LYUMJEV Solution for injection (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Lyumjev 100 units/mL solution for injection in vial. Lyumjev 100 units/mL solution for injection in cartridge. Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen. Lyumjev 100 units/mL ...

2. Qualitative and quantitative composition

Each mL contains 100 units of insulin lispro* (equivalent to 3.5 mg). Lyumjev 100 units/mL solution for injection in vial: Each vial contains 1000 units insulin lispro in 10 mL solution. Lyumjev ...

3. Pharmaceutical form

Solution for injection. Clear, colourless, aqueous solution.

4.1. Therapeutic indications

Treatment of diabetes mellitus in adults.

4.2. Posology and method of administration

Posology Lyumjev is a mealtime insulin for subcutaneous injection and should be administered zero to two minutes before the start of the meal, with the option to administer up to 20 minutes after starting ...

4.3. Contraindications

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

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Hypoglycaemia Hypoglycaemia ...

4.5. Interaction with other medicinal products and other forms of interaction

The following substances may reduce insulin requirement: Antidiabetic medicinal products (oral or injectable), salicylates, sulphonamides, certain antidepressants (monoamine oxidase inhibitors (MAOIs), ...

4.6. Pregnancy and lactation

Pregnancy A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no malformative nor feto/neonatal toxicity of insulin lispro. Lyumjev can be used during pregnancy if clinically ...

4.7. 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 ...

4.8. Undesirable effects

Summary of safety profile The most frequently reported adverse reaction during treatment is hypoglycaemia (very common) (see sections 4.2, 4.4 and 4.9). The following related adverse reactions from clinical ...

4.9. Overdose

Overdose causes hypoglycaemia with accompanying symptoms that include listlessness, confusion, palpitations, sweating, vomiting, and headache. Hypoglycaemia may occur as a result of an excess of insulin ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting ATC code: A10AB04 Mechanism of action The primary activity of Lyumjev is the regulation ...

5.2. Pharmacokinetic properties

Absorption Absorption of insulin lispro was accelerated and the duration of exposure was shorter in healthy subjects and patients with diabetes following injection of Lyumjev compared to Humalog. In patients ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development ...

6.1. List of excipients

Glycerol Magnesium chloride hexahydrate Metacresol Sodium citrate dihydrate Treprostinil sodium Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide (for pH adjustment)

6.2. Incompatibilities

This medicinal product must not be mixed with any other insulin or any other medicinal product except those mentioned in section 6.6.

6.3. Shelf life

Before use: 2 years. After first use: 28 days. Lyumjev 100 units/mL solution for injection in vial: When the vial is diluted for intravenous use: Chemical, physical in-use stability ...

6.4. Special precautions for storage

Before use Store in the refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light After first use Do not store above 30°C. Do not freeze. Lyumjev 100 units/mL ...

6.5. Nature and contents of container

Lyumjev 100 units/mL solution for injection in vial: Type I clear glass vials, sealed with halobutyl stoppers and secured with aluminium seals. 10 mL vial: Packs of 1 or 2 vials or 5 (5 packs of ...

6.6. Special precautions for disposal and other handling

Lyumjev should look clear and colourless. It should not be used if it is cloudy, coloured, or has particles or clumps in it. Lyumjev should not be used if it has been frozen. A new needle must always be ...

7. Marketing authorization holder

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

8. Marketing authorization number(s)

EU/1/20/1422/001 EU/1/20/1422/002 EU/1/20/1422/003 EU/1/20/1422/004 EU/1/20/1422/005 EU/1/20/1422/006 EU/1/20/1422/007 EU/1/20/1422/008 EU/1/20/1422/009 EU/1/20/1422/010 EU/1/20/1422/011 EU/1/20/1422/012 ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 24 March 2020

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