4.4 Special warnings and precautions for use
Inclusion of standard text concerning injection site reactions has been added:
“As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation. Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions. Reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of Actrapid”.
4.5 Interaction with other medicinal products and other forms of interaction
Anabolic steroids and sulphonamides have been added to the list of substances which my reduce insulin requirements. Oral contraceptives have been added to the list of substances which may increase insulin requirements. These changes are to ensure consistency with the corresponding section in the SPCs for analogue insulins.
4.8 Undesirable effects
The following information has been inserted
… “including isolated reports. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness”.
5.2 Pharmacokinetic properties
Addition of heading:
Children and adolescents:
6.1 List of excipients
“for pH adjustment” has been added for sodium hydroxide
6.2 Incompatibilities
Addition of standard statement that insulin should only be added to compounds with which it is known to be compatible
This information has been added: “Insulin products should only be added to compounds with which it is known to be compatible”.
This information has been deleted “Upon mixing Actrapid with infusion fluids an unpredictable amount of insulin will be adsorbed to the infusion material. Monitoring of the patient's blood glucose during infusion is therefore recommended”.
6.3 Shelf life
“when stored between 2˚C-8˚C” has been added to the shelf life of 30 months.
“when used or stored at room temperature (below 25˚C)” has been added to the shelf life of 6 weeks.
“After first opening” has been deleted.
“when used or stored at room temperature (below 25˚C)” has been added to the shelf life of 6 weeks.
6.4 Special precautions for storage
There have been a number of editorial changes to these sections, generally to standardise the statements. There have been no changes to the actual shelf life or storage conditions.
“Before use” has been added in front of: “Store in a refrigerator (2°C - 8°C)”.
This sentence has been added “Do not store them in or too near the freezer section or cooling element”.
6.5 Nature and contents of container
Size of container has been specified as “10ml”.
6.6 Special precautions for disposal and other handling
These sentences have been added:
“For intravenous use, infusion systems with Actrapid at concentrations 0.05 IU/ml – 1.0 IU/ml insulin human in he following infusion fluids: 0.9% sodium chloride, 5% dextrose and 10% dextrose inclusive 40 mmol/l potassium chloride, using polypropylene infusion bags, are stable at room temperature for 24 hours. Although stable over time, a certain amount of insulin will initially be absorbed to the material of the infusion bag. Monitoring of blood glucose is necessary during the infusion”.
“Any unused product or waste material should be disposed of in accordance with local requirements”.
9. Date of first authorisation/renewal of the authorisation
Date of last renewal: 18 October 2007
10. Date of revision of the text
09/2007
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