TOUJEO Solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen. Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen.
Qualitative and quantitative composition
Each ml contains 300 units insulin glargine* (equivalent to 10.91 mg). SoloStar pen: Each pen contains 1.5 ml of solution for injection, equivalent to 450 units. DoubleStar pen: Each pen contains 3 ml ...
Pharmaceutical form
Solution for injection (injection). Clear colourless solution.
Therapeutic indications
Treatment of diabetes mellitus in adults.
Posology and method of administration
Posology Toujeo is a basal insulin for once-daily administration at any time of the day, preferably at the same time every day. The dose regimen (dose and timing) should be adjusted according to individual ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Toujeo is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered intravenously is recommended in such cases. In case of insufficient glucose control ...
Interaction with other medicinal products and other forms of interaction
A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine. Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia ...
Fertility, pregnancy and lactation
Pregnancy There is no clinical experience with use of Toujeo in pregnant women. For insulin glargine no clinical data on exposed pregnancies from controlled clinical studies are available. A large amount ...
Effects on ability to drive and use machines
The patients ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment. This may constitute a risk in situations ...
Undesirable effects
Summary of the safety profile The following adverse reactions were observed during clinical studies conducted with Toujeo (see section 5.1) and during clinical experience with insulin glargine 100 units/ml. ...
Overdose
Symptoms Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia. Management Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustments ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting ATC Code: A10AE04 Mechanism of action The primary activity of insulin, including insulin glargine, is ...
Pharmacokinetic properties
Absorption and distribution slower and more prolonged absorption resulting in a flatter time-concentration profile after subcutaneous injection of Toujeo in comparison to insulin glargine 100 units/ml. ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
List of excipients
Zinc chloride Metacresol Glycerol Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
Toujeo must not be mixed or diluted with any other insulin or other medicinal products. Mixing or diluting Toujeo changes its time/action profile and mixing causes precipitation.
Shelf life
<u>Toujeo SoloStar:</u> 30 months. <u>Toujeo DoubleStar:</u> 24 months. <u>Shelf life after first use of the pen:</u> The medicinal product may be stored for a maximum of 6 weeks below 30°C and away from ...
Special precautions for storage
Before first use Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer compartment or a freezer pack. Keep the pre-filled pen in the outer carton in order to protect from light. ...
Nature and contents of container
SoloStar pen Cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed ...
Special precautions for disposal and other handling
Before first use, the pen must be stored at room temperature at least 1 hour before use. Before using Toujeo SoloStar or Toujeo DoubleStar pre-filled pen, the Instructions for Use included in the package ...
Marketing authorization holder
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Marketing authorization number(s)
EU/1/00/133/033 EU/1/00/133/034 EU/1/00/133/035 EU/1/00/133/036 EU/1/00/133/037 EU/1/00/133/038 EU/1/00/133/039 EU/1/00/133/040
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 June 2000 Date of latest renewal: 17 February 2015
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