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.
Insulatard SmPC
4.2 Posology and method of administration
Administration
Insulatard InnoLet is
a pre-filled pen designed to be used with NovoFine or NovoTwist disposable short cap needles up to a length of 8 mm. or shorter in length. The needle box is marked with an S. InnoLet delivers 1-50 units in increments of 1 unit.
InnoLet delivers 1-50 units in increments of 1 unit.
The patient should be advised not to use any counterfeit needles.
In 4.4 Special warnings and precautions for use the addtion of the following paragraph,
Combination of Insulatard with pioglitazone
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Insulatard is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Date of revision of text 02/2011
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 Insulatard"
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 may 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"
5.3 Pharmacokinetic propertiesPreclinical has been changed to "Non-clinical"
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
6.3 Shelf life
"when stored between 2C-8C" has been added to the shelf life of 30 months.
¡°Insulatard:¡± heading inserted.¡°After first opening¡± has been deleted
Additional sentence included ¡°when used or stored at room temperature (below 25¢ªC)¡± has been added to the shelf life of 6 weeks.
¡°Insulatard Penfill and Insulatard InnoLet:¡± heading inserted¡°6 weeks when used or carried as a spare (below 30¢ªC)¡± additional sentence
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¡ÆC - 8¡ÆC)¡±.This sentence has been added ¡°Do not store them in or too near the freezer section or cooling element¡±.
Insulatard:Deleted: ¡°Keep the vial in the outer carton in order to protect from light.¡±
Inserted : ¡°Keep the vial in the outer carton in order to protect from light.Protect from excessive heat and sunlight¡± has been inserted
Insulatard Penfill:Deleted: ¡°Keep the cartridge in the outer carton in order to protect from light¡± has been deleted.Inserted: ¡°Keep the cartridge in the outer carton in order to protect from light.Protect from excessive heat and sunlight¡± has been inserted.
These sentences have been added:
¡°After removing Insulatard, Insulatard Penfill or Insulatard InnoLet from the refrigerator it is recommended to allow the vial, Penfill or InnoLet to reach room temperature (not above 25¢ªC) before resuspending the insulin as instructed for first time use.¡±.
¡°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