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Novo Nordisk Limited
Broadfield Park, Brighton Road, Crawley, West Sussex, RH11 9RT
Telephone: +44 (0)1293 613555
Fax: +44 (0)1293 613535
Medical Information Direct Line: +44 (0)845 600 5055
Medical Information e-mail: ukmedicalinfo@novonordisk.com
Customer Care direct line: +44 (0)845 600 5055
Medical Information Fax: +44 (0)1293 613211

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 19/05/2011
SPC Insulatard 100 IU/ml, Insulatard Penfill 100 IU/ml, Insulatard InnoLet 100 IU/ml

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 19/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


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.

 

The patient should be advised not to use any counterfeit needles

 
Updated on 02/03/2011 and displayed until 19/05/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.4 Special warnings and precautions for use, the addition 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

02/2011
Updated on 24/09/2010 and displayed until 02/03/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.2, the sentence relating to the types of Novo Nordisk needles which can be used with the Penfill has been updated to include NovoTwist needles, as well as NovoFine needles.
Updated on 13/12/2007 and displayed until 24/09/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
  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 properties

Preclinical 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 (2°C - 8°C). 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°c)"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°c)" 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°C - 8°C).

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.

 6.5 Nature and contents of container

Size of glass vial has been specified as 10ml.

Size of glass cartridge (type1) has been specified as 3ml.

 6.6 Deleted: "Instructions for use" Inserted "Special precautions for disposal and other handling"

 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°c)  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
Updated on 10/01/2006 and displayed until 13/12/2007
Reasons for adding or updating:
  • Change to joint SPC covering all presentations
Updated on 02/11/2004 and displayed until 10/01/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/07/2003 and displayed until 02/11/2004
Reasons for adding or updating:
  • Change to section 1 - trade name
  • SPC Retired pending re-submission
Updated on 21/08/2001 and displayed until 18/07/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 19/09/2000 and displayed until 21/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  human insulin