AMOXICILLIN GRANULES FOR SUSPENSION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Διαθέσιμο από:

SANIS HEALTH INC

Φαρμακολογική κατηγορία (ATC):

J01CA04

INN (Διεθνής Όνομα):

AMOXICILLIN

Δοσολογία:

250MG

Φαρμακοτεχνική μορφή:

GRANULES FOR SUSPENSION

Σύνθεση:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

75/100/150ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

AMINOPENICILLINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0131314003; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2010-11-02

Αρχείο Π.Χ.Π.

AMOXICILLIN
1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR AMOXICILLIN
AMOXICILLIN CAPSULES, USP
Capsules, 250 mg and 500 mg amoxicillin (as amoxicillin trihydrate),
Oral
AMOXICILLIN GRANULES FOR ORAL SUSPENSION, USP
Suspension, 250 mg/5 mL amoxicillin (as amoxicillin trihydrate) after
reconstitution, Oral
AMOXICILLIN SUGAR-REDUCED GRANULES FOR ORAL SUSPENSION,
Manufacturer’s Standard
Suspension, 250 mg/5 mL amoxicillin (as amoxicillin trihydrate) after
reconstitution, Oral
Antibiotic
Sanis Health Inc.
Date of Initial Authorization:
1 President’s Choice Circle
JUN 16, 2010
Brampton, Ontario
L6Y 5S5
Date of Revision:
www.sanis.com
AUG 14, 2023
Submission Control Number: 277120
AMOXICILLIN
2
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
08/2023
7 WARNINGS AND PRECAUTIONS
08/2023
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
......................................................................................................................
4
1.2
Geriatrics
.......................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................ 5
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.............................................................. 5
4.3
Reconstitution
.....................................................................................