TRESIBA Solution for injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Tresiba 100 units/mL solution for injection in pre-filled pen. Tresiba 200 units/mL solution for injection in pre-filled pen. Tresiba 100 units/mL solution for injection in cartridge.
Qualitative and quantitative composition
Tresiba 100 units/mL solution for injection in pre-filled pen: One pre-filled pen contains 300 units of insulin degludec in 3 mL solution. 1 mL solution contains 100 units insulin degludec* (equivalent ...
Pharmaceutical form
Tresiba 100 units/mL solution for injection in pre-filled pen: Solution for injection (FlexTouch). Tresiba 200 units/mL solution for injection in pre-filled pen: Solution for injection (FlexTouch). Tresiba ...
Therapeutic indications
Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.
Posology and method of administration
Posology This medicinal product is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day. The potency of insulin analogues, including ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Hypoglycaemia Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see ...
Interaction with other medicinal products and other forms of interaction
A number of medicinal products are known to interact with glucose metabolism. The following substances may reduce the insulin requirement Oral antidiabetic medicinal products, GLP-1 receptor agonists, ...
Fertility, pregnancy and lactation
Pregnancy There is no clinical experience with the use of Tresiba in pregnant women. Animal reproduction studies have not revealed any difference between insulin degludec and human insulin regarding embryotoxicity ...
Effects on ability to drive and use machines
This medicinal product has no or negligible influence on the ability to drive and use machines. However, the patients ability to concentrate and react may be impaired as a result of hypoglycaemia. This ...
Undesirable effects
Summary of the safety profile The most frequently reported adverse reaction during treatment is hypoglycaemia (see section Description of selected adverse reactions below). Tabulated list of adverse reactions ...
Overdose
A specific overdose for insulin cannot be defined. However, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required: Mild hypoglycaemic episodes can be treated ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, long-acting ATC code: A10AE06 Mechanism of action Insulin degludec binds specifically to the human insulin receptor ...
Pharmacokinetic properties
Absorption After subcutaneous injection, soluble and stable multi-hexamers are formed creating a depot of insulin in the subcutaneous tissue. Insulin degludec monomers gradually separate from the multi-hexamers ...
Preclinical safety data
Non-clinical data reveal no safety concerns for humans based on studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction. The ratio of mitogenic relative ...
List of excipients
Glycerol Metacresol Phenol Zinc acetate Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
This medicinal product must not be mixed with any other medicinal products. Substances added to Tresiba may cause degradation of insulin degludec. Tresiba must not be added to infusion fluids.
Shelf life
30 months. Tresiba 100 units/mL solution for injection in pre-filled pen: After first opening or carried as a spare, the medicinal product may be stored for a maximum of 8 weeks. Do not store above 30°C. ...
Special precautions for storage
Tresiba 100 units/mL solution for injection in pre-filled pen Before first use: Store in a refrigerator (2°C–8°C). Do not freeze. Keep away from the freezing element. Keep the cap on the pen in order to ...
Nature and contents of container
Tresiba 100 units/mL solution for injection in pre-filled pen: 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a ...
Special precautions for disposal and other handling
This medicinal product is for use by one person only. It must not be refilled. Tresiba must not be used if the solution does not appear clear and colourless. Tresiba which has been frozen must not be used. ...
Marketing authorization holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Marketing authorization number(s)
Tresiba 100 units/mL solution for injection in pre-filled pen: EU/1/12/807/001 EU/1/12/807/002 EU/1/12/807/003 EU/1/12/807/004 EU/1/12/807/005 Tresiba 200 units/mL solution for injection in pre-filled ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 January 2013 Date of latest renewal: 21 September 2017
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