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RENVELA Powder for oral suspension (2023)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Renvela 2.4 g powder for oral suspension.

Qualitative and quantitative composition

Each sachet contains 2.4 g sevelamer carbonate. <u>Excipient with known effect:</u> This medicine contains 25.27 mg propylene glycol alginate (E405) in each 2.4 g sachet. For the full list of excipients, ...

Pharmaceutical form

Powder for oral suspension. Pale yellow powder.

Therapeutic indications

Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renvela is also indicated for the control of hyperphosphataemia in adult patients ...

Posology and method of administration

Posology Starting dose Adults The recommended starting dose of sevelamer carbonate for adults is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level. Renvela must be taken three times ...

Contraindications

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

Special warnings and precautions for use

The safety and efficacy of sevelamer carbonate have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l. Therefore it is currently not ...

Interaction with other medicinal products and other forms of interaction

Dialysis Interaction studies have not been conducted in patients on dialysis. Ciprofloxacin In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety ...

Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of sevelamer in pregnant women. Animal studies have shown some reproductive toxicity when sevelamer was administered to rats at high doses ...

Effects on ability to drive and use machines

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

Undesirable effects

Summary of the safety profile The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class. Most of these adverse reactions were mild ...

Overdose

Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse reactions. ...

Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> All other therapeutic products, drugs for treatment of hyperkalemia and hyperphosphataemia <b>ATC code:</b> V03AE02 Mechanism of action Renvela contains sevelamer, a non-absorbed ...

Pharmacokinetic properties

Pharmacokinetic studies have not been carried out with sevelamer carbonate. Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, is not absorbed from the gastrointestinal ...

Preclinical safety data

Non-clinical data with sevelamer reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity. Carcinogenicity studies with oral sevelamer ...

List of excipients

Propylene glycol alginate (E405) Citrus cream flavour Sodium chloride Sucralose Iron oxide yellow (E172)

Incompatibilities

Not applicable.

Shelf life

3 years. After reconstitution: The oral suspension must be administered within 30 minutes. The sachet has to be discarded after 24 hours of opening

Special precautions for storage

The medicinal product does not require any special storage conditions.

Nature and contents of container

Sachet of ethylene methacrylic acid copolymer, polyester, LDPE and aluminium foil laminate, with a heat seal. Each sachet contains 2.4 g of sevelamer carbonate. Each carton contains 60 or 90 sachets. ...

Special precautions for disposal and other handling

The powder should be dispersed in 60 mL of water per sachet prior to administration. The suspension powder is pale yellow with a citrus flavour. The powder may also be pre-mixed with cold beverage or unheated ...

Marketing authorization holder

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Marketing authorization number(s)

EU/1/09/521/006 EU/1/09/521/007

Date of first authorization / renewal of the authorization

Date of first authorisation: 10 June 2009 Date of latest renewal: 20 February 2019

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