DOXYCYCLINE CAPSULES

Country: Կանադա

language: անգլերեն

source: Health Canada

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06-03-2019

active_ingredient:

DOXYCYCLINE (DOXYCYCLINE HYCLATE)

MAH:

SANIS HEALTH INC

ATC_code:

J01AA02

INN:

DOXYCYCLINE

dosage:

100MG

pharmaceutical_form:

CAPSULE

composition:

DOXYCYCLINE (DOXYCYCLINE HYCLATE) 100MG

administration_route:

ORAL

units_in_package:

100/200

prescription_type:

Prescription

therapeutic_area:

TETRACYCLINES

leaflet_short:

Active ingredient group (AIG) number: 0105569001; AHFS:

authorization_status:

APPROVED

authorization_date:

2015-02-19

SPC

                                1
_ _
_ _
_ _
_ _
_PRESCRIBING INFORMATION _
PR
DOXYCYCLINE CAPSULES
Doxycycline Hyclate Capsules, USP
_100 mg doxycycline (as doxycycline hyclate) _
PR
DOXYCYCLINE TABLETS_ _
Doxycycline Hyclate Tablets, USP
_100 mg doxycycline (as doxycycline hyclate) _
_Antibiotic _
Sanis Health Inc.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
www.sanis.com
Revision Date:
March 6, 2019
CONTROL NUMBER: 224459
2
NAME OF DRUGS
PR DOXYCYCLINE CAPSULES
Doxycycline Hyclate Capsules, USP
_100 mg doxycycline (as doxycycline hyclate) _
PR DOXYCYCLINE TABLETS_ _
Doxycycline Hyclate Tablets, USP
_100 mg doxycycline (as doxycycline hyclate) _
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
Doxycycline hyclate is a broad-spectrum antibiotic and is active
against a wide range of
Gram-negative and Gram-positive organisms. Doxycycline exerts its
bacteriostatic effect
by the inhibition of protein synthesis.
INDICATIONS AND CLINICAL USE
Doxycycline_ _Capsules / Doxycycline Tablets (doxycycline hyclate) may
be indicated for
the treatment of:
Pneumonia:
Single and multilobe pneumonia and bronchopneumonia due to
susceptible
strains
of
_Streptococcus _
_pneunomiae_
and
other
_Streptococcus_
spp.,
_Staphylococcus_
spp.,
_H. _
_influenzae_
and
_Klebsiella pneumoniae_.
Other Respiratory
Tract Infections:
Pharyngitis, tonsillitis, sinusitis, otitis media, bronchitis caused
by
susceptible strains of β-hemolytic _Streptococcus_, _Staphylococcus _
spp., _Streptococcus pneumoniae_ and _H. influenzae_.
Genitourinary Tract
Infections:
Pyelonephritis, cystitis, urethritis caused by susceptible strains of
_Klebsiella_ spp., _Enterobacter aerogenes, E. coli_, _Enterococcus_
spp., _Staphylococcus_ spp., _Streptococcus_ spp. and gonococcal
3
urethritis caused by_ Neisseria gonorrhoeae. _
In adult patients with urethritis, cervicitis and vaginitis with a
positive test for _Chlamydia trachomatis _ and/or _Ureaplasma _
_urealyticum_, clinical resolution and absence of detectable
organisms have only been observed at completion of ORAL
therapy with doxycycli
                                
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SPC SPC ֆրանսերեն 06-03-2019