CYCLAVANCE- cyclosporine oral solution solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Virbac AH Inc

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION

Wskazania:

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.

Podsumowanie produktu:

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.

Status autoryzacji:

Abbreviated New Animal Drug Application

Charakterystyka produktu

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