KENTERA Transdermal patch (2021)
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Περιεχόμενα
Name of the medicinal product
Kentera 3.9 mg/24 hours transdermal patch.
Qualitative and quantitative composition
Each transdermal patch contains 36 mg of oxybutynin. The area of the patch is 39 cm², releasing a nominal 3.9 mg of oxybutynin per 24 hours. For a full list of excipients, see section 6.1.
Pharmaceutical form
Transdermal patch. The patch is a clear plastic with an adhesive backing, protected by a release liner that is to be removed prior to application.
Therapeutic indications
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.
Posology and method of administration
Posology The recommended dose is one 3.9 mg transdermal patch applied twice weekly (every 3 to 4 days). Elderly Based on clinical trial experience no dose adjustment is considered necessary in this population. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Kentera is contraindicated in patients with urinary retention, severe gastro-intestinal condition, myasthenia gravis or narrow-angle ...
Special warnings and precautions for use
Kentera should be used with caution in patients with hepatic or renal impairment. The use of Kentera in patients with hepatic impairment should be carefully monitored. Other causes of frequent urination ...
Interaction with other medicinal products and other forms of interaction
The concomitant use of oxybutynin with other anticholinergic medicinal products or with other agents that compete for CYP3A4 enzyme metabolism may increase the frequency or severity of dry mouth, constipation, ...
Pregnancy and lactation
Pregnancy There are no adequate data on the use of oxybutynin transdermal patch in pregnant women. Studies in animals have shown minor reproductive toxicity (see section 5.3). Kentera should not be used ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Because Kentera may produce drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution ...
Undesirable effects
The most commonly reported adverse drug reactions were application site reactions, occurring in 23.1% of patients. Other commonly occurring adverse drug reactions reported were dry mouth (8.6%), constipation ...
Overdose
Plasma concentration of oxybutynin declines within 1 to 2 hours after removal of transdermal system(s). Patients should be monitored until symptoms resolve. Overdosage with oxybutynin has been associated ...
Pharmacodynamic properties
Pharmacotherapeutic group: urinary antispasmodic ATC code: G04BD04 Mechanism of action Oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in ...
Pharmacokinetic properties
Absorption Kentera has a concentration of oxybutynin sufficient to maintain continuous transport over the 3 to 4 day dosing interval. Oxybutynin is transported across intact skin and into the systemic ...
Preclinical safety data
Pre-clinical data reveal no special hazard for humans based on studies for acute toxicology, repeat dose toxicity, genotoxicity, carcinogenic potential and local toxicity. At a concentration of 0.4 mg/kg/day ...
List of excipients
<u>Backing film:</u> Clear polyester/ethylene-vinyl acetate (PET/EVA) <u>Middle layer:</u> Triacetin Acrylic copolymer adhesive solution containing 2-ethylhexyl acrylate, N-vinyl pyrrolidone and hexamethyleneglycol ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not refrigerate or freeze.
Nature and contents of container
The transdermal patches are individually contained in LDPE/paper laminate sachets and supplied in Patient Calendar Boxes of 2, 8 or 24 patches. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Apply immediately upon removal from the protective sachet. After use the patch still contains substantial quantities of active ingredients. Remaining active ingredients of the patch may have harmful effects ...
Marketing authorization holder
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/03/270/001 8 transdermal patches EU/1/03/270/002 24 transdermal patches EU/1/03/270/003 2 transdermal patches
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 June 2004 Date of latest renewal: 30 April 2009
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