PROQUAD

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MEASLES VIRUS ENDERS EDMONSTON STRAIN (LIVE, ATTENUATED); MUMPS VIRUS JERYL LYNN™ (LEVEL B) STRAIN (LIVE, ATTENUATED); RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED); VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)

Available from:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC code:

J07BD54

Pharmaceutical form:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Composition:

MEASLES VIRUS ENDERS EDMONSTON STRAIN (LIVE, ATTENUATED); VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED); RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED); MUMPS VIRUS JERYL LYNN™ (LEVEL B) STRAIN (LIVE, ATTENUATED)

Administration route:

S.C, I.M

Prescription type:

Required

Manufactured by:

MERCK SHARP & DOHME LLC, USA

Therapeutic area:

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

Therapeutic indications:

ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella, and varicella in individuals from 12 months of age to 12 years of age.ProQuad can be administered to individuals from 9 months of age under special circumstances: outbreak situations, or travel to a region with high prevalence of measles.

Authorization date:

2020-10-31

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ProQuad
®
powder and solvent for suspension for injection in a pre-filled
syringe.
Measles, mumps, rubella and varicella vaccine (live).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one dose (0.5 mL) contains:
Measles virus
1
Enders’ Edmonston strain (live, attenuated) ......... not less than
3.00 log
10
TCID
50
*
Mumps virus
1
Jeryl Lynn™ (Level B) strain (live, attenuated) .... not less than
4.30 log
10
TCID
50
*
Rubella virus
2
Wistar RA 27/3 strain (live, attenuated) ................ not less
than 3.00 log
10
TCID
50
*
Varicella virus
3
Oka/Merck strain (live, attenuated) ..................... not less
than 3.99 log
10
PFU**
*50% tissue culture infectious dose
**plaque-forming units
(
1
) Produced in chick embryo cells.
(
2
) Produced in human diploid lung (WI-38) fibroblasts.
(
3
) Produced in human diploid (MRC-5) cells.
The vaccine may contain traces of recombinant human albumin (rHA).
This vaccine contains a trace amount of neomycin. See section 4.3.
Excipient(s) with known effect
The vaccine contains 16 milligrams of sorbitol per dose. See section
4.4.
For the full list of excipients, see section 6.1.
_ _
_ _
3.
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection in a pre-filled
syringe.
Before reconstitution, the powder is a white to pale yellow compact
crystalline cake and the solvent is a
clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
ProQuad is indicated for simultaneous vaccination against measles,
mumps, rubella, and varicella in
individuals from 12 months of age to 12 years of age.
2
ProQuad can be administered to individuals from 9 months of age under
special circumstances: outbreak
situations, or travel to a region with high prevalence of measles (see
sections 4.2, 4.4, and 5.1).
4.2
Posology and method of administration
Posology
ProQuad should be used in accordance to official recommendations.
•
Individuals 12 months of age to 12 years of age
Individual