Xuvan/Xuvan XL

Xuvan/Xuvan XL

sodium hyaluronate

Manufacturer:

Mega Lifesciences

Distributor:

Metro Drug
Full Prescribing Info
Contents
Sodium hyaluronate.
Description
Characteristics: Sodium Hyaluronate is the physiological substance that is widely distributed in the extra cellular matrix of connective tissues in both animals and man. For example, it is present in the vitreous and aqueous humor of the eye, the synovial fluid, the skin, and the umbilical cord. Sodium Hyaluronate derived from various human or animal tissues does not differ chemically.
Xuvan: Xuvan is a sterile, non-pyrogenic, transparent viscoelastic preparation of highly purified, non-inflammatory, high molecular weight fraction of Sodium Hyaluronate. Xuvan contains 10 mg/mL of Sodium Hyaluronate dissolved in Physiological Sodium Phosphate buffer (pH 7.0-7.5). This polymer consists of repeating disaccharide units of N-acetyl-glucosamine and Sodium glucoronate linked by β (1-3) and β (1-4) glycosidic bonds.
Each mL contains: Sodium Hyaluronate BP 10 mg, Sodium chloride USP 8.5 mg, Di-Sodium Hydrogen Phosphate Dihydrate USP 0.28 mg, Monosodium Phosphate Monohydrate USP 0.04 mg, Water for Injection USP q.s.
Xuvan XL: Xuvan XL is a sterile, clear, viscoelastic preparation containing non-pyrogenic, high molecular weight (average 6 million Dalton), non-inflammatory fraction of cross linked water insoluble sodium hyaluronate and water soluble sodium hyaluronate polymers. This polymer consists of repeating disaccharide units of N-acetyl-glucosamine and sodium glucuronate linked by β 1-3 and β 1-4 glycosidic bonds. The hydration fluid is isotonic sodium chloride solution (pH 7.2).
Each mL contains: Sodium Hyaluronate BP 8 mg, Sodium chloride USP 8.50 mg, Disodium Hydrogen Phosphate Dihydrate USP 0.16 mg, Monosodium Phosphate Monohydrate USP 0.04 mg, Water for Injection USP q.s.
Contains no preservatives.
Action
Xuvan: Pharmacology: Mechanism of action: The precise mechanism of action of sodium hyaluronate is unknown; however, proposed dual mechanisms of sodium hyaluronate activity include: Mechanical/Physical: Replaces osteoarthritis (OA) synovial fluid with higher HA concentration-improves viscosity.
Restores shock-absorbing, lubricating ability of depleted synovial fluid.
Maintains boundary layer around nociceptors, reducing pain induction.
Physiological: Induces biosynthesis of HA and extracellular matrix components.
Reduces proteoglycan loss in cartilage and apoptosis of chondrocytes.
Reduces inflammatory cell activities to reduce HA degradation.
Reduces induction of pain mediators.
Pharmacokinetics: Hyaluronic acid occurs naturally in body tissues and fluids. It is secreted by cells in synovial membranes, in healthy synovial joints, maintains viscosity of synovial fluid and supports lubricating and shock absorbing properties of the cartilage. In osteoarthritis synovial fluid is decreased in viscosity and elasticity. Sodium hyaluronate replaces diseased synovial fluid. Following intraarticular use, sodium hyaluronate permeates cartilage and solely moves through joint tissues, it then passes through the lymph system into systemic circulation. Hyaluronic acid is metabolized by hyaluronidase in synovium.
Indications/Uses
Xuvan/Xuvan XL is indicated for the treatment of pain in osteoarthritis (OA) of the knee, in patients who have failed to respond adequately to conservative non-pharmacologic therapy, and to simple analgesics, e.g., acetaminophen/paracetamol.
Dosage/Direction for Use
Strict aseptic administration technique must be followed. Inject subcutaneous lidocaine or similar local anesthesia/anesthetic prior to injection of Xuvan/Xuvan XL.
Aspirate joint effusion before injection of Xuvan/Xuvan XL. Do not use the same syringe for removing joint effusion and for injection of Xuvan/Xuvan XL.
Take care to remove the tip cap of the syringe and needle aseptically. Inject Xuvan/Xuvan XL into the joint through a 19G sterile Needle/19 gauge needle.
The syringe is intended for single use. The contents of the PFS/syringe must be used immediately once the container is opened. Before injection, the air bubbles are removed from the injection.
Xuvan: Direction for Use: Xuvan is administered by intra articular injection. A treatment cycle consists of three to five injections given at weekly intervals. Several joints can be treated simultaneously.
Inject the full 2 mL in one knee only. If treatment is bilateral, a separate syringe should be used for each knee.
Xuvan XL: A single injection of Xuvan XL is administered by intra-articular route.
Inject the full 6 mL in one knee only. If treatment is bilateral, a separate syringe should be used for each knee.
Overdosage
Xuvan: Seek emergency medical attention if the patient has received too much of this medicine. An overdose of sodium hyaluronate is not expected to produce life-threatening symptoms.
Contraindications
Xuvan: Do not administer to patients with known hypersensitivity to hyaluronate preparations.
Intra-articular injections are contraindicated in cases of present infections or skin diseases in the area of the injection site to reduce the potential for developing septic arthritis.
Xuvan XL: Xuvan XL is contraindicated in patients with known history of hypersensitivity (allergy) to sodium hyaluronate (hyaluronan) preparations.
