Trulicity 0.75mg solution for injection in pre-filled pen

Country: Малезија

Језик: Енглески

Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активни састојак:

dulaglutide

Доступно од:

ZUELLIG PHARMA SDN BHD

INN (Међународно име):

dulaglutide

Јединице у пакету:

4pieces mL

Произведен од:

ELI LILLY & CO

Информативни летак

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TRULICITY SOLUTION FOR INJECTION IN
PRE-FILLED PEN
Dulaglutide (0.75 mg, 1.5 mg)
WHAT IS IN THIS LEAFLET
1.
What Trulicity is used for
2.
How Trulicity works
3.
Before you use Trulicity
4.
How to use Trulicity
5.
While you are using Trulicity
6.
Side effects
7.
Storage and Disposal of Trulicity
8.
Product Description
9.
Manufacture and Product
Registration Holder
10.
Date of revision
WHAT TRULICITY IS USED FOR
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 mealtime insulin given
by injection
HOW TRULICITY WORKS
Trulicity
contains
an
active
substance
called dulaglutide and is used to lower
blood sugar (glucose) in adults with type
2 diabetes mellitus.
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. Your
body can also make too much sugar.
When this happens, sugar (glucose)
builds up in the blood.
BEFORE YOU USE TRULICITY
_- When you must not use it _
DO NOT USE TRULICITY
if you are allergic
to
dulaglutide
or
any
of
the
other
ingredients of this medicine (see section
PRODUCT DESCRIPTION
).
_Pregnancy and breast-feeding _
It is not known if dulaglutide could harm
your unborn child. Women who could
become
pregnant
should
use
contraception
during
treatment
with
dulaglutide. Tell your doctor if you are
pregnant, think you may be pregnant or
are planning to have a baby, as Trulicity
should not be used during pregnancy.
Talk to your doctor about the best way to
control your blood sugar while you are
pregnant.
Talk to your doctor if you would like to
or are breast-feeding before taking this
medicine. Do not use Trulicity if you are
breast-feeding.
It
is
not
known
if
dulaglutide
passes
int

Карактеристике производа

TRULICITY 0.75 MG SOLUTION FOR
INJECTION IN PRE-FILLED PEN
TRULICITY 1.5 MG SOLUTION FOR
INJECTION IN PRE-FILLED PEN
TRULICITY 0.75 MG SOLUTION FOR
INJECTION IN PRE-FILLED PEN
TRULICITY 1.5 MG SOLUTION FOR
INJECTION IN PRE-FILLED PEN
NL033DAEN00
NL033DAEN00
EUSPC17JUN2021
TRULICITY
™
0.75 MG OR 1.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
Prescription only.
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
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.
Not all strengths, pack sizes, or presentations may be marketed.
*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 adults 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Monotherapy_
The recommended dose is 0.75 mg once weekly.
_Add-on therapy_
The recommended dose is 1.5 mg once weekly.
For potentially vulnerable populations 0.75 mg once weekly can be
considered as a starting dose.
When Trulicity is added to existing metformin and/or pioglitazone
therapy, the current dose of
metformin and/or pioglitazone can be continued. When Trulici