MOUNJARO 12.5 MG0.5 ML

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

TIRZEPATIDE

Prieinama:

ELI LILLY ISRAEL LTD, ISRAEL

ATC kodas:

A10BX16

Vaisto forma:

SOLUTION FOR INJECTION

Sudėtis:

TIRZEPATIDE 25 MG/ML

Vartojimo būdas:

S.C

Recepto tipas:

Required

Pagaminta:

ELI LILLY AND COMPANY, USA

Gydymo sritis:

TIRZEPATIDE

Terapinės indikacijos:

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.

Leidimo data:

2023-03-14

Pakuotės lapelis

Page 1 of 11
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a physician’s prescription only
MOUNJARO
2.5 MG/0.5 ML
SOLUTION FOR INJECTION IN A PRE-
FILLED PEN
MOUNJARO
5 MG/0.5 ML
SOLUTION FOR INJECTION IN A PRE-
FILLED PEN
MOUNJARO
7.5 MG/0.5 ML
SOLUTION FOR INJECTION IN A PRE-
FILLED PEN
MOUNJARO
10 MG/0.5 ML
SOLUTION FOR INJECTION IN A PRE-
FILLED PEN
MOUNJARO
12.5 MG/0.5 ML
SOLUTION FOR INJECTION IN A PRE-
FILLED PEN
MOUNJARO
15 MG/0.5 ML
SOLUTION FOR INJECTION IN A PRE-
FILLED PEN
THE ACTIVE INGREDIENT AND ITS CONCENTRATION:
Each pre-filled pen contains 2.5 mg/ 5 mg/ 7.5 mg/ 10 mg/ 12.5 mg/ 15
mg Tirzepatide in 0.5 ml
solution.
INACTIVE INGREDIENTS AND ALLERGENS: see chapter 6 “Additional
Information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information regarding this medicine. If you have any further
questions, contact your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if it seems to you that their medical condition is similar.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
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.
THERAPEUTIC GROUP: drugs used in diabetes.
It is important to continue to follow the advice on diet and exercise
given to you by your doctor,
pharmacist or nurse.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
BEFORE TREATMENT WITH MOUNJARO, TALK TO YOUR DOCTOR IF:
-
you have severe problems with food digestion or food remaining in your
stomach for
longer than normal (including severe gastroparesis).
-
you have ever had pancreatitis (inflammation of the pancreas which may

Prekės savybės

X MOUNPN I 01
Page 1 of 20
1.
NAME OF THE MEDICINAL PRODUCT
Mounjaro 2.5 mg/0.5ml
Mounjaro 5 mg/0.5ml
Mounjaro 7.5 mg/0.5ml
Mounjaro 10 mg/0.5ml
Mounjaro 12.5 mg/0.5ml
Mounjaro 15 mg/0.5ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Mounjaro 5 mg solution for injection in pre-filled pen
Each pre-filled pen contains 5 mg of tirzepatide in 0.5 ml solution.
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.
Mounjaro 10 mg solution for injection in pre-filled pen
Each pre-filled pen contains 10 mg of tirzepatide in 0.5 ml solution.
Mounjaro 12.5 mg solution for injection in pre-filled pen
Each pre-filled pen contains 12.5 mg of tirzepatide in 0.5 ml
solution.
Mounjaro 15 mg solution for injection in pre-filled pen
Each pre-filled pen contains 15 mg of tirzepatide in 0.5 ml solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear to opalescent, colourless to slightly yellow or brown,
essentially free of particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
X MOUNPN I 01
Page 2 of 20
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
The starting dose of tirzepatide is 2.5 mg once weekly. After 4 weeks,
the dose should be increased to 5 mg once weekly.
If needed, dose increases can be made in 2.5 mg increments after a
minimum of 4 weeks on the current dose.
The recommended maintenance doses are 5, 10 and