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Sinovial Mini

8 mg/1 ml hyaluronic acid sodium salt

Viscosuppletive device for small joints.

Sterile – disposable.

Sinovial ® Mini is made up of a buffered physiological solution of hyaluronic acid sodium salt with visco-elastic properties.

Sinovial ® Mini contains 0.8% of highly purified hyaluronic acid sodium salt with a molecular weight between 800 and 1,200 kDalton. The other components of the product are: sodium chloride, sodium phosphate and water for injectable preparations.

Hyaluronic acid sodium salt (hyaluronan*) is formed by repeated chains of disaccharide units of N-acetylglucosamine and sodium glucuronate. It is a fundamental component of the synovial fluid, to which it gives the particular visco-elastic properties.

The hyaluronic acid sodium salt of Sinovial Mini is obtained by fermentation and has not undergone any chemical modification processes.

Sinovial ® Mini is presented in a 1.25 ml glass syringe containing 1 ml of solution.

The content of the syringe is sterile and pyrogen-free.

Indications

A visco-suppletive treatment for small joints: all the joints of the wrist and hand, including the interphalangeal, intercarpal, metacarpal-phalangeal, carpo-metacarpal, distal radio-ulnar and the radio carpal joint, all the joints in the foot and the temporo-mandibular joint.

Sinovial® Mini substitutes the synovial fluid, which restores the physiological and rheological properties of arthrosic joints.

This therapeutic action is carried out by the special characteristics of the hyaluronic acid used.

The hyaluronic acid in Sinovial® Mini, obtained by fermentation and not chemically modified, shows excellent tolerability.

By restoring the visco-elastic properties of the synovial fluid, Sinovial® Mini reduces pain and re-establishes joint mobility.

Sinovial® Mini acts only at the joint level into which it is injected, without exercising any systemic action.

2-3 treatments a year are recommended, at an interval of 4-6 months, according to medical opinion.

Contraindications

Sinovial ® Mini must not be injected in the presence of an infected or seriously inflamed joint or if the patient has a cutaneous disease or an infection in the area of the injection site.

Side Effects

Extra-articular seepage of Sinovial ® Mini may cause undesired effects locally. During the use of Sinovial® Mini, symptoms such as pain, the sensation of heat, reddening or swelling may appear at the injection site. These secondary emergences can be relieved by applying ice to the treated joint. They generally disappear in a short space of time. Doctors must ensure that patients notify them of any undesired effects which occur after the treatment.

Warnings and Precautions

- The content of the pre-filled syringe is sterile. The syringe is packed in a sealed blister pack. The external surface of the syringe is not sterile.

- Do not use Sinovial® Mini after the expiry date shown on the pack.

- Do not use Sinovial ® Mini if the packaging is open or damaged.

- The injection site must be on healthy skin.

- Do not inject vascularly. Do not inject outside the joint cavity, into the synovial tissue or into the articular capsule.

- Do not administer Sinovial ® Mini in the presence of heavy intra-articular effusion.

- Do not sterilize again. The device was foreseen as a throwaway device only.

- Do not reuse to avoid any risk of contamination.

- Store at 0 °- 25°C away from heat sources. Do not freeze.

- Once opened, Sinovial ® Mini must be used immediately and discarded after use.

- Keep out of reach of children.

- After the intra-articular injection advise the patient to avoid any intense physical activity and to resume his or her normal activities only after several days.

- The presence of an air bubble does not alter in any way the quality of the product.

Precautions for use

Do not mix Sinovial Mini with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may be formed.

Drug Interactions

To date no interactions between Sinovial ® Mini and other medicinal products are known.

Packaging

Packs of 1 and 3 syringes.

Pre-filled syringe (8 mg hyaluronic acid sodium salt in 1 ml buffered physiological solution of sodium chloride).

Steam sterilized.

Instructions for use

- Aspirate any joint effusion before proceeding with the injection of Sinovial® Mini.

- Insert the grip support, included, pushing until it is perfectly in place in the flange of the syringe.

- Pull out the cap of the syringe, being particularly careful to avoid contact with the opening.

- Insert the needle, of 18-22 G diameter.

- Screw the needle tightly to the Luer type closure neck of the syringe to ensure an airtight seal and prevent leakage of liquid during the medication.

- Inject Sinovial® Mini at ambient temperature and under strict asepsis conditions. Inject Sinovial ®Mini only into the synovial space.

TO BE SOLD ON MEDICAL PRESCRIPTION ONLY.

