ROPIVACAINE HYDROCHLORIDE INJECTION, USP SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ROPIVACAINE HYDROCHLORIDE

Tersedia dari:

FRESENIUS KABI CANADA LTD

Kode ATC:

N01BB09

INN (Nama Internasional):

ROPIVACAINE

Dosis:

5MG

Bentuk farmasi:

SOLUTION

Komposisi:

ROPIVACAINE HYDROCHLORIDE 5MG

Rute administrasi :

BLOCK/INFILTRATION

Unit dalam paket:

10ML

Jenis Resep:

Ethical

Area terapi:

LOCAL ANESTHETICS

Ringkasan produk:

Active ingredient group (AIG) number: 0133273003; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-03-30

Karakteristik produk

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ROPIVACAINE HYDROCHLORIDE INJECTION, USP
2 mg / mL, 5 mg / mL, and 10 mg / mL
Local Anesthetic
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Revision: September 25, 2023
Submission Control No: 277021
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Ropivacaine Hydrochloride Injection, USP - Product Monograph
Page 2 of 42
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RECENT MAJOR LABEL CHANGES
Not Applicable
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................4
1
INDICATIONS
..................................................................................................................4
1.1
Pediatrics
....................................................................................................................4
1.2
Geriatrics
....................................................................................................................4
2
CONTRAINDICATIONS
.................................................................................................4
3
DOSAGE AND ADMINISTRATION
.............................................................................5
3.1
Dosing Considerations
...............................................................................................5
3.2
Recommended Dose and Dosage Adjustment
...........................................................6
4
OVERDOSAGE
.................................................................................................................8
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..............10
6
WARNINGS AND PRECAUTIONS
.............................................................................11
6.1
Special Populations
..................................................................................................16
6.1.1
Pregnant Women
.................................................................................................16
6.1.2
Breast-feeding
......................................................................................