MEROPENEM FOR INJECTION SDZ POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

MEROPENEM (MEROPENEM TRIHYDRATE)

Dostopno od:

SANDOZ CANADA INCORPORATED

Koda artikla:

J01DH02

INN (mednarodno ime):

MEROPENEM

Odmerek:

1G

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

MEROPENEM (MEROPENEM TRIHYDRATE) 1G

Pot uporabe:

INTRAVENOUS

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

CARBAPENEMS

Povzetek izdelek:

Active ingredient group (AIG) number: 0128599003; AHFS:

Status dovoljenje:

CANCELLED PRE MARKET

Datum dovoljenje:

2023-07-26

Lastnosti izdelka

_ _
_Meropenem for Injection _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
MEROPENEM FOR INJECTION
(meropenem for injection)
500 mg and 1 g vials
USP
For intravenous use
Antibiotic
Sandoz Canada Inc.
Date of Revision: October 6, 2020
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Submission Control No: 239077
_ _
_Meropenem for Injection _
_Page 2 of 38_
TABLE OF CONTENT
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS
AND
PRECAUTIONS
.........................................................................................
5
ADVERSE
REACTIONS
...........................................................................................................
8
DRUG
INTERACTIONS
.........................................................................................................
11
DOSAGE
AND
ADMINISTRATION
.....................................................................................
12
OVERDOSAGE
.......................................................................................................................
15
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
16
STABILITY AND STORAGE RECOMMENDATIONS
........................................................ 22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL
INFORMATION
.................................................................................
24
CLINICAL
TRIALS
...................................................................