Synagis Solution for Injection

4.2    Posology and method of administration

Posology

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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 and 5.2), therefore the benefit in terms of protection beyond 5 doses has not been established.

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4.8    Undesirable effects

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Description of selected adverse reactions

...... Adverse reactions observed in patients after a sixth or greater dose were similar in character and frequency to those after the initial 5 doses.

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.

In an observational, post-marketing, database study, a small increase ......

5.1    Pharmacodynamic properties

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Studies using lyophilised palivizumab

.....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 were evaluated after administration of 7 6 doses of palivizumab within a single RSV season, . The pharmacokinetic data indicated that adequate mean palivizumab levels were achieved in all 18 14 children for whom data on 30 day trough serum concentrations after the sixth dose were available (see section 5.2) enrolled. No significant elevations of anti-palivizumab antibody titer were observed in these 14 participants.  Transient, low levels of antipalivizumab antibody were observed in one child after the second dose of palivizumab that dropped to undetectable levels at the fifth and seventh dose.

In a placebo-controlled trial in 1,287 patients .....

5.2    Pharmacokinetic properties

Lyophilised formulation of palivizumab

.....In the congenital heart disease study, monthly intramuscular doses of 15 mg/kg achieved mean 30 day trough serum active substance concentrations of approximately 55 µg/ml after the first injection and approximately 90 µg/ml after the fourth injection.

In the open label prospective trial evaluating pharmacokinetics with administration of 6 monthly intramuscular doses of 15 mg/kg of palivizumab, mean 30 day trough serum concentrations were approximately 40 mg/ml after the first dose, 120 mg/ml after the fourth dose, and 140 mg/ml after the sixth dose.

 Among 139 children in the congenital .....

10.    DATE OF REVISION OF THE TEXT

16th March 2022 14 September 2023

Inserted text, Deleted text

[…]

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: immune sera and immunoglobulins, antiviral monoclonal antibodies specific immunoglobulins; ATC Code: J06BD01 J06BB16.

[…]

10.    DATE OF REVISION OF THE TEXT

16^th March 2022 31^st August 2021

[…]

4.       Possible side effects

Addition of UK Northern Ireland details for reporting of side effects

6.       Contents of the pack and other information

Addition of local representative details for NI

This leaflet was last revised in 0308/2021.

Deletion of the following sentence;

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

6.6     Special precautions for disposal and other handling

Do not mix the palivizumab liquid and lyophilised formulations.

4.8     Undesirable effects

(addition of UK (Northern Ireland details for reporting of side effects)

United Kingdom (Northern Ireland)

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

10.     DATE OF REVISION OF THE TEXT

18^th March 31^st August 2021

Some small administrative changes have been made throughout the text.

7.       MARKETING AUTHORISATION HOLDER

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

AstraZeneca AB

SE‑151 85 Södertälje

Sweden

6.  Contents of the pack and other information

[...]

Marketing Authorisation holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

AstraZeneca AB

SE‑151 85 Södertälje

Sweden

Description of change

SmPC was updated to reflect approval of Type IB variation to transfer EU MA from UK to Germany due to Brexit for Synagis 100 mg/ml solution for injection.

The following is summary of the changes:

7.       Marketing Authorisation Holder

Updated to AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

10.       Date of Revision of Text

Updated to 05/2018.