NOVORAPID Solution for injection in vial / Cartridge / Pre-filled pen (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
NovoRapid 100 units/ml solution for injection in vial. NovoRapid Penfill 100 units/ml solution for injection in cartridge. NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen. NovoRapid ...
Qualitative and quantitative composition
NovoRapid vial: 1 vial contains 10 ml equivalent to 1,000 units. 1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). NovoRapid Penfill: 1 cartridge contains 3 ml equivalent to 300 ...
Pharmaceutical form
Solution for injection. The solution is clear, colourless and aqueous.
Therapeutic indications
NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Posology and method of administration
Posology The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units. NovoRapid dosing is individual and ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients (see 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. NovoRapid PumpCart ...
Interaction with other medicinal products and other forms of interaction
A number of medicinal products are known to interact with the glucose metabolism. The following substances may reduce the patients insulin requirements: Oral antidiabetic medicinal products, monoamine ...
Fertility, pregnancy and lactation
Pregnancy NovoRapid (insulin aspart) can be used in pregnancy. Data from two randomised controlled clinical trials (322 and 27 exposed pregnancies) do not indicate any adverse effect of insulin aspart ...
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 Adverse reactions observed in patients using NovoRapid are mainly due to the pharmacologic effect of insulin. The most frequently reported adverse reaction during treatment ...
Overdose
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patients requirement are administered: Mild hypoglycaemic ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, fast-acting ATC code: A10AB05 Mechanism of action and pharmacodynamic effects The blood glucose lowering effect ...
Pharmacokinetic properties
Absorption, distribution and elimination In NovoRapid substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers as observed with soluble human insulin. ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. In in vitro ...
List of excipients
Glycerol Phenol Metacresol Zinc chloride Disodium phosphate dihydrate Sodium chloride Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
Substances added to NovoRapid may cause degradation of insulin aspart. This medicinal product must not be diluted or mixed with other medicinal products except for mixing with NPH (Neutral Protamine Hagedorn) ...
Shelf life
<u>Before opening:</u> 30 months. <u>NovoRapid vial/NovoRapid Penfill/NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch:</u> During use or when carried as a spare: The product must be stored for ...
Special precautions for storage
For storage conditions of the medicinal product, see section 6.3. <u>Before opening:</u> Store in a refrigerator (2°C-8°C). Do not freeze. NovoRapid vial/NovoRapid Penfill <u>During use or when carried ...
Nature and contents of container
NovoRapid vial: 10 ml solution in vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap. Pack sizes of 1 or 5 vials of 10 ml or a multipack 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. NovoRapid 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)
<u>NovoRapid vial:</u> EU/1/99/119/001 EU/1/99/119/008 EU/1/99/119/015 <u>NovoRapid Penfill:</u> EU/1/99/119/003 EU/1/99/119/006 <u>NovoRapid FlexPen:</u> EU/1/99/119/009 EU/1/99/119/010 EU/1/99/119/011 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 7 September 1999 Date of last renewal: 30 April 2009
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