REVANESSE SHAPE + LIDOCAINE

REVANESSE SHAPE + LIDOCAINE is a gel:
- Transparent, odourless and colourless, of synthetic origin and water-based.
- It has high viscosity and cohesion.
- The formulation is biocompatible and hydrophilic.

- PROLLENIUM MEDICAL TECHNOLOGIES INC.
- NAME: REVANESSE SHAPE + LIDOCAINE
- COMPOSITION: Cross-linked hyaluronic acid 25 mg/ml, Lidocaine 3 mg/ml (0.3 % w/w).
- PRESENTATION: 2 x 1.2 ml.
- NEEDLES: 2 x 27G.
- INDICATIONS: Indicated for the treatment of medium and deep facial wrinkles, the restoration of lost volume, the correction of contour defects and anatomical deformities, the increase in lip volume and the shaping of skin depressions.
- INJECTION DEPTH: Central or deep part of the dermis.
- DURATION: 12 to 18 months.
- USE: Strict medical use.

- Syringe: 2 x 1.2 ml.
- Needles: 2 x 27G.

Medium and deep facial wrinkles and increased lip volume.

Cross-linked hyaluronic acid 25 mg/ml, Lidocaine 3 mg/ml (0.3 % w/w).

- In the case of accidental intravascular injection, toxic effects occur within 1-3 minutes, so doctor and patient must be careful
- The effect of lidocaine may be reduced if injected into infected or inflamed areas
- Caution should be exercised in patients with partial or complete atrioventricular blockade, advanced liver disease, severe renal insufficiency, epilepsy, respiratory insufficiency, advanced age, poor general physical condition or on therapy with class III antiarrhythmics (e.g. amiodarone); require close medical monitoring, including ECG
- Use caution in patients taking other topical anaesthetics or drugs similar to amide anaesthetics, as systemic toxic effects may be cumulative
- Local anaesthetics may have mild effects on motor coordination and vigilance, depending on the dosage
- Do not inject in areas with other fillers or permanent implants, as there are no clinical data on possible reactions
- Hyaluronic acid is not compatible with quaternary ammonium salts such as benzalkonium chloride; avoid any contact
- Do not use for breast augmentation or implants in bone, tendons, ligaments or muscles
- Avoid touching the treated area for 12 hours and prolonged exposure to sun, UV, extreme heat or cold
- Patients with cold sores may be at risk of reactivation due to needle sticks
- The use of aspirin, NSAIDs, St. John's Wort or high doses of vitamin E may increase bruising and bleeding
- Maximum recommended dose of lidocaine: 20 ml per 60 kg body weight per year
- Safety for patients under 18 or over 65 not established
- Patients with active infections or fever must wait for recovery
- The product should only be used by operators with appropriate training and anatomical knowledge
- Doctors must inform patients of all possible risks and symptoms of complications before treatment

REVANESSE SHAPE + LIDOCAINE is contraindicated in the following cases:
- The product is contraindicated in the case of hypersensitivity to all local anaesthetics of the amide type, not just lidocaine, and in the presence of atrioventricular blockades of any degree, sinus node dysfunction, severe reduction in myocardial contractility, porphyria or supraventricular tachycardias
- Contains lidocaine and is contraindicated for patients with known allergies to this substance
- Do not inject into the eye contours, including the periocular circle or eyelids
- Pregnant or lactating women should not be treated
- It is intended for intradermal use only and must not be injected into blood vessels, as this can cause occlusions and embolism
- Patients with a tendency to hypertrophic scars should not be treated
- Contains traces of gram-positive bacterial proteins, contraindicated in case of known allergy
- Do not use in conjunction with laser, intense pulsed light, chemical peels or dermabrasion
- Do not treat persons under 18 years of age
- Do not treat patients with acne or other inflammatory skin conditions
- Contraindicated in patients with unrealistic expectations, autoimmune disorders, immunotherapy or multiple severe allergies
- Do not use in case of acute or chronic skin diseases in the vicinity of the injection site
- Contraindicated in patients with coagulation defects or on anticoagulant therapy
- Patients with hypersensitivity to hyaluronic acid should not be treated

The product is a space-occupying tissue reconstructive material composed of hyaluronic acid gel, indicated for restoring volume lost due to lipoatrophy or lipodystrophy and/or correcting contour defects and anatomical deformities of pathological or traumatic origin in facial soft tissue. Ideal patients are those wishing to correct contour defects or deformities of the facial soft tissues, such as HIV-associated lipoatrophy.
Revanesse® Shape + is indicated for the treatment of facial wrinkles, volume restoration, lip augmentation, skin hydration and shaping of skin depressions by tissue injection.