PREVENAR 13

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19 F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F; 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

متاح من:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC رمز:

J07AL02

الشكل الصيدلاني:

SUSPENSION FOR INJECTION

تركيب:

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

طريقة التعاطي:

I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

JOHN WYETH AND BROTHER LIMITED; TRADING AS WYETH PHARMACEUTICALS, UK

المجموعة العلاجية:

PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED

المجال العلاجي:

PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED

الخصائص العلاجية:

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

تاريخ الترخيص:

2015-05-31

نشرة المعلومات

2
2020-0067741
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor’s prescription only
PREVENAR 13
®
SUSPENSION FOR INJECTION
Each dose (0.5 ml) contains:
pneumococcal polysaccharide serotype
1/3/4/5/6A/7F/9V/14/18C/19A/19F/23F 2.2 mcg each
pneumococcal polysaccharide serotype 6B 4.4 mcg
conjugated to approximately 32 mcg CRM
197
carrier protein and adsorbed on aluminium (0.125 mg)
phosphate
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 immunization for the prevention of invasive disease, pneumonia
and acute ear infection
caused by _Streptococcus pneumoniae _in infants, children, and
adolescents, from 6 weeks to 17
years of age.
Active immunization for the prevention of invasive disease and
pneumonia caused by
_Streptococcus pneumoniae _in adults aged 18 years and above and in
the elderly.
THERAPEUTIC GROUP: pneumococcal vaccine.
Prevenar 13
®
works by helping the body to make its own protection (antibodies)
against the
bacteria. These antibodies help protect you from a pneumococcal
disease.
Prevenar 13
®
helps to provide protection against infections caused by 13 types
(serotypes) of
_Streptococcus pneumoniae_ bacteria.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You or your child is sensitive (allergic) to the active ingredients or
to any of the other
ingredients in this medicine (see section 6) or to the diphtheria
toxoid.
•
You or your child has a severe infection with high fever (over 38°C)

خصائص المنتج

Prevenar 13 LPD CC technical change 10 May 2021
1
2021-0067741
PREVENAR 13 ®
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 CRM
197
carrier protein and adsorbed on aluminium phosphate
1 dose (0.5 ml) conatins approximately 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.
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.
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