REPAGLINIDE ARROW
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
14-06-2024
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Ingredient activ:
REPAGLINIDE
Disponibil de la:
Arrow ApS
Dozare:
2 Milligram
Forma farmaceutică:
Tablets
Data de autorizare:
2009-09-18
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Repaglinide Arrow 2mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg of repaglinide
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Pink round convex tablets with 'R2' on one side and '>' on the other side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Repaglinide is indicated in patients with type 2 diabetes (Non Insulin-Dependent Diabetes Mellitus (NIDDM)) whose
hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also
indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin
alone.
Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Repaglinide is given preprandially and is titrated individually to optimise glycaemic control. In addition to the usual
self-monitoring by the patient of blood and/or urinary glucose, the patient’s blood glucose must be monitored
periodically by the physician to determine the minimum effective dose for the patient. Glycosylated haemoglobin levels
are also of value in monitoring the patient’s response to therapy. Periodic monitoring is necessary to detect inadequate
lowering of blood glucose at the recommended maximum dose level (i.e. primary failure) and to detect loss of adequate
blood glucose-lowering response after an initial period of effectiveness (i.e. secondary failure).
Short-term administration of repaglinide may be sufficient during periods of transient loss of control in type 2 diabetic
patients usually controlled well on diet.
Repaglinide should be taken before main meals (i.e. prepra
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