Synagis 100 mg/1ml solution for injection

Synagis 50 mg/0.5 ml solution for injection

Synagis 100 mg/1 ml solution for injection

Active substance: palivizumab

Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV.

Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).

Children who are more likely to get severe RSV disease (high-risk children) include babies born prematurely (35 weeks or less) or babies born with certain heart or lung problems.

Synagis is a medicine to help protect your child from getting severe RSV illness.

How often will Synagis be given to my child?

Synagis should be given to your child at a dose of 15 mg/kg body weight once a month for as long as the risk of RSV infection remains. For your child’s best protection, it is necessary to take the doctor’s advice about when to return for additional doses of Synagis.

If your child is to have a heart operation (cardiac bypass surgery), he or she may be given an extra dose of Synagis after the operation. Your child can then go back to the original planned injections.

How will my child receive Synagis?

Synagis will be given by injection to your child into a muscle, usually in the outer part of the thigh.

What should you do if your child misses an injection of Synagis?

If your child misses an injection, you should contact your doctor as soon as possible. Each injection of Synagis can only help protect your child for about one month before another injection is needed.

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure about how this product will be given to your child, ask your doctor or pharmacist.

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

Synagis may cause serious side effects including:

• severe allergic reactions, such reactions may be life threatening or fatal (see "Your child should not be given Synagis" for a list of signs and symptoms).
• unusual bruising or groups of tiny red spots on the skin.

Call your doctor or get medical help right away if your child has any of the serious side effects listed above after receiving any dose of Synagis.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after ‘EXP’. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C to 8°C).

Do not freeze.

Keep the vial in the carton in order to protect from light.