What it is
Jalupro HMW is an injectable, sterile, re-absorbable implant for intradermal use in two parts: one single-use glass syringe (A) with 20 mg of sterile sodium hyaluronate gel and one single-use glass bottle (B) with 80 mg of sterile amino acid solution. The parts are reconstituted before use.
Intended use (per instructions for use)
Indicated for the treatment of skin defects and depressions caused by wrinkles and scars. The product acts as a filler and as a tissular lubricant that can minimise the evidence of skin furrows, and supports the restoration of physiological conditions of elasticity and temporary volume substitution. It is a filler for skin imperfections of mild to moderate entity; the more marked the defects, the more its efficacy and duration are reduced. It can be used concomitantly with physical or chemical treatments, such as peeling, laser therapy and dermabrasion, and then acts as an adjuvant.
Composition
Water for injection, sodium hyaluronate, glycine, L-proline, L-leucine, L-lysine HCl.
Treatment
- Contents: 1 pre-filled syringe (A) and 1 bottle (B). The package does not contain needles; the choice of needle is up to the physician.
- Reconstitution: using an aseptic technique, the gel in the syringe (A) is injected directly into the bottle (B); the needle used should preferably be discarded. The bottle is shaken until a homogeneous, moderately viscous solution is obtained, which is drawn up into the syringe before the needle is changed. The extractable volume is 2.5 ml.
- Injection: intradermally. The area is sterilised before treatment, and an anaesthetic cream can be applied about 30 minutes before. For very limited defects the papillary dermis is usually the most suitable; for marked defects the best result is obtained by injecting into the central part down to the deep reticular dermis, if necessary supplemented with a more superficial injection. Insert the needle along the furrow and withdraw it gradually while delivering the gel; inject slowly and avoid excessive amounts. Light massage if needed. The dosage is up to the physician, and the treatment must not be repeated before three days have passed. See the instructions for use for the recommended treatment course.
Important to know
For use only by physicians. Contraindicated in case of known hypersensitivity to the components, in skin irritation or inflammatory processes in progress in the area to be treated, and in patients predisposed to coagulation disorders. In pregnancy and lactation the treatment should only be performed at the physician's discretion after a careful anamnesis. The content of the syringe must not be used separately from the content of the bottle. Do not inject into veins, do not mix with other implants or injectable products, do not re-sterilise and do not freeze. The product is for single use, one patient and one session; the reconstituted product (syringe A + bottle B) must not be re-used for other applications. Rarely, local reactions (oedema, heating sensation, itching) may occur and normally resolve spontaneously within two days; infection is more rare. Do not expose the treated area to sources of heat until swelling has reabsorbed. Unused product and the used needle are disposed of as hospital waste.
Storage and shelf life
Store at 5–25 °C in a cool and dry place, protected from moisture and sources of heat. Do not freeze. The expiry date refers to the unopened and correctly stored product.
Documentation and traceability
Medical device, CE 0373 (Directive 93/42/EEC). Manufacturer: Professional Derma SA, Lugano, Switzerland. EC representative: QUASER S.r.l., Rome, Italy. Made in Italy. See the attached Norwegian instructions for use (BC translation rev. 01, 26.10.2026; the manufacturer's package leaflet was last revised 07.05.2021 according to the Ukrainian part). The additional label in the package is attached to the patient file.
