AMIKIN SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

AMIKACIN (AMIKACIN SULFATE)

Beschikbaar vanaf:

BRISTOL-MYERS SQUIBB CANADA

ATC-code:

J01GB06

INN (Algemene Internationale Benaming):

AMIKACIN

Dosering:

250MG

farmaceutische vorm:

SOLUTION

Samenstelling:

AMIKACIN (AMIKACIN SULFATE) 250MG

Toedieningsweg:

INTRAMUSCULAR

Eenheden in pakket:

2ML

Prescription-type:

Prescription

Therapeutisch gebied:

AMINOGLYCOSIDES

Product samenvatting:

Active ingredient group (AIG) number: 0111922001; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2006-05-29

Productkenmerken

PRODUCT MONOGRAPH
AMIKIN*
(amikacin sulfate, USP)
for Injection, 250 mg/mL
Antibiotic
Bristol-Myers Squibb Canada
2365 Côte de Liesse Rd
Date of Preparation:
Montreal, Canada.
October 25, 2005
*
TM of Bristol-Myers Squibb Company
used under licence by Bristol-Myers Squibb Canada
Control No.:
101906
1
PRODUCT MONOGRAPH
AMIKIN
(amikacin sulfate, USP)
for Injection, 250 mg/mL
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Amikacin is a semi-synthetic aminoglycoside antibiotic which exhibits
activity primarily against
gram-negative organisms, including Pseudomonas. It is a bactericidal
antibiotic affecting
bacterial growth by specific inhibition of protein synthesis in
susceptible bacteria.
INDICATIONS AND CLINICAL USE
AMIKIN is indicated in the short term treatment of serious infections
due to susceptible strains
of Pseudomonas species, _Escherichia coli_, Proteus species,
Klebsiella - Enterobacter - Serratia
species, Providencia species, Salmonella species, Citrobacter species
and _Staphylococcus_
_aureus_.
Clinical studies have shown AMIKIN to be effective in bacteremia,
septicemia (including neo-
natal sepsis), osteomyelitis, septic arthritis; respiratory tract,
urinary tract, intra-abdominal
(including peritonitis) infections and soft tissue abscesses.
Appropriate bacteriological studies should be performed in order to
identify and determine the
susceptibility of the causative organism. Relevant surgical procedures
should be performed
when indicated.
CONTRAINDICATIONS
AMIKIN is contraindicated in patients with known allergy to amikacin
or any component of the
formulation. A history of hypersensitivity or serious toxic reactions
to aminoglycosides may
contraindicate the use of any aminoglycoside because of the known
cross sensitivities of
patients to drugs in this class.
WARNINGS
Patients receiving AMIKIN should be under close observation and
evaluation because of the
potential ototoxicity and nephrotoxicity associated with its use.
Safety for treatment periods
which are longer than 14 da