SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Synagis 50 mg/0.5ml solution for injection

Synagis 100 mg/1 ml solution for injection

Active substance: palivizumab

Read all of this leaflet carefully before your child is given this medicine because it contains important information for you and your child

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of thepackage leaflet:

1. What is Synagis and what is it used for
2. What you need to know before your child is given Synagis
3. How Synagis will be given to your child
4. Possible side effects
5. Storage of Synagis
6. Contents of the pack and further information

1. What is Synagis and what is it used for

Synagis contains the active substance palivizumab, a monoclonal antibody that acts specifically against the respiratory syncytial virus (RSV).

Your child is at high risk of contracting an RSV infection.

Children who are more susceptible to contracting severe RSV disease (high-risk children) include premature babies (born at 35 weeks gestation or less) or babies with certain heart or lung problems.

Synagis is a medicine used to protect your child against this serious RSV disease.

2. What you need to know before your child is given Synagis

Your child should not be given Synagis

If they are allergic to palivizumab or any of the other ingredients of this medicine (listed in section 6). The signs and symptoms of a severe allergic reaction may include:

• severe rash, hives or itching of the skin
• swelling of the lips, tongue and face
• closure of the throat, difficulty swallowing
• blue discoloration of the skin, lips or under the nails
• muscle weakness or floppiness
• drop in blood pressure
• loss of consciousness

Warnings and precautions

Be careful with Synagis

Other medicines and Synagis

No interactions with other medicines have been observed with Synagis. However, before administration of Synagis, inform your doctor or pharmacist of all the medicines your child is taking.

3. How Synagis will be given to your child

How often will Synagis be given to your child?

Synagis should be administered in doses of 15 mg/kg of body weight, once a month during the time of RSV infection risk. For the best protection of your child, it is necessary to follow the doctor's instructions on when to receive the next doses of Synagis.

If your child undergoes heart surgery (surgical intervention with extracorporeal circulation), an additional dose of Synagis will be administered after the surgery. The initial injection program will then be continued.

How will your child receive Synagis?

Synagis should be administered to your child by injection into the muscle, normally in the outer part of the thigh.

What should you do if a dose of Synagis is missed?

If a dose is missed, you should talk to your child's doctor as soon as possible. Each Synagis injection can protect your child for about a month before another dose is needed.

Follow exactly the administration instructions indicated by your doctor or pharmacist. If you are unsure about how this medicine will be administered to your child, consult your doctor or pharmacist.

4. Possible side effects

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 can 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 small red spots on the skin.

Call your doctor or seek medical help immediately if your child experiences any of the serious side effects listed above after receiving a dose of Synagis.

Additional side effects

Very common (at least 1 in 10 patients):

• rash
• fever

Common (between 1 and 10 in 100 patients):

• pain, redness or swelling at the injection site
• pauses in breathing or other breathing difficulties

Uncommon (less than 1 in 100 patients):

• seizures
• hives

Reporting of side effects

If your child experiences any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage 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 is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Keep the vial in the original package to protect it from light.

6. Contents of the pack and further information

Composition of Synagis

• The active substance is palivizumab, one ml of Synagis solution for injection contains 100 mg of palivizumab.
• Each 0.5 ml vial contains 50 mg of palivizumab.
• Each 1 ml vial contains 100 mg of palivizumab.
• The other ingredients are histidine, glycine and water for injections.

Appearance and pack size

Synagis solution for injection is a clear and slightly opalescent solution and is available in 0.5 ml or 1 ml vials.

Pack size of 1.

Marketing authorisation holder

AstraZeneca AB

SE 151 85 Södertälje

Sweden

Manufacturer

AbbVie S.r.l.

04011 Campoverde di Aprilia (LT)

Italy

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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This information is intended only for healthcare professionals:

Administration instructions

In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Palivizumab should not be mixed with any other medicinal product or diluent.

Both the 0.5 ml and 1 ml vials contain an overfill to allow for the withdrawal of 50 mg or 100 mg, respectively.

Do not dilute the product.

Do not shake the vial.

To administer, remove the portion of the tab on the vial cap and clean the stopper with ethanol 70% or equivalent. Insert the needle into the vial and withdraw into the syringe the appropriate volume of solution. Palivizumab solution for injection does not contain preservatives, is for single use only and should be administered immediately after the dose has been drawn into the syringe.

Disposal of unused medicinal product or waste material should be in accordance with local requirements.

Palivizumab is administered once a month by intramuscular injection, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site due to the risk of injury to the sciatic nerve. The injection should be administered using a standard aseptic technique. Injection volumes greater than 1 ml should be administered in divided doses.

When using palivizumab 100 mg/1 ml, the volume of palivizumab (expressed in ml) to be administered once a month = (patient's weight in kg) multiplied by 0.15.

For example, the calculation for a 3 kg baby:

(3 x 0.15) ml = 0.45 ml of palivizumab per month.