Consumer medicine information

Rotarix 1 x 10<sup>6</sup> CCID50/1.5 mL Oral Liquid

Rotavirus vaccine, live, oral

BRAND INFORMATION

Brand name

Rotarix Oral Liquid

Active ingredient

Rotavirus vaccine, live, oral

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Rotarix 1 x 10<sup>6</sup> CCID50/1.5 mL Oral Liquid.

1. Why is my child receiving ROTARIX?


ROTARIX is a live vaccine used to protect your child against gastroenteritis (diarrhoea and vomiting) caused by rotavirus RIX4414 strain. The vaccine works by causing the body to produce its own protection (antibodies) against this disease.
For more information, see Section 1. Why is my child receiving ROTARIX? in the full CMI.

2. What should I know before my child receives ROTARIX?


Your child should not receive ROTARIX if they have had a previous allergic reaction to ROTARIX or to any of the ingredients listed at the end of the CMI.
Talk to your doctor or nurse if your child has any other medical conditions including a history of chronic gastrointestinal disease, a rare illness affecting their immune system known as Severe Combined Immunodeficiency (SCID) or has a severe infection.
For more information, see Section 2. What should I know before my child receives ROTARIX? in the full CMI.

3. What if my child is taking other medicines?


Some medicines may interfere with ROTARIX and affect how it works.
A list of these medicines is in Section 3. What if my child is taking other medicines? in the full CMI.

4. How does my child receive ROTARIX?

  • Your doctor or nurse will administer ROTARIX to your child
  • The dose is 1.5 mL given into your child's mouth
  • Your child will receive 2 doses of ROTARIX. Each dose is given on a separate day with an interval of at least 4 weeks between them.

More instructions can be found in Section 4. How does my child receive ROTARIX? in the full CMI.

5. What should I know after my child receives ROTARIX?

Things you should do
  • Keep a record of your child's vaccination history
  • Wash your hands immediately after changing nappies and before you prepare and eat food.
  • Continue to feed your child as normal. There are no restrictions on feeding your child, including breast milk, before or after vaccination with ROTARIX.
Looking after your medicine
  • ROTARIX will usually be kept at the doctor's clinic or in the pharmacy
  • If you need to store it, keep it in the refrigerator between 2°C and 8°C. Do not freeze. Protect from light.

For more information, see Section 5. What should I know after my child receives ROTARIX? in the full CMI.

6. Are there any side effects?


Side effects which have been reported following administration of ROTARIX include diarrhoea, vomiting, abdominal pain, constipation, regurgitation of food, flatulence, fever, chest infection, hoarseness, runny nose, a loss of appetite, dehydration, muscle cramps, feeling tired increased crying, irritability, dermatitis and rash.
If your child develops any symptoms suggestive of a blocked or twisted intestine such as severe abdominal pain, persistent vomiting, bloody stools, an abdominal mass you can feel, abdominal bloating or a high fever seek medical attention immediately.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Rotarix Oral Liquid

Active ingredient

Rotavirus vaccine, live, oral

Schedule

S4

 

1 Name of Medicine

Human Rotavirus (live attenuated oral vaccine).

2 Qualitative and Quantitative Composition

Rotarix is a liquid suspension of the live attenuated RIX4414 strain of human rotavirus of the G1P(8) type for use in the prevention of rotavirus gastroenteritis. The virus strain derived from the 89-12 strain is obtained by propagation on a well characterised Vero cell line.
Each 1.5 mL dose of the vaccine contains not less than 106.0 CCID50 (cell culture infectious dose 50%) of the RIX 4414 strain of human rotavirus.
The manufacture of this product includes exposure to bovine derived materials at the very early steps of the production process. No bovine materials are used in routine production. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
The vaccine also contains sucrose. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Rotarix is presented as a clear, colourless liquid, free of visible particles, for oral administration only.

4 Clinical Particulars

4.9 Overdose

Some cases of overdose have been reported. In general, the adverse event profile reported in these cases was similar to that observed after administration of the recommended dose of Rotarix.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Rotarix has not been evaluated for genotoxicity.
Carcinogenicity. Rotarix has not been evaluated for carcinogenicity or mutagenicity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Not relevant to vaccines.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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