CAFFEINE CITRATE ORAL SOLUTION USP

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CAFFEINE CITRATE

Beschikbaar vanaf:

OMEGA LABORATORIES LIMITED

ATC-code:

N06BC01

INN (Algemene Internationale Benaming):

CAFFEINE

Dosering:

20MG

farmaceutische vorm:

SOLUTION

Samenstelling:

CAFFEINE CITRATE 20MG

Toedieningsweg:

ORAL

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Product samenvatting:

Active ingredient group (AIG) number: 0162054001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2022-04-25

Productkenmerken

Product Monograph (Caffeine Citrate Oral Solution USP)
Page 1 of 26
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CAFFEINE CITRATE ORAL SOLUTION USP
SOLUTION, 20 MG / ML, INTRAVENOUS / ORAL
(EACH ML CONTAINS 20 MG CAFFEINE CITRATE, EQUIVALENT TO 10 MG CAFFEINE
BASE)
USP
PSYCHOANALEPTICS, XANTHINE DERIVATIVES ATC CODE : N06BC01
OMEGA LABORATORIES LIMITED
11 177 HAMON STREET
MONTREAL, QUEBEC
H3M 3E4
DATE OF INITIAL APPROVAL: Apr 20, 2022
Submission Control No: 249839
Product Monograph (Caffeine Citrate Oral Solution USP)
Page 2 of 26
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
Administration.............................................................................................................
8
5
OVERDOSAGE
...................................................................................................................
8
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
....................................... 9
7
WARNINGS AND P