MENVEO

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

MENINGOCOCCAL VACCINES GROUP A; MENINGOCOCCAL VACCINES GROUP C; MENINGOCOCCAL VACCINES GROUP W; MENINGOCOCCAL VACCINES GROUP Y

Commercializzato da:

GLAXO SMITH KLINE (ISRAEL) LTD

Codice ATC:

J07AH02

Forma farmaceutica:

POWDER AND SOLUTION FOR SOLUTION FOR INJECTION

Composizione:

MENINGOCOCCAL VACCINES GROUP Y 5 MCG / 0.5 ML; MENINGOCOCCAL VACCINES GROUP W 5 MCG / 0.5 ML; MENINGOCOCCAL VACCINES GROUP C 5 MCG / 0.5 ML; MENINGOCOCCAL VACCINES GROUP A 10 MCG / 0.5 ML

Via di somministrazione:

I.M

Tipo di ricetta:

Required

Prodotto da:

GLAXO SMITHKLINE VACCINES S.R.L., ITALY

Gruppo terapeutico:

OTHER MENINGOCOCCAL MONOVALENT PURIFIED POLYSACCHARIDES ANTIGEN

Area terapeutica:

OTHER MENINGOCOCCAL MONOVALENT PURIFIED POLYSACCHARIDES ANTIGEN

Indicazioni terapeutiche:

Menveo is indicated for active immunization of children (2 years of age and above), adolescents and adults up to the age of 55 years, at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. The use of this vaccine should be in accordance with official recommendations.

Data dell'autorizzazione:

2017-08-31

Foglio illustrativo

ךיראת : ןולעה רושיא
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MENVEO
םושירה לעב םש
:
GLAXOSMITHKLINE (ISRAEL) LTD
! דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
SPECIAL WARNINGS
AND PRECAUTIONS
FOR USE
-
Anxiety
‐
related reactions, including vasovagal
reactions (syncope), hyperventilation or stress
‐
related reactions may occur in association with
vaccination as a psychogenic response to the
needle injection (see section 4.8 Undesirable
effects). It is important that procedures are in
place to avoid injury from fainting.
UNDESIRABLE
EFFECTS
-
Post-marketing experience (all age groups)
Immune system disorders
Not known: hypersensitivity including
anaphylaxis
Nervous system disorders
Not known: tonic convulsion, febrile
convulsion, syncope
Ear and labyrinth disorders
Not known: vertigo
General disorders and administration site
conditions
Not known: injection site cellulitis, injection
site swelling, including extensive swelling of
the injected limb תושקובמה תורמחהה תונמוסמ ובש ,ןולעה
ב"צמ
1בוהצ עקר לע
.הנוש עבצב )ןולעב( ונמוס תורמחה רדגב
םניאש םייוניש

Scheda tecnica

Menveo_DR V4.0_notification_13.06.2019_clean Page 1 of 16
The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved
in August 2017 and was updated according to the guidelines of the
Ministry of Health in June 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Menveo powder and solution for solution for injection
Meningococcal Group A, C, W-135 and Y conjugate vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 ml of the reconstituted vaccine) contains:
(Originally contained in the powder)

Meningococcal group A oligosaccharide
10 micrograms
Conjugated to
_ Corynebacterium diphtheriae _
CRM
197
protein
16.7 to 33.3 micrograms
_ _
(Originally contained in the solution)

Meningococcal group C oligosaccharide
5 micrograms
_ _
Conjugated to
_ Corynebacterium diphtheriae _
CRM
197
protein
7.1 to 12.5 micrograms
_ _

Meningococcal group W-135 oligosaccharide
5 micrograms
Conjugated to
_ Corynebacterium diphtheriae _
CRM
197
protein
3.3 to 8.3 micrograms

Meningococcal group Y oligosaccharide
5 micrograms
_ _
Conjugated to
_ Corynebacterium diphtheriae _
CRM
197
protein
5.6 to 10.0 micrograms
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solution for solution for injection (powder and solution
for injection).
The powder is a white to off - white cake.
The solution is a colourless clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Menveo is indicated for active immunization of children (from 2 years
of age), adolescents and adults up to the
age of 55, at risk of exposure to
_Neisseria meningitidis_
group A, C, W-135 and Y, to prevent invasive disease.
The use of this vaccine should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Children (from 2 years of age), adolescents and adults _
Menveo should be administered as a single dose (0.5ml).
Menveo_DR V4.0_notification_13.06.2019_clean Page 2 of 16
To ensure optimal a