TRULICITY INJECTION 1.5MG0.5ML

Држава: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Dulaglutide

Доступно од:

DKSH SINGAPORE PTE. LTD.

АТЦ код:

A10BJ05

Фармацеутски облик:

INJECTION, SOLUTION

Састав:

Dulaglutide 1.5mg/0.5ml

Пут администрације:

SUBCUTANEOUS

Тип рецептора:

Prescription Only

Произведен од:

Eli Lilly and Company

Статус ауторизације:

ACTIVE

Датум одобрења:

2016-03-18

Информативни летак

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INSTRUCTIONS FOR USE
TRULICITY
TM
1.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
dulaglutide

Unfold and lay flat
→
Read both sides for full instructions
ABOUT TRULICITY PRE-FILLED PEN
PLEASE READ THESE INSTRUCTIONS FOR USE AND THE PACKAGE INSERT
CAREFULLY AND COMPLETELY BEFORE
USING YOUR PRE-FILLED PEN. TALK TO YOUR DOCTOR, PHARMACIST OR NURSE
ABOUT HOW TO INJECT TRULICITY
CORRECTLY.
•
The pen is a disposable, pre-filled delivery device that is ready to
use. Each pen contains one
weekly dose of Trulicity (1.5 mg). Each pen delivers one dose only.
•
TRULICITY IS ADMINISTERED ONCE A WEEK.
You may want to mark your calendar to remind you
when to inject your next dose.
•
When you press the green injection button, the pen will automatically
insert the needle
INTO
YOUR SKIN,
inject the medicine, and pull back (retract) the needle
AFTER THE INJECTION IS
COMPLETE.
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BEFORE YOU GET STARTED
REMOVE
CHECK
INSPECT
PREPARE
from the refrigerator.
Leave the Base Cap
on until you are ready
to inject.
the label to make sure
you have the correct
medicine and it has
not expired.
the pen. Do not use if
you notice that the pen
is damaged, or the
medicine is cloudy,
discoloured or has
particles in it.
by washing your hands.
CHOOSE YOUR INJECTION SITE
•
Your doctor, pharmacist or nurse can
help you choose the injection site that is
best for you.
•
You may inject the medicine into your
stomach (abdomen) or thigh.
•
Another person may give you the
injection in your upper arm.
•
Change (rotate) your injection site each
week. You may use the same area of
your body, but be sure to choose a
different injection site in that area.
FRONT
BACK
Page
3
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1.
UNCAP
2.
PLACE AND UNLOCK
3.
PRESS AND HOLD
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
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1
UNCAP
Make sure the pen is
LOCKED
.
•
Pull off the grey base cap.
DO NOT PUT THE BASE CAP BACK ON –
THIS COULD DAMAGE THE NEEDLE. DO
NOT TOUCH THE NEEDLE.
• When removed, the grey base cap
appears as shown and can be
discarded.
2
PLACE AND UNLOCK
•
P

Карактеристике производа

Page 1 of 25
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
Page 2 of 25
_ _
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 Trulicity is
added to existing metformin
and/or sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy, the
current dose of metformin
and/or SGLT2i can be continued. When it is added to existing therapy
of a sulphonylurea or insul