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Synagis 100 mg./ml. 0.5 ml. 1 vial

Product Code: Synagis 100 mg./ml. 0.5 ml. 1 vial
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What Synagis is and what it is used for
Synagis contains the active substance palivizumab, which is an antibody specifically acting against respiratory syncytial virus (PCB).
Your child is at an increased risk of RSV disease.
The children most likely to develop RSV-induced severe diseases (children at high risk) are premature babies (week 35 or earlier) or infants born with certain heart or lung problems.
Synagis is a medicine that helps prevent your child from developing severe PCB-induced illnesses.

2. What you need to know before your child is given Synagis
Your child should not be given Synagis:

If it 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;
swelling of the lips, tongue or face;
tightness in the throat, difficulty in swallowing;
difficulty, rapid or uneven breathing;
bluish skin, lips or nail;
muscle weakness or looseness;
decrease in blood pressure;
lack of reaction.
Warnings and precautions
Take special care with Synagis:

if your child does not feel well. Please tell your doctor if your child does not feel well to delay the administration of Synagis;
if your child has any bleeding disorders because Synagis is usually injected into the thigh.
Other medicines and Synagis
There is no data on the interaction of Synagis with other medicines. However, before you start Synagis, you should tell your doctor about all the medicines your child is taking.

3. How will Synagis be given to my child
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 until there is a risk of PCB infection. For best child protection, it is necessary to remember the doctor's advice about when to come back for further placement of Synagis.
If your child needs to have heart surgery (heart bypass), he or she may be given an extra dose of Synagis after surgery. The child will then return to the previously planned schedule of administration.

How will my child use Synagis?
Synagis is given by injection into a muscle, usually on the outside of the thigh.

What should you do if your child misses an injection of Synagis?
If your child misses an injection, you should call your doctor as soon as possible. Each Synagis injection can protect your baby for about a month until the next injection is needed.
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure 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 everyone gets them.

Synagis can cause serious side effects, including:

severe allergic reactions, these reactions may be life-threatening or fatal (see "Your child should not be given Synagis" for the list of signs and symptoms);
unusual bruises or small red spots on the skin.
If your child gets any of the serious side effects listed above after having taken any dose of Synagis, contact your doctor or seek medical advice immediately.

Additional side effects
Very common (affects at least 1 in 10 patients):

Common (affects 1 to 10 users in 100):

pain, redness and swelling at the injection site;
short-term breathing or other breathing difficulties.
Uncommon (affects less than 1 in 100 patients):

Reporting of side effects
If your child gets any side effects, talk to your doctor. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.

5. How to store Synagis
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the pack.
Store in a refrigerator (2 ° C to 8 ° C)
Do not freeze.
Keep the vial in the outer carton in order to protect from light.

6. Package Contents and Additional Information
What Synagis contains
The active substance is palivizumab. One ml of Synagis solution for injection contains 100 mg palivizumab.
Each 0.5 ml vial contains 50 mg 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 comes in vials of either 0.5 ml or 1 ml.
Pack of 1.

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