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SANCUSO Transdermal patch (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

SANCUSO 3.1 mg/24 hours transdermal patch.

Qualitative and quantitative composition

Each 52 cm² transdermal patch contains 34.3 mg of granisetron releasing 3.1 mg of granisetron per 24 hours. For the full list of excipients, see section 6.1.

Pharmaceutical form

Transdermal patch. Thin, translucent, matrix-type, rectangular-shaped transdermal patch with rounded corners.

Therapeutic indications

SANCUSO transdermal patch is indicated in adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, ...

Posology and method of administration

Posology Adults Apply a single transdermal patch 24 to 48 hours before chemotherapy, as appropriate. Due to a gradual increase in plasma levels of granisetron following application of the transdermal patch, ...

Contraindications

Hypersensitivity to the active substance, to other 5-HT<sub>3</sub> receptor antagonists or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Application site reactions In clinical trials with SANCUSO, application site reactions were reported which were generally mild in intensity and did not lead to discontinuation of use. If severe reactions, ...

Interaction with other medicinal products and other forms of interaction

For serotonergic medicinal products (e.g. SSRIs and SNRIs), there have been reports of serotonin syndrome following concomitant use of 5-HT<sub>3</sub> antagonists and other serotonergic medicinal products ...

Fertility, pregnancy and lactation

Pregnancy There are no data on the use of granisetron 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

SANCUSO has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The safety profile of SANCUSO is derived from controlled clinical trials and from post-marketing experience. The most commonly reported adverse reaction in clinical studies ...

Overdose

There is no specific antidote for granisetron. In the event of overdose, the transdermal patch should be removed. Symptomatic treatment should be given.

Pharmacodynamic properties

Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT<sub>3</sub>) antagonists ATC code: A04AA02 Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine ...

Pharmacokinetic properties

Absorption Granisetron crosses intact skin into the systemic circulation by a passive diffusion process. Following SANCUSO application, granisetron is absorbed slowly, with maximal concentrations reached ...

Preclinical safety data

Preclinical data did not reveal any special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity. Carcinogenicity studies ...

List of excipients

<u>Backing layer:</u> Polyester <u>Matrix layer:</u> Acrylate-vinylacetate copolymer <u>Release liner:</u> Siliconised polyester

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Store in the original package in order to protect from light.

Nature and contents of container

Each transdermal patch is packaged in a heat-sealed sachet composed of polyester-coated paper/aluminium/LLDPE. Each carton contains 1 transdermal patch.

Special precautions for disposal and other handling

The transdermal patch will still contain active substance following use. After removal, the used transdermal patch should be folded firmly in half, adhesive side inwards and then discarded out of the reach ...

Marketing authorization holder

Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands, Tel: +31 (0) 237200822

Marketing authorization number(s)

EU/1/12/766/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 20 April 2012 Date of latest renewal: 9 January 2017

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