REVOLAX Deep WITHOUT Lidocaine is a thick injectable hyaluronic acid gel used to treat deep wrinkles and nasolabial creases or augmentation of the cheeks, chin and lips.

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

REVOLAX ™ Deep without lidocaine is a clear, biodegradable, non-animal based, cross-linked dermal filler offering high viscosity and elasticity.

Composition of Revolax Deep without lidocaine

Hyaluronic acid:  24 mg / ml

Volume 1.1ml

Duration Revolax Deep without lidocaine:  12 to 18 months

Across is a Korean laboratory. 

It is CE marked.

REVOLAX:

- High purity hyaluronic acid non-animal

- Natural substances extracted from bacteria

- High purity (endotoxin <0,0015 UI / mg)

- Biodegradable (natural absorption)

- High cross-linking: Across fine cross-linking technology

- Improving durability

- Highly coherent single-phase

- Regular and dense pattern

- Stable and constant gel structure

- Natural effect / Soft injection

- High viscosity and elasticity

- Intensify the persistence of longer durability

- Maintains elasticity by tightly supporting the skin tissue

REVOLAX DEEP WITHOUT LIDOCAINE TECHNICAL SPECIFICATIONS SHEET

DESCRIPTION OF REVOLAX DEEP WITHOUT LIDOCAINE:

REVOLAX DEEP without lidocaine is a sterile, pyrogen-free physiological gel of cross-linked hyaluronic acid of non-animal origin. It is a colourless, unscented and highly viscous aqueous gel.

REVOLAX DEEP without lidocaine is provided as a sterile volume of 1.1 ml in a single-use glass syringe with two sterilized needles.

INSTRUCTIONS OF REVOLAX DEEP WITHOUT LIDOCAINE:

REVOLAX DEEP without Lidocaine is recommended for intradermal implantation for volume loss and morphological asymmetry of the face. 

CONTRAINDICATIONS OF REVOLAX DEEP WITHOUT LIDOCAINE:

· Do not inject REVOLAX DEEP without Lidocaine into the eye area (eye circle or eyelids).

· Do not inject REVOLAX DEEP without Lidocaine into the blood vessels (intravascular).

· REVOLAX DEEP without Lidocaine should not be used in:

- Pregnant or nursing women 

- Persons under 18 years of age

- Patients known to be hypersensitive to hyaluronic acid.

- Patients who tend to develop hypertrophic scars.

· REVOLAX DEEP without Lidocaine should not be used in combination with laser therapy, chemical peeling or skin abrasion.

· REVOLAX DEEP without Lidocaine should not be used in areas with inflammatory and infectious skin problems.

WARNING 

REVOLAX DEEP without lidocaine is intended for use as an intradermal implant only.

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

If reused, this may lead to reduced performance of the device and serious cross-infection. Used needles and syringes must be thrown away in a designated container.

PRECAUTIONS FOR REVOLAX DEEP WITHOUT LIDOCAINE USE 

REVOLAX DEEP without lidocaine is packaged for single patient use. Do not re-sterilize. 

. Do not use if the packaging is open or damaged.

· REVOLAX DEEP without Lidocaine should not be injected into an area where there is an implant.

· REVOLAX DEEP without Lidocaine should not be mixed with other products prior to implantation.

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

· Patients are advised not to wear make-up for 12 hours after the injection and to avoid extended exposure to sunlight, UV light and extreme cold and heat for 2 weeks after the injection.

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

UNDESIRABLE EFFECTS OF REVOLAX DEEP WITHOUT LIDOCAINE

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

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

· Nodules or indurations may also occur at the injection spot.

· Bruises

· Coloration or discoloration of the injection site.

· Poor or weak filling effect.

· 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 to their doctor as soon as possible any inflammatory reactions that persist for more than a week or any other side effects that develop. The doctor should treat these reactions properly.

Any other undesirable side effects associated with REVOLAX DEEP without lidocaine injection should be reported to the distributor and/or manufacturer.