Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
Tirzepatide
Eli Lilly Nederland B.V.
A10BX16
tirzepatide
Drugs used in diabetes
Diabetes Mellitus, Type 2
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.
Revision: 3
Authorised
2022-09-15
123 B. PACKAGE LEAFLET 124 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 Soma hati kamili
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 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled pen _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. Vial _Mounjaro 2.5 mg solution for injection in vial _ Each vial contains 2.5 mg of tirzepatide in 0.5 ml solution. _Mounjaro 5 mg solution for injection in vial _ Each vial contains 5 mg of tirzepatide in 0.5 ml solution. _Mounjaro 7.5 mg solution for inj Soma hati kamili