TEVA-CEPHALEXIN CAPSULE

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE)

Disponibbli minn:

TEVA CANADA LIMITED

Kodiċi ATC:

J01DB01

INN (Isem Internazzjonali):

CEFALEXIN

Dożaġġ:

250MG

Għamla farmaċewtika:

CAPSULE

Kompożizzjoni:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE) 250MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

50/100/250/500/1000

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

FIRST GENERATION CEPHALOSPORINS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0105911004; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2014-07-11

Karatteristiċi tal-prodott

1
PRODUCT MONOGRAPH
PR
TEVA-CEPHALEXIN
250 mg and 500 mg
Cephalexin Capsules, USP
PR
TEVA-CEPHALEXIN
250 mg and 500 mg
Cephalexin Tablets, USP
PR
TEVA-CEPHALEXIN 125
125 mg/5 mL Cephalexin For Oral Suspension, USP
PR
TEVA-CEPHALEXIN 250
250 mg/5 mL Cephalexin For Oral Suspension, USP
ANTIBIOTIC
Teva Canada Limited
Date of Revision:
30 Novopharm Court
August 12, 2020
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control # 237728
2
PRODUCT MONOGRAPH
PR
TEVA-CEPHALEXIN
250 mg and 500 mg
Cephalexin Capsules, USP
PR
TEVA-CEPHALEXIN
250 mg and 500 mg
Cephalexin Tablets, USP
PR
TEVA-CEPHALEXIN 125
125 mg/5 mL Cephalexin For Oral Suspension, USP
PR
TEVA-CEPHALEXIN 250
250 mg/5 mL Cephalexin For Oral Suspension, USP
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
TEVA-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
TEVA-CEPHALEXIN may be indicated for the treatment of bacterial
infections of the
respiratory tract
(1,12)(l3,l4)
, 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 TEVA-
CEPHALEXIN and other antibacterial drugs, TEVA-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.
3
CONTRAINDICATIONS
TEVA-CEPHALEXIN (cephalexin) is contraindicated in patients with known
allergy to the
cephalosporin group of antibiotics.
WARNINGS
Before therapy with TEVA-CEPHALEXIN
(c