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UNITED STATES
77 4TH AVENUE
WALTHAM, MA 02451
USA

OFFICE NUMBER: +1 781-786-7370
CANADA
1155 NORTH SERVICE ROAD WEST
UNIT 11, ONTARIO, OAKVILLE
L6M 3E3 CANADA

OFFICE NUMBER: +1 289-291-3852

Patient safety is a priority for Sobi. We are committed to collecting, analyzing, and reacting upon any new information about the benefits and risks of our Products. If you have information about a side effect or adverse reaction associated with any of our products, please let us know via drugsafety@sobi.com.  Adverse reactions may also be reported to your national health authority as applicable according to national legislation.

For Product Complaints, please contact complaints@sobi.com

For Medical Information, please contact: medinfo.us@sobi.com

Contact us on Sobi's corporate website: www.sobi.com

INDICATION AND IMPORTANT SAFETY INFORMATION


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What is SYNAGIS® (palivizumab)?

SYNAGIS is a prescription medication that is injected (50 mg and 100 mg) in certain children to help prevent serious lung disease caused by respiratory syncytial virus (RSV). You should know that SYNAGIS is used to prevent RSV, and not to treat children who already have RSV, including children:

  • born prematurely (at or before 35 weeks) and who are 6 months of age or less at the beginning of RSV season

INDICATION AND IMPORTANT SAFETY INFORMATION

What is SYNAGIS® (palivizumab)?

SYNAGIS is a prescription medication that is injected (50 mg and 100 mg) in certain children to help prevent serious lung disease caused by respiratory syncytial virus (RSV). You should know that SYNAGIS is used to prevent RSV, and not to treat children who already have RSV, including children:

  • born prematurely (at or before 35 weeks) and who are 6 months old or younger at the beginning of RSV season
  • diagnosed with a chronic lung condition called bronchopulmonary dysplasia (BPD) that needed medical treatment within the last 6 months and who are 24 months old or younger at the beginning of RSV season
  • born with certain types of heart disease and who are 24 months old or younger at the beginning of RSV season

You Should Know: It is not known if SYNAGIS is safe and works in children who are over 24 months old when they started taking SYNAGIS.

IMPORTANT SAFETY INFORMATION

You Should Know: SYNAGIS may cause severe allergic reactions.

  • Signs and symptoms of a severe allergic reaction could include:
    • Severe rash, hives, or itchy skin
    • Swelling of the lips, tongue, face, or throat or difficulty swallowing
    • Difficult, rapid, or irregular breathing
    • Bluish color of skin, lips, or under fingernails
    • Muscle weakness or floppiness
    • Unresponsiveness

Call the child’s healthcare provider or get medical help right away if the child has any of the signs or symptoms of a severe allergic reaction after getting SYNAGIS. They can be life threatening or cause death.

You Should Know: SYNAGIS is given by injection. If the child has a problem with bleeding or bruises easily, an injection could cause a problem.

Before the child takes SYNAGIS, you should tell the child’s healthcare provider about all their medical conditions and medicines including vitamins, supplements, and herbal remedies.

What are the possible side effects of SYNAGIS?

The most common side effects are fever and rash.

You Should Know: These are not all the possible side effects for SYNAGIS. For more information, ask the child’s healthcare provider or review the full Prescribing Information for SYNAGIS, including Patient Information.

If you suspect that a child has experienced a side effect, call the child’s healthcare provider. You may also report side effects to Sobi North America at 1-866-773-5274 or the US Food and Drug Administration (FDA) at 1-800-FDA-1088.

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AstraZeneca has transferred all rights to SYNAGIS (palivizumab) to another manufacturer, Swedish Orphan Biovitrum AB (SOBI), in January of 2019. If you need SYNAGIS support, please contact SYNAGIS CONNECT® at (866)-285-8419(866)-285-8419.

RSV=respiratory syncytial virus.
All imagery is for illustrative purposes only.