SYNAGIS- palivizumab injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

MedImmune, LLC

SNN (starptautisko nepatentēto nosaukumu):

PALIVIZUMAB

Kompozīcija:

PALIVIZUMAB 100 mg in 1 mL

Ievadīšanas:

INTRAMUSCULAR

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

1 INDICATIONS AND USAGE Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: 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 potential. Risk Summary Synagis is not indicated for use in females of reproductive potential. The safety and effectiveness of Synagis in children older than 24 months of age at the start of dosing have not been established [see Clinical Studies (14) ] .

Produktu pārskats:

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 60574-4114-1 The 50 mg vial contains 50 mg Synagis in 0.5 mL. 100 mg vial NDC 60574-4113-1 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.

Autorizācija statuss:

Biologic Licensing Application

Produkta apraksts

SYNAGIS- PALIVIZUMAB INJECTION, SOLUTION
MEDIMMUNE, LLC
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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:
•
•
•
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
•
•
•
ADVERSE REACTIONS
Adverse reactions occurring greater than or equal to 10% and at least
1% more frequently than placebo are fever and rash.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MEDIMMUNE AT
1-877-633-4411 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Safety and effectiveness in children older than 24 months of age at
the start of dosing have not been established. (8.4)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 5/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
®
with a history of premature birth (less than or equal to 3