Trulicity

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

dulaglutide

Διαθέσιμο από:

Eli Lilly Nederland B.V.

Φαρμακολογική κατηγορία (ATC):

A10BJ05

INN (Διεθνής Όνομα):

dulaglutide

Θεραπευτική ομάδα:

Drugs used in diabetes, Blood glucose lowering drugs, excl. insulins

Θεραπευτική περιοχή:

Diabetes Mellitus, Type 2

Θεραπευτικές ενδείξεις:

Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Περίληψη προϊόντος:

Revision: 17

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-11-21

Φύλλο οδηγιών χρήσης

72
B. PACKAGE LEAFLET
73
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRULICITY 0.75 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
TRULICITY 1.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
TRULICITY 3 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
TRULICITY 4.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
dulaglutide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Trulicity is and what it is used for
2.
What you need to know before you use Trulicity
3.
How to use Trulicity
4.
Possible side effects
5.
How to store Trulicity
6.
Contents of the pack and other information
1.
WHAT TRULICITY IS AND WHAT IT IS USED FOR
Trulicity contains an active substance called dulaglutide and is used
to lower blood sugar (glucose) in
adults and children aged 10 years and above, with type 2 diabetes
mellitus and can help prevent heart
disease.
Type 2 diabetes is a condition in which your body does not make enough
insulin, and the insulin that
your body produces does not work as well as it should.
When this happens, sugar (glucose) builds up in the blood.
Trulicity is used:
-
on its own if your blood sugar is not properly controlled by diet and
exercise alone, and you
can’t take metformin (another diabetes medicine).
-
or with other medicines for diabetes when they are not enough to
control your blood sugar
levels. These other medicines may be medicines taken by mouth and/or
insulin given by
injection.
It is important to continue to follow the advice on diet and exercise
given to you by your doctor,
pharmac

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Trulicity 0.75 mg solution for injection in pre-filled pen
Trulicity 1.5 mg solution for injection in pre-filled pen
Trulicity 3 mg solution for injection in pre-filled pen
Trulicity 4.5 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trulicity 0.75 mg solution for injection in pre-filled pen
Each pre-filled pen contains 0.75 mg of dulaglutide* in 0.5 ml
solution.
Trulicity 1.5 mg solution for injection in pre-filled pen
Each pre-filled pen contains 1.5 mg of dulaglutide* in 0.5 ml
solution.
Trulicity 3 mg solution for injection in pre-filled pen
Each pre-filled pen contains 3 mg of dulaglutide* in 0.5 ml solution.
Trulicity 4.5 mg solution for injection in pre-filled pen
Each pre-filled pen contains 4.5 mg of dulaglutide* in 0.5 ml
solution.
*produced in CHO cells by recombinant DNA technology.
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
Type 2 Diabetes Mellitus
Trulicity is indicated for the treatment of patients 10 years and
above with insufficiently controlled
type 2 diabetes mellitus as an adjunct to diet and exercise
•
as monotherapy when metformin is considered inappropriate due to
intolerance or
contraindications
•
in addition to other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic
control and cardiovascular events,
and the populations studied, see sections 4.4, 4.5 and 5.1.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_Adults _
_ _
_Monotherapy _
The recommended dose is 0.75 mg once weekly.
_Add-on therapy_
The recommended dose is 1.5 mg once weekly.
If needed,
•
the 1.5 mg dose can be increased after at least 4 weeks to 3 mg once
weekly.
•
the 3 mg dose can be increased after at least 4 weeks to 4.5 mg once
weekly.
The maximum dose is 4.5 mg once weekly.
_Paediatri