SYNAGIS STERILE POWDER FOR INJECTION 100 mgvial

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

PALIVIZUMAB

Tilgjengelig fra:

ABBVIE PTE. LTD.

ATC-kode:

J06BB16

Dosering :

100 mg/vial (100mg/ml)

Legemiddelform:

INJECTION, POWDER, FOR SOLUTION

Sammensetning:

PALIVIZUMAB 100 mg/vial (100mg/ml)

Administreringsrute:

INTRAMUSCULAR

Resept typen:

Prescription Only

Produsert av:

BOEHRINGER INGELHEIM PHARMA GmbH & Co. KG

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2000-01-13

Informasjon til brukeren

 
SYNAGIS
® 

(PALIVIZUMAB) 
INTRAMUSCULAR 
INJECTION

DESCRIPTION 
Palivizumab is a humanized IgG1 monoclonal antibody directed to
an epitope in the A antigenic site of the 
fusion protein of respiratory syncytial virus (RSV).  

This humanized monoclonal antibody is composed of 95% human and
5% murine amino acid sequences. 
Palivizumab is composed of two heavy chains and
two light chains having a molecular weight of 
approximately 148,000 Daltons. 

Synagis
®
 (Palivizumab) is supplied as a sterile lyophilized
product for reconstitution with sterile water for 
injection for intramuscular injection. Upon
reconstitution, Synagis
®
 (Palivizumab) contains the following 
excipients: 47 mM histidine, 3.0 mM glycine and
5.6% mannitol and the active ingredient, palivizumab, at a 
concentration of 100 milligrams per mL. The reconstituted
solution should appear clear or slightly 
opalescent. 

CLINICAL PHARMACOLOGY 
MECHANISM OF ACTION 
Synagis
®
 (Palivizumab) exhibits neutralizing and
fusion-inhibitory activity against RSV. These activities 
inhibit RSV replication in laboratory experiments. Although
resistant RSV strains may be isolated in 
laboratory studies, a panel of clinical RSV isolates were
all neutralized by Synagis
®
 (Palivizumab). Synagis
®

(Palivizumab) serum concentrations of approximately 30 mcg/mL
have been shown to produce a mean 99% 
reduction in pulmonary RSV replication in the cotton rat model. 

The _in vivo_ neutralizing activity of the active
ingredient in Synagis
® 
(Palivizumab) was assessed in a 
randomized, placebo-controlled study of 35 pediatric patients tracheally intubated because
of RSV disease. 
In these patients, Synagis
®
 (Palivizumab) significantly reduced the quantity of RSV in
the lower respiratory 
tract compared to control patients. 

PHARMACOKINETICS 
In studies in adult�

Preparatomtale

SYNAGIS
®
(PALIVIZUMAB)
INTRAMUSCULAR INJECTION
DESCRIPTION
Palivizumab is a humanized IgG1 monoclonal antibody directed to an
epitope in the A antigenic site of the
fusion protein of respiratory syncytial
virus (RSV) and is produced by DNA technology in mouse myeloma
host cells.
This humanized monoclonal antibody is composed of 95% human and 5%
murine amino acid sequences.
Palivizumab is composed of two heavy chains and two light chains
having a molecular weight of
approximately 148,000 Daltons.
LYOPHILIZED FORMULATION
Synagis
®
(Palivizumab) is supplied as a sterile lyophilized product for
reconstitution with sterile water for
injection for intramuscular injection. Upon reconstitution, Synagis
®
(Palivizumab) contains the following
excipients: 47 mM histidine, 3.0 mM glycine and 5.6% mannitol and the
active ingredient, palivizumab, at a
concentration of 100 milligrams per mL. The reconstituted solution
should appear clear or slightly
opalescent.
LIQUID FORMULATION
Palivizumab is supplied as a sterile solution for intramuscular
injection. Palivizumab contains the following
excipients: 25 mM histidine and 1.6 mM glycine and the active
ingredient, palivizumab, at a concentration of
100 milligrams per mL. The solution is clear or slightly opalescent.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Synagis
®
(Palivizumab) exhibits neutralizing and fusion-inhibitory activity
against RSV. These activities
inhibit RSV replication in laboratory experiments. Although resistant
RSV strains may be isolated in
laboratory studies, a panel
of clinical RSV isolates were all neutralized by Synagis
®
(Palivizumab). Synagis
®
(Palivizumab) serum concentrations of approximately 30 mcg/mL have
been shown to produce a mean 99%
reduction in pulmonary RSV replication in the cotton rat model.
The_ in vivo_ neutralizing activity of the active ingredient in
Synagis
®
(Palivizumab) was assessed in a
randomized, placebo-controlled study of 35 pediatric patients
tracheally intubated because of RSV disease.
In these patients, Synagis
®
(Pa