Insulin lispro Sanofi

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

insulin lispro

Available from:

Sanofi Winthrop Industrie

ATC code:

A10AB04

INN (International Name):

insulin lispro

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus

Therapeutic indications:

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus.

Product summary:

Revision: 9

Authorization status:

Authorised

Authorization date:

2017-07-19

Patient Information leaflet

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
INSULIN LISPRO SANOFI 100 UNITS/ML SOLUTION FOR INJECTION IN VIAL
insulin lispro
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Insulin lispro Sanofi is and what it is used for
2.
What you need to know before you use Insulin lispro Sanofi
3.
How to use Insulin lispro Sanofi
4.
Possible side effects
5.
How to store Insulin lispro Sanofi
6.
Contents of the pack and other information
1.
WHAT INSULIN LISPRO SANOFI IS AND WHAT IT IS USED FOR
Insulin lispro Sanofi is used to treat diabetes. It works more quickly
than normal human insulin
because the insulin molecule has been changed slightly.
You get diabetes if your pancreas does not make enough insulin to
control the level of glucose in your
blood. Insulin lispro Sanofi is a substitute for your own insulin and
is used to control glucose in the
long term. It works very quickly and lasts a shorter time than soluble
insulin (2 to 5 hours). You
should normally use
Insulin lispro Sanofi within 15 minutes of a meal.
Your doctor may tell you to use Insulin lispro Sanofi as well as a
longer-acting insulin. Each kind of
insulin comes with another patient information leaflet to tell you
about it. Do not change your insulin
unless your doctor tells you to. Be very careful if you do change
insulin.
Insulin lispro Sanofi is suitable for use in adults and children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE INSULIN LISPRO SANOFI
DO NOT USE INSULIN LISPRO SANOFI
-
if you think
HYPOGLYCAEMIA
(low blood

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Insulin lispro Sanofi 100 units/ml solution for injection in vial
Insulin lispro Sanofi 100 units/ml solution for injection in cartridge
Insulin lispro Sanofi 100 units/ml solution for injection in
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 100 units (equivalent to 3.5 mg) insulin
lispro*.
Insulin lispro Sanofi 100 units/ml solution for injection in vial
Each vial contains 10 ml equivalent to 1,000 units insulin lispro.
Insulin lispro Sanofi 100 units/ml solution for injection in cartridge
Each cartridge contains 3 ml equivalent to 300 units insulin lispro.
Insulin lispro Sanofi 100 units/ml solution for injection in
pre-filled pen
Each pre-filled pen contains 3 ml equivalent to 300 units insulin
lispro.
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
Insulin lispro Sanofi 100 units/ml solution for injection in vial and
in cartridge
Solution for injection (injection).
Insulin lispro Sanofi 100 units/ml solution for injection in a
pre-filled pen
Solution for injection (injection) in pre-filled pen (SoloStar).
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of adults and children with diabetes mellitus who
require insulin for the maintenance
of normal glucose homeostasis. Insulin lispro Sanofi is also indicated
for the initial stabilisation of
diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be determined by the physician, according to the
requirement of the patient.
3
Insulin lispro may be given shortly before meals. When necessary
insulin lispro can be given soon
after meals.
Insulin lispro takes effect rapidly and has a shorter duration of
activity (2 to 5 hours) given
subcutaneously as compared with regular insulin. This rapid onset of
activity allows an Insulin