Revolax Deep Lidocaine 1 .0 ml 1 .0 ml

REVOLAX Deep Lidocaine is a thick injectable hyaluronic acid gel used to treat deep wrinkles and nasolabial folds or cheek, chin and lip augmentation.

It should be injected into the deep dermis or subcutaneous tissue.

REVOLAX™ Deep with Lidocaine is a clear, biodegradable, non-animal based, cross-linked dermal filler with high viscoelasticity.

Composition of Revolax Deep Lidocaine 

Hyaluronic Acid:  24 mg/ml

Lidocaine HCl 0.3%

Volume 1.1ml

Duration of action of REVOLAX DEEP LIDOCAINE

12-18 months

Across is a Korean laboratory. 

It has CE marking.

REVOLAX:

– High purity hyaluronic acid Non-animal

– Natural substances extracted from bacteria

– High purity (endotoxin <0.0015 IU/mg)

– Biodegradable (natural absorption)

– High crosslinking: Across fine crosslinking technology

– Improved sustainability

– Highly coherent monophasic

– Regular and dense pattern

– Stable and constant gel structure

– Natural effect/ Gentle injection

– High viscoelasticity

– Intensify longer durability persistence

– Maintains elasticity by firmly supporting skin tissue

REVOLAX DEEP TECHNICAL DATA SHEET

DESCRIPTION of REVOLAX DEEP LIDOCAINE 

REVOLAX DEEP lidocaine is a sterile, pyrogen-free, physiological gel of cross-linked hyaluronic acid of non-animal origin with the addition of 0.3% lidocaine hydrochloride. It is a colorless, odorless, and highly viscous aqueous gel.

REVOLAX DEEP lidocaine is presented as a sterile 1.1 ml volume in a single-use glass syringe, accompanied by two sterilized needles.

INDICATIONS FOR REVOLAX DEEP LIDOCAINE INJECTIONS 

REVOLAX DEEP Lidocaine is indicated for intradermal implantation for volume loss as well as for morphological asymmetry of the face. The addition of lidocaine provides an analgesic effect during treatment.

CONTRAINDICATIONS FOR REVOLAX DEEP LIDOCAINE INJECTIONS 

· Do not inject REVOLAX DEEP Lidocaine into the eye area (eye circle or eyelids).

· Do not inject REVOLAX DEEP Lidocaine into blood vessels (intravascular).

· REVOLAX DEEP Lidocaine should not be used in:

– Pregnant or breastfeeding women.

– Persons under 18 years of age.

– Patients known to have hypersensitivity to hyaluronic acid.

– Patients who tend to develop hypertrophic scars.

· REVOLAX DEEP Lidocaine should not be used in conjunction with laser therapy, chemical peels or skin abrasions.

· REVOLAX DEEP Lidocaine should not be used in areas with inflammatory and infectious skin processes.

· The total dose of lidocaine administered should be considered if a dental block or topical administration of lidocaine is used concurrently.

High doses of lidocaine (over 400 mg) may cause acute toxic reactions manifesting as symptoms affecting the central nervous system and cardiac conduction.

· Lidocaine should be used with caution in patients receiving other local anesthetics or structurally related agents, e.g., some antiarrhythmics, because systemic toxic effects may be additive.

· Lidocaine should be used with caution in patients with epilepsy, impaired cardiac conduction, severely impaired liver function, or severe renal dysfunction. Peribulbar injections of local anesthetics carry a small risk of persistent ocular muscle dysfunction.

REVOLAX DEEP LIDOCAINE WARNING 

REVOLAX DEEP lidocaine is intended for use as an intradermal implant only .

Ensure the product is not expired and sterility has not been compromised before use. The product is for single use only; do not reuse.

If reused, this may result in reduced device performance and serious cross-infection. Used needles and syringes should be disposed of in a designated container.

PRECAUTIONS FOR USE OF REVOLAX DEEP LIDCOAINE INJECTIONS 

REVOLAX DEEP lidocaine is packaged for single patient use only. Do not re-sterilize. Do not use if the package is opened or damaged.

· REVOLAX DEEP Lidocaine should not be injected into an area where there is an implant.

· REVOLAX DEEP Lidocaine should not be mixed with other products prior to device implantation.

· Hyaluronic acid products have a known incompatibility with quaternary ammonium salts such as benzalkonium chloride.

· Do not use in patients with coagulation disorders or in patients who have been treated with thrombolytic anticoagulants or platelet aggregation inhibitors in the previous 2 weeks. Similarly, it is recommended to avoid taking aspirin, non-steroidal anti-inflammatory drugs or high-dose vitamin C in the week before the injection.

· Patients are advised not to wear makeup for 12 hours after the injection and to avoid prolonged exposure to the sun, UV rays, and extreme cold and heat for two weeks after the injection.

· If the needle is blocked, do not increase the pressure on the plunger rod but stop the injection and replace the needle.

SIDE EFFECTS OF REVOLAX DEEP LIDOCAINE INJECTIONS 

Physicians should inform patients that there are potential adverse effects that may occur immediately or be delayed after injection. These adverse effects include, but are not limited to:

· Inflammatory reactions such as redness, swelling and tenderness may occur at the injection site. These reactions may last for two weeks.

· Nodules or indurations are also possible at the injection site.

· Hematomas.

· Coloring or discoloration of the injection site.

· Poor or weak filling effect.

· Cases of glabellar necrosis, abscess formation, granuloma and immediate or delayed hypersensitivity have been reported in the literature following hyaluronic administration and injection. It is therefore important to consider these possible complications.

Patients should report inflammatory reactions that persist for more than one week or any other side effects that develop to their physician as soon as possible. The physician should treat these reactions appropriately.

Any other adverse side effects associated with REVOLAX DEEP lidocaine injection should be reported to the distributor and/or manufacturer.