Synagis - patient leaflet, side effects, dosage

1. What Synagis is and what it is used for

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.

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

Your child should not be given Synagis

If he/she is allergic to palivizumab or any of the other ingredients of this medicine (listed in section 6).

Signs and symptoms of a severe allergic reaction include:

• – severe rash, hives, or itching skin

• – swelling of the lips, tongue, or face

• – closing of the throat, difficulty swallowing

• – difficult, rapid, or irregular breathing

• – bluish colour of skin, lips, or under fingernails

• – muscle weakness or floppiness

• – a drop in blood pressure

• – unresponsiveness

Warnings and precautions

Take special care with Synagis

– if your child is unwell. Please tell your doctor if your child is unwell, as the use of Synagis may need to be delayed.

– if your child has any bleeding disorders as Synagis is usually injected into the thigh.

Other medicines and Synagis

Synagis is not known to interact with other medicines. However, you should inform your doctor of all medicines your child is currently taking before starting Synagis.

• 3. How will my child receive Synagis

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.

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 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.

Additional side effects

Very common (affects at least 1 user in 10):

• rash
• fever

Common (affects 1 to 10 users in 100):

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

Uncommon (affects less than 1 user in 100):

• fits
• hives

Reporting of side effects

If your child gets any side effects, talk to your doctor. This includes any possible side effects 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. How to store 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.

6. Contents of the pack and other information

What Synagis contains

• – 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.

What Synagis looks like and contents of the pack

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

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Etnrapua AcTpa3eHeKa Etnrapua EOOfl Ten.: +359 2 44 55 000	Luxembourg/Lu­xemburg AstraZeneca S.A./N.V. Tél/Tel: +32 2 370 48 11
Česká republika AstraZeneca Czech Republic s.r.o Tel: +420 222 807 111	Magyarország AstraZeneca Kft. Tel.: +36 1 883 6500
Danmark AstraZeneca A/S Tlf: +45 43 66 64 62	Malta Associated Drug Co. Ltd Tel: +356 2277 8000
Deutschland AstraZeneca GmbH Tel: +49 41 03 7080	Nederland AstraZeneca BV Tel: +31 79 363 2222
Eesti AstraZeneca Tel: +372 6549 600	Norge AstraZeneca AS Tlf: +47 21 00 64 00
EZZáSa AstraZeneca A.E. Tql: +302 106871500	Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00	Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
France AstraZeneca Tél: +33 1 41 29 40 00	Portugal AstraZeneca Produtos Farmacéuticos, Lda. Tel: +351 21 434 61 00
Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000	Romania AstraZeneca Pharma SRL Tel: +40 21 317 60 41
Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100	Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777
Italia AstraZeneca S.p.A. Tel: +39 02 9801 1	Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010
Kúnpog ÁZsKTOJp «'DappaKsuuKií At5 Tql: +357 22490305	Sverige AstraZeneca AB Tel: +46 8 553 26 000
Latvija SIA AstraZeneca Latvija Tel: +371 67377100	United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 836

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:.

The following information is intended for medical or healthcare professionals only:

Administrator’s In­structions

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

Palivizumab should not be mixed with any medicinal products or diluents.

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

Do not dilute the product.

Do not shake the vial.

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

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

Palivizumab is administered once a month intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The injection should be given using standard aseptic technique.

Injection volumes over 1 ml should be given as a divided dose.

When using Palivizumab 100 mg/1 ml, the volume (expressed in ml) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15

For example, for a baby with a body weight of 3 kg, the calculation becomes:

(3 × 0.15) ml = 0.45 ml palivizumab per month.

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