THE INTRA-ARTICULAR INJECTION MAY ONLY BE ADMINISTERED BY A DOCTOR

VISCODERM


0.8%-8mg/1ml Hyaluronic acid sodium salt

1.6%-16mg/1ml Hyaluronic acid sodium salt

2.0%-20mg/1ml Hyaluronic acid sodium salt

TRIO-1.6% – 1.5ml Hyaluronic acid sodium salt

Pre-filled 1ml or 1.5ml syringe

Medical device for intra-dermal use

Sterile-Disposable

Description

Hyaluronic acid (HA) is a polysaccharide which is naturally present in the human body. Its main function consists of maintaining the correct moisturization of the tissues, thanks to its intrinsic capacity to bind a large amount of water. The sodium salt of Hyaluronic acid is formed of repeated chains of disaccharide units of N-acetylglucosamine and sodium glucuronate, and is a fundamentally important component of the extracellular matrix of the majority of tissues, including the skin. VISCODERM constitutes a buffered physiological solution of Hyaluronic acid. The hyaluronic acid used is obtained by fermentation and has not been subjected to chemical change processes. VISCODERM contains the sodium salt of hyaluronic acid, highly purified and with a molecular weight of around 1 million Daltons, which is very close to the natural molecular weight of endogenous hyaluronic acid. It is undoubtedly important to ensure an appropriate choice of molecular weight of the hyaluronic acid and to come close to the natural molecular wight of endogenous hyaluronic acid, as in this manner the product is rendered totally biocompatible.The other components of the product are: sodium chloride, sodium phosphate and water for injectable preparations.

Pharmaceutical Form

VISCODERM appears in the form of a 1.25ml or 2.25ml glass syringe containing 1ml or 1.5ml of solution respectively (VISCODERM TRIO)

The content of the syringe is sterile and pyrogen-free.

Indications

VISCODERM acting through a corrective/filling action of the natural and induced cutaneous hollows, intervenes:

  • In the physiological process of ageing of the skin, the effects of which include inspissation of the horny layer and changes in the elastic fibres of the dermis
  • In the dermal tissue repair process, in cases of scar results following superficial cutaneous trauma (.g. acne and chickenpox scars).

The viscoelastic and moisturizing properties of hyaluronic acid, combined with the possibility to maintain the hyaluronic acid at adequate levels in the cutaneous tissues, allows the moisturizing of the tissues and creation of the optimal condition for preventing and contrasting the skin ageing process, and favors remodeling of the tissue with a consequent corrective effect on scar results on the skin. Hyaluronic acid also has a role inside the extracellular matrix, creating the physiological conditions for the proliferation, migration and structure of the dermal cell component. Moreover, the intradermal administration of VISCODERM and therefore its action on the dermis rather than on the epidermis, allows an optimal quantity of hyaluronic acid to be brought directly into the tissue to be treated, to contrast the cytotoxic action of free radicals on the fibroblasts, ensuring the effectiveness of preventive and corrective esthetic medicine operations. The hyaluronic acid used in VISCODERM is produced through the biosynthesis of a natural substrate without further chemical transformation and VISCODERM therefore has excellent biocompatibility and its use in the dermis allows integration of the hyaluronic acid which has been reduced and modified due to the physiological ageing process of the skin or following superficial cutaneous trauma.

Concentration 0.8%-8mg/1ml Hyaluronic acid sodium salt: indicated for maintenance of the corrective effect of the treatment

Concentration 1.6%-16mg/1ml Hyaluronic acid sodium salt and 24mg/1.5ml Hyaluronic acid sodium salt: indicated for the initial course of treatment of large areas and thin, sensitive skin

Concentration 2.0%-20mg/1ml Hyaluronic acid sodium salt: indicated for the initial course of treatment mostly of the face

An initial course of three treatment sessions at one week intervals is recommended, followed if necessary by monthly maintenance sessions

Contraindications

VISCODERM must not be used with treatments such as laser resurfacing and medium deep skin-peeling

Side Effects

Extra-dermal infiltration of VISCODERM can cause undesired effects locally. During the use of VISCODERM, symptoms such a pain, the sensation of heat, reddening or swelling may appear at the injection site. These secondary emergences can be relieved by applying ice to the treated area. They generally disappear in a short space of time. Doctors must ensure that patients notify them of any undesired effects which occur after the treatment

Warnings and Precautions

Warnings

- The content of the pre-filled syringe is sterile. The syringe is packaged in asealed blister pack

- The external surface of the syringe is not sterile

- Do not use VISCODERM after the expiry date shown on the pack

- Do not use VISCODERM if the packaging is open or damaged

- The injection site must be on healthy skin

- Do not inject intravenously, into muscles, tendons or for mammary expansion

- Do not mix with other products

- Do not inject into areas where inflammation is present

- Do not sterilize again. The device was foreseen as a throwaway device only

- Do not reuse to avoid any risk of contamination

- Store at 0-250 C away from heat sources. Do not freeze

- Once opened, VISCODERM must be used immediately and discarded after use

- Keep out of reach of children

- After the injection and for the following 3-5 days, advise the patient to avoid exposing the treated area to UV rays and to protect it with total block sun-creams

- The presence of an air bubble does not alter in any way the quality of the product

Precautions

Do not concomitantly use disinfectants containing quaternary ammonium salts for skins preparation as hyaluronic acid can precipitate in their presence

Drug Interactions

None know at present

Instructions for use