Mounjaro

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

Tirzepatide

Beschikbaar vanaf:

Eli Lilly Nederland B.V.

ATC-code:

A10BX16

INN (Algemene Internationale Benaming):

tirzepatide

Therapeutische categorie:

Drugs used in diabetes

Therapeutisch gebied:

Diabetes Mellitus, Type 2

therapeutische indicaties:

Mounjaro 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 the populations studied, see sections 4.4, 4.5 and 5.1.

Product samenvatting:

Revision: 3

Autorisatie-status:

Authorised

Autorisatie datum:

2022-09-15

Bijsluiter

143
B. PACKAGE LEAFLET
144
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOUNJARO 2.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
MOUNJARO 5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
MOUNJARO 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
MOUNJARO 10 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
MOUNJARO 12.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
MOUNJARO 15 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
tirzepatide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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, nurse or
pharmacist.
-
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, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mounjaro is and what it is used for
2.
What you need to know before you use Mounjaro
3.
How to use Mounjaro
4.
Possible side effects
5.
How to store Mounjaro
6.
Contents of the pack and other information
1.
WHAT MOUNJARO IS AND WHAT IT IS USED FOR
Mounjaro contains an active substance called tirzepatide and is used
to treat adults with type 2
diabetes mellitus. Mounjaro reduces the level of sugar in the body
only when the levels of sugar are
high.
Mounjaro is also used to treat adults with obesity or overweight (with
BMI of at least 27 kg/m
2
).
Mounjaro influences appetite regulation, which may help you eat less
food and reduce your body
weight.
In type 2 diabetes, Mounjaro is used:
-
on its own when you can’t take metformin (another diabetes
medicine).
-
with other medicines for diabetes when

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Mounjaro 2.5 mg solution for injection in pre-filled pen
Mounjaro 5 mg solution for injection in pre-filled pen
Mounjaro 7.5 mg solution for injection in pre-filled pen
Mounjaro 10 mg solution for injection in pre-filled pen
Mounjaro 12.5 mg solution for injection in pre-filled pen
Mounjaro 15 mg solution for injection in pre-filled pen
Mounjaro 2.5 mg solution for injection in vial
Mounjaro 5 mg solution for injection in vial
Mounjaro 7.5 mg solution for injection in vial
Mounjaro 10 mg solution for injection in vial
Mounjaro 12.5 mg solution for injection in vial
Mounjaro 15 mg solution for injection in vial
Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen
Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen
Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen
Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen
Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen
Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled pen, single-dose
_Mounjaro 2.5 mg solution for injection in pre-filled pen _
Each pre-filled pen contains 2.5 mg of tirzepatide in 0.5 ml solution
(5 mg/ml).
_Mounjaro 5 mg solution for injection in pre-filled pen _
Each pre-filled pen contains 5 mg of tirzepatide in 0.5 ml solution
(10 mg/ml).
_Mounjaro 7.5 mg solution for injection in pre-filled pen _
Each pre-filled pen contains 7.5 mg of tirzepatide in 0.5 ml solution
(15 mg/ml).
_Mounjaro 10 mg solution for injection in pre-filled pen _
Each pre-filled pen contains 10 mg of tirzepatide in 0.5 ml solution
(20 mg/ml).
_Mounjaro 12.5 mg solution for injection in p