Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
CYCLOSPORINE (UNII: 83HN0GTJ6D) (Cyclosporine - UNII:83HN0GTJ6D)
Dechra Veterinary Products LLC
ORAL
PRESCRIPTION
Sporimune is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. Sporimune is contraindicated for use in dogs with a history of neoplasia. Do not use in dogs with a hypersensitivity to cyclosporine.
Sporimune is supplied in packages of 15 unit-dose blisters as follows: 10 mg: oval, off-white capsules imprinted with black "D 10" (NDC 17033-260-15). 25 mg: oval, gray capsules imprinted with black "D 25" (NDC 17033-261-15). 50 mg: oblong, off-white capsules imprinted with black "D 50" (NDC 17033-262-15). 100 mg: oblong, gray capsules imprinted with black "D 100" (NDC 17033-263-15).
Abbreviated New Animal Drug Application
SPORIMUNE- CYCLOSPORINE CAPSULE DECHRA VETERINARY PRODUCTS LLC ---------- SPORIMUNE™ (CYCLOSPORINE CAPSULES) 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: Sporimune (cyclosporine capsules) USP MODIFIED is an oral form of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active ingredient in Sporimune 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-L-valyl-N- methyl-L-leucyl-L-alanyl-D-ananyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl]. The structural formula is: INDICATIONS: Sporimune is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. DOSAGE AND ADMINISTRATION: The initial dose of Sporimune is 5 mg/kg/day (3.3-6.7 mg/kg/day) as a single daily dose for 30 days. Following this initial daily treatment period, the dose of Sporimune 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. Sporimune 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. DOSE ADMINISTRATION DOG BODY WEIGHT (LBS) DOG BODY WEIGHT (KG) DOSE 5 MG/KG 4 – 6.5 lbs 2 – 2.9 kg 10 mg capsule 6.6 – 9 lbs 3 – 3.9 kg 2 × 10 mg capsules 9.1 – 16 lbs 4 – 7.9 kg 25 mg capsule 16.1 – 33 lbs 8 – 14.9 kg 50 mg capsule 33.1 – 64 lbs 15 – 28.9 kg 100 mg capsule 64.1 – 79 lbs 29 – 35.9 kg 100 mg capsule +50 mg capsule 79.1 – 121 lbs 36 – 55.9 kg 2 Lire le document complet