NOVOMIX 50 Suspension for injection (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
NovoMix 50 Penfill 100 units/ml suspension for injection in cartridge. NovoMix 50 FlexPen 100 units/ml suspension for injection in pre-filled pen.
2. Qualitative and quantitative composition
<u>NovoMix 50 Penfill:</u> 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 50/50 (equivalent to 3.5 mg). 1 cartridge contains 3 ml ...
3. Pharmaceutical form
Suspension for injection. The suspension is cloudy, white and aqueous.
4.1. Therapeutic indications
NovoMix 50 is indicated for treatment of diabetes mellitus in adults.
4.2. 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. NovoMix 50 dosing is individual and ...
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
NovoMix 50 must not be administered intravenously, as it may result in severe hypoglycaemia. Intramuscular administration should be avoided. NovoMix 50 is not to be used in insulin infusion pumps. Before ...
4.5. 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 ...
4.6. Fertility, pregnancy and lactation
Pregnancy There is limited clinical experience with NovoMix 50 in pregnancy. Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity ...
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 Adverse reactions observed in patients using NovoMix are mainly due to the pharmacological effect of insulin aspart. The most frequently reported adverse reaction during treatment ...
4.9. 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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes. Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting <b>ATC code:</b> A10AD05 NovoMix 50 is a biphasic ...
5.2. Pharmacokinetic properties
Absorption, distribution and elimination In insulin aspart, substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers as observed with soluble human insulin. ...
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 and toxicity to reproduction and development. In <em>in ...
6.1. List of excipients
Glycerol Phenol Metacresol Zinc chloride Disodium phosphate dihydrate Sodium chloride Protamine sulfate Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections ...
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
<u>Before opening:</u> 2 years. <u>During use or when carried as a spare:</u> The product can be stored for a maximum of 4 weeks.
6.4. Special precautions for storage
<u>Before opening:</u> Store in a refrigerator (2°C–8°C). Keep away from the cooling element. Do not freeze. <u>NovoMix 50 Penfill:</u> During use or when carried as a spare: Store below 30°C. Do not refrigerate. ...
6.5. Nature and contents of container
<u>NovoMix 50 Penfill:</u> 3 ml suspension in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene). The cartridge contains a glass ball to facilitate resuspension. ...
6.6. Special precautions for disposal and other handling
After removing NovoMix 50 Penfill or NovoMix 50 FlexPen from the refrigerator, it is recommended to allow NovoMix 50 Penfill or NovoMix 50 FlexPen to reach room temperature before resuspending the insulin ...
7. Marketing authorization holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
8. Marketing authorization number(s)
<u>NovoMix 50 Penfill:</u> EU/1/00/142/011 EU/1/00/142/012 EU/1/00/142/013 <u>NovoMix 50 FlexPen:</u> EU/1/00/142/014 EU/1/00/142/015 EU/1/00/142/016
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 1 August 2000 Date of last renewal: 2 July 2010
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
