Lyxumia

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

lixisenatide

Saadav alates:

Sanofi Winthrop Industrie

ATC kood:

A10BJ03

INN (Rahvusvaheline Nimetus):

lixisenatide

Terapeutiline rühm:

Drugs used in diabetes, Glucagon-like peptide-1 (GLP-1) analogues

Terapeutiline ala:

Diabetes Mellitus, Type 2

Näidustused:

Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.,

Toote kokkuvõte:

Revision: 19

Volitamisolek:

Authorised

Loa andmise kuupäev:

2013-01-31

Infovoldik

49
B. PACKAGE LEAFLET
50
PACKAGE LEAFLET: INFORMATION FOR THE USER
LYXUMIA 10 MICROGRAMS SOLUTION FOR INJECTION
LYXUMIA 20 MICROGRAMS SOLUTION FOR INJECTION
lixisenatide
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lyxumia is and what it is used for
2.
What you need to know before you use Lyxumia
3.
How to use Lyxumia
4.
Possible side effects
5.
How to store Lyxumia
6.
Contents of the pack and other information
1.
WHAT LYXUMIA IS AND WHAT IT IS USED FOR
Lyxumia contains the active substance lixisenatide.
It is an injectable medicine used to help your body to control your
blood sugar level when it is too
high. It is used in adults with type 2 diabetes.
Lyxumia is used with other medicines for diabetes when they are not
enough to control your blood
sugar levels. These may include:
•
oral antidiabetics (such as metformin, pioglitazone, sulphonylurea
medicines) and/or,
•
a basal insulin, a type of insulin which works all day.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LYXUMIA
_ _
DO NOT USE LYXUMIA
-
if you are allergic to lixisenatide 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 Lyxumia if:
-
you have type 1 diabetes or diabetic ketoacidosis (a complication of
diabetes that occurs when
the body is unable to break down glucose because there is not enough
insulin) since this
medicine will not be right for you
-
you have or have had inflammation of the pancreas (pancreatitis)
-
yo

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lyxumia 10 micrograms solution for injection
Lyxumia 20 micrograms solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lyxumia 10 micrograms solution for injection
Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50
mcg per ml).
Lyxumia 20 micrograms solution for injection
Each dose (0.2 ml) contains 20 micrograms (mcg) of lixisenatide (100
mcg per ml).
Excipient(s) with known effects
Each dose contains 540 micrograms of metacresol.
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
Lyxumia is indicated for the treatment of adults with type 2 diabetes
mellitus to achieve glycaemic
control in combination with oral glucose-lowering medicinal products
and/or basal insulin when these,
together, with diet and exercise, do not provide adequate glycaemic
control (see sections 4.4 and 5.1
for available data on the different combinations).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Starting dose: dosing is initiated at 10 mcg lixisenatide once daily
for 14 days.
Maintenance dose: a fixed maintenance dose of 20 mcg lixisenatide once
daily is started on Day 15.
For the starting dose Lyxumia 10 micrograms solution for injection is
available.
For the maintenance dose Lyxumia 20 micrograms solution for injection
is available.
When Lyxumia is added to existing metformin therapy, the current
metformin dose can be continued
unchanged.
When Lyxumia is added to existing therapy of a sulphonylurea or a
basal insulin, a reduction in the
dose of the sulphonylurea or the basal insulin may be considered to
reduce the risk of hypoglycaemia.
Lyxumia should not be given in combination with basal insulin and a
sulphonylurea due to increased
risk of hypoglycaemia (see section 4.4).
The use of Lyxumia does not require specific blood glucose monitoring.
However, when used in
combination