Trulicity 1.5mg0.5ml solution for injection pre-filled pen

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Dulaglutide

Предлага се от:

Eli Lilly and Company Ltd

АТС код:

A10BJ05

INN (Международно Name):

Dulaglutide

дозиране:

3mg/1ml

Лекарствена форма:

Solution for injection

Начин на приложение:

Subcutaneous

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 06010203

Листовка

1
INSTRUCTIONS FOR USE
TRULICITY
®
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 INFORMATION FOR THE
PATIENT 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.
2
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
3
1.
UNCAP
2.
PLACE AND UNLOCK
3.
PRESS AND HOLD
4
1
UNCAP
Make sure the pen is
LOCKED
.
•
Pull off and discard the grey base
cap.
DO NOT PUT THE BASE CAP BACK ON – THIS
COULD DAMAGE THE NEEDLE. DO NOT
TOUCH THE NEEDLE.
2
PLACE AND UNLOCK
•
Place the clear base flat and
firmly against your skin at the
injection site.
UNLOCK
by turning the lock ring.
3
PRESS AND HOL

Данни за продукта

OBJECT 1
TRULICITY 1.5 MG SOLUTION FOR INJECTION IN PRE-
FILLED PEN
Summary of Product Characteristics Updated 25-May-2018 | Eli Lilly and
Company Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 0.75 mg solution for injection in pre-filled syringe.
Trulicity 1.5 mg solution for injection in pre-filled syringe.
2. Qualitative and quantitative composition
_Pre-filled pen_
Trulicity 0.75 mg solution for injection
Each pre-filled pen contains 0.75 mg of dulaglutide* in 0.5 ml
solution.
Trulicity 1.5 mg solution for injection
Each pre-filled pen contains 1.5 mg of dulaglutide* in 0.5 ml
solution.
_Pre-filled syringe_
Trulicity 0.75 mg solution for injection
Each pre-filled syringe contains 0.75 mg of dulaglutide* in 0.5 ml
solution.
Trulicity 1.5 mg solution for injection
Each pre-filled syringe contains 1.5 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 (injection).
Clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Trulicity is indicated in adults with type 2 diabetes mellitus to
improve glycaemic control as:
_Monotherapy _
When diet and exercise alone do not provide adequate glycaemic control
in patients for whom the use of
metformin is considered inappropriate due to intolerance or
contraindications.
_Add-on therapy _
In combination with other glucose-lowering medicinal products
including insulin, when these, together
with diet and exercise, do not provide adequate glycaemic control (see
section 5.1 for data with respect to
different combinations).
4.2 Posology and method of a