LEVEMIR Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Levemir Penfill 100 units/ml solution for injection in cartridge. Levemir FlexPen 100 units/ml solution for injection in pre-filled pen. Levemir InnoLet 100 units/ml solution for injection in pre-filled ...
Qualitative and quantitative composition
Levemir Penfill: 1 ml of the solution contains 100 units insulin detemir* (equivalent to 14.2 mg). 1 cartridge contains 3 ml equivalent to 300 units. Levemir FlexPen/Levemir InnoLet/Levemir FlexTouch: ...
Pharmaceutical form
Solution for injection. The solution is clear, colourless and aqueous.
Therapeutic indications
Levemir is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Posology and method of administration
Posology The potency of insulin analogues, including insulin detemir, is expressed in units, whereas the potency of human insulin is expressed in international units. 1 unit insulin detemir corresponds ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Special warnings and precautions for use
Before travelling between different time zones, the patient should seek the doctors advice since this may mean that the patient has to take the insulin and meals at different times. Hyperglycaemia Inadequate ...
Interaction with other medicinal products and other forms of interaction
A number of medicinal products are known to interact with the glucose metabolism. The following substances may reduce the patients insulin requirements: Oral antidiabetic medicinal products, GLP-1 receptor ...
Fertility, pregnancy and lactation
Pregnancy Treatment with Levemir can be considered during pregnancy, but any potential benefit must be weighed against a possibly increased risk of an adverse pregnancy outcome. In general, intensified ...
Effects on ability to drive and use machines
The patients ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car ...
Undesirable effects
Summary of the safety profile Adverse reactions observed in patients using Levemir are mainly due to the pharmacologic effect of insulin. The overall percentage of treated patients expected to experience ...
Overdose
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patients requirement are administered: Mild hypoglycaemic ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, long-acting ATC code: A10AE05 Mechanism of action and pharmacodynamic effects Levemir is a soluble, long-acting ...
Pharmacokinetic properties
Absorption Maximum serum concentration is reached between 6 and 8 hours after administration. When administered twice daily, steady state serum concentrations are reached after 2–3 dose administrations. ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. Receptor affinity ...
List of excipients
Glycerol Phenol Metacresol Zinc acetate Disodium phosphate dihydrate Sodium chloride Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
Substances added to Levemir may cause degradation of insulin detemir, e.g. if the medicinal product contains thiols or sulphites. Levemir should not be added to infusion fluids. This medicinal product ...
Shelf life
<u>Before opening:</u> 30 months. <u>During use or when carried as a spare:</u> The product can be stored for a maximum of 6 weeks.
Special precautions for storage
For storage conditions of the medicinal product, see section 6.3. <u>Before opening:</u> Store in a refrigerator (2°C–8°C). Keep away from the cooling element. Do not freeze. Levemir Penfill: During use ...
Nature and contents of container
Levemir Penfill: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene). Pack sizes of 1, 5 and 10 cartridges. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous. Levemir which has been frozen must not be used. The patient should be advised to discard the needle ...
Marketing authorization holder
Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark
Marketing authorization number(s)
<u>Levemir Penfill:</u> EU/1/04/278/001 EU/1/04/278/002 EU/1/04/278/003 <u>Levemir FlexPen:</u> EU/1/04/278/004 EU/1/04/278/005 EU/1/04/278/006 EU/1/04/278/010 EU/1/04/278/011 <u>Levemir InnoLet:</u> ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 June 2004 Date of last renewal: 16 April 2009
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