Implant Card - About our Products

Device name: CYTOCARE 502 | CYTOCARE 516 | CYTOCARE 532

Product range: CYTOCARE 

Type of device: Injectable device based on hyaluronic acid

Device class: Class III

CE marking: CE 0123

Manufacturer: REVITACARE SAS

Manufacturer’s address: 21 avenue de l’Eguillette, Parc d’Activités du Vert Galant, 95310 Saint-Ouen-l’Aumône, France

Website: www.revitacare.net

Specific information relating to your injection, such as the batch number, product reference, UDI and injection date, is provided on the implant card given to you by your practitioner.

Devices in the CYTOCARE range are indicated to reduce different ageing effects visible on the face linked to age, life style, or environment.

• CYTOCARE 502 is indicated to maintain the skin quality (to fill fine lines, to maintain hydration and radiance) of mild skin ageing type (superficial and mid-dermis of peri-orbital and perioral lines such as vertical lip lines).

• CYTOCARE 516 is indicated to improve skin quality (to fill fine lines, to maintain hydration and radiance) of moderate skin ageing type (superficial and mid-dermis of peri-orbital and perioral lines such as vertical lip lines).

• CYTOCARE 532 is indicated to improve skin quality (to fill fine lines, to restore radiance) of advanced skin ageing type (superficial and mid-dermis of peri-orbital and perioral lines such as vertical lip lines).

CYTOCARE 502: Sodium hyaluronate* 0.38 mg/mL + CT50** 18.8 mg/mL + Water For Injection (qs 5 mL)

CYTOCARE 516: Sodium hyaluronate* 3.05 mg/mL + CT50** 18.8 mg/mL + Water For Injection (qs 5 mL)

CYTOCARE 532: Sodium hyaluronate* 6.37 mg/mL + CT50** 18.8 mg/mL + Water For Injection (qs 5 mL)

*Non-cross-linked sodium hyaluronate, biotechnological origin, range molecular weight 0.6 to 1.0 106 Da (quantification of sodium hyaluronate and determination of molecular weight range performed using Gel Permeation Chromatography (GPC) coupled to refractometer detector).

**CT50 containing: Ammonium Molybdate, Ammonium Metavanadate, Calcium Chloride, Iron Sulphate, Potassium Chloride, Copper Sulphate, Magnesium Chloride, Manganese Sulphate, Sodium Acetate, Sodium Bicarbonate, Sodium Chloride, Sodium Hydrogen Phosphate, Sodium Metasilicate, Sodium Selenite, Tin Chloride, Zinc Sulphate, Alanine, Arginine, Asparagine, Aspartic Acid, Cysteine, Glutamine, Glutamic Acid, Glycine, Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Proline, Serine, Threonine, Tryptophan, Tyrosine, Valine, Adenine, Biotin, Calcium Pantothenate, Coline Chloride, Folic Acid, Inositol, Nicotinamide, Pyridoxine, Riboflavin, Thiamine, Cyanocobalamin, Deoxythymidine, Glucose, Putrescine, Sodium Pyruvate, Lipoic Acid, Hepes. None of the components are of animal and/or human origin.

CYTOCARE resorption period is 7 days. Product lifetime: 3 years (shelf life) and 7 days (resorption period).

Be sure you have been informed about contraindications to CYTOCARE injections, and that CYTOCARE cannot be injected to you:

• If you have a known hypersensitivity or allergy to any of the components,

• If you have a skin disease or alteration of any type whatsoever,

• If you have a history of auto-immune disease or I receive immunotherapy,

• If you are pregnant or breastfeeding woman,

• If you are under the age of 18.

• CYTOCARE shall not be injected into the eyelids, tear troughs (under eyes area), glabella (lion’s wrinkles) and lips.

• CYTOCARE shall not be injected into tendons, ligaments, bones, muscles and blood vessels.

• CYTOCARE should only be applied on healthy skin.

There is no clinical data available in terms of tolerance of theCYTOCARE injection in an area that has been treated with another product, whether for aesthetic purposes or not, whether permanent or not, or another aesthetic medicine technique. It is recommended that a site which has already been treated with a long-term or permanent implant is not injected.

There is no clinical data available in terms of efficacy and tolerance of the CYTOCAREinjections in patients who have a medical history of severe multiple allergies or anaphylactic shock. You must inform my doctor if you have such medical history.

CYTOCARE shall not be mixed with other products.

If you have a history of streptococcal disease (such as recurrent sorethroat or acute articular fever), you must be subject to a double test before injection. In case of acute articular fever with cardiac involvement, it is recommended NOT to inject,

If you have haemostatic disorder or you are under anticoagulant treatment, the risk of hematomas is increased.

Since CYTOCARE is administered by microinjections, you may observe side effects related to the injection techniques. You have been informed that some adverse effects can occur immediately during injection or may be delayed:

Pain or discomfort during the injection, bleeding during the injection, redness, dizzy feeling during the injection, tingling, itching, burning sensation, ecchymosis (bruising potentially with mild pain when touching), superficial wound, abnormal skin surface alteration (papules, nodules), swelling, hematoma, inflammation (signs of inflammation: redness, heat sensation, swelling, pain), infection resulting from incorrect asepsis (in case of non-respect of hygiene precaution), perioral herpes outbreak after injection, erythema (skin lesion with round papules with relief surrounded by areas of skin discoloration (dark red, red, pink), device visibility through the skin.

While not observed with CYTOCARE, other undesirable side effects have been observed with other products containing hyaluronic acids (cross-linked or not) or administered by similar methods:

Delayed inflammation signs: few weeks to few months (granuloma: small lump of fleshy tissue), tissue necrosis potentialy induced by vascular occlusion (pain, warmth, skin redness, or swelling at a wound, especially if the skin discoloration is spreading rapidly), vascular occlusion that may result in impairment of vision or blindness, seroma (abnormal swelling without visible blood coloration), compartment pressure problems and compartment syndrome (typical signs: pain, pallor, tingling, pulselessness, numbness).

You must inform the medical doctor as soon as possible if any undesirable side effect persists for longer than one week. The medical doctor must remedy it by an appropriate treatment. The distributor and/or manufacturer can be contacted at reclamation@revitacare.fr as soon as an undesirable side effect appairs.

CYTOCARE 502-516-532 has to be stored between 2~30ºC in a dry place and should be protected from sunlight, heat and frost.

SHELF LIFE: 36 months under recommended condition