RotaTeq, oral solutionRotavirus vaccine (live, oral)

Type of Medicine: vaccine against a virus

RotaTeq is an oral vaccine that helps protect infants and young children against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection. The vaccine contains five types of live rotavirus strains. Whenan infant is given the vaccine, the immune system (the body?s natural defences) will make antibodies against the most commonly occurring types of rotavirus. These antibodies help protect against gastroenteritis caused by these types of rotavirus.

Do not use RotaTeq if:

• your child is allergic to any of the components of the vaccine (see section 6).
• your child developed an allergic reaction after receiving a dose of RotaTeq or other rotavirus vaccine.
• your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).
• your child was born with a malformation of the gastrointestinal system that might predispose for intussusception.
• your child has any disease which reduces his/her resistance to infection.
• your child has a severe infection with a high temperature. It might be necessary to postpone the vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first.
• your child has diarrhoea or is vomiting. It might be necessary to postpone the vaccination until recovery.

Take special care with RotaTeq:
Inform your doctor/health care professional if your child:

• has received a blood transfusion or immunoglobulins within the last 6 weeks.
• has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system.
• has any disorder of the gastrointestinal system.
• has not been gaining weight and growing as expected.

As always, please take care to wash your hands thoroughly after changing soiled nappies.

Also see Important information about some of the ingredients of RotaTeq below.

As with other vaccines, RotaTeq may not completely protect all children who are vaccinated even after all three doses have been given.

If your child has already been infected with rotavirus but is not yet ill when vaccinated, RotaTeq may not be able to prevent the illness.

RotaTeq does not protect against diarrhoea and vomiting due to causes other than rotavirus.

Using other medicines and other vaccines:

RotaTeq may be given at the same time as your child receives other normally recommended vaccinations, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, inactivated or oral poliomyelitis, hepatitis B, pneumococcal conjugate and meningococcus group C conjugate vaccines.

Please tell your doctor/health care professional if your child is taking or has recently taken any other medicine, including medicines obtained without a prescription.

Taking RotaTeq with food and drink:

There are no restrictions on takingfood or liquid, including breast milk, either before or after vaccination with RotaTeq.

Important information about some of the ingredients of RotaTeq:

RotaTeq contains sucrose. If you have been told that your child has an intolerance to some sugars, inform your doctor/health care professional before the vaccine is administered.

RotaTeq IS FOR ORAL USE ONLY.

A doctor or nurse will administer the recommended doses of RotaTeq to your child. The vaccine (2 ml of liquid per dose) will be given by gently squeezing the tube and delivering the vaccine into your child?s mouth. The vaccine can be given without regard to food, liquid, or breast milk. In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.

Under no circumstance should this vaccine be administered by injection.

The first dose of RotaTeq may be given from the age of 6 weeks and should be given before 12 weeks of age (about 3 months). RotaTeq may be given to infants who were born early provided that the pregnancy had lasted at least 25 weeks. These infants should receive the first dose of vaccine between 6 and 12 weeks after birth.

Your child will receive 3 doses of RotaTeq given at least four weeks apart. It is important that your child receives all 3 doses of the vaccine for protection against rotavirus. It is preferred that all three doses should be given by the age of 20-22 weeks and at latest all three doses should be given by the age of 26 weeks.

When RotaTeq is given to your child for the first dose, it is recommended that your child also receives RotaTeq (and not another rotavirus vaccine) to complete the vaccination course.

If you forget an appointment for RotaTeq:

It is important that you follow the instructions of your doctor/health care professional regarding your child?s return visits for the follow-up doses. If you forget or are not able to go back to your doctor/health care professional at the scheduled time, ask him or her for advice.

Like all medicines, RotaTeq can cause side effects, although not everybody gets them.

The following side effects were reported in clinical studies with the use of RotaTeq: Very common (occurs in more than 1 in 10 infants): fever, diarrhoea, vomiting.
Common (occurs in more than 1 in 100 infants): infections of the upper respiratory system. Uncommon (occurs in less than 1 in 100 infants): stomach pains, runny nose and sore throat, ear infection, rash.
Rare (occurs in less than 1 in 1000 infants): bronchospasm (wheezing or coughing).

Side effects that have been reported during marketed use include:
blood in stool, hives.

In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.

Ask your doctor/health care professional if you want more information about side effects for RotaTeq.

If any of the side effects gets serious, or if you noticed any side effects not listed in this leaflet, please tell your doctor/health care professional. If the condition persists or worsens, seek medical attention.

