ACTRAPHANE 30 Suspension for injection (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Actraphane 30 40 international units/ml suspension for injection in vial. Actraphane 30 100 international units/ml suspension for injection in vial. Actraphane 30 Penfill 100 international units/ml suspension ...

2. Qualitative and quantitative composition

Actraphane 30 vial (40 international units/ml): 1 vial contains 10 ml equivalent to 400 international units. 1 ml suspension contains 40 international units soluble insulin human*/isophane (NPH) ...

3. Pharmaceutical form

Suspension for injection. The suspension is cloudy, white and aqueous.

4.1. Therapeutic indications

Actraphane is indicated for treatment of diabetes mellitus.

4.2. Posology and method of administration

Posology The potency of human insulin is expressed in international units. Actraphane dosing is individual and determined in accordance with the needs of the patient. Premixed insulin medicinal products ...

4.3. Contraindications

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

4.4. 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 ...

4.5. 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 ...

4.6. 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 ...

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 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 ...

4.9. 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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting, insulin (human) ATC code: A10AD01 Mechanism ...

5.2. 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 ...

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

Zinc chloride Glycerol Metacresol Phenol Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Protamine sulfate Water for injections

6.2. Incompatibilities

Insulin medicinal products should only be added to compounds with which it is known to be compatible. Insulin suspensions should not be added to infusion fluids.

6.3. Shelf life

Before opening: 30 months. Actraphane 30 vial (40 international units/ml)/Actraphane 30 vial (100 international units/ml): During use or when carried as a spare: The product can be stored for a ...

6.4. Special precautions for storage

Before opening: Store in a refrigerator (2°C–8°C). Do not freeze. Actraphane 30 vial (40 international units/ml)/Actraphane 30 vial (100 international units/ml): During use or when carried as a ...

6.5. Nature and contents of container

Actraphane 30 vial (40 international units/ml)/Actraphane 30 vial (100 international units/ml): Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof ...

6.6. Special precautions for disposal and other handling

After removing Actraphane vial, cartridge or pre-filled pen from the refrigerator, it is recommended to allow the Actraphane vial, cartridge or pre-filled pen to reach room temperature before resuspending ...

7. Marketing authorization holder

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

8. Marketing authorization number(s)

Actraphane 30 vial (40 international units/ml): EU/1/02/229/001 EU/1/02/229/002 EU/1/02/229/036 Actraphane 30 vial (100 international units/ml): EU/1/02/229/003 EU/1/02/229/004 EU/1/02/229/037 ...

9. 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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