Lantus

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

insulin glargine

Διαθέσιμο από:

sanofi-aventis Deutschland GmbH

Φαρμακολογική κατηγορία (ATC):

A10AE04

INN (Διεθνής Όνομα):

insulin glargine

Θεραπευτική ομάδα:

Drugs used in diabetes

Θεραπευτική περιοχή:

Diabetes Mellitus

Θεραπευτικές ενδείξεις:

Treatment of diabetes mellitus in adults, adolescents and children aged two years and above

Περίληψη προϊόντος:

Revision: 40

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2000-06-09

Φύλλο οδηγιών χρήσης

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
LANTUS 100 UNITS/ML SOLUTION FOR INJECTION IN A VIAL
Insulin glargine
_ _
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, pharmacist or
nurse.
-
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 Lantus is and what it is used for
2.
What you need to know before you use Lantus
3.
How to use Lantus
4.
Possible side effects
5.
How to store Lantus
6.
Contents of the pack and other information
1.
WHAT LANTUS IS AND WHAT IT IS USED FOR
Lantus contains insulin glargine. This is a modified insulin, very
similar to human insulin.
Lantus is used to treat diabetes mellitus in adults, adolescents and
children aged 2 years and above.
Diabetes mellitus is a disease where your body does not produce enough
insulin to control the level of
blood sugar. Insulin glargine has a long and steady
blood-sugar-lowering action.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LANTUS
DO NOT USE LANTUS
-
If you are allergic to insulin glargine or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Lantus.
Follow closely the instructions for posology, monitoring (blood and
urine tests), diet and physical
activity (physical work and exercise) as discussed with your doctor.
If your blood sugar is too low (hypoglycaemia), follow the guidance
for hypoglycaemia (see box at the
end of this leaflet).
Skin changes at the injection site
The injection site should be rotated to prevent skin changes such as
lumps under the skin. The insulin
may not wor

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lantus 100 units/ml solution for injection in a vial
Lantus 100 units/ml solution for injection in a cartridge
Lantus SoloStar 100 units/ml solution for injection in a pre-filled
pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units insulin glargine* (equivalent to 3.64 mg).
Lantus 100 units/ml solution for injection in a vial
Each vial contains 5 ml of solution for injection, equivalent to 500
units, or 10 ml of solution for
injection, equivalent to 1000 units.
Lantus 100 units/ml solution for injection in a cartridge, Lantus
SoloStar 100 units/ml solution for
injection in a pre-filled pen
Each cartridge or pen contains 3 ml of solution for injection,
equivalent to 300 units.
*Insulin glargine is produced by recombinant DNA technology in
_Escherichia coli_
.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
aged 2 years and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Lantus contains insulin glargine, an insulin analogue, and has a
prolonged duration of action.
Lantus should be administered once daily at any time but at the same
time each day.
_ _
The dose regimen (dose and timing) should be individually adjusted. In
patients with type 2 diabetes
mellitus, Lantus can also be given together with orally active
antidiabetic medicinal products.
The potency of this medicinal product is stated in units. These units
are exclusive to Lantus and are not
the same as IU or the units used to express the potency of other
insulin analogues (see section 5.1).
_ _
_Special population _
_Elderly population (≥65 years old) _
In the elderly, progressive deterioration of renal function may lead
to a steady decrease in insulin
requirements.
3
_Renal impairment _
In patients with renal impairment, insulin requirements may be
d