ROPIVACAINE HYDROCHLORIDE INJECTION USP SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ROPIVACAINE HYDROCHLORIDE

Disponibil de la:

PFIZER CANADA ULC

Codul ATC:

N01BB09

INN (nume internaţional):

ROPIVACAINE

Dozare:

10MG

Forma farmaceutică:

SOLUTION

Compoziție:

ROPIVACAINE HYDROCHLORIDE 10MG

Calea de administrare:

EPIDURAL

Unități în pachet:

10ML/20ML

Tip de prescriptie medicala:

Ethical

Zonă Terapeutică:

LOCAL ANESTHETICS

Rezumat produs:

Active ingredient group (AIG) number: 0133273005; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2022-10-01

Caracteristicilor produsului

_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