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SPC: HUMALOG 100 units/ml Solution for injection in vial / cartridge / KwikPen - Junior KwikPen pre-filled pen (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Humalog 100 units/ml, solution for injection in vial. Humalog 100 units/ml, solution for injection in cartridge. Humalog 100 units/ml KwikPen, solution for injection in a pre-filled pen. Humalog 100 units/ml ...

Qualitative and quantitative composition

Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg). Vial: Each vial contains 1000 units insulin lispro in 10 ml solution. Cartridge: Each cartridge contains 300 units of insulin lispro ...

Pharmaceutical form

Solution for injection. Clear, colourless, aqueous solution.

Therapeutic indications

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes ...

Posology and method of administration

Posology The dosage should be determined by the physician, according to the requirement of the patient. Junior KwikPen Humalog 100 units/ml Junior KwikPen is suitable for patients who may benefit from ...

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 Dibasic sodium phosphate 7H<sub>2</sub>O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide maybe used to adjust pH

Incompatibilities

Cartridge, KwikPen and Junior KwikPen These medicinal products should not be mixed with any other insulin or any other medicinal product. Vial This medicinal product must not be mixed with other medicinal ...

Shelf life

Shelf life Before use: 3 years. After first use/after cartridge insertion: 28 days.

Special precautions for storage

Do not freeze. Do not expose to excessive heat or direct sunlight. Before use: Store in a refrigerator (2°C-8°C). After first use/after cartridge insertion: Vial: Store in a refrigerator (2°C-8°C) or below ...

Nature and contents of container

Vial The solution is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the vial stoppers. ...

Special precautions for disposal and other handling

Instructions for use and handling To prevent the possible transmission of disease, each cartridge or pen must be used by one patient only, even if the needle on the delivery device is changed. Patients ...

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands

Marketing authorization number(s)

EU/1/96/007/002 EU/1/96/007/004 EU/1/96/007/020 EU/1/96/007/021 EU/1/96/007/023 EU/1/96/007/031 EU/1/96/007/032 EU/1/96/007/043 EU/1/96/007/044 EU/1/96/007/045

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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