CAFFEINE CITRATE INJECTION USP SOLUTION

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:

INTRAVENOUS

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 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.............
                                
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