VOKANAMET Film-coated tablet (2023)
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
Vokanamet 50 mg/850 mg film-coated tablets. Vokanamet 50 mg/1,000 mg film-coated tablets. Vokanamet 150 mg/850 mg film-coated tablets. Vokanamet 150 mg/1,000 mg film-coated tablets.
2. Qualitative and quantitative composition
<u>Vokanamet 50 mg/850 mg film-coated tablets:</u> Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 850 mg of metformin hydrochloride. <u>Vokanamet 50 mg/1,000 ...
3. Pharmaceutical form
Film-coated tablet. <u>Vokanamet 50 mg/850 mg film-coated tablets:</u> The tablet is pink, capsule-shaped, 20 mm in length, film-coated, and debossed with CM on one side and 358 on the other side. <u> ...
4.1. Therapeutic indications
Vokanamet is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise: in patients insufficiently controlled on their maximally tolerated doses of metformin alone in combination ...
4.2. Posology and method of administration
Posology Adults with normal renal function (estimated glomerular filtration rate [eGFR] ≥90 mL/min/1.73 m²) The dose of glucose-lowering therapy with Vokanamet should be individualised on the basis of ...
4.3. Contraindications
Hypersensitivity to the active substances or any of the excipients listed in section 6.1; Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis); Diabetic pre-coma; Severe ...
4.4. Special warnings and precautions for use
Lactic acidosis Lactic acidosis, a very rare but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis. Metformin accumulation occurs ...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacokinetic drug interaction studies with Vokanamet have not been performed; however, such studies have been conducted with the individual active substances (canagliflozin and metformin). Co-administration ...
4.6. Pregnancy and lactation
Pregnancy There are no data from the use of canagliflozin alone or Vokanamet in pregnant women. Studies in animals with canagliflozin have shown reproductive toxicity (see section 5.3). A limited amount ...
4.7. Effects on ability to drive and use machines
Vokanamet has no or negligible influence on the ability to drive and use machines. However, patients should be alerted to the risk of hypoglycaemia when Vokanamet is used as add-on therapy with insulin ...
4.8. Undesirable effects
Canagliflozin Summary of the safety profile The safety of canagliflozin was evaluated in 22,645 patients with type 2 diabetes, including the evaluation of canagliflozin in combination with metformin in ...
4.9. Overdose
Canagliflozin Single doses up to 1,600 mg of canagliflozin in healthy subjects and canagliflozin 300 mg twice daily for 12 weeks in patients with type 2 diabetes were generally well-tolerated. Metformin ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, combinations of blood glucose lowering drugs <b>ATC code:</b> A10BD16 Mechanism of action Vokanamet combines two oral glucose-lowering medicinal ...
5.2. Pharmacokinetic properties
Vokanamet Bioequivalence studies in healthy subjects demonstrated that Vokanamet 50 mg/850 mg, 50 mg/1,000 mg, 150 mg/850 mg, and 150 mg/1,000 mg combination tablets are bioequivalent to co-administration ...
5.3. Preclinical safety data
Canagliflozin Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity. Canagliflozin showed no effects on fertility ...
6.1. List of excipients
<u>Tablet core:</u> Microcrystalline cellulose Hypromellose Croscarmellose sodium Magnesium stearate <u>Film-coating:</u> <em>Vokanamet 50 mg/850 mg film-coated tablets:</em> Macrogol (3350) Poly(vinyl ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
HDPE bottle with child-resistant closure, induction seal, and desiccant. The bottles contain 20 or 60 film-coated tablets. <u>Pack sizes:</u> 1 20 film-coated tablets 1 60 film-coated tablets Multipack ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
8. Marketing authorization number(s)
<u>Vokanamet 50 mg/850 mg film-coated tablets:</u> EU/1/14/918/001 (20 film-coated tablets) EU/1/14/918/002 (60 film-coated tablets) EU/1/14/918/003 (180 film-coated tablets) <u>Vokanamet 50 mg/1,000 mg ...
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 23 April 2014 Date of latest renewal: 18 December 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: