SYNAGIS- palivizumab injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

PALIVIZUMAB (UNII: DQ448MW7KS) (PALIVIZUMAB - UNII:DQ448MW7KS)

Tilgængelig fra:

Swedish Orphan Biovitrum AB (publ)

Indgivelsesvej:

INTRAMUSCULAR

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: - with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season, - with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season, - with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season [see Clinical Studies (14) ]. Limitations of Use: The safety and efficacy of Synagis have not been established for treatment of RSV disease [see Warnings and Precautions (5.4)] . Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis [see Warnings and Precautions (5.1) ]. Risk Summary Synagis is not indicated for use in females of reproductive po

Produkt oversigt:

Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg per mL for intramuscular injection. 50 mg vial NDC 66658-230-01 The 50 mg vial contains 50 mg Synagis in 0.5 mL. 100 mg vial NDC 66658-231-01 The 100 mg vial contains 100 mg Synagis in 1 mL. The rubber stopper used for sealing vials of Synagis is not made with natural rubber latex. Storage Upon receipt and until use, Synagis should be stored between 2°C and 8°C (36°F and 46°F) in its original container. DO NOT freeze. DO NOT use beyond the expiration date.

Autorisation status:

Biologic Licensing Application

Produktets egenskaber

SYNAGIS - PALIVIZUMAB INJECTION, SOLUTION
SWEDISH ORPHAN BIOVITRUM AB (PUBL)
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SYNAGIS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SYNAGIS.
SYNAGIS (PALIVIZUMAB) INJECTION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Synagis is a respiratory syncytial virus (RSV) F protein inhibitor
monoclonal antibody indicated for the
prevention of serious lower respiratory tract disease caused by
respiratory syncytial virus (RSV) in pediatric
patients:
with a history of premature birth (less than or equal to 35 weeks
gestational age) and who are 6
months of age or younger at the beginning of RSV season,
with bronchopulmonary dysplasia (BPD) that required medical treatment
within the previous 6 months
and who are 24 months of age or younger at the beginning of RSV
season,
with hemodynamically significant congenital heart disease (CHD) and
who are 24 months of age or
younger at the beginning of RSV season.
Limitations of Use: The safety and efficacy of Synagis have not been
established for treatment of RSV
disease. (1)
DOSAGE AND ADMINISTRATION
15 mg per kg of body weight, administered intramuscularly prior to
commencement of the RSV season
and remaining doses administered monthly throughout the RSV season.
(2.1)
Children undergoing cardio-pulmonary bypass should receive an
additional dose of Synagis as soon as
possible after the cardio-pulmonary bypass procedure (even if sooner
than a month from the previous
dose). Thereafter, doses should be administered monthly as scheduled.
(2.1, 12.3)
DOSAGE FORMS AND STRENGTHS
Single-dose liquid solution vials: 50 mg per 0.5 mL and 100 mg per 1
mL. (3)
CONTRAINDICATIONS
Previous significant hypersensitivity reaction to Synagis. (4)
WARNINGS AND PRECAUTIONS
Anaphylaxis and anaphylactic shock (including fatal cases), and other
severe acute hypersensitivity
reactions have been reported. Permanently discontinue Synagis and
administer appr