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Croma Saypha Volume with Lidocaine (1 x 1 ml)

Croma Saypha Volume with Lidocaine (1 x 1 ml)

Saypha (by Croma)

Medical device – dermal filler
  • CE Marked hyaluronic acid dermal filler for intradermal/subcutaneous injection in accordance with applicable European medical device regulations.
  • Manufactured under ISO 13485 Compliant quality management system by Croma Pharma GmbH.
  • Non Animal origin hyaluronic acid with low residual BDDE in line with regulatory safety requirements.
Cross-linked hyaluronic acid filler with lidocaine for deep wrinkles and volumising

Description

Croma Saypha Volume with Lidocaine (1 x 1 ml) is a CE-marked, cross-linked hyaluronic acid dermal filler designed for the correction of deep wrinkles and folds, restoration and creation of facial volume, and contouring of facial features. It contains 23 mg/ml of non-animal, BDDE-cross-linked hyaluronic acid in a phosphate-buffered solution with 0.3% lidocaine hydrochloride for improved treatment comfort. Injected into the deep dermis or subcutis, it is indicated for volumising areas such as cheeks, chin and facial contours, and for treating deep nasolabial folds, marionette lines and other pronounced depressions. Results are immediate and typically last 6–9 months, and in some patients up to about 12 months, depending on individual factors.

Bnefits

  • Effectively treats deep facial wrinkles and folds, including nasolabial folds and marionette lines.
  • Restores and enhances facial volume and contours (e.g. cheeks, chin, mid-face).
  • Provides immediate visible results after treatment.
  • Long-lasting effect typically from 6 to 9 months, with some patients maintaining results up to 12 months depending on skin type, age, lifestyle and injection technique.
  • Contains 0.3% lidocaine for increased patient comfort and reduced injection pain.
  • Non-animal, high molecular weight hyaluronic acid with BDDE cross-linking for durable yet natural-feeling results.
  • Supreme Monophasic and Reticulated Technology (S.M.A.R.T.) gel structure for smooth injections and good tissue integration.
  • Supplied as a sterile, apyrogenic single-use pre-filled syringe with thin-wall needles for precise placement.

Indications

  • Correction of deep wrinkles and folds (e.g. deep nasolabial folds, marionette lines, oral commissure lines).
  • Treatment of cutaneous depressions and volume loss in the mid and lower face.
  • Increase or restoration of facial volume (e.g. cheeks, zygomatic area, chin).
  • Remodelling and shaping of facial contours (e.g. jawline definition).
  • Reconstructive purposes in the treatment of facial lipoatrophy, debilitating scars or morphological asymmetry (at the clinician’s discretion).

Composition

  • Cross-linked hyaluronic acid 23 mg/ml (2.3%) of non-animal origin, high molecular weight.
  • Lidocaine hydrochloride 0.3%.
  • Phosphate buffer solution (pH approximately 6.8–7.4).
  • Sodium chloride (NaCl).
  • BDDE (1,4-butanediol diglycidyl ether) as cross-linking agent (residual level ≤ 2 ppm).

Formulation

  • Sterile, pyrogen-free, physiological, viscoelastic gel of cross-linked hyaluronic acid in a phosphate buffer.
  • Hyaluronic acid concentration: 23 mg/ml (2.3%).
  • Lidocaine concentration: 0.3%.
  • Cross-linking technology: BDDE using Croma’s S.M.A.R.T. (Supreme Monophasic and Reticulated Technology).
  • Non-animal origin HA, monophasic, homogeneous gel for deep dermal/subcutaneous injection.

Packaging

  • Box containing 1 x 1 ml pre-filled glass syringe of Saypha Volume with Lidocaine.
  • 2 x 27G ½" thin-wall Terumo-type sterile needles.
  • Instructions for use and traceability labels for patient records and practitioner documentation.

Usage

  • For professional use only: must be injected by suitably qualified and trained healthcare professionals in accordance with local regulations.
  • Intended injection depth: deep dermis or subcutis, depending on the indication and area to be treated.
  • Typical treatment areas: cheeks, cheekbones, chin, jawline, deep nasolabial folds, marionette lines and other deep wrinkles or depressions.
  • Use aseptic technique: disinfect the treatment area and prepare the syringe and needles according to the instructions for use.
  • Inject slowly using appropriate techniques (e.g. linear retrograde, serial puncture, fan technique) to obtain the desired volume and contour while minimising risk of complications.
  • Gently massage the treated area after injection to ensure even distribution of the gel, unless contraindicated.
  • Do not overcorrect; consider individual anatomy, skin quality and volume deficit when determining injection volume.
  • After treatment, advise the patient to avoid makeup on the treated area for several hours, and to avoid extreme temperatures (sauna, sunbeds, intense cold), strenuous exercise and alcohol for 24–48 hours or as per clinic protocol.
  • Follow-up: results and any need for touch-up treatment should be evaluated by the practitioner several weeks after the initial injection.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, lidocaine, amide-type local anaesthetics or any of the excipients.
  • Patients with a history of severe allergy or anaphylactic reaction.
  • Presence of active skin disease, inflammation or infection (e.g. acne, herpes, dermatitis) at or near the intended injection sites.
  • Tendency to develop hypertrophic scars or keloids.
  • Autoimmune diseases or immunosuppressive therapy, unless, in the opinion of the treating physician, the potential benefits outweigh the risks.
  • Blood coagulation disorders or concomitant anticoagulant / antiplatelet therapy where intradermal or subcutaneous injections may pose additional risk, unless carefully assessed.
  • Pregnancy and breastfeeding (not recommended due to insufficient safety data).
  • Injection into blood vessels, glabellar region, or other contraindicated high-risk anatomical zones.

Adverse Effects

  • Common, usually transient injection-site reactions: redness (erythema), swelling, tenderness, pain, itching, bruising or small lumps/bumps, typically resolving within a few days.
  • Short-term altered sensation or discomfort due to lidocaine and needle insertion.
  • Occasional induration, palpable nodules or asymmetry that may require massage, observation or further management by the practitioner.
  • Rare but more serious events: infection, granuloma formation, hypersensitivity reactions, prolonged inflammation or discoloration.
  • Very rare but severe complications: intravascular injection leading to tissue ischemia or necrosis, visual impairment or embolic events; requires immediate recognition and emergency management by an experienced injector.
  • Any unexpected or persistent adverse event must be evaluated and managed by a qualified healthcare professional.

Storage Conditions

  • Store at a temperature as specified by the manufacturer (typically between 2 °C and 25 °C).
  • Protect from freezing and do not expose to excessive heat or direct sunlight.
  • Keep the syringe in its original blister and carton until use to maintain sterility and protect from light.
  • Do not use after the expiry date printed on the packaging.
  • Single-use device: once the syringe has been used for one patient, any remaining product must be discarded and must not be resterilised or reused.
  • Keep out of the sight and reach of children.

Duration

Clinical results generally last between 6 and 9 months. In some patients, effects may persist up to approximately 12 months, depending on factors such as skin type, age, lifestyle, metabolism, treatment area and injection technique. Periodic maintenance treatments are recommended to sustain optimal results.

Onset

Immediate volumising and wrinkle-correcting effect visible directly after injection, with final outcome settling over the following days as any transient swelling or redness subsides.

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