Abasaglar (previously Abasria)

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

insulin glargine

Διαθέσιμο από:

Eli Lilly Nederland B.V.

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 2 years and above.

Περίληψη προϊόντος:

Revision: 12

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-09-09

Φύλλο οδηγιών χρήσης

57
B. PACKAGE LEAFLET
58
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABASAGLAR 100 UNITS/ML SOLUTION FOR INJECTION
IN A CARTRIDGE
insulin glargine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU. THE INSTRUCTIONS FOR USING THE INSULIN
PEN ARE PROVIDED WITH YOUR
INSULIN PEN. REFER TO THEM BEFORE USING YOUR MEDICINE.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ABASAGLAR is and what it is used for
2.
What you need to know before you use ABASAGLAR
3.
How to use ABASAGLAR
4.
Possible side effects
5.
How to store ABASAGLAR
6.
Contents of the pack and other information
1.
WHAT ABASAGLAR IS AND WHAT IT IS USED FOR
ABASAGLAR contains insulin glargine. This is a modified insulin, very
similar to human insulin.
ABASAGLAR 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 ABASAGLAR
_ _
DO NOT USE ABASAGLAR
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 ABASAGLAR.
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

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ABASAGLAR 100 units/mL solution for injection in a cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 100 units insulin glargine* (equivalent to 3.64 mg).
Each cartridge contains 3 mL of solution for injection, equivalent to
300 units.
*produced by recombinant DNA technology in
_Escherichia coli_
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (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
ABASAGLAR contains insulin glargine, an insulin analogue and has a
prolonged duration of action.
ABASAGLAR 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, ABASAGLAR 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 insulin glargine
and are not the same as IU or the units used to express the potency of
other insulin analogues (see
section 5.1).
_Special populations _
_ _
_Elderly population (≥65 years old) _
In the elderly, progressive deterioration of renal function may lead
to a steady decrease in insulin
requirements.
_Renal impairment _
In patients with renal impairment, insulin requirements may be
diminished due to reduced insulin
metabolism.
_ _
_Hepatic impairment _
In patients with hepatic impairment, insulin requirements may be
diminished due to reduced capacity
for gluconeogenesis and reduced insulin metabolism.
3
_Paediatric population _
_ _
_Adolescents and children aged 2 years and older _
The safety and efficacy of insulin glargine have been established in
adolescents and children aged
2 years and older (see section 5.1). The dose