CAFFEINE CITRATE INJECTION USP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CAFFEINE CITRATE

Tilgjengelig fra:

OMEGA LABORATORIES LIMITED

ATC-kode:

N06BC01

INN (International Name):

CAFFEINE

Dosering :

20MG

Legemiddelform:

SOLUTION

Sammensetning:

CAFFEINE CITRATE 20MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2022-04-25

Preparatomtale

Product Monograph (Caffeine Citrate Injection USP)
Page 1 of 25
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CAFFEINE CITRATE INJECTION 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:
April 20, 2022
Submission
Control No: 251391
Product Monograph (Caffeine Citrate Injection USP)
Page 2 of 25
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..................................................... 5
4
DOSAGE AND ADMINISTRATION
.............................................................................
5
4.1 Dosing Considerations
.................................................................................................
5
4.2 Recommended Dose and Dosage
Adjustment................................................................
5
4.3 Administration
.............................................................................................................
7
5
OVERDOSAGE...............................................................................................................
8
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.............