Xultophy

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

insulin degludec, liraglutide

Beschikbaar vanaf:

Novo Nordisk A/S

ATC-code:

A10

INN (Algemene Internationale Benaming):

insulin degludec, liraglutide

Therapeutische categorie:

Drugs used in diabetes

Therapeutisch gebied:

Diabetes Mellitus, Type 2

therapeutische indicaties:

Xultophy is indicated for the treatment of adults with type-2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control.

Product samenvatting:

Revision: 16

Autorisatie-status:

Authorised

Autorisatie datum:

2014-09-18

Bijsluiter

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XULTOPHY 100 UNITS/ML + 3.6 MG/ML SOLUTION FOR INJECTION
insulin degludec + liraglutide
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 Xultophy is and what it is used for
2.
What you need to know before you use Xultophy
3.
How to use Xultophy
4.
Possible side effects
5.
How to store Xultophy
6.
Contents of the pack and other information
1.
WHAT XULTOPHY IS AND WHAT IT IS USED FOR
WHAT XULTOPHY IS USED FOR
Xultophy is used to improve blood glucose (sugar) levels in adult
patients with type 2 diabetes
mellitus. You have diabetes because your body:
•
does not make enough insulin to control the level of sugar in your
blood or
•
is not able to use the insulin properly.
HOW XULTOPHY WORKS
Xultophy contains two active substances that help your body control
your blood sugar:
•
insulin degludec – a long-acting basal insulin which lowers your
blood sugar levels.
•
liraglutide – a ‘GLP-1 analogue’ that helps your body make more
insulin during meals and
lowers the amount of sugar made by your body.
XULTOPHY AND ORAL MEDICINES FOR DIABETES
Xultophy is used with oral medicines for diabetes (such as metformin,
pioglitazone and sulfonylurea
medicines). It is prescribed when these medicines (used alone or with
GLP-1 treatment or with basal
insulin) are not enough to control your blood sugar levels.
IF YOU USE GLP-1 TREATMENT
You should stop your GLP-1 treatment prior to starting on Xultophy.
IF YOU USE INSULIN

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xultophy 100 units/mL + 3.6 mg/mL solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL solution contains 100 units insulin degludec* and 3.6 mg
liraglutide*.
*Produced in
_Saccharomyces cerevisiae _
by recombinant DNA technology.
One pre-filled pen contains 3 mL equivalent to 300 units insulin
degludec and 10.8 mg liraglutide.
One dose step contains 1 unit of insulin degludec and 0.036 mg of
liraglutide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, isotonic solution.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xultophy is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes mellitus
to improve glycaemic control as an adjunct to diet and exercise in
addition to other oral medicinal
products for the treatment of diabetes. For study results with respect
to combinations, effects on
glycaemic control, and the populations studied, see sections 4.4, 4.5
and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Xultophy is given once daily by subcutaneous administration. Xultophy
can be administered at any
time of the day, preferably at the same time of the day.
Xultophy is to be dosed in accordance with the individual patient’s
needs. It is recommended to
optimise glycaemic control via dose adjustment based on fasting plasma
glucose.
Adjustment of dose may be necessary if patients undertake increased
physical activity, change their
usual diet or during concomitant illness.
Patients who forget a dose are advised to take it upon discovery and
then resume their usual once-daily
dosing schedule. A minimum of 8 hours between injections should always
be ensured. This also
applies when administration at the same time of the day is not
possible.
Xultophy is administered as dose steps. One dose step contains 1 unit
of insulin degludec and
0.036 mg of liraglutide. The pre-filled pen can provide from 1 up to
50 dose