Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Synagis

Synagis 50 mg/0.5 ml solution for injection Synagis 100 mg/1 ml solution for injection · Abschnitt 4.3 · PDF-Seite 3

HOS-090189 · Präparat HOS-084025

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Synagis

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HOS-090190 · Präparat HOS-084025

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): placebo (HOS-088378)

Wechselwirkungen · Synagis

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HOS-090191 · Präparat HOS-084025

3 vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Synagis

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HOS-090192 · Präparat HOS-084025

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Synagis

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HOS-090193 · Präparat HOS-084025

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): lead (HOS-085592)

Nebenwirkungen · Synagis

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HOS-090194 · Präparat HOS-084025

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Synagis

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HOS-090195 · Präparat HOS-084025

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Synagis

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HOS-090196 · Präparat HOS-084025

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Synagis

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HOS-090197 · Präparat HOS-084025

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 Clinical studies # ADRs identified from post-marketing surveillance

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Synagis

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HOS-090198 · Präparat HOS-084025

Description of selected adverse reactions Post-marketing experience Post-marketing serious spontaneous adverse reactions reported during palivizumab treatment between 1998 and 2002 covering four RSV seasons were evaluated. A total of 1,291 serious reports were received where palivizumab had been administered as indicated and the duration of therapy was within one season. The onset of the adverse reactions occurred after the sixth or greater dose in only 22 of these reports (15 after the sixth dose, 6 after the seventh doses and 1 after the eight dose). These adverse reactions are similar in character to those after the initial five doses.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Synagis

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HOS-090199 · Präparat HOS-084025

Palivizumab treatment schedule and adverse reactions were monitored in a group of nearly 20,000 infants tracked through a patient compliance registry between 1998 and 2000. Of this group 1,250 enrolled infants had 6 injections, 183 infants had 7 injections, and 27 infants had either 8 or 9 injections. Adverse reactions observed in patients after a sixth or greater dose were similar in character and frequency to those after the initial 5 doses.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Synagis

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HOS-090200 · Präparat HOS-084025

In a small open label prospective trial of 14 subjects, who received 6 doses, the adverse events reported were consistent with the known safety profile of palivizumab.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Synagis

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HOS-090201 · Präparat HOS-084025

In an observational, post-marketing, database study, a small increase in the frequency of asthma was observed among preterm palivizumab recipients; however, the causal relationship is uncertain.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Synagis

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HOS-090202 · Präparat HOS-084025

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.