RENVELA Film-coated tablet (2023)
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Περιεχόμενα
Name of the medicinal product
Renvela 800 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 800 mg sevelamer carbonate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet (tablet). The white to off-white tablets are imprinted with RENVELA 800 on one side.
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 The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level. Renvela must be taken three times per day with ...
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 ...
Fertility, 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
<u>Tablet core:</u> Microcrystalline cellulose Sodium chloride Zinc stearate <u>Film-coating:</u> Hypromellose (E464) Diacetylated monoglycerides
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Keep the bottle tightly closed in order to protect from moisture. This medicinal product does not require any special temperature storage conditions.
Nature and contents of container
HDPE bottles with a polypropylene cap and a foil induction seal. Each bottle contains 30 tablets or 180 tablets. Packs of 1 bottle of 30 or 180 tablets (without outer carton) and a multipack containing ...
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
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/09/521/001 EU/1/09/521/002 EU/1/09/521/003
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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