LYXUMIA Solution for injection (2023)
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Περιεχόμενα
Name of the medicinal product
Lyxumia 10 micrograms solution for injection. Lyxumia 20 micrograms solution for injection.
Qualitative and quantitative composition
<u>Lyxumia 10 micrograms solution for injection:</u> Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50 mcg per ml). <u>Lyxumia 20 micrograms solution for injection:</u> Each dose (0.2 ...
Pharmaceutical form
Solution for injection (injection). Clear, colourless solution.
Therapeutic indications
Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, ...
Posology and method of administration
Posology <u>Starting dose:</u> dosing is initiated at 10 mcg lixisenatide once daily for 14 days. <u>Maintenance dose:</u> a fixed maintenance dose of 20 mcg lixisenatide once daily is started on Day 15. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
There is no therapeutic experience with lixisenatide in patients with type 1 diabetes mellitus and it should not be used in these patients. Lixisenatide should not be used for treatment of diabetic ketoacidosis. ...
Interaction with other medicinal products and other forms of interaction
Lixisenatide is a peptide and is not metabolised by cytochrome P450. In <em>in vitro</em> studies, lixisenatide did not affect the activity of cytochrome P450 isozymes or human transporters tested. The ...
Pregnancy and lactation
Women of childbearing potential Lyxumia is not recommended in women of childbearing potential not using contraception. Pregnancy There are no adequate data from the use of Lyxumia in pregnant women. Studies ...
Effects on ability to drive and use machines
Lixisenatide has no or negligible influence on the ability to drive or use machines. When used in combination with a sulphonylurea or a basal insulin, patients should be advised to take precautions to ...
Undesirable effects
Summary of the safety profile Over 2,600 patients have received Lyxumia either alone or in combination with metformin, a sulphonylurea (with or without metformin) or a basal insulin (with or without metformin, ...
Overdose
During clinical studies, doses up to 30 mcg of lixisenatide twice a day were administered to type 2 diabetic patients in a 13-week study. An increased incidence of gastrointestinal disorders was observed. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in Diabetes, Glucagon-like peptide-1 (GLP-1) analogues <b>ATC code:</b> A10BJ03 Mechanism of action Lixisenatide is a selective GLP-1 receptor agonist. The ...
Pharmacokinetic properties
Absorption Following subcutaneous administration to patients with type 2 diabetes, the rate of lixisenatide absorption is rapid and not influenced by the dose administered. Irrespective of the dose and ...
Preclinical safety data
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology and toxicology. In 2-year subcutaneous carcinogenicity studies, non-lethal C-cell thyroid tumours ...
List of excipients
Glycerol 85% Sodium acetate trihydrate Methionine Metacresol Hydrochloric acid (for pH adjustment) Sodium hydroxide solution (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. <u>After first use:</u> 14 days.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store away from the freezer compartment. After first use: Store below 30°C. Do not freeze. Do not store with a needle attached. Keep the cap on the pen ...
Nature and contents of container
Type I glass cartridge with a (bromobutyl) rubber plunger, flanged caps (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the inside and polyisoprene on the outside). Each cartridge ...
Special precautions for disposal and other handling
Lyxumia should not be used if it has been frozen. Lyxumia can be used with 29 to 32 gauge disposable pen needles. Pen needles are not included. The patient should be instructed to discard the needle after ...
Marketing authorization holder
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Marketing authorization number(s)
<u>Lyxumia 10 micrograms solution for injection:</u> EU/1/12/811/001 (1 pre-filled pen) <u>Lyxumia 20 micrograms solution for injection:</u> EU/1/12/811/002 (1 pre-filled pen) EU/1/12/811/003 (2 pre-filled ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 February 2013 Date of latest renewal: 18 September 2017
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