SYNAGIS 50 mg powder and solvent for solution for injection

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

Your child should not be given SYNAGIS

• if he/she has ever had an allergic (hypersensitive) reaction to the active ingredient of SYNAGIS (palivizumab) or to any of the other ingredients of SYNAGIS (see a full list of ingredients in Section 6)

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.

Taking other medicines

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.

Instructions for proper use

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 injection.

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 you feel that your child has become ill while being treated with SYNAGIS? If your child becomes ill, please contact your doctor immediately.

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.

If you have any further questions on how this product will be given to your child, ask your doctor or pharmacist.

Like all medicines, SYNAGIS can causeside effects, although not everybody gets them.

What side effects may occur while taking SYNAGIS?

Common (affects 1 to 10 users in 100):
fever;
nervousness;
redness or swelling at the injection site;
diarrhoea.

Uncommon (affects 1 to 10 users on 1000):
colds;
coughs;
runny nose;
wheeze;
vomiting
rash;
pain;
viral infection;
bleeding;
weakness;
constipation;
drowsiness;
hyperactivity;
decrease in white blood cell counts;
increase in liver function tests which will be seen in blood tests;
upper respiratory infection.

Not known (occurence cannot be estimated):
fits;
reduced platelet count (cells that are needed for blood clotting)
a pause in breathing or other breathing difficulties
severe allergic reactions

What should you do if side effects occur?

If your child shows any side effects after receiving SYNAGIS you should contact your doctor. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, contact your doctor.

Keep out of the reach and sight of children.

Do not use SYNAGIS after the expiry date which is stated on the label.

Store in a refrigerator (2ºC-8 °C)
After reconsititution use within 3 hours.
Do not freeze.
Store in the original container

What SYNAGIS contains

• The active substance is palivizumab. 50 mg per vial, providing 100 mg/ml of palivizumab when reconstituted as recommended.
• The other ingredients are, -for the powder: histidine, glycine and mannitol. -for the solvent: water for injections.

What SYNAGIS looks like and contents of the pack

SYNAGIS is presented as a powder and solvent for solution for injection (50 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1.

SYNAGIS is a white to off-white cake.

Marketing Authorisation holder

Abbott Laboratories Ltd
Abbott House,
Vanwall Business Park
Vanwall Road
Maidenhead
Berkshire
SL6 4XE
United Kingdom

Manufacturer

AbbottSRL
I 04011 Campoverde di Aprilia
(Latina) Italy

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

BelgiëBelgiqueBelgien Abbott SA TélTel 32 10 475311 LuxembourgLuxemburg Abbott SA BelgiqueBelgien TélTel 32 10 475311

.. ..Te. 359 2 489 19 50 Magyarország Abbott Laboratories Magyarország Kft. Tel.36 1 465 2100

eská republika Abbott Laboratories s. r. o. Tel 420 267 292 111 Malta V.J.Salomone Pharma Limited Tel 356 22983201

Danmark Abbott Laboratories AS Tlf 45 39 77-00-00 Nederland Abbott B.V. Tel 31 0 88 8222 688

Deutschland Abbott GmbH Co. KG Tel 49 0 6122 58-0 Norge Abbott Norge AS Tlf 47 81 55 99 20

Eesti Abbott Laboratories Baltics LätiTel 371 67605580 Österreich Abbott Ges.m.b.H. Tel 43 1 891-22

Abbott Laboratories .... 30 21 0 9985-222 Polska Abbott Laboratories Poland Sp. z o.o. Tel. 48 22 606-10-50

España Abbott Laboratories, S.A. Tel 34 9 1 337-5200 Portugal Abbott Laboratórios, Lda. Tel 351 0 21 472 7100

France Abbott France Tél 33 0 1 45 60 25 00 România Abbott Laboratories S.A. Tel 40 21 529 30 00

Ireland Abbott Laboratories, Ireland, Ltd Tel 353 0 1 469-1500 Slovenija Abbott Laboratories d.o.o. Tel 386 1 23 63 160

Ísland Vistor hf. Tel 354 535 7000 Slovenská republika Abbott Laboratories Slovakia s.r.o.Tel 421 0 2 4445 4176

Italia Abbott SRL Tel 39 06 928921 SuomiFinland Abbott OY PuhTel 358 0 9 7518 4120

Lifepharma Z.A.M. Ltd . 357 22 34 74 40 Sverige Abbott Scandinavia AB Tel 46 0 8 5465 67 00

Latvija Abbott Laboratories Baltics Tel 371 67605580 United Kingdom Abbott Laboratories Ltd Tel 44 0 1628 773355

Lietuva

Abbott Laboratories Baltics
LatvijaTel: + 371 67605580

This leaflet was last approved in

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

ADMINISTRATOR?S INSTRUCTIONS

SLOWLY add 0.6 ml of water for injections along the inside wall of the vial to minimise foaming. After the water is added, tilt the vial slightly and gently rotate the vial for 30 seconds.

DO NOT SHAKE VIAL.

Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies. Palivizumab solution does not contain a preservative and should be administered within 3 hours of preparation. Any remaining contents should be discarded after use.

When reconstituted as recommended the final concentration is 100 mg/ml.

Palivizumab should not be mixed with any medicinal products or diluents other than water for injections.

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.

Palivizumab dose per month (ml) = patient weight (kg) x dose (15 mg/kg)
100 mg/ml palivizumab

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

3 x 15 = 0.45 ml palivizumab dose per month

100