Libytec Chondryal Plus injectable solution in pre-filled syringe. 1pc

Libytec Chondryal Plus Temporary Arthritic Fluid Supplement With Syringe 1 Piece

The normal function of articular cartilage is to protect the bones and is to ensure sliding and the damping of the forces during loading. The articular cartilage is constantly exposed to mechanical pressures, which are essential for its health. The loss of the ability to respond to the pressures and the metabolic changes caused by them, leads to degeneration as observed in OA.

Cartilage consists of chondrocytes, intercellular substance, collagen fibers and proteoglycans.

Synovial fluid is a yellowish viscous fluid that fills the joint cavity. It is an ultrafiltrate of the plasma   contains various substances   and hyaluronic acid. Its main functions are the nutritional support and lubrication of the cartilage and the absorption of shocks. The action of synovial fluid as a shock absorber protects the cartilage and bones from the pressures that develop when we move, we walk, run, etc. 

Hyaluronic acid is produced by chondrocytes and synovial membrane cells and is released from them into the synovial cavity. It penetrates the surface layer of the cartilage and synovial membrane creating a protective layer against mechanical injuries and chemical irritations.

In the case of osteoarthritis, the elasticity and viscosity of the synovial fluid is significantly lower compared to the normal joint. An important reason is the decrease in molecular weight and concentration of hyaluronic acid, with the result that its "lubricant" and protective effect is reduced. When this is reduced, the pressures of the weight as a result of normal movement, cause damage to the surface of the cartilage and the synovial membrane.

The exogenous administration of hyaluronic acid activates synovial membrane cells to produce normal hyaluronic acid and provides the structural framework of proteoglycans. At the same time, inflammation cells are reduced and free radicals and peroxides are controlled. 

Chondryal plus is a product for enhancement of viscoelasticity containing a unique combination of Sodium hyaluronate 60mg/3ml and Chondroitin sodium sulphate 90mg/3ml in a pre-filled syringe. The combination is unique and is the first to be released in Greece. The estimated duration of action of Chondryal plus is approximately one year.< /p>

The administration of Sodium hyaluronate provides symptomatic relief in osteoarthritis by restoring the viscoelasticity of the synovial fluid and stimulating the production of hyaluronic acid from the synovial membrane.

Chondroitin sulfate is fundamental to the structural and functional integrity of the joints since it constitutes the majority of the glycosaminoglycans of the articular cartilage. Chondroitin sulfate stimulates the synthesis of proteoglycans by the chondrocytes and inhibits the production of substances   that degrade the cartilage early. It also stimulates the synthesis of high molecular weight hyaluronic acid. 

The unique combination of the two substances can further improve the therapeutic effectiveness and offers:

