INSULATARD Suspension for injection (2020)
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Περιεχόμενα
1. Name of the medicinal product
Insulatard 40 international units/ml suspension for injection in vial. Insulatard 100 international units/ml suspension for injection in vial. Insulatard Penfill 100 international units/ml suspension for ...
2. Qualitative and quantitative composition
<u>Insulatard vial (40 international units/ml):</u> 1 vial contains 10 ml equivalent to 400 international units. 1 ml suspension contains 40 international units isophane (NPH) insulin human* (equivalent ...
3. Pharmaceutical form
Suspension for injection. The suspension is cloudy, white and aqueous.
4.1. Therapeutic indications
Insulatard 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. Insulatard dosing is individual and determined in accordance with the needs of the patient. The physician determines whether one ...
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 oxidase ...
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
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes. Insulins and analogues for injection, intermediate-acting, insulin (human) <b>ATC code:</b> A10AC01 Mechanism of action and pharmacodynamic effects ...
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. <u>Insulatard vial (40 international units/ml):</u> During use or when carried as a spare: The product can be stored for a maximum of 4 weeks. Store below 25°C. <u>Insulatard ...
6.4. Special precautions for storage
Before opening: Store in a refrigerator (2°C–8°C). Do not freeze. <u>Insulatard vial (40 international units/ml)/Insulatard vial (100 international units/ml):</u> During use or when carried as a spare: ...
6.5. Nature and contents of container
<u>Insulatard vial (40 international units/ml)/Insulatard vial (100 international units/ml):</u> Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic ...
6.6. Special precautions for disposal and other handling
After removing Insulatard vial, cartridge or pre-filled pen from the refrigerator, it is recommended to allow the Insulatard 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)
Insulatard vial (40 international units/ml): EU/1/02/233/001 EU/1/02/233/002 EU/1/02/233/016 Insulatard vial (100 international units/ml): EU/1/02/233/003 EU/1/02/233/004 EU/1/02/233/017 Insulatard Penfill: ...
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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