MEROPENEM FOR INJECTION SDZ POWDER FOR SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

MEROPENEM (MEROPENEM TRIHYDRATE)

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

J01DH02

INN (Kansainvälinen yleisnimi):

MEROPENEM

Annos:

500MG

Lääkemuoto:

POWDER FOR SOLUTION

Koostumus:

MEROPENEM (MEROPENEM TRIHYDRATE) 500MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

CARBAPENEMS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0128599001; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2023-07-26

Valmisteyhteenveto

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_Meropenem for Injection _
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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
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_Meropenem for Injection _
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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
...................................................................