Last Updated on eMC 05-03-2018 View medicine  | Eli Lilly and Company Limited Contact details

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.

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:27-02-2018

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Changes

 

Added (underline) deleted (strikethrough)

 

 

7.         MARKETING AUTHORISATION HOLDER

 

Eli Lilly Regional Operations GmbH., Kölblgasse 8-10, 1030, Vienna, Austria.

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

 

 

 

 

10.       DATE OF REVISION OF THE TEXT

 

             1 February 201827 February 2018

 

 

                                                                                                                                    AB4MAB5M

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:01-02-2018

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Changes

 

Added (underline) deleted (strikethrough)

 

1.       NAME OF THE MEDICINAL PRODUCT

 

ABASAGLAR] 100 units/mL solution for injection in a cartridge

 

4.8   Undesirable effects

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, website: www.hpra.ie, e-mail: [email protected], United Kingdom: Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

 

6.5   Nature and contents of container

 

Cartridges

3 mL solution in a cartridge (type 1 colourless glass) with a plunger (chlorobutylhalobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutylhalobutyl rubber) with aluminium seal.

 

Packs of 1, 2, 5, 10 and multipacks containing 10 (2 packs of 5) cartridges. Not all pack sizes may be marketed.

 

Pre‑filled pens   

3 mL solution in a cartridge (type 1 colourless glass) with a plunger (chlorobutylhalobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutylhalobutyl rubber) with aluminium seal.

 

 

 

 

 

10.       DATE OF REVISION OF THE TEXT

 

             19 January 20171 February 2018

]ABASAGLAR (insulin glargine) is a trademark of Eli Lilly and Company.                    AB3MAB4M

 

 

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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:19-01-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



New text is underlined in bold, removed text is struckthough in bold.

 

Changes

 

4.         CLINICAL PARTICULARS

4.2      Posology and method of administration

 

……

Transition Switch from other insulins to ABASAGLAR

When changing switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with ABASAGLAR, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products).

 

Switch from twice daily NPH insulin to ABASAGLAR

To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with ABASAGLAR should reduce their daily dose of basal insulin by 20-30 % during the first weeks of treatment.

 

Switch from insulin glargine 300 units/ml to ABASAGLAR

ABASAGLAR and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable. To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with ABASAGLAR should reduce their dose by approximately 20%.

 

During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.

 

As with other insulin analogues, patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with ABASAGLAR.

 

Close metabolic monitoring is recommended during the transition switch and in the initial weeks thereafter.

With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypoglycaemia or hyperglycaemia (see section 4.4).

 

Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with ABASAGLAR.

 

………..

 

4.4       Special warnings and precautions for use

 

……….

Pens to be used with ABASAGLAR cartridges

 

The cartridges should only be used in conjunction with a Lilly reusable insulin pen recommended for the use with Lilly insulin cartridges and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.

………..

 

6.         PHARMACEUTICAL PARTICULARS

6.6          Special precautions for disposal and other handling

 

ABASAGLAR must not be mixed with any other insulin or medicinal products or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.

 

Insulin pen

 

The ABASAGLAR cartridges are to be used only in conjunction with a Lilly reusable insulin pen recommended for the use with Lilly insulin cartridges (see section 4.4).

 

The pen should be used as recommended in the information provided bywith the device manufacturer.

 

The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.

 

If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.

 

If the pen malfunctions (see instructions for using the pen), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 units/mL) and injected.

 

It is important to ensure that syringes do not contain traces of any other material.

 

 ………….

 

10.          DATE OF REVISION OF THE TEXT

 

19 January 2017

Reasons for adding or updating:

  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:21-05-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Addition of new marketing authorisation numbers for 80 unit pre-filled pens.

 

8.             MARKETING AUTHORISATION NUMBER(S)

 

Cartridges

EU/1/14/944/001                                Pack of 1 cartridge

EU/1/14/944/002                                Pack of 2 cartridges

EU/1/14/944/003                                Pack of 5 cartridges

EU/1/14/944/004                                Pack of 10 (2 x 5) cartridges

EU/1/14/944/009                                Pack of 10 (2 x 5) cartridges

 

Pre‑filled pens (60 Units)  

EU/1/14/944/005                                Pack of 1 pre-filled pen

EU/1/14/944/006                                Pack of 2 pre-filled pens

EU/1/14/944/007                                Pack of 5 pre-filled pens

EU/1/14/944/008                                Pack of 10 (2 x 5) pre-filled pens

 

 

Pre‑filled pens (80 Units)  

EU/1/14/944/010                                Pack of 1 pre-filled pen

EU/1/14/944/011                                Pack of 2 pre-filled pens

EU/1/14/944/012                                Pack of 5 pre-filled pens

EU/1/14/944/013                                Pack of 10 (2 x 5) pre-filled pens

 

 

10.          DATE OF REVISION OF THE TEXT

 

21 May 2015

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES