TAGAMET PREVENT TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

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Prenos Lastnosti izdelka (SPC)
22-03-2023

Aktivna sestavina:

CIMETIDINE

Dostopno od:

MEDTECH PRODUCTS INC

Koda artikla:

A02BA01

INN (mednarodno ime):

CIMETIDINE

Odmerek:

200MG

Farmacevtska oblika:

TABLET

Sestava:

CIMETIDINE 200MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

OTC

Terapevtsko območje:

HISTAMINE H2-ANTAGONISTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0111925005; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2023-04-06

Lastnosti izdelka

                                _ _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
TAGAMET® PREVENT
Cimetidine Tablets
Tablet, 200 mg, Oral
USP
Histamine H
2
– Receptor Antagonist
ATC Code: A02BA01
Medtech Products Inc.
660 White Plains Rd., Suite 250
Tarrytown, NY 10591
USA
Date of Initial Authorization:
Apr 12, 2000
Date of Revision:
Mar 22, 2023
Submission Control Number: 270508
_ _
_ _
_Page 2 of 24_
RECENT MAJOR LABEL CHANGES
None.
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
..............................................................................................................
2
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
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.5
Missed Dose
...........................................................................................................
5
5
OVERDOSAGE
................................................
                                
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