RIVA-AZITHROMYCIN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)

Disponibil de la:

LABORATOIRE RIVA INC.

Codul ATC:

J01FA10

INN (nume internaţional):

AZITHROMYCIN

Dozare:

250MG

Forma farmaceutică:

TABLET

Compoziție:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 250MG

Calea de administrare:

ORAL

Unități în pachet:

6/100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

OTHER MACROLIDES

Rezumat produs:

Active ingredient group (AIG) number: 0126072001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2006-03-15

Caracteristicilor produsului

manufacturer’s standard
PRODUCT
MONOGRAPH
PR
RTVA
-
AZITHROMYCIN
Azithromycin
Dihydrate
Tablets
250
mg
Azithromycin
(
supplied
as
azithromycin
dihydrate
)
,
Antibacterial
Agent
LABORATOIRE
RIVA
INC
.
660
Boul
.
Industriel
,
Blainville
,
Quebec
J
7
C
3
V
4
DATE
OF
REVISION
:
August
21
,
2020
www
.
labriva
.
com
CONTROL
NO
.
:
242159
_RIVA_
_-_
_AZITHROMYCIN_
_-_
_Product_
_Monograph_
_Page_
_l_
_of_
_63_
TABLE
OF
CONTENTS
PART
I
:
HEALTH
PROFESSIONAL
INFORMATION
SUMMARY
PRODUCT
INFORMATION
INDICATIONS
AND
CLINICAL
USE
CONTRAINDICATIONS
WARNINGS
AND
PRECAUTIONS
ADVERSE
REACTIONS
DRUG
INTERACTIONS
DOSAGE
AND
ADMINISTRATION
OVERDOSAGE
ACTION
AND
CLINICAL
PHARMACOLOGY
STORAGE
AND
STABILITY
DOSAGE
FORMS
,
COMPOSITION
AND
PACKAGING
3
3
3
4
5
9
15
20
21
21
24
24
PART
II
:
SCIENTIFIC
INFORMATION
PHARMACEUTICAL
INFORMATION
CLINICAL
TRIALS
DETAILED
PHARMACOLOGY
MICROBIOLOGY
TOXICOLOGY
REFERENCES
25
25
26
31
36
39
54
PATIENT
MEDICATION
INFORMATION
59
_RIVA_
_-_
_AZITHROMYCIN_
_-_
_Product_
_Monograph_
_Page_
_2_
_of_
_63_
anufacturer’s standard
(group A β
PR
RIVA
-
AZITHROMYCIN
Azithromycin
Dihydrate
Tablets
M
PART
I
:
HEALTH
PROFESSIONAL
INFORMATION
SUMMARY
PRODUCT
INFORMATION
DOSAGE
FORM
/
STRENGTH
NONMEDICAL
INGREDIENTS
ROUTE
OF
ADMINISTRATION
Dibasic
calcium
phosphate
,
croscarmellose
sodium
,
pregelatinized
starch
,
magnesium
stearate
,
microcrystalline
cellulose
,
purified
water
,
sodium
lauryl
sulphate
and
lactose
monohydrate
.
Oral
Tablet
/
250
mg
Coating
material
:
Hypromellose
,
lactose
monohydrate
,
titanium
dioxide
,
triacetin
and
D
&
C
Red
#
30
Aluminum
lake
.
INDICATIONS
AND
CLINICAL
USE
RIVA
-
AZITHROMYCIN
(
azithromycin
dihydrate
)
for
oral
administration
is
indicated
for
treatment
of
mild
to
moderate
infections
caused
by
susceptible
strains
of
the
designated
microorganisms
in
the
following
diseases
and
specific
conditions
.
As
recommended
dosages
,
durations
of
therapy
and
applicable
patient
populations
vary
among
these
infections
,
see
DOSAGE
AND
ADMINISTRATION
for
specific
dosing
recommendations
.
Bec