Gialurom cs prosthesis synovial fluid 60mg / 3ml + chondroitin sulfate 90mg / 3m in syringes of 3ml

Description

Composition
Active substance:
1 the syringe comprises sodium hyaluronate 60.00 mg of sodium chondroitin sulfate 90.00 mg.
Excipients:
10.50 mg sodium chloride, sodium dihydrogen phosphate monohydrate 1.35 mg disodium phosphate dodecahydrate 15.15 mg, sodium hydroxide and / or hydrochloric acid (to adjust pH) to pH = 7,4 ± 0,2, water for injection to 3 , 00 ml.
Description:
Gialurom CS – prosthesis synovial fluid, sterile, transparent viscoelastic solution composed of Sodium hyaluronate 60 mg / 3 ml and sodium chondroitin sulfate 90 mg / 3 ml (registered in the RF of 10.09.2008 № RC n N014581 / 01) . Hyaluronic acid is a major component of synovial fluid, determining its viscoelastic properties. It forms the entire inner surface of the joint covering layer which protects the cartilage and synovial membrane from mechanical damage, as well as free radicals and inflammatory factors. Chondroitin sulfate is a natural glycosaminoglycans (GAG’s) composed of alternate sugars D-glucuronic acid and N-acetyl-Dgalaktozamina. Chondroitin sulfate is obtained as the sodium salt from bovine trachea and used for preparing active pharmaceutical ingredients. Chondroitin sulfate is a stimulator of tissue regeneration, it promotes water retention and cushioning functions in the reconstruction of cartilaginous tissues. It promotes the synthesis of collagen and protection, which is the structural basis of all connective tissue and increases the production of hyaluronic acid in the synovial cells that has a beneficial effect on the maintenance of viscosity of synovial fluid. Use of chondroitin sulfate together with sodium hyaluronate helps slow degradation and stimulate cartilage regeneration
Gialurom CS transparent viscous solution from colorless to brown in disposable glass syringes hydrolytic class I, equipped with a needle fixation system Luer Lock type, complete with needle with a triangular laser grinding, sharpening angle alpha (11 +/- 2) °. Graduations syringe offline, it is not required, since the contents of one syringe is used once and is used for only one patient. The injection needle (brand DIN1.4306, DIN1.4301) of austenitic stainless medical stainless steel with a low carbon content, sterilized with ethylene oxide (EO). 2/4 Gialurom CS has a dynamic viscosity in the range 80-140 Pa • s, osmolality is 275-365 mOsmol / kg, the density of the solution – 1,013-1,043 g / cm3. Scope: surgery, traumatology, orthopedics, rheumatology.
Product form:
Gialurom CS – sterile solution for intra-articular administration in prefilled disposable syringes glass of hydrolytic class I to 3 ml containing sodium hyaluronate 60 mg / 3 ml and sodium chondroitin sulfate 90 mg / 3 ml. 1 a pre-filled syringe 1 sterile injection needle (EO) 0,8h40 mm (21G) in acheikova polymer packaging together with instructions for use in a stack of cardboard.
Contraindications
– Identify increased sensitivity to components of the medical device; – the presence of active inflammatory or infectious processes in the joint; – signs of active skin disease or skin infection in the proposed injection; – application in patients with an established diagnosis of autoimmune disease or undergoing immunotherapy; – application in pregnancy or lactation; – up to age 18 years.
Dosage
60 mg + 90 mg
Indications
CS Gialurom used: – for the symptomatic treatment of osteoarthritis, mild, moderate or severe; – with pain and limited mobility caused by degenerative-dystrophic or post-traumatic changes of the knee, hip and other synovial joints; – to relieve pain after arthroscopy (application is possible not earlier than 1 week after the intervention).
pharmachologic effect
Pharmacological properties:
Gialurom CS is intended to compensate for the volume and restore the viscosity of the synovial fluid in the joints. CS Gialurom dissolved in the synovial fluid, exerting a beneficial effect. It is subjected to local transformation into the joint cavity, normalizes the properties of the synovial fluid, restoring its lubricating and shock-absorbing functions. The highest concentration of hyaluronic acid in studies detected in synovial fluid and articular capsule, lower concentrations – in the synovial membrane surrounding ligaments and muscles, excretion is mainly carried out by the kidneys. Recommended administration of a single injection, the effect lasts for at least 6 months. This therapy of osteoarthritis is a common, safe and effective. CS Gialurom administered in single restores lubricating and cushioning properties of synovial fluid, has a marked and lasting analgesic effect and significantly reduces the restriction of mobility of joints. Sodium hyaluronate obtained by bacterial fermentation. Data on the incompatibility of the application at the same time there are no drugs. Gialurom CS is a medical device.
side effects
May experience moderate pain and swelling at the injection site. The above symptoms are transient and usually disappear after 72 hours.
Storage conditions
Store at a temperature not higher than 25 C, in the original package, in a dry place.
Do not freeze. Keep out of the reach of children.
Dosing and Administration
CS Gialurom designed for intraarticular injection.
The solution should not be injected outside the joint cavity, as well as patients with infections, or diseases of the skin at the injection site.
Intra-articular injection should be administered experts trained art intraarticular injection and performed under aseptic conditions in hospitals. Perhaps the use of local anesthetics prior to the intra-articular injection, eg, subcutaneous injection of lidocaine.
It is necessary to properly disinfect the injection site (use 70% alcohol solution or other disinfectants). It should not be used disinfectants comprising quaternary ammonium salts (e.g., benzalkonium chloride), since the precipitation reaction is possible.
Before the introduction of Gialuroma CS should remove fluid from the joint cavity. Recommended holding artrotsenteza before the introduction of the solution. After removal of the protective cap from the syringe tip, to attach the sterile syringe needle. Typically, the knee joint using a needle size 0,8h40 mm (21G), to other joints we recommend using a needle desired size (from 17G to 22G), depending on the joint. CS Gialurom injected into the joint in the amount depending on the size of the joint. joint cavity must not be overloaded.
Each pre-filled syringe is intended for single use. Contents of the syringe should be used immediately after opening. Unused completely dissolved can not be stored and should not be re-sterilized.
After injection Gialuroma CS, the patient is advised to adhere gentle treatment and to avoid excessive or prolonged stress on the joints (e.g., running or tennis game) for 48 hours.
PRECAUTIONS FOR ADMINISTRATION
Before use, check the expiry date and the integrity of the packaging. Do not use after the expiration date printed on the package. The use of open and / or damaged sterile packaging is not allowed. Used for the injection needle and syringe should not be reused. Re-sterilization is not allowed.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist