CETIRIZINE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

CETIRIZINE HYDROCHLORIDE

Dostupné s:

SANIS HEALTH INC

ATC kód:

R06AE07

INN (Mezinárodní Name):

CETIRIZINE

Dávkování:

20MG

Léková forma:

TABLET

Složení:

CETIRIZINE HYDROCHLORIDE 20MG

Podání:

ORAL

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Terapeutické oblasti:

SECOND GENERATION ANTIHISTAMINES

Přehled produktů:

Active ingredient group (AIG) number: 0122686003; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2021-05-11

Charakteristika produktu

PRODUCT MONOGRAPH
PR
CETIRIZINE
CETIRIZINE HYDROCHLORIDE TABLETS
20MG
Histamine H
1
Receptor Antagonist
Date of Revision:
May 6, 2021
Sanis Health Inc.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control # 249306
e249306 CETIRIZINE
Sanis Cetirizine PM (E)
Pg. 1
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
PART II: SCIENTIFIC INFORMATION
PHARMACEUTICAL INFORMATION
CLINICAL TRIALS
DETAILED PHARMACOLOGY
TOXICOLOGY
REFERENCES
PART III: CONSUMER INFORMATION
e249306 CETIRIZINE
Sanis Cetirizine PM (E)
Pg. 2
PR
CETIRIZINE
CETIRIZINE HYDROCHLORIDE TABLETS
20 MG
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
Route of
Administration
Dosage Form/ Strength
All Nonmedicinal ingredients
Oral
Prescription Film-coated
tablets 20 mg
Croscarmellose sodium, microcrystalline
cellulose, colloidal silicon dioxide,
magnesium stearate and opadry white
(hydroxypropyl methylcellulose and
titanium dioxide).
INDICATIONS AND CLINICAL USE
ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER:
CETIRZINE 20 mg Tablet (cetirizine hydrochloride) is indicated for the
fast relief of nasal and non-
nasal symptoms associated with seasonal and perennial allergic
rhinitis (i.e. sneezing, rhinorrhea, post-
nasal discharge, nasal congestion/stuffiness, tearing and redness of
the eyes, itchy nose/throat) and
chronic idiopathic urticaria (e.g. pruritus and hives).
PEDIATRICS (<12 YEARS OF AGE)
CETIRIZINE 20 mg Tablet
is not recommended in children less than 12 years of age, as safety
and
efficacy have not been established in this age group.
CONTRAINDICATIONS
CETIRIZINE 20 mg Tablet (Cetirizine hydrochloride) is contraindicated
in those patients with a known
hypersensitivity to it or to its parent compound, hydroxyzine, or to
piperazine derivatives, in patients
who