Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)
Butler Animal Health Supply
PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE SODIUM PHOSPHATE 10 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Prednisolone Sodium Phosphate Ophthalmic Solution 1% or 1/8% is for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation, corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, is recommended for moderate to severe inflammations, particularly when unusually rapid control is desired. In stubborn cases of anterior segment eye disease, systemic adrenocortical hormone therapy may be required. When deeper ocular structures are involved, systemic therapy is necessary. The use of this preparation is contraindicated in the presence of: 1] Acute superficial herpes simplex ke
Prednisolone Sodium Phosphate Ophthalmic Solution USP, 1% is supplied in a plastic squeeze bottle with a controlled drop tip in the following sizes: 5 mL bottle - Prod. No. 04307 10 mL bottle - Prod. No. 04309 15 mL bottle - Prod. No. 04311 Store between 15° - 30° C (59° - 86° F). Protect from light. Keep tightly closed. DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN. Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9101401 (Folded) 9101501 (Flat)
Abbreviated New Drug Application
PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS BUTLER ANIMAL HEALTH SUPPLY ---------- PREDNISOLONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION USP, 1% (STERILE) RX ONLY DESCRIPTION: Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, is a sterile solution for ophthalmic administration having the following composition: EACH ML CONTAINS: ACTIVE: Prednisolone Sodium Phosphate 10 mg (1%) [equivalent to 9.1 mg/mL prednisolone phosphate] in a buffered isotonic solution containing INACTIVES: Hypromellose, Monobasic and Dibasic Sodium Phosphate, Sodium Chloride, Edetate Disodium and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust the pH (6.2 - 8.2). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. The chemical name for prednisolone sodium phosphate is Pregna-1, 4-diene - 3, 20-dione, 11, 17- dihydroxy-21-(phosphonooxy)-, disodium salt, (11 β) -, which has the following structural formula: Molecular formula: C H Na O P Molecular Weight: 484.39 CLINICAL PHARMACOLOGY: Prednisolone sodium phosphate causes inhibition of inflammatory response to inciting agents of mechanical, chemical, or immunological nature. No generally accepted explanation of this steroid property has been advanced. INDICATIONS AND USAGE: Prednisolone Sodium Phosphate Ophthalmic Solution 1% or 1/8% is for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation, corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. 21 27 2 8 Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, is recommended for moderate to severe inflammations, particularly when unusually rapid control is desired. In stubborn cases of anteri Прочитайте повний документ