MOUNJARO Solution for injection (2024)
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Περιεχόμενα
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 ...
2. Qualitative and quantitative composition
Pre-filled pen, single-dose <u>Mounjaro 2.5 mg solution for injection in pre-filled pen:</u> Each pre-filled pen contains 2.5 mg of tirzepatide in 0.5 ml solution (5 mg/ml). <u>Mounjaro 5 mg solution for ...
3. Pharmaceutical form
Solution for injection (injection). Clear, colourless to slightly yellow solution.
4.1. Therapeutic indications
Type 2 diabetes mellitus 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 ...
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 ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Acute pancreatitis Tirzepatide has not been studied in patients with a history of pancreatitis, and should be used with caution in these patients. Acute pancreatitis has been reported in patients treated ...
4.5. Interaction with other medicinal products and other forms of interaction
Tirzepatide delays gastric emptying and thereby has the potential to impact the rate of absorption of concomitantly administered oral medicinal products. This effect, resulting in decreased C<sub>max</sub> ...
4.6. Pregnancy and lactation
Pregnancy There are no or a limited amount of data from the use of tirzepatide in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Tirzepatide is not recommended during ...
4.7. Effects on ability to drive and use machines
Tirzepatide has no or negligible influence on the ability to drive or use machines. When tirzepatide is used in combination with a sulphonylurea or insulin, patients should be advised to take precautions ...
4.8. Undesirable effects
Summary of safety profile In 9 completed phase 3 studies, 7 702 patients were exposed to tirzepatide alone or in combination with other glucose lowering medicinal products. The most frequently reported ...
4.9. Overdose
In the event of overdose, appropriate supportive treatment should be initiated according to the patients clinical signs and symptoms. Patients may experience gastrointestinal adverse reactions including ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, blood glucose lowering drugs, excl. insulins <b>ATC code:</b> A10BX16 Mechanism of action Tirzepatide is a long acting GIP and GLP-1 receptor agonist. ...
5.2. Pharmacokinetic properties
Tirzepatide consists of 39-amino acids and has a C20 fatty diacid moiety attached, which enables albumin binding and prolongs half-life. Absorption Maximum concentration of tirzepatide is reached 8 to ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeat-dose toxicity or genotoxicity. A 2-year carcinogenicity study was conducted with tirzepatide ...
6.1. List of excipients
<u>Pre-filled pen, single-dose; vial, single-dose:</u> Disodium hydrogen phosphate heptahydrate (E339) Sodium chloride Concentrated hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) ...
6.2. Incompatibilities
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
<u>Pre-filled pen, single-dose; vial, single-dose:</u> <em>Before use</em> 2 years. Mounjaro may be stored unrefrigerated for up to 21 cumulative days at a temperature below 30ºC and then the pre-filled ...
6.4. Special precautions for storage
Store in a refrigerator (2ºC–8ºC). Do not freeze. <u>Pre-filled pen, single-dose; vial, single-dose:</u> Store in original package in order to protect from light. <u>Pre-filled pen (KwikPen), multi-dose: ...
6.5. Nature and contents of container
<u>Pre-filled pen, single-dose:</u> Glass syringe encased in a disposable pre-filled pen. The pre-filled pen has a hidden needle, which will automatically insert into the skin when the injection button ...
6.6. Special precautions for disposal and other handling
Instructions for use Inspect Mounjaro visually before use and discard for particulate matter or discolouration. Mounjaro that has been frozen must not be used. <u>Pre-filled pen, single-dose:</u> The pre-filled ...
7. Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
8. Marketing authorization number(s)
EU/1/22/1685/001 EU/1/22/1685/002 EU/1/22/1685/003 EU/1/22/1685/004 EU/1/22/1685/005 EU/1/22/1685/006 EU/1/22/1685/007 EU/1/22/1685/008 EU/1/22/1685/009 EU/1/22/1685/010 EU/1/22/1685/011 EU/1/22/1685/012 ...
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 15 September 2022
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