevenar 20 helps the body to make its own protection (antibodies)
against the bacteria.
These antibodies help protect you from pneumococcal disease._ _
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:

you are sensitive (allergic) to the active ingredients or to any of
the other ingredients in
this medicine (see section 6), or to other vaccines containing
diphtheria toxoid.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE VACCINATION WITH PREVENAR 20, TELL YOUR DOCTOR IF:

you have or have had medical problems after any dose of Prevenar 20,
such as an
allergi

Summary of Product characteristics

Prevenar 20 LPD CC 010523
1
PREVENAR 20
1.
NAME OF THE MEDICINAL PRODUCT
Prevenar 20
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 and
pneumonia caused by
_ Streptococcus _
_pneumoniae _
in individuals 18 years of age and older.
See sections 4.4 and 5.1 for information on protection against
specific pneumococcal serotypes.
Prevenar 20 should be used in accordance with official
recommendations.
2
2023-0084870
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Individuals 18 years of age and older _
Prevenar 20 is to be administered as a single dose to
_ _
individuals
_ _
18 yea