SAYPHA® FILLER with Lidocaine

Description

Name: SAYPHA® FILLER with Lidocaine
Active Substance(s): HYALURONIC ACID, LIDOCAINE
Volume & Packaging: Two vials
Manufacturer: Croma
Strength: 23mg/ml HA, 3mg/ml Lidocaine
Origin: EUROPE.
Also Included: Package Insert, 2-27G 1/2 needles, 2 traceabillity labels
Package Content: 1 x 1 ml Pre-Filled Syringe, 2 x 27G ½” (0.4 x 12 mm) Needles

Saypha Filler with Lidocaine is a non-animal soft tissue filler manufactured by an Austrian pharmaceutical company, Croma Pharma. The active ingredient—hyaluronic acid—is derived from the fermentation of bacterial cultures and is then processed to be a monophasic gel at a concentration of 23mg/mL. A quick-acting local anaesthetic, lidocaine, has been integrated to provide a painless treatment session for patients. This sterile and pyrogen-free gel is supplied in a single, disposable 1mL syringe and comes with a package insert and 2-27G sterilised needles.

Hyaluronic acid is an extremely versatile and effective substance. It is actually found abundantly in various parts of the human body. Optimal skin hydration and elasticity depend on an adequate amount of hyaluronic acid molecules in the skin’s structure. However, as the body’s biological ageing progresses, the amount and activity of hyaluronic acid diminishes. Hence, the skin’s structure weakens, and lines and wrinkles become more prominent. In addition, some external factors like sun damage and smoking can cause more damage to already aging skin. Saypha Filler with Lidocaine was designed to give a boost of hydration and volume. Once injected, the gel binds to water molecules. Skin is lifted and appears smooth and firm. The gel is administered via small needles for precise results and generally does not cause discomfort. Nevertheless, lidocaine is still integrated to ensure painless injection sessions.

Soft tissue filler injections fall under medical procedure and must be treated as such. The entire treatment must be conducted aseptically in accordance to intradermal injection guidelines. Besides that, only certified medical practitioners with skills and experience in administering skin fillers are permitted to carry out this procedure. During initial consultation sessions, advise your patients to stop consuming any blood-thinning agents (e.g. anticoagulants and anti-inflammatory drugs) a week before treatment day to reduce the risk of bleeding. Before injecting the implant gel, clean and sanitise the proposed area thoroughly. You can still apply some topical numbing cream for patients with poor pain tolerance. Once the skin is ready, administer Saypha Filler with Lidocaine intradermally via mid to deep dermis injections. Lightly massage the skin for best gel distribution.

• Avoid wearing makeup for at 12 hours after treatment;
• Avoid exposing the treated area to harsh temperatures (e.g. direct sunlight, sauna, tanning beds, sunbathing) for a week after treatment.

Patients who have recently had other dermal procedures (e.g. dermabrasions, chemical peels) should wait until complete skin recovery before getting this treatment. Refer to package insert for a detailed list of instructions.

A single Saypha Filler with Lidocaine treatment can improve your patients’ problematic skin instantly after injections, with the effects lasting up to 12 months. The bioresorbable gel is disintegrated into nearby tissues gradually, making it temporary filler. Your patients can get touch-up injections after that period to maintain their radiant visage. Nevertheless, filler’s residence time and effects vary across patients.

Saypha Filler with Lidocaine is a dermal filler renowned for its quality and patient safety profile. Since hyaluronic acid is of non-animal origin, the risk of disease-transmission and allergic reactions from animal proteins is reduced. In addition, hyaluronic acid is a naturally occurring substance in the human body. So, the risk of developing foreign body reactions is also low. That being said, this gel is contraindicated in certain groups of people, including:

• Patients with hypersensitivity to hyaluronan-based products;
• Patients with autoimmune disease;
• Patients on immunomodulators;
• Patients with dermal disorders (e.g. hypertrophic scarring, acne, hives, cold sores);
• Pediatric patients (below 18 years of age);
• Expecting and/or breastfeeding patients.

Refer to package insert for a detailed list of contraindications and warnings.

Patients may experience some discomfort after treatment due to injection process.

• Temporary pain
• Redness
• Swelling
• Bruising

Inform your patients of the possibility of these side effects and assure them that these reactions are normal. Said side effects are mild and should abate within a week. The patient can apply cold packs on treated site to soothe the reactions.

Refer to package insert for a detailed list of adverse side effects.

Saypha Filler with Lidocaine is a hyaluronic acid-based soft tissue filler made from a non-animal source. Bacterial fermentation is conducted in a controlled laboratory setting to produce HA molecules. Advanced cross-linking process reticulates the molecules into a cohesive monophasic gel using 1,4-butanediol diglycidyl ether (BDDE). Lidocaine is added for its quick-acting pain-relief property.

Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.