Serological studies for detection of antibodies against Legionella, Mycoplasma pneumoniae, Chlamydia pneumoniae and psittaci, influenza virus types A and B, RSV, adenovirus and parainfluenza virus were performed.

This helps to prevent RSV infection.

The RSV hospitalisation rate was 10.6 % in the placebo group.

No significant difference in safety profile was observed between children without active RSV infection and those hospitalised for RSV.

Subsequent doses should be administered monthly throughout the RSV season.

Subsequent doses should resume monthly through the remainder of the RSV season for children that continue to be at high risk of RSV disease (see section 5.2).

Synagis is a medicine to help protect your child from getting severe RSV illness.

Clinical studies In a placebo-controlled trial of RSV disease prophylaxis in (IMpact-RSV trial) 1502 high-risk children (1002 Synagis; 500 placebo), 5 monthly doses of 15 mg/ kg reduced the incidence of RSV related hospitalisation by 55 % (p = < 0.001).

The RSV hospitalisation rate was 9.7 % in the placebo group and 5.3 % in the Synagis group.

Where possible, the first dose should be administered prior to commencement of the RSV season.

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:

It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains.

To reduce risk of rehospitalisation, it is recommended that children receiving palivizumab who are hospitalised with RSV continue to receive monthly doses of palivizumab for the duration of the RSV season.

Palivizumab has been designed to bind to a protein called ‘ fusion protein A ’ on the surface of RSV.

Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).

Studies carried out in rodents gave no indication of enhancement of RSV replication, or RSV-induced pathology or generation of virus escape mutants in the presence of palivizumab under the chosen experimental conditions.

Synagis was more effective than placebo in reducing RSV-related hospitalisations: 4.8 % of the children who received Synagis were admitted to hospital for RSV infection during the study, compared with 10.6 % of those who received placebo.

Antibody to palivizumab was observed in approximately 1 % of patients in the IMpact-RSV during the first course of therapy.

Since the monoclonal antibody is specific for RSV, palivizumab is not expected to interfere with the immune response to vaccines.

The Committee for Medicinal products for Human Use (CHMP) decided that Synagis’ s benefits are greater than its risks for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by RSV in children at high risk for RSV disease.

Secondary efficacy endpoints showed significant reductions in the Synagis group compared to placebo in total days of RSV hospitalisation (56 % reduction, p = 0.003) and total RSV days with increased supplemental oxygen (73 % reduction, p = 0.014) per 100 children.

Synagis should be given to your child at a dose of 15 mg/ kg body weight once a month for as long as the risk of RSV infection remains.

In both studies, the main measure of effectiveness was the number of children who had to be admitted to hospital because of RSV infection.

Synagis is given once a month when there is a risk of RSV infection in the community: in the northern hemisphere, this is from November to April.

Deaths associated with RSV infection occurred in 2 patients in the palivizumab group and 4 patients in the placebo group and were not drug-related.

A total of 222 children were enrolled in two separate studies to examine the safety of palivizumab when it is administered for a second RSV season.

Post-marketing serious spontaneous adverse events reported during palivizumab treatment between 1998 and 2002 covering four RSV seasons were evaluated.

Synagis is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) that would require hospitalisation.

Recommended dose 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.

Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV.

Palivizumab serum concentrations of approximately 30 μ g/ ml have been shown to produce a 99 % reduction in pulmonary RSV replication in the cotton rat model.

Palivizumab is a humanised IgG1κ monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV).

The wheezing observed in the younger age group could be attributed to a number of diagnoses (viral infection, RSV bronchiolitis, or early symptoms of classic asthma).

The efficacy of palivizumab when administered to patients as a second course of treatment during an ensuing RSV season has not been formally investigated in a study performed with this objective.

The severity of RSV disease in children hospitalised despite prophylaxis with palivizumab in terms of days in ICU stay per 100 children and days of mechanical ventilation per 100 children was not affected.

The possible risk of enhanced RSV infection in the season following the season in which the patients were treated with palivizumab has not been conclusively ruled out by studies performed aiming at this particular point.

The main study of Synagis was carried out in 1,502 high-risk children and compared its effectiveness with that of placebo (a dummy treatment) during one RSV season. Another study was also carried out 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.

However, as the efficacy of palivizumab when administered to patients as a second course of treatment during an ensuing RSV season has not been formally investigated in a study performed with this objective, the relevance of these data in terms of efficacy is unknown.

In an open label prospective trial designed to evaluate pharmacokinetics, safety and immunogenicity after administration of 7 doses of palivizumab within a single RSV season, pharmacokinetic data indicated that adequate mean palivizumab levels were achieved in all 18 children enrolled.

In a placebo-controlled trial in 1287 patients ≤ 24 months of age with haemodynamically significant congenital heart disease (639 Synagis; 648 placebo), 5 monthly doses of 15 mg/ kg Synagis reduced the incidence of RSV hospitalisations by 45 % (p = 0.003) (congenital heart disease study).

• 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.

In the phase III IMpact-RSV study in the premature and bronchopulmonary dysplasia paediatric populations, the proportions of patients in the placebo and palivizumab groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.