• Pain relief
• Improved mobility
• Protection of the cartilage

Active Substance: Sodium hyaluronate &Chondroitin sulfate 

Pharmaceutical Form: Inj sol 60mg/3ml

90mg/3ml

Packaging: btx1

DIRECTIONS FOR USE
1. TRADE NAME OF THE MEDICAL TECHNOLOGICAL PRODUCT
CHONDRYAL PLUS
Sodium hyaluronate 60 mg/3 ml and chondroitin sodium sulfate 90 mg/3 ml, injectable solution in
pre-filled syringe.
2.ROUTE OF ADMINISTRATION
For intra-articular injection.
3.DESCRIPTION
DESCRIPTION:
CHONDRYAL is a sterile, viscoelastic solution containing two high
purity cross-linked biopolymers, sodium hyaluronate and chondroitin sulfate sodium. CHONDRYAL PLUS consists of sodium hyaluronate which
derived from bacterial fermentation of Streptococcus strains and sodium chondroitin sulfate
produced from bovine cartilage.
CHONDRYAL PLUS is a sterile viscoelastic solution administered
using aseptic techniques and supplied in a glass syringe containing 3mL
of solution COMPOSITION: Each pre-filled syringe contains sodium hyaluronate 60 mg, chondroitin sodium sulfate 90 mg, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, sodium hydroxide and/or hydrochloric acid (for pH adjustment), water for injections. 4. INDICATIONS INDICATIONS: CHONDRYAL PLUS is indicated as a viscoelastic supplement or as a replacement for synovial fluid in the knee joint. CHONDRYAL PLUS is indicated for the indicated for the symptomatic treatment of
mild to severe osteoarthritis of the knee.The actions of CHONDRYAL PLUS are
lubrication and mechanical support.
5.CONTRA-INDICATIONS
CONTRA-INDICATIONS:< br>CHONDRYAL PLUS is contraindicated in patients with:
known allergy (hypersensitivity) to sodium hyaluronate, chondroitin sulfate, or to
any of the components of CHONDRYAL PLUS
pre-existing infections or skin diseases in the area of infusion.
known infection of the treated joint
known systemic bleeding disorders or bleeding tendency.
CHONDRYAL PLUS may contain traces of proteins from gram-positive bacteria
and is contraindicated in patients with a history of these allergies.
CHONDRYAL PLUS should not be administered to patients with known hypersensitivity to
bovine derivatives.
6.ADVERSE EFFECTS
ADVERSE EFFECTS:
Swelling and transient pain may occur after the intra-articular injection. These
reactions usually resolve within 72 hours.
Reporting of Product-Related Adverse Reactions
The most common adverse reactions associated with CHONDRYAL PLUS injection which
have been reported after circulation of the drug are as follows: arthralgia, joint stiffness, joint swelling, joint hyperthermia, gait disturbance. Cases of fever and malaise have also been reported. These reactions responded to treatment within a few days, by applying
ice to the injection site or treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or with
antipyretics.
DOSAGE AND METHOD OF ADMINISTRATION:
Not intended for intravenous infusion.
The product is administered strictly by intra-articular injection. Do not inject outside the joints.
Strictly aseptic conditions must be observed.
The injection site must be properly disinfected (70% alcohol or other antiseptics).
Do not use , for skin preparation, antiseptics containing quaternary
ammonium salts because hyaluronic acid can precipitate in their presence.
Remove excess fluid, if present, before infusing with CHONDRYAL PLUS.
Recommended puncture before injection.
Remove the pre-filled syringe from the package.Before administration, break the
visible cover and remove the cap from the pre-filled syringe.Apply a
sterile hypodermic needle of an appropriate size (diameter ) and length (inches),
depending on the joint being treated and confirm that it is properly
adjusted by twisting it slightly.
Common needle diameters for knee injection are 18 – 21 gauge (1.2 – 0.8 mm). The final
choice of needle for intra-articular injection is determined by the physician.
Subcutaneous administration of lidocaine or similar anesthetic may be recommended prior to
injection of CHONDRYAL PLUS.
As with any invasive joint procedure , it is recommended that the patient avoid intense or prolonged activities (e.g. more than one hour) that are strenuous such as
running or tennis, for 48 hours after the intra-articular injection. are high
purity biological polymers, the physician should be aware of the potential for
allergic hazards involved in the use of any biological material.
Usual general
precautions should be observed when administering the intra-articular injection.
br>CHONDRYAL PLUS should be administered into the joint space only by
health professionals trained in the intra-articular administration technique.
If pain increases during the infusion process, the infusion should be stopped
and the needle withdrawn.
Patients should be carefully examined before treatment to identify
signs of acute inflammation, and the physician should assess whether the patient should
start treatment with CHONDRYAL PLUS in such a case.
Patients who experience abnormal sequelae after intra-articular administration of
CHONDRYAL PLUS should be consulted a doctor immediately.
The safety and effectiveness of CHONDRYAL PLUS have not been established in
children, adolescents, pregnant or lactating women.
Because there is no clinical data available for the use of sodium hyaluronate and
sodium chondroitin sulfate in patients with coexisting inflammatory arthropathy (such as
rheumatoid arthritis, gout), recent orthopedic surgery, or
trauma to the treated joint, treatment with CHONDRYAL
PLUS is not recommended in these patients.
Cases of increased INR (International Normalized Ratio) have been reported in patients who
received warfarin and glucosamine-chondroitin supplements at the same time.Due to
limited data, caution is required when administering CHONDRYAL PLUS to
patients receiving anticoagulants and antiplatelet agents
CAUTIONS:
Check the expiration date and package integrity before use. Do not
use CHONDRYAL PLUS after the “Expiry Date” stated on the
package.
Do not use the syringe if it is unsealed or damaged.
The product is administered only if the solution is clear.
After opening, the contents of the syringe should be used immediately.
CHONDRYAL PLUS product is for single use!Do not reuse.Each
CHONDRYAL PLUS pre-filled syringe is intended for single use on one patient.
Used needles and syringes must be discarded after injection and must not
be kept for other treatments .Reusing needles or syringes that have
already been used can result in the transmission of infectious agents
(including HIV and hepatitis).
Do not resterilize as this may damage or alter the product.
CHARACTERISTICS AND MODE OF ACTION:
CHONDRYAL PLUS is a viscoreplenishing product, which is safe,
effective and an established treatment for osteoarthritis recommended
injecting a hyaluronic acid solution into the affected joint.< br>CHONDRYAL PLUS acts as a temporary replacement and supplement for synovial
fluid.
CHONDRYAL PLUS relieves joint pain, improves joint
mobility and protects cartilage.
Hyaluronic acid is a major component of synovial fluid and cartilage and, due to its
viscoelastic and rheological properties it is responsible for the lubrication and
absorption of shocks in the joints. It reduces the friction between the articular
surfaces and protects soft tissues from injury by acting as a
shock absorber.
The quantity and quality of hyaluronic acid in the synovial fluid is reduced in patients
suffering from osteoarthritis because its synthesis by the cells of the synovial membrane and
articular cartilage is disturbed. The protection of the articular surfaces is modified
significantly, the cartilage becomes vulnerable and exposed to structural degradation due to the forces
of friction and compression.
Chondroitin sulfate, a sulfated glycosaminoglycan, is an important structural component of the extracellular matrix of cartilage. The role of chondroitin sulfate is to optimize the rheological behavior of hyaluronic acid, due to specific interactions. Additionally, in in vitro studies, the Chondroitin sulfate inhibits the main enzymes involved
in the degradation of the extracellular matrix: metalloproteinases and aggrecanases. Chondroitin sulfate also inhibits the secretion of pro-inflammatory factors. These
data support the observed symptomatic slow clinical action
active in osteoarthritis by improving pain and enhancing functionality.
CHONDRYAL PLUS, given as a single injection, restores good lubrication and
shock absorption in the joint and provides significant improvement of
symptoms.
PACKAGING:
Each CHONDRYAL PLUS pre-filled syringe contains 3 ml of sterile viscoelastic
solution with 60 mg of sodium hyaluronate and 90 mg of chondroitin sulfate sodium.
CHONDRYAL PLUS is available in a carton containing : one blister with
pre-filled syringe and instructions for use.
CHONDRYAL PLUS is a medical device.To be used under the
guidance of a physician.
11.STORAGE
LIFE LIFE AND STORAGE:
Store at temperatures below 25°C, in the original packaging, to
protect from light.
Do not freeze.
12.DATE OF REVISION OF THE TEXT
Date of revision of the text: March 2018< /p>