SAMSCA Tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Samsca 7.5 mg tablets. Samsca 15 mg tablets. Samsca 30 mg tablets.
Qualitative and quantitative composition
Samsca 7.5 mg tablets: Each tablet contains 7.5 mg tolvaptan. Excipient with known effect: 51 mg lactose (as monohydrate) per tablet Samsca 15 mg tablets: Each tablet contains 15 mg tolvaptan. Excipient ...
Pharmaceutical form
Tablet. Samsca 7.5 mg tablets: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with OTSUKA and 7.5 on one side. Samsca 15 mg tablets: Blue, triangular, shallow-convex ...
Therapeutic indications
Samsca is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Posology and method of administration
Due to the need for a dose titration phase with close monitoring of serum sodium and volume status (see section 4.4), treatment with Samsca has to be initiated in hospital. Posology Tolvaptan has to be ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to benzazepine or benzazepine derivatives (see section 4.4) Anuria Volume depletion Hypovolemic hyponatremia ...
Special warnings and precautions for use
Urgent need to raise serum sodium acutely Tolvaptan has not been studied in a setting of urgent need to raise serum sodium acutely. For such patients, alternative treatment has to be considered. Access ...
Interaction with other medicinal products and other forms of interaction
Co-administration with other treatments for hyponatremia and medicinal products that increase serum sodium concentration There is no experience from controlled clinical trials with concomitant use of Samsca ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of tolvaptan in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. ...
Effects on ability to drive and use machines
Samsca has no or negligible influence on the ability to drive or use machines. However, when driving or using machines it should be taken into account that occasionally dizziness, asthenia or syncope may ...
Undesirable effects
Summary of the safety profile The adverse reaction profile of tolvaptan in SIADH is based on a clinical trials database of 3,294 tolvaptan-treated patients and is consistent with the pharmacology of the ...
Overdose
Single doses up to 480 mg and multiple doses up to 300 mg per day for 5 days have been well tolerated in clinical trials in healthy volunteers. There is no specific antidote for tolvaptan intoxication. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Diuretics, vasopressin antagonists ATC code: C03XA01 Mechanism of action Tolvaptan is a selective vasopressin V2-receptor antagonist that specifically blocks the binding of arginine ...
Pharmacokinetic properties
Absorption After oral administration, tolvaptan is rapidly absorbed with peak plasma concentrations occurring about 2 hours after dosing. The absolute bioavailability of tolvaptan is about 56%. Co-administration ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential. Teratogenicity was noted in rabbits ...
List of excipients
Maize starch Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Indigo carmine aluminium lake (E132)
Incompatibilities
Not applicable.
Shelf life
Samsca 7.5 mg tablets: 5 years. Samsca 15 mg tablets and Samsca 30 mg tablets: 4 years.
Special precautions for storage
Store in the original package in order to protect from light and moisture.
Nature and contents of container
Samsca 7.5 mg tablets: 10 tablets in PP/Alu blisters 30 tablets in PP/Alu blisters 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters Samsca 15 ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
Marketing authorization number(s)
Samsca 7.5 mg tablets: EU/1/09/539/005 (10 tablets) EU/1/09/539/006 (30 tablets) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet) Samsca 15 mg tablets: EU/1/09/539/001 (10 × 1 tablet) EU/1/09/539/002 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 03 August 2009 Date of latest renewal: 19 June 2014
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