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SPC: KENTERA Transdermal patch (2019)

Αναφορές

Βιβλιογραφική αναφορά

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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

The patch should be applied to dry, intact skin on the abdomen, hip, or buttock immediately after removal from the protective sachet. A new application site should be selected with each new patch to avoid ...

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

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 during pregnancy ...

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

Backing film: Clear polyester/ethylene-vinyl acetate (PET/EVA) Middle layer: Triacetin Acrylic copolymer adhesive solution containing 2-ethylhexyl acrylate, N-vinyl pyrrolidone and hexamethyleneglycol ...

Incompatibilities

Not applicable.

Shelf life

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)

8 transdermal patches: EU/1/03/270/001 24 transdermal patches: EU/1/03/270/002 2 transdermal patches: EU/1/03/270/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 15/06/2004 Date of latest renewal: 30/04/2009

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