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SPC: ACTRAPID Solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Actrapid 40 international units/ml solution for injection in vial. Actrapid 100 international units/ml solution for injection in vial. Actrapid Penfill 100 international units/ml solution for injection ...

Qualitative and quantitative composition

Actrapid vial (40 international units/ml): 1 vial contains 10 ml equivalent to 400 international units. 1 ml solution contains 40 international units insulin human* (equivalent to 1.4 mg). Actrapid vial ...

Pharmaceutical form

Solution for injection. The solution is clear, colourless and aqueous.

Therapeutic indications

Actrapid is indicated for treatment of diabetes mellitus.

Posology and method of administration

Posology The potency of human insulin is expressed in international units. Actrapid dosing is individual and determined in accordance with the needs of the patient. It can be used alone or in combination ...

Contraindications

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

Special warnings and precautions for use

Before travelling between different time zones, the patient should seek the doctors advice since this may mean that the patient has to take the insulin and meals at different times. Hyperglycaemia Inadequate ...

Interaction with other medicinal products and other forms of interaction

A number of medicinal products are known to interact with glucose metabolism. The following substances may reduce the patients insulin requirement: Oral antidiabetic medicinal products, monoamine oxidase ...

Fertility, pregnancy and lactation

Pregnancy There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier. Both hypoglycaemia and hyperglycaemia, which can occur in inadequately ...

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 the safety profile The most frequently reported adverse reaction during treatment is hypoglycaemia. The frequencies of hypoglycaemia vary with patient population, dose regimens and level of ...

Overdose

A specific overdose of insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high a dose relative to the patients requirement is administered: Mild hypoglycaemic episodes ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, fast-acting, insulin (human) ATC code: A10AB01 Mechanism of action and pharmacodynamic effects The blood glucose ...

Pharmacokinetic properties

Insulin in the blood stream has a half-life of a few minutes. Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. This process is influenced ...

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. ...

List of excipients

Zinc chloride Glycerol Metacresol Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections

Incompatibilities

Insulin medicinal products should only be added to compounds with which it is known to be compatible. Medicinal products added to the insulin solution may cause degradation of the insulin, e.g. if the ...

Shelf life

Shelf life Before opening: 30 months. Actrapid vial (40 international units/ml): During use or when carried as a spare: The product can be stored for a maximum of 4 weeks. Store below 25°C. Actrapid vial ...

Special precautions for storage

Before opening: Store in a refrigerator (2°C-8°C). Do not freeze. Actrapid vial (40 international units/ml)/Actrapid vial (100 international units/ml) During use or when carried as a spare: Store below ...

Nature and contents of container

Actrapid vial (40 international units/ml)/Actrapid vial (100 international units/ml): Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing ...

Special precautions for disposal and other handling

Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous. Actrapid which has been frozen must not be used. The patient should be advised to discard the needle ...

Marketing authorization holder

Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark

Marketing authorization number(s)

Actrapid vial (40 international units/ml): EU/1/02/230/001 EU/1/02/230/002 EU/1/02/230/016 Actrapid vial (100 international units/ml): EU/1/02/230/003 EU/1/02/230/004 EU/1/02/230/017 Actrapid Penfill: ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 07 October 2002 Date of latest renewal: 18 September 2007

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