VELTASSA Powder for oral suspension (2019)
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Περιεχόμενα
Name of the medicinal product
Veltassa 8.4 g powder for oral suspension. Veltassa 16.8 g powder for oral suspension. Veltassa 25.2 g powder for oral suspension.
Qualitative and quantitative composition
Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium). Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium). Each sachet contains 25.2 g patiromer (as patiromer sorbitex ...
Pharmaceutical form
Powder for oral suspension. Off white to light brown powder, with occasional white particles.
Therapeutic indications
Veltassa is indicated for the treatment of hyperkalaemia in adults.
Posology and method of administration
Posology The recommended starting dose is 8.4 g patiromer once daily. The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Low Magnesium In clinical studies, serum magnesium values <1.4 mg/dL (0.58 mmol/L) occurred in 9% of patients treated with patiromer. Mean decreases in serum magnesium were 0.17 mg/dL (0.070 mmol/L) or ...
Interaction with other medicinal products and other forms of interaction
Effect of patiromer on other medicinal products Patiromer has the potential to bind some oral co administered medicinal products, which could decrease their gastrointestinal absorption. As patiromer is ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of patiromer in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a ...
Effects on ability to drive and use machines
Patiromer has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The majority of the adverse reactions (ARs) reported from trials were gastrointestinal disorders, with the most frequently reported ARs being constipation (6.2%), diarrhoea ...
Overdose
Since excessive doses of Veltassa may result in hypokalaemia, serum potassium levels should be monitored. Patiromer is excreted after approximately 24 to 48 hours, based on average gastrointestinal transit ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia ATC code: V03AE09 Mechanism of action Patiromer is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol ...
Pharmacokinetic properties
Patiromer works by binding potassium in the gastrointestinal tract and thus the serum concentration is not relevant for its efficacy. Due to the insolubility and nonabsorptive characteristics of this medicinal ...
Preclinical safety data
In radiolabeled studies in rats and dogs, patiromer was not systemically absorbed and was excreted in the faeces. Quantitative whole-body autoradiography analysis in rats demonstrated that radioactivity ...
List of excipients
Xanthan gum
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store and transport refrigerated (2°C–8°C). Patients may store Veltassa below 25°C for up to 6 months. For either storage condition, Veltassa should not be used after the expiry date printed on the sachet. ...
Nature and contents of container
8.4 g, 16.8 g or 25.2 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper. Pack sizes: boxes of 30, 60 or 90 sachets. Not all pack sizes ...
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/1/17/1179/001 EU/1/17/1179/002 EU/1/17/1179/003 EU/1/17/1179/004 EU/1/17/1179/005 EU/1/17/1179/006 EU/1/17/1179/007 EU/1/17/1179/008 EU/1/17/1179/009
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 July 2017
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