When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
The safety and efficacy of Targinact in children below 18 years has not been established. No data are available.
Targinact is not recommended for use in children and adolescents below the age of 18 years due to a lack of data on safety and efficacy.
Text with strike-through has been deleted, text in red has been added.
excipients listed in section 6.1 (text in red has been added)
4.4 Special warnings and precautions for use
The major risk from of opioids excess is respiratory depression.
Section 4.5 Interaction with other medicinical products and other forms of interaction
This section has been re-written.
4.6 Fertility, Pregnancy and lactation
The heading lactation has been replaced with Breastfeeding.
There are no data with respect to fertility.
Text in red has been added.
4.8 Undesirable effects
There have been many changes and additions throughout this section.
5.2 Pharmacokinetic properties
The heading Metabolism has been replaced with Biotransformation.
In vitro studies suggest that therapeutic doses of cimetidine are not likely to significantly influence the production of noroxycodone. has been removed
The heading Metabolism and elimination has been replaced with Biotransformation and elimination.
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