ADMELOG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

INSULIN LISPRO

Available from:

SANOFI - AVENTIS ISRAEL LTD

ATC code:

A10AB04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

INSULIN LISPRO 100 U/ML

Administration route:

I.V, S.C

Prescription type:

Required

Manufactured by:

SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY

Therapeutic area:

INSULIN LISPRO

Therapeutic indications:

Admelog is indicated for the treatment of adults with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Admelog is also indicated for the initial stabilisation of diabetes mellitus.

Authorization date:

2020-07-29

Summary of Product characteristics

Admelog Vial & SoloStar Pen – SPC - version 1.0 - August 2020
1
ADMELOG
1.
NAME OF THE MEDICINAL PRODUCT
Admelog
100 units/ml, solution for injection in vial
Admelog
100 units/ml, solution for injection in a pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units of insulin lispro* (equivalent to 3.5 mg).
Vial
Each vial contains 1,000 units of insulin lispro in 10 ml solution.
Pre-filled pen
Each pre-filled pen contains 300 units of insulin lispro in 3 ml
solution.
Each pre-filled pen delivers 1-80 units in steps of 1 unit.
* produced in E.coli by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
For the treatment of adults with diabetes mellitus who require insulin
for the maintenance of normal
glucose homeostasis. Insulin lispro Sanofi is also indicated for the
initial stabilization of diabetes
mellitus.
4.2
Posology and method of administration
Posology
The dosage should be determined by the physician, according to the
requirement of the patient.
Admelog may be given shortly before meals. When necessary Admelog can
be given soon after meals.
Admelog takes effect rapidly and has a shorter duration of activity (2
to 5 hours) given subcutaneously
as compared with soluble insulin. This rapid onset of activity allows
an Admelog injection to be given
very close to mealtime. The time course of action of any insulin may
vary considerably in different
individuals or at different times in the same individual. The faster
onset of action compared
to soluble
human insulin is maintained regardless of injection site. As with all
insulin preparations, the duration
of action of Admelog is dependent on dose, site of injection, blood
supply, temperature, and physical
activity.
2
Admelog can be used in conjunction with a longer-acting insulin or
oral sulphonylurea agents, on the
advice of a physician.
Admelog (insulin lispro 100 units/ml