MINODIAB Tablet (2016)
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
Minodiab 5 mg Tablets.
2. Qualitative and quantitative composition
5 mg Glipizide. <u>Excipient with known effect:</u> Each tablet contains 153 mg lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White biconvex tablets scored on both sides. The score line is not intended for breaking the tablet.
4.1. Therapeutic indications
Glipizide is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
4.2. Posology and method of administration
Posology As for any hypoglycaemic agent, dosage must be adapted for each individual case. Short term administration of glipizide may be sufficient during periods of transient loss of control in patients ...
4.3. Contraindications
Hypersensitivity to glipizide, other sulfonylureas or sulfonamides, or to any of the excipients listed in section 6.1. Insulin-dependent diabetes mellitus, diabetic ketoacidosis, diabetic coma. Severe ...
4.4. Special warnings and precautions for use
Glucose-6-phosphate dehydrogenase deficiency Since glipizide belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency. Treatment of patients with G6PD deficiency ...
4.5. Interaction with other medicinal products and other forms of interaction
The following products are likely to increase the hypoglycaemic effect: <b>Contraindicated combinations:</b> <u>Miconazole:</u> Increase in hypoglycaemic effect, possibly leading to symptoms of hypoglycaemia ...
4.6. Pregnancy and lactation
Pregnancy Glipizide is contraindicated in pregnancy. Glipizide was found to be mildly fetotoxic in rat reproductive studies. No teratogenic effects were found in rat or rabbit studies. Prolonged severe ...
4.7. Effects on ability to drive and use machines
The effect of glipizide on the ability to drive or operate machines has not been studied; however, there is no evidence to suggest that glipizide may affect these abilities. Patients should be aware of ...
4.8. Undesirable effects
The majority of side effects have been dose related, transient, and have responded to dose reduction or withdrawal of the medication. However, clinical experience thus far has shown that, as with other ...
4.9. Overdose
There is no well documented experience with glipizide overdosage. Overdosage of sulfonylureas including glipizide can produce glycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, blood glucose lowering drugs excl. insulins, sulfonylureas <b>ATC code:</b> A10BB07 Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea ...
5.2. Pharmacokinetic properties
Absorption Gastrointestinal absorption of glipizide in humans is uniform, rapid and essentially complete. Peak plasma concentrations occur 1 to 3 hours after a single oral dose. The half-life of elimination ...
5.3. Preclinical safety data
Acute toxicity studies showed no specific susceptibility. The acute oral toxicity of glipizide was extremely low in all species tested (LD50 greater than 4 g/kg). Chronic toxicity tests in rats and dogs ...
6.1. List of excipients
Microcrystalline cellulose Starch Stearic acid Lactose
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Blister strips containing 28 or 60 tablets in a carton. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
8. Marketing authorization number(s)
PL 00057/1016
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 4<sup>th</sup> September 2012 Date of latest renewal: 5<sup>th</sup> April 2002
10. Date of revision of the text
08/2016
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
