Reasons for adding or updating:

• Change to section 5.1 - Pharmacodynamic properties
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 10-Nov-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



(New text bold. Text struck-through removed)

 

 

Changes

5.1       Pharmacodynamic properties

 

Figure 2:   the abbreviated term for units, ‘U’, is replaced with the full spelling (i.e.- ‘units/ml’). 

 

 

10.       DATE OF REVISION OF THE TEXT

 

01 January 2016   10 November 2016

Reasons for adding or updating:

• Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC: 01-Jan-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Minor change to SPC section 4.8 to add reporting details for suspected adverse reactions for Ireland (HPRA).

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

Date of revision of text on the SPC: 01-Jan-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



(New text bold. Text struck-through removed)

 

 

Changes

 

4.             CLINICAL PARTICULARS

 

4.2        Posology and method of administration

 

……..…

 

Humalog 100 units/ml KwikPen and Humalog 200 units/ml KwikPen

Humalog KwikPen is available in two strengths. For both, the needed dose is dialled in units. Both pre-filled pens, the Humalog 100 units/ml KwikPen and the Humalog 200 units/ml KwikPen deliver 1 – 60 units in steps of 1 unit in a single injection. The dose counter shows the number of units is shown in the dose window of the pen regardless of strength and no dose conversion should be done when transferring a patient to a new strength.

Humalog 200 units/ml KwikPen should be reserved for the treatment of patients with diabetes requiring daily doses of more than 20 units of rapid-acting insulin. The insulin lispro solution containing 200 units/ml should not be withdrawn from the pre-filled pen (the KwikPen) or mixed with any other insulin (see section 4.4 and section 6.2).

 

 

4.4         Special warnings and precautions for use

 

                ………..

 

      Instructions for use and handling

To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.

 

Avoidance of medication errors when using insulin lispro (200 units/ml) in pre-filled pen:

The insulin lispro solution for injection containing 200 units/ml must not be transferred from the pre-filled pen, the KwikPen, to a syringe. The markings on the insulin syringe will not measure the dose correctly. Overdose can result causing severe hypoglycaemia.  The insulin lispro solution for injection containing 200 units/ml must not be transferred from the KwikPen to any other insulin delivery device, including insulin infusion pumps.

Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between the two different strengths of Humalog as well as other insulin products.

 

Excipients

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium‑free”.

 

 

6.6   Special precautions for disposal and other handling

 

Instructions for use and handling

To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.

 

                …………

 

7.            MARKETING AUTHORISATION HOLDER

 

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht Grootslag 1-5, NL-3991 RA, Houten
The Netherlands

 

 

10.          DATE OF REVISION OF THE TEXT

 

14 December 2015     01 January 2016

 

 

Reasons for adding or updating:

• New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO