LUPIN-CEPHALEXIN POWDER FOR SUSPENSION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE)

Disponibil de la:

LUPIN PHARMA CANADA LIMITED

Codul ATC:

J01DB01

INN (nume internaţional):

CEFALEXIN

Dozare:

250MG

Forma farmaceutică:

POWDER FOR SUSPENSION

Compoziție:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE) 250MG

Calea de administrare:

ORAL

Unități în pachet:

100ML/150ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

FIRST GENERATION CEPHALOSPORINS

Rezumat produs:

Active ingredient group (AIG) number: 0105911002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2017-10-23

Caracteristicilor produsului

1
PRODUCT
MONOGRAPH
PR
LUPIN-CEPHALEXIN
125 mg/5 mL and 250 mg/5 mL
Cephalexin for Oral Suspension, Manufacturer Standard
AN
T
I
B
IOTI
C
Lupin Pharma Canada Ltd.
Date of Revision:
1001 De Maisonneuve Est, Suite 304
October 23, 2020
Montréal, Quebec
H2L 4P9
Control # 243769
2
PRODUCT
MONOGRAPH
PR
LUPIN-CEPHALEXIN
125 mg/5 mL Cephalexin for Oral Suspension, Manufacturer Standard
PR
LUPIN-CEPHALEXIN
250 mg/5 mL Cephalexin for Oral Suspension, Manufacturer Standard
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
LUPIN-CEPHALEXIN (cephalexin) is bactericidal against many
gram-positive and gram-negative
organisms. _In vitro _tests demonstrate that the cephalosporins are
bactericidal through their inhibition
of cell-wall synthesis
(15)
.
INDICATIONS
LUPIN-CEPHALEXIN (cephalexin) may be indicated for the treatment of
bacterial infections of
the respiratory tract
(1,12)(13,14)
, including otitis media
(1,2)
, genitourinary tract
(3)
, bone and joints
(4,5)
,
skin and soft tissue
(6,7)
, when the infection is caused by susceptible organisms. Culture and
susceptibility studies should be performed.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of LUPIN-
CEPHALEXIN and other antibacterial drugs, LUPIN-CEPHALEXIN should be
used only to treat
infections that are proven or strongly suspected to be caused by
susceptible bacteria. When culture
and susceptibility information are available, they should be
considered in selecting or modifying
antibacterial therapy. In the absence of such data, local epidemiology
and susceptibility patterns
may contribute to the empiric selection of therapy.
CONTRAINDICATIONS
LUPIN-CEPHALEXIN (cephalexin) is contraindicated in patients with
known allergy to the
cephalosporin group of antibiotics.
WARNINGS
Before therapy with LUPIN-CEPHALEXIN (cephalexin) is instituted,
careful inquiry should be
made concerning previous hypersensitivity reactions to cephalosporins,
penicillins or other drugs.
LUPIN-CEPHALEXIN should be given only with caution to
penicillin-sensitive