‘Apidra should be given by subcutaneous injection or by continuous subcutaneous pump infusion.’ Has been reworded as ‘Apidra should be given by subcutaneous injection shortly (0‑15 min) before or soon after meals or by continuous subcutaneous pump infusion.’
Section 4.4
The following paragraph:
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, etc.), species (animal) and/or method of manufacturing may result in a change in dosage. Concomitant oral antidiabetic treatment may need to be adjusted.
Has been re-worded as follows:
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, neutral protamine Hagedorn [NPH], lente, long-acting, etc.), source (animal, human, human insulin analogue) and/or method of manufacture may result in the need for for a change in dose. Concomitant oral antidiabetic treatment may need to be adjusted.
The following has been added:
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium‑free’.
Apidra contains metacresol, which may cause allergic reactions.
Section 4.8
Adverse events are now listed in a table according to frequency
Section 4.9
In the sentence, ‘There are no specific data available concerning overdose with insulin glulisine. However, hypoglycaemia may develop over sequential stages’
The word ‘overdose’ has been replaced by ‘overdoses’
Section 5.1
‘Pharmacotherapeutic group: insulin and analogues, fast-acting. ATC code: A10AB06’
changed to ‘Pharmacotherapeutic group: Insulins and analogues for injection, fast‑acting. ATC code: A10AB06’
The paragraph beginning ‘Studies in healthy volunteers and patients with diabetes’ has been updated to ‘Studies in healthy volunteers and patients with diabetes demonstrated that insulin glulisine is more rapid in onset of action and of shorter duration of action than regular human insulin when given subcutaneously. When insulin glulisine is injected subcutaneously, the glucose lowering activity will begin within 10 – 20 minutes. After intravenous administration, a faster onset and shorter duration of action, as well as a greater peak response were observed as compared with subcutaneous administration. The glucose‑lowering activities of insulin glulisine and regular human insulin are equipotent when administered by intravenous route. One unit of insulin glulisine has the same glucose ‑ lowering activity as one unit of regular human insulin.’
Other minor changes to wording and inclusion of abbreviated terms such as BMI, GIR etc.
Section 5.2
Addition of ‘Intravenous bolus administration of insulin glulisine resulted in a higher systemic exposure when compared to subcutaneous injection, with a Cmax approximately 40 fold higher.’
‘U’ has been repaced with ‘Units’
Sections 6.2 to 6.6 and 7
Minor changes to text formatting, punctuation etc.
Also in section 6.5 the bold text has been added:
3 ml solution in a cartridge (colourless glass) with a plunger (elastomeric bromobutyl rubber) and a flanged cap (aluminium) with a stopper (elastomeric bromobutyl rubber).
Section 9
Addition of date of last renewal
Section 10
New date