Xuvan XL is contraindicated in patients with knee joint infections or skin diseases in the area of injection site.
Warnings
Do not use concomitantly with disinfectants containing quaternary ammonium compounds for skin preparations, because Sodium Hyaluronate acid can precipitate in their presence.
Do not inject Xuvan/Xuvan XL extra-articularly or into the synovial tissues and articular capsules. This will generally result in local and systemic adverse events.
Intravascular injections of Xuvan/Xuvan XL may lead to systemic adverse events.
Special Precautions
General: The safety and effectiveness of the use of sodium hyaluronate solution in joints other than the knee have not been established.
The safety and effectiveness of the use of sodium hyaluronate solution concomitantly with other intra-articular injectables have not been established.
Strict aseptic administration technique must be followed to avoid infections in the injection site.
The safety and effectiveness of the use of Xuvan/Xuvan XL in severely inflamed knee joints have not been established.
The pre-filled syringe is intended for single use. Use the contents of the syringe immediately after its packaging is opened. Discard any unused Xuvan/Xuvan XL.
Opened or damaged packages of Xuvan/Xuvan XL should not be used. Always store in the original packaging (protected from light) at 30°C (86°F). DO NOT FREEZE.
Aspirate synovial effusion, if present, before each Xuvan/Xuvan XL injection.
Xuvan/Xuvan XL should be used with caution when there is evidence of lymphatic or venous stasis in that leg.
Xuvan: The effectiveness of a single treatment cycle of less than 3-5 injections has not been established.
Xuvan XL: Xuvan XL should be used with caution in diabetic patients and patients with chronic disorders.
Information for Patients: Transient pain, and/or swelling of the injected joint may occur after intra-articular injection of sodium hyaluronate solution.
As with any invasive joint procedure, it is recommended that the patient should avoid any strenuous activities or prolonged (i.e., more than 1 hour) weight-bearing activities such as jogging or playing tennis within 48 hours following the intra-articular injection. The patient should consult the attending physician regarding the appropriate time to resume such activities.
Xuvan: Provide patients with a copy of the Patient Information prior to use.
Xuvan XL: In some cases effusion may be considerable and can cause pronounced pain. Discuss with the physician if the swelling is extensive.
If the patient needs to repeat the dose, the second injection of Xuvan XL should be administered at least after 6 months.
Xuvan: Effects on ability to drive and use machines: Xuvan is not expected to affect the ability of the patient to operate machinery or drive a motor vehicle. However, it is recommended to watch for any signs of discomfort following the intra-articular administration.
Use in Pregnancy: Teratogenic Effects: The safety and effectiveness of sodium hyaluronate solution have not been established in pregnant women.
Use in Lactation: It is not known if sodium hyaluronate solution is excreted in human milk. The safety and effectiveness of sodium hyaluronate solution have not been established in lactating women.
Use in Children: The safety and effectiveness of sodium hyaluronate solution have not been demonstrated in children.
Xuvan XL: Use in Specific Populations: Pregnant women, Nursing mothers and Pediatric age group: The safety and effectiveness of Xuvan XL have not been established in pregnant women, lactating mothers and pediatric patients, defined as patients ≤ 21 years of age.
Use In Pregnancy & Lactation
Xuvan: Use in Pregnancy: Teratogenic Effects: The safety and effectiveness of sodium hyaluronate solution have not been established in pregnant women.
Use in Lactation: It is not known if sodium hyaluronate solution is excreted in human milk. The safety and effectiveness of sodium hyaluronate solution have not been established in lactating women.
Xuvan XL: Pregnant women and Nursing mothers: The safety and effectiveness of Xuvan XL have not been established in pregnant women and lactating mothers.
Adverse Reactions
Placing an ice pack on the treated joint for 5 to 10 minutes would reduce the occurrence of such side effects.
Xuvan: Intra articular injection may lead to local side effects like pain, heat sensation, reddening and swelling at the treated joint.
Xuvan XL: The following adverse events are among those that may occur in association with intra-articular injections, including Xuvan XL: Arthralgia, Joint stiffness, Joint effusion, Joint swelling, Joint warmth, Injection site pain, Arthritis, Arthropathy, Gait disturbance.
Drug Interactions
Xuvan XL: No information available.
Storage
Protect from light and moisture.
Store below 30°C.
Do not freeze.
ATC Classification
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Presentation/Packing
Xuvan: Inj (pre-filled syringe) 20 mg/2 mL (sterile, non-pyrogenic, viscoelastic preparation) x 2 mL x 1's.
Xuvan XL: Inj (pre-filled syringe) 8 mg/mL (sterile, non-pyrogenic viscoelastic preparation) x 6 mL x 1's.
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