CAFFEINE CITRATE ORAL SOLUTION USP

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CAFFEINE CITRATE

Pieejams no:

OMEGA LABORATORIES LIMITED

ATĶ kods:

N06BC01

SNN (starptautisko nepatentēto nosaukumu):

CAFFEINE

Deva:

20MG

Zāļu forma:

SOLUTION

Kompozīcija:

CAFFEINE CITRATE 20MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2022-04-25

Produkta apraksts

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