Humalog

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

Product summary:

Revision: 34

Authorization status:

Authorised

Authorization date:

1996-04-30

Patient Information leaflet

113
B. PACKAGE LEAFLET
114
PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMALOG 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 Humalog is and what it is used for
2.
What you need to know before you use Humalog
3.
How to use Humalog
4.
Possible side effects
5.
How to store Humalog
6.
Contents of the pack and other information
1.
WHAT HUMALOG IS AND WHAT IT IS USED FOR
Humalog is used to treat diabetes. Humalog 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. Humalog 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 Humalog within 15 minutes of a meal.
Your doctor may tell you to use Humalog 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.
Humalog is suitable for use in adults and children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HUMALOG
DO NOT USE HUMALOG
-
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 use more
Humalog than you should).
-
if you are
ALLERGIC
t

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Humalog 100 units/ml solution for injection in vial
Humalog 100 units/ml solution for injection in cartridge
Humalog 100 units/ml KwikPen solution for injection in a pre-filled
pen
Humalog 100 units/ml Junior KwikPen solution for injection in a
pre-filled pen
Humalog 100 units/ml Tempo Pen solution for injection in a pre-filled
pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg).
Vial
Each vial contains 1000 units insulin lispro in 10 ml solution.
Cartridge
Each cartridge contains 300 units of insulin lispro in 3 ml solution.
KwikPen and Tempo Pen
Each pre-filled pen contains 300 units of insulin lispro in 3 ml
solution.
Each pre-filled pen 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. Humalog 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
_Junior KwikPen _
_ _
Humalog 100 units/ml Junior KwikPen is suitable for patients who may
benefit from finer insulin dose
adjustments.
Humalog may be given shortly before meals. When necessary Humalog can
be given soon after meals.
Humalog 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 Humalog injection (or, in the
case of administratio