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SPC: VELPHORO Chewable tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Velphoro 500 mg chewable tablets.

Qualitative and quantitative composition

Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches. The active ingredient sucroferric oxyhydroxide ...

Pharmaceutical form

Chewable tablet. Brown, circular tablets embossed with PA500 on one side. Tablets have a 20 mm diameter and a thickness of 6.5 mm.

Therapeutic indications

Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). Velphoro should be used within the context ...

Posology and method of administration

Posology Starting dose The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets) per day, divided across the meals of the day. Velphoro is for oral administration only and must be taken with ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Haemochromatosis and any other iron accumulation disorders.

Special warnings and precautions for use

Peritonitis, gastric and hepatic disorders and gastrointestinal surgery Patients with a recent history of peritonitis (within the last 3 months), significant gastric or hepatic disorders and patients with ...

Interaction with other medicinal products and other forms of interaction

Velphoro is almost not absorbed from the gastrointestinal tract. Although the potential for interactions with medicinal products seems low, for concomitant treatment with medicinal products with a narrow ...

Fertility, pregnancy and lactation

Pregnancy There are no available clinical data from the use of sucroferric oxyhydroxide on exposed human pregnancies. Reproductive and developmental toxicity studies in animals revealed no risk with respect ...

Effects on ability to drive and use machines

Velphoro has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The current safety profile of Velphoro is based on a total of 778 patients on haemodialysis and 57 patients on peritoneal dialysis, who received Velphoro treatment of up to ...

Overdose

Any instances of overdose of Velphoro (e.g. hypophosphataemia) should be treated by standard clinical practice.

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia ATC code: V03AE05 Mechanism of action Velphoro contains a mixture of polynuclear iron(III)-oxyhydroxide (pn-FeOOH), ...

Pharmacokinetic properties

Velphoro works by binding phosphate in the gastrointestinal tract and thus the serum concentration is not relevant for its efficacy. Due to the insolubility and degradation characteristics of Velphoro, ...

Preclinical safety data

Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Effects seen in the rabbit embryo-foetal development ...

List of excipients

Woodberry flavour Neohesperidin-dihydrochalcone Magnesium stearate Colloidal anhydrous silica

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years. Shelf life after first opening of the bottle: 90 days.

Special precautions for storage

Store in the original package in order to protect from moisture.

Nature and contents of container

High density polyethylene (HDPE) bottle with child-resistant polypropylene closure and foil induction seal, containing a molecular sieve desiccant and cotton. Pack sizes of 30 or 90 chewable tablets. ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042, Paris la Défense Cedex, France

Marketing authorization number(s)

EU/1/14/943/001 EU/1/14/943/002 EU/1/14/943/003 EU/1/14/943/004

Date of first authorization / renewal of the authorization

Date of first authorisation: 26 August 2014

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