Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
miconazole nitrate (UNII: VW4H1CYW1K) (miconazole - UNII:7NNO0D7S5M), polymyxin B sulfate (UNII: 19371312D4) (polymyxin B - UNII:J2VZ07J96K), prednisolone acetate (UNII: 8B2807733D) (prednisolone - UNII:9PHQ9Y1OLM)
Vetoquinol USA Inc
miconazole nitrate
miconazole nitrate 23 mg in 1 mL
AURICULAR (OTIC)
PRESCRIPTION
SUROLAN is indicated for the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius ). SUROLAN is contraindicated in dogs with suspected or known hypersensitivity to miconazole nitrate, polymyxin B sulfate, or prednisolone acetate. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity.
SUROLAN is available in 15 mL and 30 mL plastic dispensing bottles with applicator tip for otic use. Store at or below 25 °C (77 °F).
New Animal Drug Application
SUROLAN- MICONAZOLE NITRATE, POLYMYXIN B SULFATE, AND PREDNISOLONE ACETATE SUSPENSION/ DROPS VETOQUINOL USA INC ---------- SUROLAN otic suspension (miconazole nitrate, polymyxin B sulfate, prednisolone acetate) RX Antifungal, antibacterial and anti-inflammatory _For otic use in dogs only_ CAUTION Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION SUROLAN contains 23 mg/mL miconazole nitrate, 0.5293 mg/mL polymyxin B sulfate and 5 mg/mL prednisolone acetate. Inactive ingredients are colloidal silicon dioxide and liquid paraffin. INDICATIONS SUROLAN is indicated for the treatment of canine otitis externa associated with susceptible strains of yeast (_Malassezia pachydermatis)_ and bacteria (_Staphylococcus pseudintermedius_). DOSAGE AND ADMINISTRATION Shake well before use. The external ear should be thoroughly cleaned and dried before the initiation of treatment. Verify that the eardrum is intact. Instill 5 drops of SUROLAN in the ear canal twice daily and massage the ear. Therapy should continue for 7 consecutive days. CONTRAINDICATIONS SUROLAN is contraindicated in dogs with suspected or known hypersensitivity to miconazole nitrate, polymyxin B sulfate, or prednisolone acetate. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. WARNINGS Not for use in humans. Keep this and all drugs out of reach of children. ANIMAL WARNINGS Do not administer orally. For otic use only. ® PRECAUTIONS Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membranes are not ruptured. If overgrowth of non-susceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted. Long-term use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hypoadrenalcorticism in dogs. The safe use of SUROLAN in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evalua read_full_document