ROPIVACAINE HYDROCHLORIDE INJECTION USP SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ROPIVACAINE HYDROCHLORIDE

Disponible depuis:

PFIZER CANADA ULC

Code ATC:

N01BB09

DCI (Dénomination commune internationale):

ROPIVACAINE

Dosage:

2MG

forme pharmaceutique:

SOLUTION

Composition:

ROPIVACAINE HYDROCHLORIDE 2MG

Mode d'administration:

BLOCK/INFILTRATION

Unités en paquet:

100ML/200ML

Type d'ordonnance:

Ethical

Domaine thérapeutique:

LOCAL ANESTHETICS

Descriptif du produit:

Active ingredient group (AIG) number: 0133273001; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2022-04-29

Résumé des caractéristiques du produit

_Product Monograph – Ropivacaine Hydrochloride Injection USP _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ROPIVACAINE HYDROCHLORIDE INJECTION USP
Parenteral sterile solution
2 mg / mL ropivacaine hydrochloride per flexible container
5 mg / mL and 10 mg / mL ropivacaine hydrochloride per vial
Local Anaesthetic
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision:
May 19, 2020
Submission Control No: 236564
_ _
_Product Monograph – Ropivacaine Hydrochloride Injection USP _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
Warnings and Precautions (6)
10/2018
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
........................................................................................
2
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
DOSAGE AND ADMINISTRATION
................................................................................
5
3.1
Dosing Considerations
...........................................................................................
5
3.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4
OVERDOSAGE
...............................................................................................................
7
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 9
6