CAFFEINE CITRATE ORAL SOLUTION USP

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CAFFEINE CITRATE

Disponibil de la:

OMEGA LABORATORIES LIMITED

Codul ATC:

N06BC01

INN (nume internaţional):

CAFFEINE

Dozare:

20MG

Forma farmaceutică:

SOLUTION

Compoziție:

CAFFEINE CITRATE 20MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2022-04-25

Caracteristicilor produsului

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