Liprolog

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

insulin lispro

Available from:

Eli Lilly Nederland B.V.

ATC code:

A10AB04, A10AD04

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. Liprolog is also indicated for the initial stabilisation of diabetes mellitus.

Product summary:

Revision: 30

Authorization status:

Authorised

Authorization date:

2001-08-01

Patient Information leaflet

104
B. PACKAGE LEAFLET
105
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIPROLOG 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 Liprolog is and what it is used for
2.
What you need to know before you use Liprolog
3.
How to use Liprolog
4.
Possible side effects
5.
How to store Liprolog
6.
Contents of the pack and other information
1.
WHAT LIPROLOG IS AND WHAT IT IS USED FOR
Liprolog is used to treat diabetes. Liprolog 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. Liprolog 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 Liprolog within 15 minutes of a meal.
Your doctor may tell you to use Liprolog 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.
Liprolog is suitable for use in adults and children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LIPROLOG
DO NOT USE LIPROLOG
-
if you think
HYPOGLYCAEMIA
(low blood sugar) is starting. Further in this leaflet it tells you
how to
deal with mild hypoglycaemia (see Section 3: If you take more Liprolog
than you need).
-
if you

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Liprolog 100 units/ml, solution for injection in vial
Liprolog 100 units/ml, solution for injection in cartridge
Liprolog 100 units/ml KwikPen, solution for injection in a pre-filled
pen
Liprolog 100 units/ml Junior KwikPen, solution for injection in a
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units insulin lispro* (equivalent to 3.5mg).
Vial
Each vial contains 1000 units of insulin lispro in 10 ml solution.
Cartridge
Each cartridge contains 300 units of insulin lispro in 3 ml solution.
KwikPen
Each pre-filled pen contains 300 units of insulin lispro in 3 ml
solution.
Each KwikPen delivers 1-60 units in steps of 1 unit.
Junior KwikPen
Each pre-filled pen contains 300 units of insulin lispro in 3 ml
solution.
Each Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units.
*produced in
_E.coli_
by recombinant DNA technology.
For a 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 and children with diabetes mellitus who
require insulin for the maintenance
of normal glucose homeostasis. Liprolog is also indicated for the
initial stabilisation 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.
_Junior KwikPen _
Liprolog 100 units/ml Junior KwikPen is suitable for patients who may
benefit from finer insulin dose
adjustments.
Liprolog may be given shortly before meals. When necessary Liprolog
can be given soon after meals.
3
Liprolog 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
a Liprolog injection (or, in the
case of administration by continuous subcutaneous infusion, a Liprolog
bolus) to be given very close
to