DUFORZIG Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
DUFORZIG 5 (Tablet). DUFORZIG 10 (Tablet).
2. Qualitative and quantitative composition
<u>DUFORZIG 5:</u> Each tablet contains the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol. Contains sugar: 25 mg lactose anhydrous per 5 mg tablet <u>DUFORZIG 10:</u> Each tablet contains ...
3. Pharmaceutical form
Tablets. <u>DUFORZIG 5:</u> Yellow, biconvex, 0.7 cm diameter round, film-coated tablet with 5 debossed on one side and 1427 debossed on the other side. <u>DUFORZIG 10:</u> Yellow, biconvex, approximately ...
4.1. Therapeutic indications
Type 2 diabetes mellitus DUFORZIG is indicated in adults aged 18 years and older with type 2 diabetes mellitus: as monotherapy as an adjunct to diet and exercise to improve glycaemic control as add-on ...
4.2. Posology and method of administration
Type 2 diabetes mellitus Monotherapy and add-on combination therapy The recommended dose is 10 mg DUFORZIG once daily for monotherapy and add-on combination therapy with other glucose-lowering medicines, ...
4.3. Contraindications
Hypersensitivity to dapaglifozin or to any of the excipients of DUFORZIG. Moderate and severe renal impairment with GFR <45 mL/min/1,73 m², end stage renal failure or patients on dialysis when used for ...
4.4. Special warnings and precautions for use
General DUFORZIG may cause a decrease in systolic blood pressure and diastolic blood pressure. DUFORZIG should not be used for the treatment of diabetic ketoacidosis. Metabolic acidosis including ketoacidosis ...
4.5. Interaction with other medicinal products and other forms of interaction
The metabolism of dapagliflozin is primarily mediated by UGT1A9- dependent glucuronide conjugation. The major metabolite, dapagliflozin 3-O-glucuronide, is not an SGLT2 inhibitor. In in-vitro studies, ...
4.6. Fertility, pregnancy and lactation
Pregnancy DUFORZIG is contraindicated in pregnancy. Maternal exposure to DUFORZIG in rat studies was associated with increased incidence and/or severity of renal pelvic and tubular dilatations in progeny. ...
4.7. Effects on ability to drive and use machines
Patients must bear in mind the possibility of hypoglycaemia and its effects on their motor skills.
4.8. Undesirable effects
a. Summary of the safety profile More than 28000 patients with type 2 diabetes and heart failure were randomised, including 15000 patients treated for type 2 diabetes and more than 2000 subjects treated ...
4.9. Overdose
In overdose, side effects may be elicited or exacerbated. Appropriate symptomatic and supportive treatment should be initiated as dictated by the patients clinical status. The removal of DUFORZIG by haemodialysis ...
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A 21.2 Oral hypoglycaemics Mechanism of action Dapagliflozin is a reversible inhibitor of sodium glucose co-transporter 2 (SGLT2) that improves glycaemic control ...
5.2. Pharmacokinetic properties
Absorption Dapagliflozin was absorbed after oral administration and can be administered with or without food. Maximum dapagliflozin plasma concentrations (C<sub>max</sub>) were usually attained within ...
6.1. List of excipients
<u>Tablet core:</u> Crospovidone Lactose anhydrous Magnesium stearate Microcrystalline cellulose Silicon dioxide <u>Film-coating:</u> Hydrolysed polyvinyl alcohol Titanium dioxide Polyethylene glycol ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 months Bristol-Myers Squibb. 36 Months AstraZeneca Pharmaceuticals.
6.4. Special precautions for storage
Store at or below 30°C. This medicine does not require any special storage conditions.
6.5. Nature and contents of container
Silver aluminium/aluminium foil blister packs of 14, 28, 30, 90 and 98 tablets packed in a carton. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
7. Marketing authorization holder
AstraZeneca Pharmaceuticals (Pty) Limited, Building 2, Northdowns Office Park, 17 Georgian Crescent West, Bryanston, Johannesburg 2191
9. Date of first authorization / renewal of the authorization
29 March 2022
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