VASEXTEN Modified release capsules (2013)
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Περιεχόμενα
Name of the medicinal product
Vasexten 10, 10 mg modified release capsules.
Qualitative and quantitative composition
Vasexten contains barnidipine hydrochloride. Vasexten 10 modified release capsules, hard, contain 10 mg barnidipine hydrochloride, equivalent to 9.3 mg barnidipine per capsule. Excipients with known effect: ...
Pharmaceutical form
Modified release capsules, hard. Vasexten 10 modified release capsules are yellow and marked: 155 10
Therapeutic indications
Mild to moderate essential hypertension.
Posology and method of administration
Posology The recommended starting dosage is 10 mg once daily, in the morning. It may be increased to 20 mg once daily if necessary. The decision to increase the dosage should only be taken after complete ...
Contraindications
Hypersensitivity to the active substance (or to any dihydropyridine) or to any of the excipients. Hepatic impairment. Severe renal impairment (creatinine clearance < 10 ml/min). Unstable angina pectoris ...
Special warnings and precautions for use
Vasexten should be used with caution in patients with mild to moderate renal impairment (creatinine clearance between 10 and 80 ml/min) (see section 4.2 Posology and method of administration). The combination ...
Interaction with other medicinal products and other forms of interaction
The concurrent administration of barnidipine and other antihypertensive drugs may result in an additional antihypertensive effect. Vasexten can be used concurrently with betablockers or ACE inhibitors. ...
Pregnancy and lactation
Pregnancy No clinical experience with barnidipine in pregnancy or lactation is present. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal or postnatal development. ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed Vasexten. However, caution should be exercised because dizziness/vertigo may occur during antihypertensive treatment. ...
Undesirable effects
System organ class 10 mg dosage 20 mg dosage Immune system disorders Anaphylactoid reaction Not known (frequency cannot be estimated from the available data) Not known (frequency cannot be estimated ...
Overdose
Symptoms of intoxication In general, clinical symptoms following an overdose of calcium antagonists develop within 30 to 60 minutes after administration of a dose five to ten times higher than the therapeutic ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antihypertensives ATC code: C08CA12 Mechanism of action Barnidipine (pure S,S isomer) is a lipophilic 1,4-dihydropyridine calcium antagonist showing high affinity for the calcium ...
Pharmacokinetic properties
Absorption After repeated administration of Vasexten 20 to healthy individuals, the concomitant intake of food did not have a statistically significant effect on AUC, C<sub>max</sub>, T<sub>max</sub> or ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
List of excipients
The excipients of Vasexten capsules are: <u>Capsule content:</u> carboxymethylethylcellulose, polysorbate 80, sucrose, ethylcellulose, talc. <u>Capsule shell:</u> titanium dioxide (E171), yellow iron oxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Vasexten modified release capsules are packed in boxes containing 10, 14, 20, 28, 30, 50, 56, 98 or 100 capsules in aluminium-aluminium (with PVC and polyamide coating) blisters. A blister contains 7, ...
Special precautions for disposal and other handling
Do not remove granules from the capsules.
Marketing authorization holder
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
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