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APIDRA Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Apidra 100 Units/ml solution for injection in a vial. Apidra 100 Units/ml solution for injection in a cartridge. Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen.

Qualitative and quantitative composition

Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg). Apidra 100 Units/ml solution for injection in a vial: Each vial contains 10 ml of solution for injection, equivalent to 1000 Units. ...

Pharmaceutical form

Apidra 100 Units/ml solution for injection in a vial: Solution for injection in a vial. Apidra 100 Units/ml solution for injection in a cartridge: Solution for injection in a cartridge. Apidra SoloStar ...

Therapeutic indications

Treatment of adults, adolescents and children 6 years or older, with diabetes mellitus, where treatment with insulin is required.

Posology and method of administration

Posology The potency of this preparation is stated in units. These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues (see section ...

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 should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, neutral protamine Hagedorn [NPH], lente, ...

Interaction with other medicinal products and other forms of interaction

Studies on pharmacokinetic interactions have not been performed. Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur. A ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of insulin glulisine in pregnant women. Animal reproduction studies have not revealed any differences between ...

Effects on ability to drive and use machines

The patients ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment. This may constitute a risk in situations ...

Undesirable effects

Summary of the safety profile Hypoglycaemia, the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. Tabulated list of adverse ...

Overdose

Symptoms Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure. There are no specific data available concerning overdoses with insulin glulisine. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting ATC code: A10AB06 Mechanism of action Insulin glulisine is a recombinant human insulin analogue that ...

Pharmacokinetic properties

In insulin glulisine the replacement of the human insulin amino acid asparagine in position B3 by lysine and the lysine in position B29 by glutamic acid favours more rapid absorption. In a study with 18 ...

Preclinical safety data

Non-clinical data did not reveal toxicity findings others than those linked to the blood glucose lowering pharmacodynamic activity (hypoglycaemia), different from regular human insulin or of clinical relevance ...

List of excipients

Metacresol Sodium chloride Trometamol Polysorbate 20 Hydrochloric acid, concentrated Sodium hydroxide Water for injections

Incompatibilities

Apidra 100 Units/ml solution for injection in a vial Subcutaneous use In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except NPH human insulin. ...

Shelf life

Shelf life: 2 years. Apidra 100 Units/ml solution for injection in a vial Shelf life after first use of the vial: The product may be stored for a maximum of 4 weeks below 25°C away from direct heat or ...

Special precautions for storage

Apidra 100 Units/ml solution for injection in a vial Unopened vials: Store in a refrigerator (2°C-8°C). Do not freeze. Do not put Apidra next to the freezer compartment or a freezer pack. Keep the vial ...

Nature and contents of container

Apidra 100 Units/ml solution for injection in a vial: 10 ml solution in a vial (type I colourless glass) with a stopper (flanged aluminium overseal, elastomeric chlorobutyl rubber) and a polypropylene ...

Special precautions for disposal and other handling

Apidra 100 Units/ml solution for injection in a vial Subcutaneous use Apidra vials are for use with insulin syringes with the corresponding unit scale and for use with an insulin pump system (see section ...

Marketing authorization holder

Sanofi-Aventis Deutschland GmbH, D-65926, Frankfurt am Main, Germany

Marketing authorization number(s)

Apidra 100 Units/ml solution for injection in a vial: EU/1/04/285/001-004 Apidra 100 Units/ml solution for injection in a cartridge: EU/1/04/285/005-012 Apidra SoloStar 100 Units/ml solution for injection ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 27 September 2004 Date of latest renewal: 20 August 2009

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