K-BROVET- potassium bromide solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
28-12-2022

Aktivni sastojci:

POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06)

Dostupno od:

Pegasus Laboratories, Inc.

INN (International ime):

POTASSIUM BROMIDE

Sastav:

POTASSIUM BROMIDE 250 mg in 1 mL

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION

Terapijske indikacije:

K-BroVet should not be used in animals with a history of hypersensitivity to Bromide or any of the components of the solution or tablets.

Proizvod sažetak:

Oral Solution, 10 FL OZ (300 mL), NDC 49427-245-07 Oral Solution, 2 FL OZ (59 mL), NDC 49427-245-03

Status autorizacije:

unapproved drug other

Svojstava lijeka

                                K-BROVET- POTASSIUM BROMIDE SOLUTION
PEGASUS LABORATORIES, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
DESCRIPTION:
K-BroVet Oral Solution is a butterscotch vanilla flavored solution
containing 250 mg/mL
of potassium bromide, cyanocobalamin and pyridoxine HCl.
HOW SUPPLIED:
Oral Solution, 10 FL OZ (300 mL), NDC 49427-245-07
Oral Solution, 2 FL OZ (59 mL), NDC 49427-245-03
STORAGE CONDITIONS:
Store in a tightly sealed container at room temperature (59-86°F).
INDICATION:
K-BroVet potassium bromide is used to treat seizure disorders in dogs.
It can be used in
addition to therapy with other agents or as the sole anticonvulsant.
CONTRAINDICATIONS:
K-BroVet should not be used in animals with a history of
hypersensitivity to Bromide or
any of the components of the solution or tablets.
DOSAGE AND ADMINISTRATION:
RECOMMENDED DOSAGE FOR K-BROVET ORAL SOLUTION:
To achieve a serum level of approximately 1 mg/mL, give 120 mg/kg PO
daily for 5 days
then reduce to 30 mg/kg PO once daily. To achieve a serum level of
approximately 1.5
mg/mL, give 160 mg/kg PO for 5 days and then reduce to 40 mg/kg PO
once daily
thereafter.
Among dogs responses to bromide may vary, treatment should be tailored
to the
individual dog, based on serum bromide concentration, success of
seizure control, and
the observation of adverse effects. Steady state serum concentrations
generally take 4
(R-21)
to 5 months in dogs; therapeutic concentrations may be reached before
steady state at
about 4 weeks after the beginning of treatment, serum bromide
concentration may be
tested to assess the response to product and, if results are
satisfactory , the next
testing for steady state serum levels is typically about 4 months. If
the dog's serum
concentration is within range and the dog is doing well in the
therapeutic range , serum
concentration may then be tested every 6 to 12 months. Serum bromide
is typi
                                
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