Lusduna
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
22-01-2019
Charakterystyka produktu
(SPC)
22-01-2019
Sprawozdanie z oceny publicznego
(PAR)
22-01-2019
Składnik aktywny:
insulin glargine
Dostępny od:
Merck Sharp & Dohme B.V.
Kod ATC:
A10AE04
INN (International Nazwa):
insulin glargine
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Diabetes Mellitus
Wskazania:
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.,
Podsumowanie produktu:
Revision: 2
Status autoryzacji:
Withdrawn
Data autoryzacji:
2017-01-03
Ulotka dla pacjenta
29
B. PACKAGE LEAFLET
Medicinal product no longer authorised
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
LUSDUNA 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN
Insulin glargine
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY INCLUDING THE LUSDUNA NEXVUE
PRE-FILLED PEN INSTRUCTIONS FOR
USE, 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What LUSDUNA is and what it is used for
2.
What you need to know before you use LUSDUNA
3.
How to use LUSDUNA
4.
Possible side effects
5.
How to store LUSDUNA
6.
Contents of the pack and other information
1.
WHAT LUSDUNA IS AND WHAT IT IS USED FOR
LUSDUNA contains insulin glargine. This is a modified insulin, very
similar to human insulin.
LUSDUNA 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 LUSDUNA
DO NOT USE LUSDUNA
-
If you are allergic to insulin glargine or any of the other
ingredients of this medicine (listed in
section 6).
LUSDUNA is only suitable for injection just under the skin. Speak to
your doctor if you need to inject
your insulin by another method.
WARNINGS AND PRECAUTIONS
Talk to your
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
LUSDUNA 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).
Each 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 (injection). Nexvue.
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
LUSDUNA contains insulin glargine, an insulin analogue, and has a
prolonged duration of action.
LUSDUNA 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, LUSDUNA can also be given together with oral 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.
Medicinal product no longer authorised
3
_Hepatic impairment_
In patients with hepatic impairment, insulin r
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