HUMALOG 200 units/ml Solution for injection KwikPen pre-filled pen (2018)
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Περιεχόμενα
Name of the medicinal product
Humalog 200 units/ml KwikPen, solution for injection in a pre-filled pen.
Qualitative and quantitative composition
Each ml contains 200 units insulin lispro* (equivalent to 6.9 mg). Each pre-filled pen contains 600 units of insulin lispro in 3 ml solution. Each KwikPen delivers 1-60 units in steps of 1 unit. * produced ...
Pharmaceutical form
Solution for injection. Clear, colourless, aqueous solution.
Therapeutic indications
For the treatment of adults with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog 200 units/ml KwikPen is also indicated for the initial stabilisation of ...
Posology and method of administration
Posology The dosage should be determined by the physician, according to the requirement of the patient. Humalog may be given shortly before meals. When necessary Humalog can be given soon after meals. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypoglycaemia.
Special warnings and precautions for use
Transferring a patient to another type or brand of insulin Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), ...
Interaction with other medicinal products and other forms of interaction
Insulin requirements may be increased by medicinal products with hyperglycaemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta<sub>2</sub> stimulants ...
Fertility, pregnancy and lactation
Pregnancy Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/newborn. It is essential to maintain good control ...
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 safety profile Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in ...
Overdose
Insulins have no specific overdose definitions because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycaemia ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting ATC code: A10AB04 The primary activity of insulin lispro is the regulation of glucose metabolism. In ...
Pharmacokinetic properties
The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak blood levels 30 to 70 minutes following subcutaneous injection. When considering the clinical relevance ...
Preclinical safety data
In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro behaved in a manner that closely resembled human insulin. Studies also demonstrate that the dissociation ...
List of excipients
m-Cresol Glycerol Trometamol Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide may be used to adjust pH
Incompatibilities
This medicinal product should not be mixed with any other insulin or any other medicinal product. The solution for injection should not be diluted.
Shelf life
<u>Before use:</u> 3 years. <u>After first use:</u> 28 days.
Special precautions for storage
Do not freeze. Do not expose to excessive heat or direct sunlight. <u>Before use:</u> Store in a refrigerator (2°C-8°C). <u>After first use:</u> Store below 30°C. Do not refrigerate. The pre-filled pen ...
Nature and contents of container
Type I glass cartridges, sealed with halobutyl disc seals and plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the cartridge plunger, and/or the glass ...
Special precautions for disposal and other handling
Instructions for use and handling To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed. The patient should discard the needle after ...
Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands
Marketing authorization number(s)
EU/1/96/007/039 EU/1/96/007/040 EU/1/96/007/041 EU/1/96/007/042
Date of first authorization / renewal of the authorization
Date of first authorisation: 30<sup>th</sup> April 1996 Date of last renewal: 30<sup>th</sup> April 2006
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