ROPIVACAINE HYDROCHLORIDE INJECTION, USP SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ROPIVACAINE HYDROCHLORIDE

Mevcut itibaren:

FRESENIUS KABI CANADA LTD

ATC kodu:

N01BB09

INN (International Adı):

ROPIVACAINE

Doz:

7.5MG

Farmasötik formu:

SOLUTION

Kompozisyon:

ROPIVACAINE HYDROCHLORIDE 7.5MG

Uygulama yolu:

NERVE BLOCK

Paketteki üniteler:

10ML/20ML

Reçete türü:

Ethical

Terapötik alanı:

LOCAL ANESTHETICS

Ürün özeti:

Active ingredient group (AIG) number: 0133273004; AHFS:

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2023-03-10

Ürün özellikleri

_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ROPIVACAINE HYDROCHLORIDE INJECTION, USP
2 mg / mL, 5 mg / mL, 7.5 mg / mL and 10 mg / mL
Local Anesthetic
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Revision: October 7, 2019
Submission Control No: 228440
_ _
Ropivacaine Hydrochloride Injection, USP - Product Monograph
Page 2 of 41
_ _
RECENT MAJOR LABEL CHANGES
Warnings and Precautions (6)
10/2018
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
1
INDICATIONS
...........................................................................................................3
1.1
Pediatrics
...........................................................................................................
3
1.2
Geriatrics
...........................................................................................................
3
2
CONTRAINDICATIONS
...........................................................................................3
3
DOSAGE AND ADMINISTRATION
.......................................................................4
3.1
Dosing Considerations
......................................................................................
4
3.2
Recommended Dose and Dosage Adjustment
.................................................. 5
4
OVERDOSAGE
...........................................................................................................7
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .........9
6
WARNINGS AND PRECAUTIONS
.......................................................................10
6.1
Special Populations
.........................................................................................
14
6.1.1
Pregnant
Women.............................................................................................
15
6.1.2
Breast-feeding
.................................................................................................
15
6.1.3
Pediatrics
..................