DIVES MED HYDRA ROYAL BOOSTER (3x1ml)

DIVES MED

Injectables & Skinboosters

Hyaluronic acid skin booster for mesotherapy / redermalization

CE Marked medical device, CE0297.
Manufactured under ISO 13485 Certified quality management system.
Patent protection EP2170961 related to the Hydra Royal technology.

CE Marked medical device, CE0297.
Manufactured under ISO 13485 Certified quality management system.
Patent protection EP2170961 related to the Hydra Royal technology.

Hyaluronic acid skin booster for mesotherapy / redermalization

Description

DIVES MED HYDRA-ROYAL BOOSTER is a CE-marked medical device based on non-cross-linked, monophasic hyaluronic acid intended for intradermal injection. With a high HA concentration of 60 mg/3 ml (20 mg/ml) and a capacity of 3 x 1 ml, it is designed for deep redermalization, intensive revitalisation and replenishment of age-related hyaluronic acid deficits. The preparation optimises cell regeneration and metabolism, supports fibroblast activity and restores optimal skin water balance, providing multidimensional, long-lasting skin rejuvenation and smoothing visible at the cellular level after just one treatment.

Bnefits

High-concentration non-cross-linked hyaluronic acid 60 mg/3 ml for intensive hydration and redermalization of the skin.
Deep replenishment of endogenous hyaluronic acid deficits that occur with age, improving tissue volume and turgor.
Monophasic, sterile, pyrogen-free injectable medical device designed specifically for aesthetic medicine procedures.
Optimises cellular regeneration and metabolic processes and supports fibroblast activity to improve skin quality and density.
Provides multidimensional and long-lasting rejuvenation and smoothing effects, often visible after a single treatment.
Improves skin water balance, hydration and radiance, giving a pronounced "royal skin" effect.
Reduces the appearance of fine lines, mimic and chronological wrinkles and restores natural skin tension.
Supported by ISO 13485-certified quality system and CE0297 medical device certification.
Can be used in a structured series (4 treatments every 10–14 days) to build cumulative and durable results.
Compatible with established microdepot and retrograde linear injection techniques using needle or cannula, allowing tailored protocols.

Indications

Progressive skin ageing and tissue atrophy.
Numerous wrinkles and skin creases (mimic and chronological).
Dehydrated, dry and dull skin lacking elasticity and turgor.
Photoaging and solar elastosis.
General skin refreshing and revitalisation for tired, devitalised skin.

Composition

Non-cross-linked hyaluronic acid 60 mg/3 ml (20 mg/ml).
Sterile, pyrogen-free aqueous solution with physiological excipients (buffering agents, sodium chloride, water for injection).
Free from lidocaine.

Formulation

Monophasic, non-cross-linked hyaluronic acid injectable booster.
Sterile, pyrogen-free, transparent gel/solution intended for intradermal injection.
Medical device for professional use in aesthetic medicine.
Hyaluronic acid concentration: 60 mg/3 ml (20 mg/ml).

Packaging

Box containing 3 prefilled syringes x 1 ml each (total 3 ml).
Each 1 ml unit contains non-cross-linked hyaluronic acid 20 mg/ml.
Pack designed for multiple separate treatments within a treatment series (according to protocol).

Usage

Product intended strictly for medical use by appropriately trained and qualified healthcare professionals in aesthetic medicine.
Assess patient’s medical history, indications and contraindications prior to treatment; obtain informed consent and follow local regulations.
Cleanse and disinfect the treatment area (face, neck, décolleté, hands or other indicated regions) according to aseptic protocols.
Administer intradermally using appropriate injection techniques, such as microdeposit (micro-papular) technique with a needle or retrograde linear technique with needle or cannula, following the manufacturer’s treatment protocol.
Do not exceed the total recommended volume per session (up to 3 ml across treatment areas, according to clinical judgment and protocol).
Recommended treatment series: 4 sessions performed every 10–14 days, with possible maintenance sessions as clinically indicated.
After injection, gently massage the treated area if appropriate to ensure even distribution and to smooth visible irregularities.
Provide post-treatment care instructions, including avoiding excessive sun exposure, saunas, intense exercise and makeup for a specified period after treatment, in line with clinic protocol.
Monitor for early adverse reactions immediately after injection and instruct the patient on signs that require prompt medical review (e.g. intense pain, blanching, persistent erythema, unusual swelling or discoloration).
Do not mix with other products in the same syringe; if combined with other members of the Hydra Royal family, follow the official combination protocol and volumes.

Contraindications

Hypersensitivity or allergy to hyaluronic acid or any component of the formulation.
Active skin infections or inflammatory processes at or near the treatment site (e.g. herpes, bacterial, fungal or viral lesions).
Autoimmune diseases or uncontrolled systemic diseases where injectable aesthetic procedures are not advised.
Known tendency to hypertrophic scars or keloids in the planned treatment area.
Pregnancy and breastfeeding.
Bleeding disorders or current use of anticoagulant or antiplatelet therapy where injections may increase bleeding risk (unless carefully assessed by a physician).
Recent dermal procedures, laser, peels or other treatments at the same site that may interfere with healing, as per clinical judgment.
Any other contraindication described in the official product leaflet or local clinical guidelines for injectable HA skin boosters.

Adverse Effects

Transient injection-site reactions such as redness, swelling, tenderness, bruising, itching or mild pain.
Small papules or nodules at injection points, usually resolving spontaneously as the product integrates into the tissue.
Temporary disturbances of skin sensitivity (hypo- or hypersensitivity) in the treated area.
In rare cases, inflammatory reactions, prolonged oedema, induration or palpable lumps requiring medical management.
Very rare risk of vascular compromise, ischaemia or necrosis in the event of inadvertent intravascular injection or compression; requires immediate medical intervention according to HA complications protocols.
As with all injectable HA procedures, allergic or hypersensitivity reactions are possible, and emergency management resources should be available.

Storage Conditions

Store at a controlled room temperature, typically between 2°C and 25°C (or as specified in the product leaflet).
Protect from direct sunlight and sources of heat.
Do not freeze.
Keep in the original blister/outer carton until use to maintain sterility and protect from physical damage.
Keep out of the reach and sight of children.
Do not use after the expiry date printed on the packaging or if the blister or syringe appears damaged or previously opened.

Duration

Typically used in an initial series of 4 treatments at 10\u201314 day intervals; longevity of effects and the need for maintenance sessions depend on individual patient factors and clinician assessment.

Onset

Hydration, smoothing and radiance are often visible shortly after the first treatment, with further improvement developing over subsequent sessions as dermal regeneration processes are stimulated.