Synagogue – Palivizumab uses, dose and side effects


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.

One vial per pack.

Marketing Authorisation Holder


AbbVie Srl

04011 Campoverde di Aprilia (LT)


For further information about this medicine, contact the representative of the marketing authorization holder.

AstraZeneca SA/NV
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
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 62MaltaAssociated Drug Co. LtdPhone: +356 2277 8000
DeutschlandAstraZeneca GmbHPhone: +49 40 809034100The NetherlandsAstraZeneca BVPhone: +31 79 363 2222
EstoniaAstraZenecaPhone: +372 6549 600NorwayAstraZeneca iPhone: +47 21 00 64 00
GreeceAstraZeneca iPhone: +30 2 106871500AustriaAstraZeneca Österreich GmbHPhone: +43 1 711 31 0
SpainAstraZeneca Farmacéutica Spain, SAPhone: +34 91 301 91 00PolishAstraZeneca Pharma Poland Sp. z o. oTel.: +48 22 245 73 00
FranceAstraZenecaTel: +33 1 41 29 40 00Portugal
AstraZeneca Produtos Farmacêuticos, Lda.Phone: +351 21 434 61 00
HrvatskaAstraZeneca dooPhone: +385 1 4628 000RomaniaAstraZeneca Pharma SRLPhone: +40 21 317 60 41
IrelandAstraZeneca Pharmaceuticals (Ireland) DACPhone: +353 1609 7100SlovenijaAstraZeneca UK Limited
Tel: +386 1 51 35 600
IcelandVistor hf.Telephone: +354 535 7000Slovenian RepublicAstraZeneca AB, ozone: +421 2 5737 7777
ItaliaAstraZeneca S.p.APhone: +39 02 00704500Finland/FinlandAstraZeneca OyPhone/Tel: +358 10 23 010
CyprusΑλέκτωρ Φαρµακευτική Λτδ
Τηλ: +357 22490305
SwedenAstraZeneca ABPhone: +46 8 553 26 000
LatviaSIA AstraZeneca LatvijaPhone: +371 67377100United Kingdom (Northern Ireland)AstraZeneca UK LtdPhone: +44 1582 386836

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