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SPC: INVOKANA Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Invokana 100 mg film-coated tablets. Invokana 300 mg film-coated tablets.

Qualitative and quantitative composition

Invokana 100 mg film-coated tablets: Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin. Excipient(s) with known effect: Each tablet contains 39.2 mg lactose. Each tablet ...

Pharmaceutical form

Film-coated tablet (tablet). Invokana 100 mg film-coated tablets: The tablet is yellow, capsule-shaped, approximately 11 mm in length, immediate-release and film-coated, with CFZ on one side and 100 on ...

Therapeutic indications

Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due ...

Posology and method of administration

Posology The recommended starting dose of canagliflozin is 100 mg once daily. In patients tolerating canagliflozin 100 mg once daily who have an estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Renal impairment The efficacy of canagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions Diuretics Canagliflozin may add to the effect of diuretics and may increase the risk of dehydration and hypotension (see section 4.4). Insulin and insulin secretagogues Insulin ...

Pregnancy and lactation

Pregnancy There are no data from the use of canagliflozin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Canagliflozin should not be used during pregnancy. When ...

Effects on ability to drive and use machines

Canagliflozin has no or negligible influence on the ability to drive and use machines. However, patients should be alerted to the risk of hypoglycaemia when canagliflozin is used as add-on therapy with ...

Undesirable effects

Summary of the safety profile The safety of canagliflozin was evaluated in 18,248 patients with type 2 diabetes, including 11,078 patients treated with canagliflozin and 7,170 patients treated with comparator ...

Overdose

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. Therapy In the event of ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excluding insulins ATC code: A10BK02 Mechanism of action The SGLT2 transporter, expressed in the proximal renal tubules, ...

Pharmacokinetic properties

The pharmacokinetics of canagliflozin are essentially similar in healthy subjects and patients with type 2 diabetes. After single-dose oral administration of 100 mg and 300 mg in healthy subjects, canagliflozin ...

Preclinical safety data

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 and early ...

List of excipients

Tablet core: Lactose Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Film-coating: Invokana 100 mg film-coated tablets: Poly (vinylalcohol) Titanium dioxide (E171) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Polyvinyl chloride/Aluminum (PVC/Alu) perforated unit dose blister. Pack sizes of 10 1, 30 1, 90 1, and 100 1 film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization number(s)

Invokana 100 mg film-coated tablets: EU/1/13/884/001 (10 film-coated tablets) EU/1/13/884/002 (30 film-coated tablets) EU/1/13/884/003 (90 film-coated tablets) EU/1/13/884/004 (100 film-coated tablets) ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 15 November 2013 Date of latest renewal: 26 July 2018

Πηγαίο έγγραφο

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