| In Section 4.2 removal of recommendations for ECG and continuous monitoring requirements and addition of recommended frequency of monitoring for respiratory depression
In Section 4.3 additional contra indications listed
In Section 4.4 requirement for hospitals to have protocols / policies in place prior to use, investigation of hypotension, addition of sodium content and statement relating to use in paediatric population
In Section 4.5 interaction data with therapeutic dose of local anaesthetic added
In Section 4.6 data on fertility and discontinuation of breast feeding added
In Section 4.8 Adverse reactions tabulated by MedDRA SOCs
In Section 5.1 Headings added relating to Mechanism of Action and Pharmacodynamic Effects
In Section 5.2 lack of data in paediatric population added
In Section 5.3 teratogenic and embryofetal effects of morphine added
In Section 6.5 statement re non-marketed packs added
In Section 6.6 Enviromental Risk Assessment added along with additional recommendations for use and handling
In Section 10 date of revision updated
|
