SYNFLORIX

देश: इसराइल

भाषा: अंग्रेज़ी

स्रोत: Ministry of Health

सक्रिय संघटक:

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19 F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V

थमां उपलब्ध:

GLAXO SMITH KLINE (ISRAEL) LTD

ए.टी.सी कोड:

J07AL02

फार्मास्यूटिकल फॉर्म:

SUSPENSION FOR INJECTION

रचना:

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19 F 3 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 3 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 3 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 1 MCG / 0.5 ML

प्रशासन का मार्ग:

I.M

प्रिस्क्रिप्शन प्रकार:

Required

द्वारा बनाया गया:

GLAXO SMITH KLINE BIOLOGICALS S.A

चिकित्सीय समूह:

PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED

चिकित्सीय क्षेत्र:

PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED

चिकित्सीय संकेत:

Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F in infants and children from 6 weeks up to 5 years of age.The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact on pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographical areas.10.07.2017 בקשה לשינוי משטר מינוןThree-dose primary seriesThe recommended immunisation series to ensure optimal protection consists of four doses, each of 0.5 ml. The primary infant series consists of three doses with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six 6 weeks of age. A booster (fourth) dose is recommended at least 6 months after the last priming primary dose and may be given from the age of 9 months onwards (preferably between 12 and

प्राधिकरण की तारीख:

2015-01-31

सूचना पत्रक

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
) ךיראת
08.2014 םושירה רפסמו תילגנאב רישכת םש
SYNFLORIX )142-81-32006( םושירה לעב םש
GLAXOSMITHKLINE )ISRAEL( LTD :
! דבלב תורמחהה טורפל דעוימ הז ספוט
אפורל ןולעב
אפורל ןולעב
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
UNDESIRABLE EFFECTS
-
Vascular disorders
Very rare
Kawasaki disease תושקובמה תורמחהה תונמוסמ ובש ,ןולעה
ב"צמ
.בוהצ עקר לע
עבצב )ןולעב( ונמוס תורמחה רדגב םניאש
םייוניש
קורי
.

उत्पाद विशेषताएं

Synflorix SPC V8.0 June 2020 Page 1 of 21
_ _
_. _
1.
NAME OF THE MEDICINAL PRODUCT
_ _
Synflorix suspension for injection in pre-filled syringe
Synflorix suspension for injection
Synflorix suspension for injection in multidose container (2 doses)
Synflorix suspension for injection in multidose container (4 doses)
Pneumococcal polysaccharide
_ _
conjugate vaccine (adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Pneumococcal polysaccharide serotype 1
1,2
1 microgram
Pneumococcal polysaccharide serotype 4
1,2
3 micrograms
Pneumococcal polysaccharide serotype 5
1,2
1 microgram
Pneumococcal polysaccharide serotype 6B
1,2
1 microgram
Pneumococcal polysaccharide serotype 7F
1,2
1 microgram
Pneumococcal polysaccharide serotype 9V
1,2
1 microgram
Pneumococcal polysaccharide serotype 14
1,2
1 microgram
Pneumococcal polysaccharide serotype 18C
1,3
3 micrograms
Pneumococcal polysaccharide serotype 19F
1,4
3 micrograms
Pneumococcal polysaccharide serotype 23F
1,2
1 microgram
1
adsorbed on aluminium phosphate
0.5 milligram Al
3+
2
conjugated to protein D (derived from non-typeable
_Haemophilus influenzae_
) carrier protein
9–16 micrograms
3
conjugated to tetanus toxoid carrier protein
5–10 micrograms
4
conjugated to diphtheria toxoid carrier protein
3–6 micrograms
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_ _
Suspension for injection (injection).
The vaccine is a turbid white suspension.
4.
CLINICAL PARTICULARS
_ _
4.1
THERAPEUTIC INDICATIONS
_ _
Active immunisation against invasive disease, pneumonia and acute
otitis media caused by
_Streptococcus pneumoniae_
serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F in infants and
children
from 6 weeks up to 5 years of age.
_ _
_ _
The use of Synflorix should be determined on the basis of official
recommendations taking into
consideration the impact on pneumococcal diseases in different age
groups as well as the variability of
the epidemiology in different geographical areas.
4.2
POSOLOGY AND METHOD OF ADMINISTR