PRIORIX TETRA

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

LIVE ATTENUATED MEASLES VIRUS; LIVE ATTENUATED MUMPS VIRUS; LIVE ATTENUATED RUBELLA VIRUS; LIVE ATTENUATED VARICELLA VIRUS

可用日期:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC代码:

J07BD54

药物剂型:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

组成:

LIVE ATTENUATED MEASLES VIRUS 10^ 3.0 CCID50; LIVE ATTENUATED MUMPS VIRUS 10^ 4.4 CCID50; LIVE ATTENUATED RUBELLA VIRUS 10^ 3.0 CCID50; LIVE ATTENUATED VARICELLA VIRUS 10^ 3.3 PFU

给药途径:

S.C

处方类型:

Required

厂商:

GLAXO SMITH KLINE BIOLOGICALS S.A

治疗组:

MEASLES, COMBINATIONS WITH MUMPS, RUBELLA AND VARICELLA, LIVE ATTENUATED

治疗领域:

MEASLES, COMBINATIONS WITH MUMPS, RUBELLA AND VARICELLA, LIVE ATTENUATED

疗效迹象:

Priorix-Tetra is indicated for active immunisation against measles, mumps, rubella and varicella in children from the age of 12 months up and including 12 years of age.

授权日期:

2023-07-31

资料单张

ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
05.2013
05.2013
05.2013
)
)
)
ךיראת
:
10/12/2017
תילגנאב רישכת םש
:
TETRA
PRIORIX
םושירה רפסמ :
00
-
31847
-
98
-
138
םושירה לעב םש
:
GLAXOSMITHKLINE (ISRAEL) LTD
! דבלב תורמחהה טורפל דעוימ הז ספוט
אפורל ןולעב
אפורל ןולעב
אפורל ןולעב
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
INTERACTION WITH
OTHER MEDICAMENTS
AND OTHER FORMS OF
INTERACTION
----------
4.5 INTERACTION WITH OTHER
MEDICINAL PRODUCTS AND OTHER
FORMS OF INTERACTION
…
Due to an increased risk of fever,
tenderness at the injection site,
change in eating habits and
-
irritability when Bexsero was co
Tetra,
-
administered with Priorix
separate vaccinations can be
considered when possible.
... תושקובמה תורמחהה תונמוסמ ובש ,ןולעה
ב"צמ
.בוהצ עקר לע
עבצב )ןולעב( ונמוס תורמחה רדגב םניאש
םייוניש
קורי
.

产品特点

Page 1 of 13
_ _
PRIORIX TETRA
1.
NAME OF THE MEDICINAL PRODUCT
Priorix Tetra – powder and solvent for solution for injection.
Measles, mumps, rubella and varicella vaccine (live)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
Measles virus
1
Schwarz strain (live, attenuated)
not less than 10
3.0
CCID
50
3
Mumps virus
1
RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated)
not less than 10
4.4
CCID
50
3
Rubella virus
2
Wistar RA 27/3 strain (live, attenuated)
not less than 10
3.0
CCID
50
3
Varicella virus
2
OKA strain (live, attenuated)
not less than 10
3.3
PFU
4
1
produced on chick embryo cells
2
produced on human diploid (MRC-5) cells
3
Cell culture infective dose 50%
4
Plaque forming units
This vaccine contains a trace amount of neomycin. See section 4.3.
Excipient with known effect
The vaccine contains 14 mg of sorbitol per dose
The vaccine contains 6.5 nanograms of para-aminobenzoic acid per dose
and 583 micrograms of
phenylalanine per dose (see section 4.4).
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Before reconstitution, the powder is a white to slightly pink coloured
cake and the solvent is a clear
colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Priorix Tetra is indicated for active immunisation against measles,
mumps, rubella and varicella in
children from the age of 12 months up and including 12 years of age.
Use in infants aged 9-11 months could be considered under special
circumstances. See section 4.2.
Note: The use of Priorix Tetra should be based on official
recommendations.
Page 2 of 13
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Children from 12 months up to 12 years _
Infants and children aged from 12 months up to 12 years should receive
two doses (each of 0.5 ml) of
Priorix-Tetra. The age at which infants or children may receive
Priorix Tetra should reflect applicable
official recommendations*, which vary according to the epid