Cevidra® Calixarene 50ml

Presentation

Cevidra® Calixarene cleansing & decontaminating cream in 50 mL tube.

Commercialised under license from the IRSN Patent FR0858703

Composition

Ingredient: Calixarène carboxylique (0,75 %)

Excipients : Paraffin oil, Water, Emulsifiers, Surfactants et Preservatives

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Indications and limits on use

Cevidra® Calixarene is a medical device intended to treat external contamination with radionuclides  (uranium, plutonium, americium, thorium, Cobalt, Caesium and Strontium).

Its use on wet skin and/or hair under medical supervision is part of a decontamination protocol and must be followed by copious rinsing.

puce atom To be used on healthy skin.

The studies carried out have confirmed the performance of Cevidra® Calixarene on undamaged and excoriated skin. In studies on Frantz diffusion cells carried out by the IRSN, no diffusion of carboxylic calixarene has been observed across excoriated skin.
There is no data available on the performance of Cevidra® Calixarene in case of injury.
The characteristics of the injury (extent and depth) could influence the diffusion of the calixarene: it is recommended to avoid use on injured skin.

puce atom Avoid direct contact with eyes.

puce atom To be used with care on people with a known allergy to one of the components.

puce atom For external use, do not swallow.

Instructions for use

A tube of Cevidra® Calixarene is intended for a single use to decontaminate the hair, scalp and body or to decontaminate a contaminated area of the body (hands, face, an arm, etc.) during the emergency decontamination procedure put in place on the site.

The areas to be decontaminated are carefully washed by gentle friction using decontaminating cream.

The cream acts immediately by its specific chelating effect for actinides and by its cleansing effect for all radionuclides that may be present in a more or less soluble form.

So as to optimise the contact between the Cevidra® Calixarene cream and the body area to be contaminated, it is preferable to wet the skin and/or the hair in advance.

After using the decontaminating cream, the treated area must be rinsed with water starting from the top of the treated area and finishing with the lowest part.

It is not necessary to leave the product in prolonged contact with the skin and/or the hair to increase the efficacy of decontamination. For increased decontamination of a heavily exposed area, it is recommended to repeat the wash/rinse cycle several times over the same area.

If one dose is not sufficient to wash the whole body surface to be decontaminated, several doses may be used.

Management of serious incidents, undesirable effects and quality problems

Any anomaly noted before, during or after the use of Cevidra® Calixarene must be notified to the manufacturer of the medical device. Cevidra will investigate this anomaly as part of its materiovigilance procedure.

Laboratoire CEVIDRA
45, boulevard Marcel Pagnol – 06130 Grasse
Tel. : +33 (0)4 93 70 58 31 ; Fax : +33 (0)4 93 77 24 62 ; contact@cevidra.com

Any serious incident linked to the use of the medical device must be notified to the manufacturer or to the competent authority in the member state.