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Croma Saypha Croma Saypha Volumea + Lidocaine 1 Prefilled Syringe Of 1ml

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€77.89
From €79.00
Croma Saypha Croma Saypha Volumea + Lidocaine 1 Prefilled Syringe Of 1ml
Croma Saypha Croma Saypha Volumea + Lidocaine 1 Prefilled Syringe Of 1ml
Description Our selection Customer reviews

CROMA PHARMA
Saypha Volumea + lidocaine
Highly cross-linked Hyaluronic Acid 23 mg/ml
For correcting deeper wrinkles and folds, increasing or restoring Face volume and remodelling facial contours
1 pre-filled syringe containing 1.0 ml of solution, two disposable sterile needles 27 G and 1/2" and instructions for use. The bottom of the box has a set of two labels bearing the batch number.

The device is a sterile, biodegradable, viscoelastic, clear, transparent, isotonic and homogenised injectable gel implant. It consists of cross-linked Hyaluronic Acid (Ah Anti-age), obtained from the Streptococcus equi bacterium, formulated at a concentration of 23 mg/mil in physiological buffer with 0.3% lidocaine hydrochloride added. The accessory role of lidocaine hydrochloride is to reduce the pain associated with injections into the Skin. Each carton contains a pre-filled syringe of 1.0ml solution, two sterile disposable needles of 27G and 1/2" and instructions for use. At the bottom of the carton is a set of two labels bearing the batch number. One of these labels should be placed in the patient's file and the other given to the patient for traceability purposes.

The device is designed to correct deeper wrinkles and folds, increase or restore facial volumes and reshape facial contours. It should be used for medical reconstruction, for example in the treatment of facial lipoatrophy, disabling scars or morphological asymmetry. It should be injected into the hypodermis or deep dermis.

Please note that the injection of Saypha Volume + lidocaine requires a medical procedure that can only be carried out by a doctor (a doctor specialising in dermo-aesthetics, a dermatologist or a plastic surgeon).
THE PRODUCTS SOLD ON OUR WEBSITE ARE PARAPHARMACEUTIC PRODUCTS, SO THEY CAN BE SOLD FREE OF CHARGE AND DO NOT REQUIRE AN ORDER
This is a medical device.
This product cannot be returned or exchanged.

REF:
9003502003433

The composition may be subject to variations, so we advise you to always check the list on the purchased product.

Composition:

- Highly cross-linked sodium hyaluronate 23mg/ml
- With 0.3% lidocaine hydrochloride
- Phosphate citrate buffer pH 6.8-7.3 qsp
- sodium chloride


Exclusion criteria: The device should not be used in :
- patients with a tendency to develop hypertrophic or keloid scars and with pigmentation disorders.
- patients with a history of autoimmune diseases or undergoing immunity treatment.
- Patients with a known hypersensitivity to Hyaluronic Acid.
- Patients in whom permanent fillers have already been injected into the area to be treated.
- Pregnant or Milk feeding women.
- Patients under 18 years of age.
Patients taking anticoagulants or anti-platelet agents (e.g. acetylsalicylic acid) should not be treated with the device without consulting their doctor. The device must not be used in areas with skin reactions or inflammatory and/or infectious processes (e.g. acne, herpes, etc.). The device must not be used in association with laser treatment, chemical peeling, dermabrasion or mesotherapy.

Precautions for use :
The use of this device is reserved for doctors who have received specific training in the injection technique designed to restore the volumes of the Face. Sensitive Skin can be pre-treated with a cream or local anaesthetic patch. Dispose of the syringe, remaining product and needle after use in a special container.

Undesirable effects :
Physicians should inform the patient of adverse reactions and/or incompatibilities potentially associated with the implantation of this device which may occur immediately or at a later time. The following reactions and adverse reactions have been observed with the device or similar products: abscesses, angioedema, bacterial infections, bulging/bumping, bleeding, bruising, burns, discolouration (depigmentation), discomfort, oedema, erythema, hypertonicity, granulomas, haematoma, reactivation of herpes, hypersensitivity, implant site mass, visible implant, induration, inflammation, irritation, itching, livedoid lesions after accidental arterial embolisation, malar oedema, migration, necrosis due to vascular damage, nodules (inflammatory and non-inflammatory), numbness, pain, paresthesia, perforation marks, redness, retinal artery occlusion, cutaneous sarcoidosis on scar, scleromyxedema (generalised), swelling, telangiectasia, tenderness, vasculitis, vascular spasm, vasovagal reaction during injection, loss of vision due to retinal artery occlusion. In very rare cases, injections of other soft tissue fillers into the glabella and nasal wings have resulted in retinal artery occlusion. Reactivation of the herpes virus may occur in rare cases following direct needle injury to neural axons or tissue manipulation and inflammatory reaction following injection of a filler. Dissection of the sub-epidermal plane when using a fan-shaped injection needle may increase the incidence of local adverse reactions. Too superficial placement of the filler or uneven distribution of the injected product may lead to the appearance of visible, pale nodules in the Skin. It is therefore important to be aware of these possible complications. Patients should inform their doctor as soon as possible of any inflammatory reaction lasting more than a week or of any other side effect. Any other adverse reactions associated with the injection of the device should be reported to the distributor and/or manufacturer.

Warnings: Check the integrity of the syringe and the expiry date before use. Do not use a syringe with an open or displaced protective cap inside the protective packaging. Only use syringes or needles supplied by the manufacturer
Do not handle/twist the needle.
Do not reuse; quality and sterility can only be guaranteed for a syringe in its original packaging. Reuse of the device entails a risk of infection for patients or users. If the 27 G and 1/2" needle is blocked, do not increase the pressure on the plunger rod but interrupt the injection and replace the needle. There are no clinical data (efficiency, Tolérance) available concerning the injection of the device into an area already treated with another filling product. Do not inject into blood vessels, bones, tendons, ligaments, nerves or muscles. Do not inject into the periorbital area (including the lacrimal fold, upper periorbital area and eyelids), the glabella or the wings of the nose. Do not inject into nevi. Do not overcorrect. Patients should be advised not to apply make-up for 12 hours after injection and to avoid prolonged exposure to the Sun and UV rays as well as the use of saunas or Turkish baths for one week after injection. To avoid any risk of mobility of the product, the patient should be advised not to massage the treatment site in the days following the injection. There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds such as benzalkonium chloride solutions. The device must therefore never be placed in contact with these substances or with medical and surgical instruments which have been in contact with these substances.
Storage: The device must be stored between 2-25°C / 36-77°F in a dry place in the original packaging, protected from light, heat and frost. Handle with care.

The list of ingredients may be subject to variations, so we advise you always to check the list on the product purchased.

The device must be injected into healthy, disinfected, non-inflammatory skin. The technique used is essential to the success of the treatment. Use the 27G 1/2" needle supplied with the syringe and inject slowly using the appropriate injection technique. Inject small volumes in two or more sessions rather than large volumes in one session. The quantity injected will depend on the wrinkle or hollow to be corrected. The maximum dose is 10ml per session. Do not inject more than 20ml per year. After the injection, doctors can perform a light massage to ensure even distribution of the product. The patient should remain in the surgery for a few minutes after the injection in order to detect any whitening caused by arterial occlusions.

To view the leaflet, click on this link

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