Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
cyclosporine (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)
Virbac AH Inc
ORAL
PRESCRIPTION
CYCLAVANCE is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs (1.8 kg) body weight. CYCLAVANCE is contraindicated for use in dogs with a history of neoplasia. Do not use in dogs with a hypersensitivity to cyclosporine.
CYCLAVANCE is supplied in glass amber vials of 5, 15, 30 and 50 mL at 100 mg/mL. - 5 and 15 mL vials are supplied with a 1 mL Luer-Lok® oral dosing syringe. - 30 and 50 mL vials are supplied with a 1 mL and 3 mL Luer-Lok® oral dosing syringes.
Abbreviated New Animal Drug Application
CYCLAVANCE- CYCLOSPORINE ORAL SOLUTION SOLUTION VIRBAC AH INC ---------- CYCLAVANCE® (CYCLOSPORINE ORAL SOLUTION) USP MODIFIED CAUTION: Federal (USA) Law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of reach of children. DESCRIPTION: CYCLAVANCE® (cyclosporine oral solution) USP MODIFIED is an oral form of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active ingredient in CYCLAVANCE, is a cyclic polypeptide, immune modulating agent consisting of 11 amino acids. It is produced as a metabolite by the fungal species _Beauveria nivea_. Chemically, cyclosporine A is designated Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2- (methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-Lvalyl-N- methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl]. INDICATIONS: CYCLAVANCE is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs (1.8 kg) body weight. DOSAGE AND ADMINISTRATION: ALWAYS PROVIDE THE INSTRUCTIONS FOR ASSEMBLING THE DISPENSING SYSTEM AND PREPARING A DOSE OF CYCLAVANCE AND THE INFORMATION FOR DOG OWNERS WITH THE PRESCRIPTION. The initial dose of CYCLAVANCE is 5 mg/kg/day as a single daily dose for 30 days. Following this initial daily treatment period, the dose of CYCLAVANCE may be tapered by decreasing the frequency of dosing to every other day or twice weekly, until a minimum frequency is reached which will maintain the desired therapeutic effect. CYCLAVANCE should be given at least one hour before or two hours after a meal. If a dose is missed, the next dose should be administered (without doubling) as soon as possible but dosing should be no more frequent than once daily. The dispensing system for the 5 and 15 mL vial sizes includes a 1 mL oral dosing syringe graduated in 0.05 mL increments. To dose the dog, administer 0.05 mL of CYCLAVANCE per 2.2 lbs of body weight. The dispensing system for the 30 and 50 mL vial sizes includes Olvassa el a teljes dokumentumot