Aesthetic medicine injectable (dermal filler / medical device)
Peptide\u2013hyaluronic acid dermal filler for medium-to-deep facial wrinkles and skin rejuvenation
Certifications
CE Marked medical device dermal filler (as indicated by European distributors and labelling).
Manufactured by Caregen Co., Ltd., an ISO 13485 Certified medical device manufacturer (and ISO 9001/14001 quality and environmental management certifications at corporate level).
Produced under Good Manufacturing Practice (GMP) Compliant conditions for injectable medical devices.
CE Marked medical device dermal filler (as indicated by European distributors and labelling).
Manufactured by Caregen Co., Ltd., an ISO 13485 Certified medical device manufacturer (and ISO 9001/14001 quality and environmental management certifications at corporate level).
Produced under Good Manufacturing Practice (GMP) Compliant conditions for injectable medical devices.
Supplied in Europe via authorised aesthetic and medical device distributors that comply with local regulatory requirements.
Peptide\u2013hyaluronic acid dermal filler for medium-to-deep facial wrinkles and skin rejuvenation
Description
Prostrolane Natural B is an injectable dermal filler and skin revitalizer developed by Caregen. It combines 0.7% sodium hyaluronate with a patented biomimetic peptide complex in a phosphate-buffered saline (PBS) gel. Designed for mid-to-deep dermal implantation, it corrects moderate to severe facial wrinkles and folds (such as nasolabial folds, marionette lines and perioral lines), helps contour the face and improves skin elasticity, thickness and hydration. The sustained-release peptide technology provides gradual, natural-looking correction while stimulating collagen and elastin synthesis, inhibiting free radicals and supporting long-term skin renewal. The 1 x 2 ml presentation is intended for professional use by trained aesthetic practitioners seeking subtle, natural enhancements and a refreshed, youthful appearance.
Bnefits
Natural-looking correction of moderate to severe facial wrinkles and folds, including nasolabial folds, marionette lines and perioral lines.
0.7% hyaluronic acid delivers deep, long-lasting hydration and volume, improving skin texture and radiance.
Patented peptide complex stimulates fibroblast activity, collagen and elastin synthesis for firmer, thicker, more elastic skin.
Anti-ageing action via free-radical inhibition and support of skin renewal processes.
Sustained-release peptide technology provides a gradual, long-lasting effect rather than an abrupt volumising change.
Suitable for treating medium-to-deep wrinkles across multiple areas: forehead, perioral region, nasolabial folds, marionette lines and temporal fine lines.
CE-marked, biocompatible formulation with low allergenic potential when used as directed in suitable patients.
Indications
Correction of moderate-to-severe facial wrinkles and folds (e.g. nasolabial folds, marionette lines, perioral lines, forehead lines).
Restoration and enhancement of facial contours and shape in areas of volume loss.
Skin revitalisation and rejuvenation for dull, tired or sun-damaged skin.
Improvement of skin elasticity, density and thickness in the face and selected body areas (e.g. back of hands).
Prostrolane Natural B peptide complex: Oligopeptide-24, Decapeptide-36, Octapeptide-11, Oligopeptide-34, Oligopeptide-92.
Low-viscosity gel base suitable for intradermal implantation (full excipient profile proprietary to manufacturer).
Formulation
Sterile, transparent injectable gel for mid-to-deep dermal implantation.
Non-animal origin sodium hyaluronate 0.7% combined with a proprietary biomimetic peptide complex.
Time-delayed, sustained-release technology for gradual peptide delivery over several weeks.
Packaging
1 pre-filled glass syringe containing 2 ml Prostrolane Natural B gel.
Two traceability labels (for patient record and clinic documentation).
Needles are typically not included in the pack and must be sourced separately according to local regulations.
Sterile, single-use, intended for one patient only.
Usage
For professional use only; must be administered by qualified healthcare practitioners trained in dermal injection techniques.
Intended for mid-to-deep dermal injection in indicated areas (e.g. nasolabial folds, marionette lines, perioral region, forehead, temporal fine lines).
Common needle choice: 27G or 30G hypodermic needle, or appropriate microcannula, assembled carefully to the syringe as per IFU.
Recommended techniques include microinjection (without papules), microbolus, linear retrograde threading, or multipuncture, selected according to the area and treatment objective.
Typical protocol from manufacturer materials: approximately 2 ml per treatment area per session (maximum around 4 ml per area) with injections every 2 weeks; many protocols suggest a course of 2–3 sessions, with some clinics using up to 4 sessions based on patient needs.
Before injection, clean and disinfect the treatment area; topical anaesthetic may be applied according to clinic protocol.
Inject slowly and evenly, avoiding intravascular injection; gently massage the treated area after injection to ensure even distribution and reduce the risk of nodules.
After treatment, advise patients to avoid makeup on the treated areas for at least 12–24 hours, and to avoid intense heat, sun/UV exposure, saunas and vigorous exercise for several days or until initial swelling and erythema have resolved.
Document treatment, including lot number and site map, and affix the traceability label to the patient’s record.
Contraindications
Hypersensitivity or known allergy to hyaluronic acid, peptides, or any component of the product.
Active skin infections, inflammatory lesions, or dermatologic disease (e.g. active acne, dermatitis, herpes) at or near the intended injection sites.
History of severe allergic reactions or anaphylaxis, particularly to injectable hyaluronic-acid-based or peptide-based products.
Autoimmune diseases or significant immunological disorders where injectable aesthetic procedures are contraindicated, as per physician judgment.
Uncontrolled diabetes mellitus or significant coagulation disorders that increase risk of bruising or bleeding.
Current systemic infection, fever or severe systemic illness.
Pregnancy or breastfeeding.
Age under 18 years.
Concurrent use of certain medications or treatments that significantly increase bleeding risk or impair healing, as determined by the treating practitioner.
Any general contraindication to dermal filler / mesotherapy-type injections (e.g. recent aggressive skin procedures in the same area) based on professional guidelines.
Adverse Effects
Common, usually transient injection-site reactions: redness (erythema), swelling, tenderness, itching, warmth, slight pain or discomfort.
Bruising or small haematomas at injection sites.
Temporary irregularities such as palpable nodules, induration or mild asymmetry, typically resolving with massage or over time.
Short-term edema or accentuation of lines immediately after treatment, generally settling within days.
Rare local inflammatory reactions, prolonged edema or persistent nodules that may require medical management.
Very rare but serious complications associated with dermal injections, such as vascular occlusion, tissue ischemia or necrosis, or visual disturbances if product is inadvertently injected intravascularly or near critical vessels; emergency protocols should be in place.
Hypersensitivity or allergic reactions (immediate or delayed), though overall risk is low in appropriately selected patients.
Storage Conditions
Store in the original blister and outer carton to protect from light and contamination.
Keep at controlled room/cool storage temperature as specified in the IFU (commonly in the 2–25 °C range for HA-based medical devices); do not freeze.
Do not use after the expiry date indicated on the packaging.
Do not resterilize; single use only. Discard any unused gel and used syringes/needles in appropriate sharps containers.
Keep out of reach of children and unauthorised persons.
Duration
A typical treatment course consists of 2\u20133 sessions spaced about 2 weeks apart (some protocols use 2\u20134 sessions depending on indication and severity). Clinical effects are generally reported to last around 6\u201312 months, influenced by patient age, skin condition, treatment area, lifestyle and metabolism; maintenance sessions can be performed as needed.
Onset
Initial improvement in wrinkle depth, skin hydration and radiance may be visible shortly after the first treatment. Due to sustained-release peptide technology, the rejuvenating and firming effects typically build progressively over 2\u20134 weeks and continue to evolve over the following months.
