ATOPICA FOR CATS- cyclosporine solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

cyclosporine (UNII: 83HN0GTJ6D) (cyclosporine - UNII:83HN0GTJ6D)

Tillgänglig från:

Elanco US Inc.

INN (International namn):

Cyclosporine

Sammansättning:

Cyclosporine 100 mg in 1 mL

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION

Terapeutiska indikationer:

Do not use in cats with a history of malignant disorders or suspected malignancy. Do not use in cats infected with feline leukemia virus (FeLV) or feline immunodeficiency virus (FIV). Do not use in cats with a hypersensitivity to cyclosporine. Instructions for Assembling the Dispensing System and Preparing a Dose of ATOPICA ™ for Cats (cyclosporine oral solution) USP MODIFIED Assembling the Dispensing System The dispensing system consists of 4 parts: - A bottle containing the medicine, with rubber stopper and a screw cap to close the bottle after use. - A plastic adapter with dip tube that you will push into the neck of the bottle. The adapter must always remain in the bottle after first use. - An oral dosing syringe that fits into the top of the plastic adapter to withdraw the prescribed dose of medicine from the bottle. - A plastic vial containing the plastic adapter and oral dosing syringe. Save the plastic vial to store the oral dosing syringe between each use. Fitting the Plastic Adapter into the New B

Produktsammanfattning:

ATOPICA for Cats (cyclosporine oral solution) USP MODIFIED is supplied in glass amber bottles of 5 and 17 mL at 100 mg/mL. A dispensing system is included (See Instructions for Assembling the Dispensing System and Preparing a Dose of ATOPICA for Cats ). Manufactured for: Elanco US Inc. Greenfield, IN 46140, USA Product of Ireland Approved by FDA under NADA # 141-329 Revision Date: August 2021 Atopica, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2021 Elanco or its affiliates

Bemyndigande status:

New Animal Drug Application

Produktens egenskaper

ATOPICA FOR CATS- CYCLOSPORINE SOLUTION
ELANCO US INC.
----------
ATOPICA™ FOR CATS
(CYCLOSPORINE ORAL SOLUTION) USP MODIFIED
100 MG/ML
CAUTION:
Federal (USA) Law restricts this drug to use by or on the order of a
licensed
veterinarian.
DESCRIPTION:
ATOPICA for Cats (cyclosporine oral solution) USP MODIFIED is an oral
formulation of
cyclosporine that immediately forms a microemulsion in an aqueous
environment.
Cyclosporine, the active ingredient in ATOPICA for Cats, 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-methylL-leucyl-L-valyl-N-
methyl-L-leucyl-L-alanyl-D-ananyl-Nmethyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl].
The structural formula is:
INDICATION:
ATOPICA for Cats is indicated for the control of feline allergic
dermatitis as manifested by
excoriations (including facial and neck), miliary dermatitis,
eosinophilic plaques, and self-
induced alopecia in cats at least 6 months of age and at least 3 lbs
(1.4 kg) in body
weight.
DOSAGE AND ADMINISTRATION:
ALWAYS PROVIDE THE INSTRUCTIONS FOR ASSEMBLING THE DISPENSING SYSTEM
AND
PREPARING A DOSE OF ATOPICA FOR CATS AND THE INFORMATION FOR CAT
OWNERS
WITH PRESCRIPTION.
The initial dose of ATOPICA for Cats is 3.2 mg/lb/day (7 mg/kg/day) as
a single daily dose
for a minimum of 4 to 6 weeks or until resolution of clinical signs.
Following this initial
daily treatment period, the dose of ATOPICA for Cats may be tapered by
decreasing the
frequency of dosing to every other day or twice weekly to maintain the
desired
therapeutic effect. ATOPICA for Cats should be administered directly
on a small amount
of food or orally just after feeding. Whenever possible, ATOPICA for
Cats should be
administered on a consistent schedule with regard to meals and time of
day. If a dose is
missed, the next dose should be administered (wi