Priorix-Tetra

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Measles vaccine, Schwarz strain 1000 CCID50 (per dose);  ; Mumps virus, live attenuated, RIT 4385 25119 CCID50 (per dose);  ;  ; Rubella virus, Wistar RA27/3 strain 1000 CCID50 (per dose);  ; Varicella vaccine 1995 PFU (per dose (Oka strain));  

Beschikbaar vanaf:

GlaxoSmithKline NZ Limited

INN (Algemene Internationale Benaming):

Measles vaccine, Schwarz strain 1000 CCID50 (per dose)

Dosering:

0.5 mL

farmaceutische vorm:

Powder for injection with diluent

Samenstelling:

Active: Measles vaccine, Schwarz strain 1000 CCID50 (per dose)   Mumps virus, live attenuated, RIT 4385 25119 CCID50 (per dose)     Rubella virus, Wistar RA27/3 strain 1000 CCID50 (per dose)   Varicella vaccine 1995 PFU (per dose (Oka strain))   Excipient: Amino acids Lactose monohydrate Mannitol Sorbitol Water for injection

Eenheden in pakket:

Combination pack, vaccine vial plus diluent ampoule, 1 dose unit

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

GlaxoSmithKline Biologicals SA

therapeutische indicaties:

PRIORIX-TETRA is indicated for active immunisation in infants and children from the age of 9 months up to 12 years of age inclusive against measles, mumps, rubella and varicella.

Product samenvatting:

Package - Contents - Shelf Life: Combination pack, vaccine vial plus diluent ampoule - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, vaccine vial plus diluent syringe, no needle supplied - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, vaccine vial plus diluent syringe, plus 2 needles - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, vaccine vial plus diluent ampoule - 10 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, vaccine vial plus diluent syringe, no needle supplied - 10 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, vaccine vial plus diluent syringe, plus 2 needles - 10 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, single dose, - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisatie datum:

2004-07-27

Productkenmerken

1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
PRIORIX-TETRA Live attenuated measles, mumps, rubella and varicella
vaccine, powder and
diluent for solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PRIORIX-TETRA is a sterile lyophilised mixed preparation of the
attenuated Schwarz measles,
RIT 4385 mumps (derived from Jeryl Lynn strain), Wistar RA 27/3
rubella and OKA varicella
strains of viruses, separately produced in chick embryo cells (mumps
and measles) or human
diploid MRC
5
cells (rubella and varicella).
Each 0.5 mL dose of the reconstituted vaccine contains not less than
10
3.0
CCID
50
of the Schwarz
measles, not less than 10
4.4
CCID
50
of the RIT 4385 mumps, not less than 10
3.0
CCID
50
of the
Wistar RA 27/3 rubella and not less than 10
3.3
PFU of the varicella virus strains.
PRIORIX-TETRA meets the World Health Organisation requirements for
manufacture of biological
substances and for measles, mumps, rubella, and varicella vaccines and
combined vaccines
(live).
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Powder and diluent for solution for injection.
PRIORIX-TETRA is presented as a cake with a slightly pink colour in a
glass vial. The sterile
diluent is clear peach to fuschia and presented in a glass prefilled
syringe or ampoule.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PRIORIX-TETRA is indicated for active immunisation in infants and
children from the age of 9
months up to 12 years of age inclusive against measles, mumps, rubella
and varicella.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
Infants and children from the age of 9 months up to and including 12
years of age should receive 2
doses of PRIORIX-TETRA to ensure optimal protection against measles,
mumps, rubella and
varicella (see Section 5.1 Pharmacodynamic properties, Pharmacodynamic
effects).
An interval of at least 6 weeks between doses is recommended. As with
other live vaccines, in no
circumstances should this interval be less than 4 weeks.
Alternatively, and in accordance