Aragan Plus

Each syringe (2 mL) contains Sodium Hyaluronate 20 mg.

Deforming Gonarthrocace, Periomarthritis.

Adults: The contents of one pre-filled syringe (20 mg) to be injected into the affected joint once a week to a total of three injections, using a standard technique. Dosage frequency is adjusted according to symptoms. Strict aseptic administration technique must be followed.

Patients with hypersensitivity to any components of this product.
Patients with skin diseases or infections in the area of injection site.
Patients with hepatic failure or history thereof. (Abnormal value of AST and ALT has been reported in patients with history of hepatic failure.)
Patients with a hypersensitivity to avian proteins.

In case that joint inflammation is severe due to deforming gonarthrocace, topical inflammation may become worse with this drug. So, it is recommended to get rid of inflammatory symptom prior to injection of ARAGAN PLUS.
As transient pain in the injected joint may occur after intra-articular injection of ARAGAN PLUS, treatment such as topical stabilization is exercised.
Leaked drug beyond articular cavity may cause pain. Therefore, this injection should be correctly injected by intra-articular injection.
Transient increase of inflammation in the injected knee may occur after ARAGAN PLUS injection in some patients with inflammatory arthritis such as rheumatoidal arthritis or gouty arthritis.
It is recommended patients avoid any strenuous activities such as jogging or tennis or prolonged (i.e. more than 1 hour) weight-bearing activities within 48 hours after intra-articular injection.
Use in Children: The safety and effectiveness of ARAGAN PLUS Inj. have not been established in children.
Use in Elderly: Generally elderly is in the status of low physiological function. Therefore, careful observation is required.

Pregnancy: 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 pregnancy should be administered only if the therapeutic benefits justify the potential risks.
Nursing Mothers: In animal test studies, it was reported the drug is excreted into milk. Therefore, nursing should be discontinued during the therapy.

Shock: Since shock may occur, careful observation is required. In case of adverse reaction, the drug should be discontinued and appropriate measures be taken.
Hypersensitivity: Edema (facial edema, palpebral edema), facial flare, rare rash, urticaria and itching may occur. In case of adverse reaction, the drug should be discontinued and appropriate measures 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.

Since there is limited experience available, this drug should not be administered simultaneously or mixed with other intra-articular injectables.

Cautions on application: Cautions on injection: Strict aseptic administration technique must be followed.
If symptom is not improved after 3 injections, therapy should be discontinued.
Joint effusion, if necessary, should be aspirated by arthrocentesis prior to injection of ARAGAN PLUS.
Others: This preparation should not be administered by intravenous injection.
This preparation should not be used for ophthalmic.
Caution is required because disinfectants such as benzalkonium chloride (quaternary ammonium salts) and chlorhexidine can precipitate.
The syringe is intended for single use. The contents of the syringe must be used immediately once the container has been opened.
Discard any unused ARAGAN PLUS.
Inject topical anesthetic (e.g., lidocaine) prior to administration.
Instruction for Use: The effective period of pain easing may last less than 6 months under the condition of the patient.
Do not use other than for intended purpose.
A skin disinfectant such as alcohol should be applied on the injection site just before actual injection.
ARAGAN PLUS shall be used by a specialized doctor only.
Users should be connected the tip of the needle safely.
It is recommended to use 22-23G needle for injection.
Any product that is damaged, discolored or change in quality should be replaced or refund in the place where the product was delivered.
ARAGAN PLUS is disposable and reuse of the product is prohibited.

Place in a light-resistant, hermetic container and store the product at temperature not exceeding 30°C without freezing.
Shelf life: 36 months from the manufacturing date.

Other Drugs Acting on Musculo-Skeletal System

M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.