Synagis · 4.1 Therapeutic indications · 1

HOS-084032 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile The most serious adverse reactions occurring with palivizumab are anaphylaxis and other acute hypersensitivity reactions. Common adverse reactions occurring with palivizumab are fever, rash, and injection site reaction. Tabulated list of adverse reactions Adverse reactions both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1,000 to < 1/100; rare ≥ 1/10,000 to <1/1,000 ) in studies conducted in premature and bronchopulmonary dysplasia paediatric patients, and paediatric congenital heart disease patients. The adverse reactions identified via post-marketing surveillance are reported voluntarily from a population of uncertain size; it is not always possible to reliably estimate their frequency or establish a causal relationship to palivizumab exposure. The frequency for these "ADRs" as presented in the table below was estimated using the safety data of the two registration clinical studies. The incidences of these reactions in these studies showed no difference between the palivizumab and placebo groups and the reactions were not drug related. 4  Undesirable effects in clinical studies* and post-marketing reports in paediatric patients MedDRA system organ Frequency ADR class Blood and lymphatic Uncommon Thrombocytopenia# system disorders Immune system disorders Not known Anaphylaxis, anaphylactic shock (in some cases, fatalities have been reported.)# Nervous system disorders Uncommon Convulsion# Respiratory, thoracic and Common Apnoea# mediastinal disorders Skin and subcutaneous Very common Rash tissue disorders Uncommon Urticaria# General disorders and Very common Pyrexia administrative site conditions Common Injection site reaction *For full study description, see Section 5.1 Cli

Auszug; vollständigen Abschnitt im Original lesen.

HOS-084028 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to other humanised monoclonal antibodies.

HOS-084027 · has-indication-information · PDF-Seite 2

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.

HOS-084030 · has-interaction-information · PDF-Seite 3

No formal interactions studies with other medicinal products were conducted. 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 3 vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents. Since the monoclonal antibody is specific for RSV, palivizumab is not expected to interfere with the immune response to vaccines. Palivizumab may interfere with immune-based RSV diagnostic tests, such as some antigen detection based assays. In addition, palivizumab inhibits virus replication in cell culture and, therefore, may also interfere with viral culture assays. Palivizumab does not interfere with reverse transcriptase polymerase chain reaction-based assays. Assay interference could lead to false-negative RSV diagnostic test results. Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical findings to guide medical decisions.

HOS-084031 · has-pregnancy-information · PDF-Seite 4

Not relevant. Synagis is not indicated for use in adults. Data on fertility, pregnancy and lactation are not available.

HOS-084029 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Allergic reactions including very rare cases of anaphylaxis and anaphylactic shock have been reported following palivizumab administration. In some cases, fatalities have been reported (see section 4.8). Medicinal products for the treatment of severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, should be available for immediate use following administration of palivizumab. A moderate to severe acute infection or febrile illness may warrant delaying the use of palivizumab, unless, in the opinion of the physician, withholding palivizumab entails a greater risk. A mild febrile illness, such as mild upper respiratory infection, is not usually reason to defer administration of palivizumab. Palivizumab should be given with caution to patients with thrombocytopenia or any coagulation disorder. 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 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.