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HSA Approval

BUFENCON INJECTION

SIN07795P

BUFENCON INJECTION

BUFENCON INJECTION

July 15, 1994

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

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

BETAMETHASONE DIPROPIONATE EQV BETAMETHASONE

5 mg/ml

Betamethasone

BETAMETHASONE PHOSPHATE DISODIUM EQV BETAMETHASONE

2 mg/ml

Betamethasone

Documents

Package Inserts

Attachment 3 Proposed Clean PI.pdf

Approved: May 21, 2021

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