50 mg/0.5 ml and 100 mg/1 ml solution
for injection
Active substance: palivizumab
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.
Synagis is a medicine that helps prevent your child from getting severe RSV disease.
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
- inadmissibility
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.
Always use this medicine as directed by your doctor or pharmacist. If you are not sure how this medicine will be given to your child, ask your doctor or pharmacist.
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)
- rash
- fever
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)
- convulsions
- hives
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.
Store the vial in the outer carton. Light sensitive.
Contents of the packaging and other information
Contents declaration
- 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
Manufacturer
AbbVie Srl
04011 Campoverde di Aprilia (LT)
Italy
For further information about this medicine, contact the representative of the marketing authorization holder.
| België/Belgique/Belgien AstraZeneca SA/NV Tel: +32 2 370 48 11 | Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 |
Bulgaria AstraZeneca Bulgaria EOOD Tel .: +359 2 44 55 000 | Luxembourg/Luxembourg AstraZeneca SA/NVTél/Tel: +32 2 370 48 11 |
| Czech RepublicAstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111 | MagyarországAstraZeneca Kft.Tel.: +36 1 883 6500 |
| DenmarkAstraZeneca A/SPhone: +45 43 66 64 62 | MaltaAssociated Drug Co. LtdPhone: +356 2277 8000 |
| DeutschlandAstraZeneca GmbHPhone: +49 40 809034100 | The NetherlandsAstraZeneca BVPhone: +31 79 363 2222 |
| EstoniaAstraZenecaPhone: +372 6549 600 | NorwayAstraZeneca iPhone: +47 21 00 64 00 |
| GreeceAstraZeneca iPhone: +30 2 106871500 | AustriaAstraZeneca Österreich GmbHPhone: +43 1 711 31 0 |
| SpainAstraZeneca Farmacéutica Spain, SAPhone: +34 91 301 91 00 | PolishAstraZeneca Pharma Poland Sp. z o. oTel.: +48 22 245 73 00 |
| FranceAstraZenecaTel: +33 1 41 29 40 00 | Portugal AstraZeneca Produtos Farmacêuticos, Lda.Phone: +351 21 434 61 00 |
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| IrelandAstraZeneca Pharmaceuticals (Ireland) DACPhone: +353 1609 7100 | SlovenijaAstraZeneca UK Limited Tel: +386 1 51 35 600 |
| IcelandVistor hf.Telephone: +354 535 7000 | Slovenian RepublicAstraZeneca AB, ozone: +421 2 5737 7777 |
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| CyprusΑλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305 | SwedenAstraZeneca ABPhone: +46 8 553 26 000 |
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