Cevidra® cleansing & decontaminating cream is available in tubes of 30 mL and 50 mL.
Commercialised under license from the IRSN Patent FR0858703.
Active ingredient: calixarène carboxylique (0.75 %).
Excipients : paraffin oil, water, surfactants and preservatives.
Indications and limits on use
Cevidra® is a medical device for first line treatment of external contamination from the following radionuclides: uranium, plutonium, thorium, americium, cobalt, cesium, strontium, zirconium, silver, antimony and manganese.
Its use is part of a decontamination protocol and must be performed under the supervision of a radio-decontamination qualified person.
For external use, do not swallow.
Avoid direct contact with eyes.
To be used with care on people with a known allergy to one of the components.
The characteristics of the lesion (length and depth) having potential influence on the diffusion of calixarene, it is recommended to avoid use on damaged skin.
This medical device has not been studied on children or women who are pregnant or breastfeeding. As a precautionary measure, it is recommended to avoid its use in these populations. However, for these populations the decision will be made, on a case-by-case basis, by a healthcare professional, taking into account the benefit/risk ratio assessment he should have performed.
Instructions for use
One tube of Cevidra® is made only for a single decontamination procedure and can be used to decontaminate either the entirety or part of the body and/or hair, during an emergency on-site decontamination procedure.
For effective decontamination, carry out the following operations on the area(s) to be decontaminated:
Wet or dampen the skin (optional step): this operation facilitates contact between the Cevidra cream and the body area to be decontaminated. It proves useful for spreading the cream onto less accessible areas like the hair, the beard, or across large skin areas.
Apply the cream and wash thoroughly: areas to be decontaminated are thoroughly washed by gently rubbing Cevidra cream for optimal contact between the cream and the contaminant. The cream acts immediately. Leaving the product on the contaminated area following application will not improve the results of the decontamination.
Remove the cream by rinsing with water (all body areas) or wiping with wet woven compresses (only for skin areas). Removing the cream is necessary to complete the decontamination. This step should avoid eye areas.
Mode of action
The composition of Cevidra® cream gives it the potential for multiple interactions: specific by virtue of the carboxylic calixarene and non-specific by virtue of its other ingredients. The carboxylic calixarene is a specific chelating agent that captures actinides (uranium, plutonium, americium, thorium), antimony, cesium, cobalt, manganese, silver, strontium and/or zirconium present on skin or hair/beard. Through its cleansing action, Cevidra® also eliminates from the skin other more or less soluble forms of radionuclides. Cevidra® prevents these radionuclides from penetrating the organism with scientifically proven efficacy. The average diameter of the oily particles of Cevidra® cream allows access to contaminants deposited in the anfractuosities and interstices of the skin and hair/beard.
Medical device efficacy
The rapid elimination of actinides deposited on the skin or hair/beard prevents them from passing into the body, and thus from fixing onto target organs where they are toxic in the short, medium and long terms.
In the case decontamination is not total following initial application:
You can repeat the operation several times on the same area. If one tube is not sufficient to treat the whole of the target area, several tubes may be used.
In the case of delayed application of the product relative to time of contamination:
The quantity of radionuclides that penetrates the skin depends on the initial quantity of contaminants, their chemical form, and skin condition. Though it is not possible to determine the remaining quantity of contaminants on the skin in cases of delayed application, the risk/benefit analysis remains favourable to use, as CEVIDRA® cream acts on the unabsorbed portion of radionuclides.
When there is no or no immediate access to a water point:
In the case of contamination, it is recommended to apply CEVIDRA® cream to the contaminated area as quickly as possible. Nevertheless, in the absence of water, the product’s consistency allows for contact of the active ingredient with the skin and contaminants, even though it is more difficult on the hair and beard. Decontamination should be followed and completed by removing the cream applied. This removal of the cream should be performed by rinsing with water (for all body areas) or wiping with wet woven compresses (only for skin areas). Removing the cream is necessary to complete the decontamination. This step should avoid eyes contamination. It is recommended to perform this decontamination step in an area designed for this purpose in order to recover and isolate any contaminated effluents and consumable products (compresses, gloves, masks). This step must be taken as soon as possible following application of the product. The biocompatibility studies conducted on CEVIDRA® cream show that the product does not cause skin irritation after 4 hours of contact on the skin.
In the case a contaminated effluent comes into contact with a non-contaminated area of the body:
The product should be removed from the contaminated area without overflowing on non-contaminated areas. However, this is not always possible. Studies show that, once chelated with the calixarene in the product, the radionuclide remains fixed in the cream. The transfer of contamination from cream containing chelated radionuclides onto intact non-contaminated skin is unlikely, except in case of eye contact. Thus, to prevent cross contamination, it is important to avoid eye areas when rinsing.
Single use: Cevidra® is a single use medical device.
Storage: It must be stored in the range of 15 °C to 25 °C.
Waste management: once used, the CEVIDRA® product, along with waste water resulting from the decontamination process, must be treated in accordance with the current procedures for the management of contaminated waste. Contaminated residue may have been left on the tube during use. To avoid any further handling of a possibly contaminated product, the opened tube must be disposed of with the other contaminated products.
Management of serious incidents, undesirable effects and quality problems
Any anomaly noted before, during or after the use of Cevidra® must be notified to the manufacturer of the medical device. Cevidra will investigate this anomaly as part of its materiovigilance procedure.
45, boulevard Marcel Pagnol – 06130 Grasse
Tel. : +33 (0)4 93 70 58 31 ; Fax : +33 (0)4 93 77 24 62 ; firstname.lastname@example.org
Any serious incident linked to the use of the medical device must be notified to the manufacturer or to the competent authority in the country.