BAYTRIL- enrofloxacin tablet, film coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

即購入

ダウンロード 製品の特徴 (SPC)
05-11-2021

有効成分:

ENROFLOXACIN (UNII: 3DX3XEK1BN) (ENROFLOXACIN - UNII:3DX3XEK1BN)

から入手可能:

Bayer HealthCare LLC Animal Health Division

INN(国際名):

ENROFLOXACIN

構図:

ENROFLOXACIN 22.7 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION

適応症:

Baytril® (brand of enrofloxacin) Antibacterial Tablets are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin. Baytril Antibacterial Tablets are indicated for use in dogs and cats. Enrofloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones. Dogs: Based on the studies discussed under the section on Animal Safety Summary, the use of enrofloxacin is contraindicated in small and medium breeds of dogs during the rapid growth phase (between 2 and 8 months of age). The safe use of enrofloxacin has not been established in large and giant breeds during the rapid growth phase. Large breeds may be in this phase for up to one year of age and the giant breeds for up to 18 months. In clinical field trials utilizing a daily oral dose of 5.0 mg/kg, there were no reports of lameness or joint problems in any breed. However, controlled studies with histological examination of the articular cartilage have not been conducted in the large or giant breeds.

製品概要:

Taste Tabs® Code No. Film Coated Code No. Baytril Tablets Tablet Size Tablets/Bottle 08711367 08713262 22.7 mg 100 Double Scored 08711375 08713289 22.7 mg 500 Double Scored 08711383 08713270 68.0 mg 50 Double Scored 08711391 08713297 68.0 mg 250 Double Scored 08711510 – 136.0 mg 50 Double Scored 08711405 – 136.0 mg 200 Double Scored Bayer, the Bayer Cross and Baytril are registered trademarks of Bayer.

認証ステータス:

New Animal Drug Application

製品の特徴

                                BAYTRIL- ENROFLOXACIN TABLET, FILM COATED
BAYER HEALTHCARE LLC ANIMAL HEALTH DIVISION
----------
BAYTRIL
(ENROFLOXACIN)
ANTIBACTERIAL TABLETS FOR DOGS AND CATS
CAUTION:
Federal (U.S.A.) law restricts this drug to use by or on the order of
a licensed
veterinarian.
Federal law prohibits the extralabel use of this drug in
food-producing animals.
DESCRIPTION:
Enrofloxacin is a synthetic chemotherapeutic agent from the class of
the quinolone
carboxylic acid derivatives. It has antibacterial activity against a
broad spectrum of Gram
negative and Gram positive bacteria (See Tables I and II). It is
rapidly absorbed from the
digestive tract, penetrating into all measured body tissues and fluids
(See Table III).
Tablets are available in two sizes (22.7 and 68.0 mg enrofloxacin).
CHEMICAL NOMENCLATURE AND STRUCTURAL FORMULA:
1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic
acid.
ACTIONS:
MICROBIOLOGY:
Quinolone carboxylic acid derivatives are classified as DNA gyrase
inhibitors. The
mechanism of action of these compounds is very complex and not yet
fully understood.
The site of action is bacterial gyrase, a synthesis promoting enzyme.
The effect on
_Escherichia coli_ is the inhibition of DNA synthesis through
prevention of DNA
®
supercoiling. Among other things, such compounds lead to the cessation
of cell
respiration and division. They may also interrupt bacterial membrane
integrity.
Enrofloxacin is bactericidal, with activity against both Gram negative
and Gram positive
bacteria. The minimum inhibitory concentrations (MICs) were determined
for a series of
39 isolates representing 9 genera of bacteria from natural infections
in dogs and cats,
selected principally because of resistance to one or more of the
following antibiotics:
ampicillin, cephalothin, colistin, chloramphenicol, erythromycin,
gentamicin, kanamycin,
penicillin, streptomycin, tetracycline, triple sulfa and
sulfa/trimethoprim. The MIC values
for enrofloxacin against these isolates are presented in Table I. Most
strain
                                
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