MMR II Vaccine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Measles vaccine 1000 TCID50 (at end of expiry); Mumps vaccine 12500 TCID50 (at end of expiry); Rubella vaccine 1000 TCID50 (at end of expiry)

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Measles vaccine 1000 TCID50 (at end of expiry)

Pharmaceutical form:

Suspension for injection

Composition:

Active: Measles vaccine 1000 TCID50 (at end of expiry) Mumps vaccine 12500 TCID50 (at end of expiry) Rubella vaccine 1000 TCID50 (at end of expiry) Excipient: Dibasic potassium phosphate Dibasic sodium phosphate monohydrate Eagle Minimum Essential medium Gelatin Medium 199 Monobasic potassium phosphate Monobasic sodium phosphate monohydrate Monosodium glutamate Neomycin Phenolsulfonphthalein Sodium bicarbonate Sorbitol Sucrose Water for injection

Units in package:

Combination pack, vaccine + diluent, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Merck Sharp & Dohme Corp

Therapeutic indications:

M-M-R II is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older.

Product summary:

Package - Contents - Shelf Life: Combination pack, vaccine + diluent - 1 dose units - 24 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) protect from light - Combination pack, 5 x vaccine + 5 x diluent - 5 dose units - 24 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) protect from light - Combination pack, 10 x vaccine + 10 x diluent - 10 dose units - 24 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) protect from light - Vial, glass, Diluent - 0.7 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, multi-dose, vaccine - 10 dose units - 24 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) protect from light - Vial, glass, single dose, vaccine - 1 dose units - 24 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) protect from light - Vial, glass, single dose, vaccine - 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

Authorization date:

1990-05-17

Patient Information leaflet

M-M-R
® II
_Measles, mumps and rubella virus vaccine live _
Single dose vial
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about M-M-R II. It does not
contain all the
available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines and vaccines have risks and benefits. Your doctor has
weighed the risks of
you being given M-M-R II against the benefits they expect it will have
for you.
If you have any concerns about being given this vaccine, ask your
doctor.
Keep this leaflet with the medicine. You may need to read it again.
WHAT M-M-R II IS USED FOR
M-M-R II is a vaccine used to help protect people from getting
measles, mumps and
rubella (German measles). It should be given to children 12 months of
age or older.
However, your doctor may recommend that M-M-R II be given to infants
between 6-12
months of age in special situations.
Protection against these infections is important as they can cause
serious problems in
some people.
Measles is a serious disease that is very easily passed from one
person to another. It
causes a high fever (temperature), cough and a rash and lasts for 1 to
2 weeks. One out
of every 10 children who catch measles will also have an ear infection
or pneumonia. On
rare occasions, measles can also cause an infection of the brain that
could lead to
seizures, hearing loss, mental retardation, and even death. Babies and
adults who catch
measles are often much sicker for a longer time or are more likely to
die than school
children and teenagers who catch measles.
Mumps is easily passed from one person to another and causes fever,
headache, and
swollen, painful glands under the jaw (salivary glands). Mumps can
sometimes be a very
serious disease and usually lasts for several days. Mumps can cause a
mild inflammation
of the coverings of the brain and spinal cord (meningitis) in about
one person in every 10
who catch it. About one out of every 4 teenage or adult males with
mumps will have a
painful swelling of the testicles for several days

Summary of Product characteristics

S-IPC-V205C-I-022020
Page 1 of 11
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
M-M-R
®
II 0.5 mL Suspension for injection
Measles mumps and rubella virus vaccine live
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
M-M-R II is a sterile lyophilised preparation of (1) ATTENUVAX
®
(Measles Virus Vaccine Live,
MSD), a more attenuated line of measles virus, derived from Enders'
attenuated Edmonston
strain and propagated in chick embryo cell culture; (2) MUMPSVAX
®
(Mumps Virus Vaccine
Live, MSD), the Jeryl Lynn (B level) strain of mumps virus propagated
in chick embryo cell
culture; and (3) MERUVAX
®
II (Rubella Virus Vaccine Live, MSD), the Wistar RA 27/3 strain
of live attenuated rubella virus propagated in WI-38 human diploid
lung fibroblasts.
The reconstituted vaccine is for subcutaneous administration. When
reconstituted as directed,
the dose for injection is 0.5 mL and contains not less than 1,000 CCID
50
(50% cell culture
infectious dose) of measles virus; 12,500 CCID
50
of mumps virus; and 1,000 CCID
50
of rubella
virus.
Excipients with known effect: Sorbitol
For the full list of excipients, see Section 6.1.
The growth medium for measles and mumps is Medium 199 (a buffered salt
solution
containing vitamins and amino acids and supplemented with foetal
bovine serum) containing
SPGA (sucrose, phosphate, glutamate, and recombinant human albumin) as
stabiliser and
neomycin.
The growth medium for rubella is Minimum Essential Medium (MEM) [a
buffered salt solution
containing vitamins and amino acids and supplemented with foetal
bovine serum] containing
recombinant human albumin and neomycin. Sorbitol and hydrolysed
gelatin stabiliser are
added to the individual virus harvests.
The cells, virus pools, and foetal bovine serum are all screened for
the absence of adventitious
agents. The product contains no preservative.
3
PHARMACEUTICAL FORM
Suspension for injection
The vaccine is supplied in vials as a sterile lyophilised preparation
together with vials of diluent
containing sterile water for injection BP. Before reconstituti