Juvederm Hydrate (1x1ml)

Juvederm

Derma fillers

Skin booster / hydrating hyaluronic acid dermal filler

CE Marked Class III medical device; European CE mark granted in December 2009 for Juvéderm Hydrate
Manufactured under medical device quality management systems in compliance with EU medical device regulations for hyaluronic acid injectables
Part of the Juvéderm ULTRA range of hyaluronic acid dermal fillers from Allergan

CE Marked Class III medical device; European CE mark granted in December 2009 for Juvéderm Hydrate
Manufactured under medical device quality management systems in compliance with EU medical device regulations for hyaluronic acid injectables
Part of the Juvéderm ULTRA range of hyaluronic acid dermal fillers from Allergan

Skin booster / hydrating hyaluronic acid dermal filler

Description

Juvederm Hydrate (1x1ml) is a non-crosslinked hyaluronic acid skin booster from the Juvéderm ULTRA family, formulated with 13.5 mg/mL hyaluronic acid and 0.9% mannitol, an antioxidant. It is a CE-marked injectable medical device designed to improve skin hydration, elasticity and luminosity in photo-damaged and ageing skin. Unlike traditional volumising fillers, Juvéderm Hydrate acts primarily as a hydrating agent: it is injected into the superficial dermis as multiple micro-deposits to attract and retain water, giving smoother, firmer and more radiant skin on the face, neck, décolletage and hands.

Bnefits

Deep, long-lasting hydration of the superficial dermis to improve skin quality rather than volume
Improves skin elasticity, texture and luminosity in areas prone to sun damage and early ageing (face, neck, décolletage, hands)
Non-crosslinked hyaluronic acid (13.5 mg/mL) provides biocompatible hydration and subtle plumping
Mannitol 0.9% acts as an antioxidant to help neutralise free radicals and slow degradation of hyaluronic acid, prolonging results
Clinically shown to enhance skin smoothness, brightness and moisture levels, with high patient satisfaction in studies
CE-marked medical device specifically developed as a skin-hydration treatment rather than a volumising filler
Suitable as a stand-alone skin revitalisation procedure or as a complement to other anti-ageing treatments

Indications

Improvement of skin hydration and elasticity in the face, neck, décolletage and hands
Photo-damaged or dull skin showing early signs of ageing such as fine lines, loss of radiance and mild laxity
Patients seeking skin revitalisation and glow without significant volumisation or contour change
Adjunctive treatment alongside other dermal fillers, botulinum toxin or aesthetic procedures, as determined by a qualified practitioner

Composition

Non-crosslinked hyaluronic acid 13.5 mg/mL (non-animal origin, produced by Streptococci bacterial fermentation)
Mannitol 0.9% (antioxidant to reduce free radical–mediated degradation of HA)
Physiological buffer and excipients (e.g. phosphate buffer solution, water for injection; exact excipient list per official IFU)
Does NOT contain lidocaine

Formulation

Class III, CE-marked sterile, pyrogen-free, viscoelastic gel for intradermal injection
Active substances: Hyaluronic acid 13.5 mg/mL and mannitol 0.9%
Non-crosslinked, non-animal hyaluronic acid skin booster, part of the Juvéderm ULTRA family
Intended for superficial dermal injections in multiple small boluses (mesotherapy / skin booster technique)
Supplied as a single 1 mL prefilled glass syringe with luer-lock connection
Pack usually includes 2 sterile 30G 1/6" needles for injection

Packaging

Single-use 1 x 1 mL prefilled syringe of Juvederm Hydrate in an individual box
Each box typically contains: 1 prefilled syringe, 2 sterile 30G 1/6" needles, traceability labels and instructions for use (IFU)
External carton printed with product name, batch number, expiry date, CE mark and manufacturer details

Usage

For use only by appropriately trained and qualified healthcare professionals experienced in dermal filler and skin booster injection techniques.
Assess the patient’s medical history, indications and contraindications before treatment; obtain informed consent.
Cleanse and disinfect the treatment area according to local clinical protocols; topical anaesthetic may be applied if needed.
Inject Juvéderm Hydrate into the superficial dermis using multiple micro-injections (mesotherapy / skin booster technique) over the selected treatment area (face, neck, décolletage, hands).
Common clinical practice is to perform a course of 2–3 sessions spaced several weeks apart, followed by maintenance sessions every 6–12 months, tailored to the patient and clinic protocol.
Do not overcorrect; distribute product evenly and massage gently if required to ensure uniform placement.
After treatment, advise the patient to avoid makeup for several hours, intense heat (sauna, sunbeds), strenuous exercise and alcohol for 24 hours, and to use sunscreen regularly.
Dispose of any unused product, the syringe and needles immediately in appropriate sharps and clinical waste containers. Do not resterilise or reuse.

Contraindications

Known hypersensitivity to hyaluronic acid, mannitol or any of the excipients in the formulation
Active skin infections, inflammatory skin diseases or lesions at the proposed injection sites
History of severe allergy or anaphylactic reaction to injectable hyaluronic acid products
Autoimmune disorders or immunosuppressive therapy, unless carefully evaluated and approved by a physician
Pregnancy and breastfeeding (use is generally not recommended due to limited safety data)
Known tendency to develop hypertrophic scars or keloids, or presence of untreated systemic disease that may impact wound healing
Injection into blood vessels, compromised skin, or in combination with certain other cosmetic procedures at the same session without appropriate clinical judgement

Adverse Effects

Transient injection-site reactions such as redness, swelling, pain, tenderness, itching or bruising
Small papules or bumps at the injection points which usually resolve within a few days
Occasional haematoma formation at injection sites
Rare inflammatory reactions, nodules or hypersensitivity responses, as with other HA-based injectables
Very rare but serious complications can occur if injected intravascularly (e.g. vascular occlusion); practitioners must be trained to recognise and manage such events
As with any minimally invasive procedure, there is a small risk of infection if aseptic technique is not strictly observed

Storage Conditions

Store in the original packaging at a controlled room temperature as specified on the box (typically between 2 °C and 25 °C).
Protect from freezing and from excessive heat or direct sunlight.
Do not use after the expiry date indicated on the packaging.
Keep the syringe and needles in their blister until immediately prior to use to maintain sterility.

Duration

Results typically last several months; published information and clinic reports suggest an average duration of around 4\u20136 months, with some sources indicating up to 6\u20138 months depending on individual factors and protocol. A course of 2\u20133 initial sessions with maintenance once or twice a year is commonly used in clinical practice.

Onset

Hydration and improved skin radiance may be noticeable within days to a few weeks after treatment; full improvement in skin texture and elasticity is usually seen after completion of the initial course of sessions and continues for several months.