NOVAMOXIN TABLET (CHEWABLE)

国: カナダ

言語: 英語

ソース: Health Canada

即購入

ダウンロード 製品の特徴 (SPC)
16-05-2023

有効成分:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

から入手可能:

TEVA CANADA LIMITED

ATCコード:

J01CA04

INN(国際名):

AMOXICILLIN

投薬量:

250MG

医薬品形態:

TABLET (CHEWABLE)

構図:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

投与経路:

ORAL

パッケージ内のユニット:

100/500

処方タイプ:

Prescription

治療領域:

AMINOPENICILLINS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2013-06-03

製品の特徴

                                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
......
                                
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