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SPC: HUMALOG Mix50 100 units/ml Suspension for injection in cartridge / KwikPen pre-filled pen (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Humalog Mix50 100 units/ml, suspension for injection in cartridge. Humalog Mix50 100 units/ml KwikPen, suspension for injection in a pre-filled pen.

Qualitative and quantitative composition

Each ml contains 100 units insulin lispro* (equivalent to 3.5mg). Humalog Mix50 consists of 50% insulin lispro solution and 50% insulin lispro protamine suspension. Cartridge: Each cartridge contains 300 ...

Pharmaceutical form

Suspension for injection. White suspension.

Therapeutic indications

Humalog Mix50 is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.

Posology and method of administration

Posology The dosage should be determined by the physician, according to the requirement of the patient. Humalog Mix50 may be given shortly before meals. When necessary, Humalog Mix50 can be given soon ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Under no circumstances should Humalog Mix50 be given intravenously. Transferring a patient to another type or brand of insulin Transferring a patient to another type or brand of insulin should be done ...

Interaction with other medicinal products and other forms of interaction

Insulin requirements may be increased by substances with hyperglycaemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta<sub>2</sub> stimulants (such ...

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, intermediate or long acting combined with fast acting ATC Code: A10AD04 The primary activity of insulin lispro is ...

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. The pharmacokinetics of insulin lispro ...

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

Protamine sulphate m-Cresol Phenol Glycerol Dibasic sodium phosphate 7H<sub>2</sub>O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide may be used to adjust pH

Incompatibilities

Mixing Humalog Mix50 with other insulins has not been studied. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

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: Cartridge: Store below 30°C. Do not refrigerate. ...

Nature and contents of container

Cartridge The suspension is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may ...

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. The patient ...

Marketing authorization holder

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

Marketing authorization number(s)

EU/1/96/007/006 EU/1/96/007/025 EU/1/96/007/035 EU/1/96/007/036

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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