CAFFEINE CITRATE ORAL SOLUTION USP

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
20-04-2022

Viambatanisho vya kazi:

CAFFEINE CITRATE

Inapatikana kutoka:

OMEGA LABORATORIES LIMITED

ATC kanuni:

N06BC01

INN (Jina la Kimataifa):

CAFFEINE

Kipimo:

20MG

Dawa fomu:

SOLUTION

Tungo:

CAFFEINE CITRATE 20MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Prescription

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2022-04-25

Tabia za bidhaa

                                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
                                
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