JAMP AMOXI CLAV TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM)

Tersedia dari:

JAMP PHARMA CORPORATION

Kode ATC:

J01CR02

INN (Nama Internasional):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dosis:

250MG; 125MG

Bentuk farmasi:

TABLET

Komposisi:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG; CLAVULANIC ACID (CLAVULANATE POTASSIUM) 125MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

AMINOPENICILLINS

Ringkasan produk:

Active ingredient group (AIG) number: 0234720008; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-11-20

Karakteristik produk

JAMP Amoxi Clav (Amoxicillin and Clavulanate Potassium Tablets) Page 1
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP AMOXI CLAV
Amoxicillin and Clavulanate Potassium Tablets
JAMP Amoxi Clav -250 tablets
250 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
JAMP Amoxi Clav -500F tablets
500 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
JAMP Amoxi Clav -875 tablets
875 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
House Standard
COMBINATIONS OF PENICILLINS, INCLUDING BETA-LACTAMASE INHIBITORS
ATC CODE: J01CR02
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
November 20, 2020
Date of Revision:
August 3, 2023
Submission Control Number: 272812
JAMP Amoxi Clav (Amoxicillin and Clavulanate Potassium Tablets) Page 2
of 37
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
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