NOVAMOXIN TABLET (CHEWABLE)

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

可用日期:

TEVA CANADA LIMITED

ATC代码:

J01CA04

INN（国际名称）:

AMOXICILLIN

剂量:

250MG

药物剂型:

TABLET (CHEWABLE)

组成:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

给药途径:

ORAL

每包单位数:

100/500

处方类型:

Prescription

治疗领域:

AMINOPENICILLINS

產品總結:

Active ingredient group (AIG) number: 0131314001; AHFS:

授权状态:

APPROVED

授权日期:

2013-06-03

产品特点

NOVAMOXIN
1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR NOVAMOXIN
AMOXICILLIN CAPSULES, USP
Capsules, 250 mg and 500 mg amoxicillin (as amoxicillin trihydrate),
Oral
AMOXICILLIN CHEWABLE TABLETS, USP
Tablets, 250 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, Teva Standard
Suspension, 250 mg/5 ml amoxicillin (as amoxicillin trihydrate) after
reconstitution, Oral
Antibiotic
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court February 9, 1979
Toronto, ON
M1B 2K9 Date of Revision:
Canada May 16, 2023
www.tevacanada.com
Submission Control Number: 268379
NOVAMOXIN
2
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
05/2023
7 WARNINGS AND PRECAUTIONS
05/2023
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
......