Keep out of the reach and sight of children.

Store in a refrigerator (2 °C to 8 °C). Keep the dosing tube in the outer carton in order to protect from light.

Do not use any of the dosing tubes of RotaTeq after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What RotaTeqcontains

The active substances in RotaTeq are 5 human-bovine reassortant rotavirus strains: G1 2.2 x 10 6 Infectious Units
G2 2.8 x 10 6 Infectious Units

2.2 x 106G3 G4 P18 2.0 x 1062.3 x 106 Infectious Units Infectious Units Infectious Units

The other ingredients in RotaTeq are: sucrose, sodium citrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, polysorbate 80, culture media (containing inorganic salts, amino acids and vitamins), and purified water.

What RotaTeq looks like and contents of the pack

Oral solution

This vaccine is contained in a single-dose tube and is a pale yellow clear liquid that may have a pink tint.

RotaTeq is available in pack size of 1, 10. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8, rue Jonas Salk, F-69007 Lyon, France

Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, The Netherlands

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien: Sanofi Pasteur MSD, Tél/Tel: +32.2.726.95.84
--------: ---- ---- - ---- -------- ----, ---. + 359 2 8193740
-eská republika: Merck Sharp & Dohme IDEA, Inc., org. sl., Tel: +420.233.010.111 Danmark: Sanofi Pasteur MSD, Tlf: +45.23.32.6929
Deutschland: Sanofi Pasteur MSD GmbH, Tel: +49.6224.5940
Eesti: Merck Sharp & Dohme OÜ, Tel: +372.613.9750
???-??: ?????? ?.?., ???: +30.210.8009111
España: Sanofi Pasteur MSD S.A., Tel: +34.91.371.78.00
France: Sanofi Pasteur MSD SNC, Tél: +33.4.37.28.40.00
Ireland: Sanofi Pasteur MSD Ltd, Tel: +3531.468.5600
Ísland: Sanofi Pasteur MSD, Sími: +32.2.726.95.84
Italia: Sanofi Pasteur MSD Spa, Tel: +39.06.664.092.11
K-????: Merck Sharp & Dohme (Middle East) Limited., ???: +357 22866700
Latvija: SIA Merck Sharp & Dohme Latvija, Tel: +371.67364.224
Lietuva: UAB Merck Sharp & Dohme, Tel. +370 5 2780 247
Luxembourg/Luxemburg: Sanofi Pasteur MSD, Tél: +32.2.726.95.84
Magyarország: MSD Magyarország Kft, Tel: + 36.1.888.5300
Malta: Merck Sharp & Dohme (Middle East) Limited., Tel: +357 22866700
Nederland: Sanofi Pasteur MSD, Tel: +31.23.567.96.00 Norge: Sanofi Pasteur MSD, Tlf: +47.67.50.50.20 Österreich: Sanofi Pasteur MSD GmbH, Tel: +43.1.866.70.22.202 Polska: MSD Polska Sp. z o.o., Tel.: +48.22.549.51.00
Portugal: Sanofi Pasteur MSD, SA, Tel: +351 21 470 45 50
România: Merck Sharp & Dohme Romania S.R.L., Tel: + 4021 529 29 00
Slovenija: Merck Sharp & Dohme, inovativna zdravila d.o.o., Tel: +386.1.520.4201 Slovenská republika: Merck Sharp & Dohme IDEA, Inc., Tel: +421.2.58282010 Suomi/Finland: Sanofi Pasteur MSD, Puh/Tel: +358.9.565.88.30
Sverige: Sanofi Pasteur MSD, Tel: +46.8.564.888.60
United Kingdom: Sanofi Pasteur MSD Ltd, Tel: +44.1.628.785.291

This leaflet was last approved in:

The following information is intended for medical or health care professionals only:

Instructions

To administer the vaccine Tear open the protective bag and remove the dosing tube. Clear the fluid from the dispensing tip by holding tube vertically and tapping the twist-off cap. Open the dosing tube in 2 easy motions 1. Puncture the dispensing tip by screwing cap clockwise until it becomes tight. 2. Remove cap by turning it counterclockwise. Administer dose by gently squeezing liquid into infants mouth toward the inner cheek until dosing tube is empty. A residual drop may remain in the tip of the tube. Discard the empty tube and cap in approved biological waste containers according to local regulations.

Any unused product or waste material should be disposed of in accordance with local requirements.

See also section 3. HOW RotaTeq IS GIVEN.