Regulatory Information
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
Therapeutic
Prescription Only
Formulation Information
INJECTION
**DOSAGE AND ADMINISTRATION:** _Intramuscular Injection:_ 1.0mL repeated according to the response of the condition. 1. Effective control of symptoms with 1.0–2.0 mL is obtained in bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis. Onset of relief has occurred within a few hours of intramuscular injection. 2. In the treatment of acute or chronic bursitis, excellent results are obtained with intramuscular injection of 1.0–2.0 mL, repeated as necessary. _Local administration:_ 1. Intra-articular Injection: Large joints (knee, hip, shoulder): 1.0–2.0 mL Medium joints (below the wrist, ankle): 0.5–1.0 mL Small joints (foot, hand, chest): 0.25–0.5 mL 2. Intradermal Injection: For dermatologic conditions, 0.2 mL/cm2 with a tuberculin syringe and a small 26-gauge needle is recommended. The total amount of Bufencon Injection injected at all sites each week should not exceed 1.0 mL. 3. Intralesional Injection: A tuberculin syringe with a small 25-gauge needle is suitable for most injections into the foot. Recommended doses at intervals of approximately one week: bursitis under heloma durum or molle, 0.25–0.5 mL; bursitis under calcaneal spur, 0.5 mL; bursitis over hallux rigidus, 0.5 mL; bursitis over digiti quinti varus, 0.5 mL; synovial cyst, 0.25–0.5 mL; Morton's neuralgia (metatarsalgia), 0.25–0.5 mL; tenosynovitis, 0.5 mL; periostitis of cuboid, 0.5 mL; acute gouty arthritis, 0.5–1.0 mL. To be administered only by a physician.
INTRAMUSCULAR, INTRADERMAL
Medical Information
**INDICATIONS:** Musculoskeletal and soft tissue inflammatory conditions, allergic dermatologic conditions, and collagen diseases.
**CONTRAINDICATIONS:** As with other corticosteroid preparations, Bufencon Injection is contra-indicated in systemic infections. Corticosteroids should not be injected into unstable joints, infected areas, or intervertebral spaces.
H02AB01
betamethasone
Manufacturer Information
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
YUNG SHIN PHARMACEUTICAL IND CO LTD
Active Ingredients
Documents
Package Inserts
Attachment 3 Proposed Clean PI.pdf
Approved: May 21, 2021