50 mg/0.5 ml and 100 mg/1 ml solution
What Synagis is and what it is used for
Synagis contains the active substance palivizumab, which is an antibody. It works specifically against a virus called a respiratory syncytial virus, RSV.
Your child is at high risk of contracting an illness caused by a virus called respiratory syncytial virus ( RSV ).
Children who are more susceptible to severe RSV disease (high-risk children) include premature children (born at 35 weeks or earlier) or children with certain heart or lung problems.
What you need to know before Synagis is given to your child
Your child should not use Synagis
If the child is allergic to palivizumab or any of the other ingredients (listed in section 6). Signs and symptoms of a severe allergic reaction may include:
- severe skin rash, hives, or itchy skin
- swelling of the lips, tongue, or face
- closing of the throat, difficulty swallowing
- difficulty breathing, rapid or irregular breathing
- bluish color on skin, lips, or under fingernails
- muscle weakness or weakness
- blood pressure drop
Warnings and precautions
Take special care with Synagis
- if your child is unwell. Tell the doctor, as treatment with Synagis, may need to be postponed.
- Synagis is usually injected into the thigh. Remember to tell the doctor if your child has any kind of bleeding disorder.
Other medicines and Synagis
It has not been shown that Synagis affects or is affected by other medicines. However, if your child is receiving other medicines, you should inform the doctor about this before starting treatment with Synagis.
How will your child receive Synagis?
How often will my child receive Synagis?
Synagis should be given to your child once a month at a dose of 15 mg per kg of body weight as long as there is a risk of an RSV infection. To get the best protection for your child, it is necessary to follow the instructions given by your doctor regarding return visits for refill doses of Synagis.
If your child is to undergo heart surgery ( bypass surgery), an additional dose of Synagis may be given after the surgery. Your child can then go back to the injection schedule that was originally planned.
How will Synagis be given to my child?
Synagis will be given by injection into a muscle, usually on the outside of the thigh.
What should I do if the child misses an injection of Synagis?
If the child misses an injection, you should contact your doctor as soon as possible. Each Synagis injection is effective for about one month, after which the next injection must be given.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Synagis can cause serious side effects that include:
- severe allergic reactions, these reactions can be life-threatening or fatal (see “Your child should not use Synagis” for a list of signs and symptoms).
- unusual bruising or groups of small red dots on the skin
Contact your doctor or seek medical attention immediately if your child experiences any of the serious side effects listed above after receiving a dose of Synagis.
Additional side effects ar
Very common (occurs in at least 1 in 10 users)
Common (affects 1 to 10 users in 100)
- pain, redness, or swelling at the injection site
- pauses in breathing or other breathing problems
Uncommon (affects less than 1 in 100 users)
How to store Synagis
Store out of sight and reach of children.
Use before the expiry date stated on the carton and label after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C-8 °C).
Do not freeze.
Contents of the packaging and other information
- 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 palivizumab
- Each 1 ml vial contains 100 mg palivizumab
- Other ingredients are histidine, glycine, and water for vials.
What Synagis looks like and pack sizes
Synagis solution for injection is a clear or slightly opalescent solution available in 0.5 ml or 1 ml vials.
Marketing Authorisation Holder
04011 Campoverde di Aprilia (LT)
For further information about this medicine, contact the representative of the marketing authorization holder.
Tel: +32 2 370 48 11
UAB AstraZeneca Lietuva
Tel: +370 5 2660550
Bulgaria AstraZeneca Bulgaria EOOD Tel
.: +359 2 44 55 000
AstraZeneca SA/NVTél/Tel: +32 2 370 48 11
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