synagis

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PALIVIZUMAB

Available from:

ASTRAZENECA (ISRAEL) LTD

ATC code:

J06BB16

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

PALIVIZUMAB 100 MG/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

ABBVIE S.R.L., ITALY

Therapeutic area:

PALIVIZUMAB

Therapeutic indications:

Abbosynagis is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: • Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season.• Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.• Children less than 2 years of age and with haemodynamically significant congenital heart disease.

Authorization date:

2021-02-28

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Synagis
̨
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Synagis solution contains 100 mg of palivizumab*.
Each 0.5 ml vial contains 50 mg of palivizumab.
Each 1 ml vial contains 100 mg of palivizumab.
*Palivizumab is a recombinant humanised monoclonal antibody produced
by DNA
technology in mouse myeloma host cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear or slightly opalescent.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Synagis is indicated for the prevention of serious lower respiratory
tract disease requiring
hospitalisation caused by respiratory syncytial virus (RSV) in
children at high risk for RSV
disease:
•
Children born at 35 weeks of gestation or less and less than 6 months
of age at the
onset of the RSV season.
•
Children less than 2 years of age and requiring treatment for
bronchopulmonary
dysplasia within the last 6 months.
•
Children less than 2 years of age and with haemodynamically
significant congenital
heart disease.
4.2
Posology and method of administration
Posology
The recommended dose of palivizumab is 15 mg/kg of body weight, given
once a month
during anticipated periods of RSV risk in the community.
The volume (expressed in ml) of // Palivizumab // to be administered
at one-monthly
intervals = [patient weight in kg] multiplied by 0.15.
Where possible, the first dose should be administered prior to
commencement of the
RSV season. Subsequent doses should be administered monthly throughout
the RSV
season. The efficacy of palivizumab at doses other than 15 mg per kg
or of dosing
differently from monthly throughout the RSV season has not been
established.
The majority of experience including the pivotal phase III clinical
trials with palivizumab
has been gained with 5 injections during one season (see section 5.1).
Data, although
limited, are available on greater than 5 doses (see sections 4.8 and
5.1); therefore the
benefit in terms of protection beyond 5 doses has