Adant Dispo

Adant Dispo

sodium hyaluronate

Manufacturer:

Meiji

Distributor:

DKSH
Full Prescribing Info
Contents
Sodium hyaluronate.
Description
Sodium hyaluronate is a purified product of fermentation using Streptococcus sp.
Adant Dispo has a pH of 6.8-7.8. Its osmotic pressure ratio (OPR) to Isotonic Sodium Chloride Solution JP (The Japanese Pharmacopoeia) is 1-1.2.
Action
Adant Dispo serves to cover and protect the surface of the articular cartilage, inhibits degenerative changes of the cartilage tissue, improves movability of the contracted joint, and inhibits articular pain.
Actions on the Articular Cartilage: Incorporation of Adant Dispo into the surface layer of cartilage was observed after injection into the intra-articular space of the knee of normal rabbits. The product distributed well in the cartilage tissue of patients with osteoarthritis of the knee (in vitro) from the surface layer to the deeper layers with the passage of time. This distribution corresponded to the sites where proteoglycans were lost.
Adant Dispo inhibited the release of proteoglycans from bovine articular cartilage cells (in vitro).
Adant Dispo inhibited further degeneration of the cartilage in the knee osteoarthritis model and fixed knee joint contracture model in rabbits by intra-articular injection.
Improvement of Articular Movability: Adant Dispo improved articular movability of the knee in a rabbit model of fixed knee joint contracture by intra-articular injection.
Pain Inhibitory Effect: Adant Dispo inhibited crystalline urate-induced pain of the knee joint in dogs.
Indications/Uses
Osteoarthritis of the knee, scapulohumeral periarthritis.
Dosage/Direction for Use
Adults: Usually, the content of 1 disposable syringe is injected once a week for 5 consecutive weeks into the intra-articular space of the knee joint or the shoulder joint (intra-articular space of the shoulder joint, subacromial bursa or long head tendon sheath of brachial biceps). However, the dosage should be adjusted according to the severity of the symptoms.
Since Adant Dispo is injected into the joint, the process should be conducted under strict aseptic conditions.
How to Use Adant Dispo: Take the syringe out of the blister pack. Since the syringe is made of glass, handle it carefully. If there is any defect, do not use this product. Cut off the tips of the wings of the finger grip on the middle of the syringe by hand and pull them apart until they are fixed. Remove the rubber stopper by turning it lightly. Put the 22G or 23G injection needle. Push the plunger rod and administer.
Note: Before the administration, disinfect the injection site thoroughly. After the administration, the syringe and needle can be disposed of separately.
Contraindications
History of hypersensitivity to any ingredient of Adant Dispo.
Special Precautions
Adant Dispo should be administered with care in the following patients:
Patients with a history of hypersensitivity to other drugs.
Patients with hepatic disorder or with a history thereof. [Abnormal values of AST (GOT), ALT (GPT) were seen in a patient with a history of hepatic disorder.]
Patients with dermatosis or infection in the joint (since Adant Dispo is injected into the joint).
Important Precautions: Adant Dispo may worsen local inflammation in patients with osteoarthritis of the knee who present with marked inflammation of the joint. Therefore, it is advisable to administer this product after the local symptom has alleviated.
Local pain may infrequently occur due to the administration of Adant Dispo. To avoid pain after the injection, the patient should be instructed to stay still for a while.
Adant Dispo must be injected exactly into the intra-articular space. Otherwise, it may cause pain.
Use in pregnancy & lactation: Adant Dispo should be used in pregnant women or women who may possibly become pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment. (No teratogenicity was detected in rabbits, but its safety in pregnant women has not been established.)
Breastfeeding must be discontinued during the administration of Adant Dispo. (Transfer of the product in milk has been confirmed in rats.)
Use in children: The safety of Adant Dispo in low birth weight infants, newborns, suckling infants, infants and children has not been established.
Use in the elderly: Since elderly patients often have reduced physiological functions, Adant Dispo should be administered with care.
Use In Pregnancy & Lactation
Use in pregnancy & lactation: Adant Dispo should be used in pregnant women or women who may possibly become pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment. (No teratogenicity was detected in rabbits, but its safety in pregnant women has not been established.)
Breastfeeding must be discontinued during the administration of Adant Dispo. (Transfer of the product in milk has been confirmed in rats.)
Adverse Reactions
Injection site pain (mainly transient pain after the administration) and swelling (<5%), edema, redness, hot feeling and heaviness in the injected site (<0.1%), hypersensitivity eg, rash and itching (<0.1%), or edema (face, eyelid, etc), facial redness, nausea, vomiting, and fever may occur. Shock symptom may occur, therefore, patients should be carefully monitored and if any abnormality is observed, the administration should be discontinued and appropriate measures should be taken.
Caution For Usage
Cautions for Injection: Since Adant Dispo is injected into the intra-articular space of the knee or shoulder joint, it should be administered under strict aseptic conditions.
Discontinue the administration of Adant Dispo if there is no improvement of symptoms even after the first 5-week course.
If even small retention of synovia is noted, drain it by arthrocentesis.
Others: Do not inject Adant Dispo into vessels.
Do not apply to the eyes.
Since Adant Dispo is viscous, it is advisable to use a 22-23G needle.
Use Adant Dispo only once and immediately after opening. Dispose of the product after use.
Contact with disinfectants eg, quaternary ammonium salts, including benzalkonium chloride, or with chlorhexidine, should be strictly avoided because they may cause precipitation of Adant Dispo.
Storage
Store between 1-30°C.
ATC Classification
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Presentation/Packing
Pre-filled syringe 25 mg/2.5 mL (viscous, aqueous, colorless, clear and odorless soln) x 1's.
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