RotaTeq

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Rotavirus reassortant strain G1 2.2e+006 [iU] (NLT, at expiry); Rotavirus reassortant strain G2 2.8e+006 [iU] (NLT, at expiry); Rotavirus reassortant strain G3 2.2e+006 [iU] (NLT, at expiry); Rotavirus reassortant strain G4 2e+006 [iU] (NLT, at expiry); Rotavirus reassortant strain P1 2.3e+006 [iU] (NLT, at expiry)

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Rotavirus reassortant strain G1 2.2e+006 IU (NLT, at expiry)

Dosage:

2 mL

Pharmaceutical form:

Oral solution

Composition:

Active: Rotavirus reassortant strain G1 2.2e+006 [iU] (NLT, at expiry) Rotavirus reassortant strain G2 2.8e+006 [iU] (NLT, at expiry) Rotavirus reassortant strain G3 2.2e+006 [iU] (NLT, at expiry) Rotavirus reassortant strain G4 2e+006 [iU] (NLT, at expiry) Rotavirus reassortant strain P1 2.3e+006 [iU] (NLT, at expiry) Excipient: Rotavirus diluent & LPKM-3 (from actives) to approx 0.3 mL. Includes animal materials as below. Monobasic sodium phosphate monohydrate Polysorbate 80 Purified water Sodium citrate dihydrate Sodium hydroxide Sucrose

Units in package:

Tube, plastic, single dose pack, 2 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Merck Sharp & Dohme Corp

Therapeutic indications:

RotaTeq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1A[8] (e.g., G9). RotaTeq may be administered as early as six weeks of age.

Product summary:

Package - Contents - Shelf Life: Tube, plastic, single dose pack - 2 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 48 hours opened stored at or below 25°C - Tube, plastic, 10 x 2mL dose pack - 20 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 48 hours opened stored at or below 25°C

Authorization date:

2005-07-25

Patient Information leaflet

ROTATEQ
®
_rotavirus vaccine, live, oral, pentavalent _
Single dose 2 mL unit dosing tube
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about RotaTeq. 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
your child being given RotaTeq against the benefits they expect it
will have for them.
If you have any concerns about your child being given this vaccine,
ask your doctor.
Keep this leaflet with the medicine. You may need to read it again.
WHAT ROTATEQ IS USED FOR
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) is a viral
vaccine that helps protect
your child against gastroenteritis (diarrhoea and vomiting) caused by
rotavirus infection.
RotaTeq works by helping the body develop natural defences against the
most common
types or “strains” of rotavirus.
The doctor has recommended or administered RotaTeq to help protect
your child against
rotavirus infection, a viral infection of the digestive tract and a
major cause of
gastroenteritis (inflammation of the stomach and intestines which
causes diarrhoea and
vomiting). The vaccine is given by mouth and is a series of 3 doses.
The first dose is
given as early as 6 weeks of age. The next two doses are given one to
two months apart.
The vaccine course is completed by the time your child is 32 weeks of
age.
Rotavirus gastroenteritis may cause fever, vomiting, and diarrhoea.
These symptoms can
lead to the loss of body fluids (dehydration) and even to death.
It is the chief cause of severe dehydrating diarrhoea among infants
and young children
around the world. Before the vaccine was used, the virus was the cause
for about 25
million physician visits per year. It also accounted for 2.1 million
hospital admissions, and
352,000 to 592,000 deaths per year worldwide.
Rotavirus infects the small intestine and usually starts with fever
and vomiting, followed by
diarrhoea. The diarrhoea can be mild

Summary of Product characteristics

RotaTeq® v5.0
Page 1 of 16
WPC-V260-OS-082016
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
RotaTeq
®
2 mL Oral solution
Rotavirus vaccine, live, oral, pentavalent
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 mL dose contains the following human-bovine rotavirus
reassortants: G1, G2, G3, G4,
and P1A[8]. The minimum dose levels of the reassortants are as
follows:
G1
2.2 X 10
6
infectious units
G2
2.8 X 10
6
infectious units
G3
2.2 X 10
6
infectious units
G4
2.0 X 10
6
infectious units
P1A[8]
2.3 X 10
6
infectious units
The reassortants are propagated in Vero cells using standard tissue
culture techniques in the
absence of antifungal agents.
Excipient with known effect: sucrose
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Oral solution
RotaTeq is a pale yellow clear liquid that may have a pink tint.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RotaTeq is an oral pentavalent vaccine indicated for the prevention of
rotavirus gastroenteritis
in infants and children caused by the serotypes G1, G2, G3, G4, and
G-serotypes that contain
P1A[8] (e.g. G9). RotaTeq may be administered as early as six weeks of
age.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
The vaccination series consists of three ready-to-use liquid doses of
RotaTeq administered
orally to infants.
The first dose of RotaTeq should be administered at 6 to 12 weeks of
age; the subsequent
doses should be administered at a minimum interval of 4 weeks between
each dose. The
vaccination course should be completed by 32 weeks of age.
There are no restrictions on the infant’s consumption of food or
liquid, including breast milk,
either before or after vaccination with RotaTeq.
RotaTeq may be given to pre-term infants according to their
chronological age.
If for any reason an incomplete dose is administered (e.g. infant
spits or regurgitates the
vaccine), a replacement dose is not recommended, since such dosing was
not studied in the
RotaTeq® v5.0
Page 2 of 16
WPC-V260-OS-082016
clinical trials. The infant should continue to receive