Aragan Plus

Aragan Plus

sodium hyaluronate

Manufacturer:

Dongkwang

Distributor:

Propharm
Full Prescribing Info
Contents
Sodium hyaluronate.
Action
Pharmacology: Aragan Plus is a high-molecular weight hyaluronic acid derivative sodium hyaluronate prepared in a pre-filled syringe. Aragan Plus is indicated for the improvement of joint function.
Hyaluronic Acid (HA) is an acidic mucopolysaccharide consisting of a chain of alternating n-acetylglucosamine and d-glucuronic acid molecules. In vivo, it combines with protein to form a proteoglycan. In this form, it is hydrophilic and viscous. It serves as a lubricant and performs protective functions.
Hyaluronic acid is a major component of synovial fluid and cartilage. HA plays many key roles in the trophic status of the cartilage and in the regulation of the intra-articular environment. HA is responsible for the viscoelastic properties (shock-absorbing and lubricating abilities) of synovial fluid, which has a lower concentration in osteoarthritis joints than in healthy ones. The molecular weight of HA in the synovial fluid of patients with rheumatoid arthritis is similar to that of patients with other joint disease and moderately but significantly lower than that of normal synovial fluid.
Intra-articular treatment with HA for rheumatoid arthritis patients with osteoarthritis knee pain and patients with periarthritis of the shoulder, is widely accepted. Osteoarthritis of the knee is characterized by pain, stiffness, decreased joint range of motion and increasing disability.
Hyaluronic acid is injected directly into the cavity of an afflicted joint to reduce pain, improve joint range of motion and prevent cartilage degradation.
Indications/Uses
Viscoelastic replacement and supplement for synovial fluid depletion in knee, shoulder joints and other synovial joints. Provides joint lubrication, cartilage protection, pain relief and improves joint range of motion in osteoarthritis, rheumatoid arthritis patients with osteoarthritis knee pain, deforming gonarthrosis and periarthritis of the shoulder.
Dosage/Direction for Use
Adults: The contents of 1 pre-filled syringe (20 mg in 2 mL) to be injected intra-articularly into the affected joint of knee or shoulder once a week for 3 consecutive weeks, strictly using aseptic technique. Several joints may be treated concurrently. Treatment cycles may be repeated if required after 3-6 months depending on the patient's condition.
Contraindications
Hypersensitivity to any components of Aragan Plus. Patients with skin diseases or infections in the area of injection site; hepatic failure or history whereby abnormal values of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been reported; hypersensitivity to avian proteins.
Special Precautions
In case joint inflammation is severe due to deforming gonarthrosis, topical inflammation may become worse with this treatment. So, it is recommended to get rid of inflammatory symptom prior to the injection of Aragan Plus.
As transient local pain in the injected joint may occur after intra-articular injection of Aragan Plus, keep local site still after the injection.
Leakage of the viscous fluid of sodium hyaluronate from the articular cavity may cause pain. Therefore, Aragan Plus should be correctly administered by intra-articular injection.
Transient increase of inflammation in the injected knee may occur after Aragan Plus is injected in some patients with inflammatory arthritis eg, rheumatoidal arthritis or gouty arthritis.
It is recommended that patients should avoid any strenuous activities eg, jogging or tennis or prolonged (ie, >1 hr) weight-bearing activities within 48 hrs after the intra-articular injection.
Use in pregnancy & lactation: Animal test studies have reported no evidence of impaired fertility. However, safety and efficacy have not been determined during pregnancy. Women who are pregnant or considering to have pregnancy should receive the treatment only if the therapeutic benefits outweigh the potential risks.
In animal test studies, it was reported that Aragan Plus is excreted in the milk. Therefore, breastfeeding should be discontinued during the therapy.
Use in children: The safety and effectiveness of Aragan Plus have not been established in children.
Use in the elderly: Generally, elderly patients have weaker physiological functions. Therefore, careful observation is required.
Use In Pregnancy & Lactation
Animal test studies have reported no evidence of impaired fertility. However, safety and efficacy have not been determined during pregnancy. Women who are pregnant or considering to have pregnancy should receive the treatment only if the therapeutic benefits outweigh the potential risks.
In animal test studies, it was reported that Aragan Plus is excreted in the milk. Therefore, breastfeeding should be discontinued during the therapy.
Adverse Reactions
Shock: Since shock may occur though rarely, careful observation is required. In case of shock, Aragan Plus should be discontinued and appropriate measures should be taken.
Hypersensitivity: Edema (facial edema, palpebral edema), facial flare, rare rash, urticaria and itching may occur. In case of any of the adverse reactions, Aragan Plus should be discontinued and appropriate measures should be taken.
Injection Site: Occasional pain (transient pain after administration), swelling, rare dropsy, flare, warmth, severe pressure on topical site and ecchymosis may occur.
Others: Nausea, vomiting, fever and headache may occur.
Drug Interactions
Since there is limited experience available, Aragan Plus should not be administered simultaneously or mixed with other intra-articular injectables.
Caution For Usage
Cautions on Intra-Articular Injection: Strict aseptic administration technique must be followed. If symptoms do not improve after 3 injections, therapy should be discontinued. Joint effusion, if necessary, should be aspirated by arthrocentesis prior to injection of Aragan Plus. Others: Aragan Plus should not be administered by IV injection. It should not be used for ophthalmic therapy.
Caution is required because disinfectants eg, benzalkonium chloride (quaternary ammonium salts) and chlorhexidine can precipitate.
The syringe is intended for single use only. The contents of the syringe must be used immediately once the container has been opened. Discard any unused Aragan Plus.
Inject topical anaesthetic (eg, lidocaine) prior to administration of Aragan Plus.
Storage
Store at 1°-30°C without freezing. Place in a light-resistant, hermetic container.
Shelf-Life: 36 months.
ATC Classification
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Presentation/Packing
Inj 20 mg (clear, colourless, viscous soln in pre-filled syringe) x 2 mL x 3's.
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