REDESCA SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Compra

Scarica Scheda tecnica (SPC)
16-03-2021

Principio attivo:

ENOXAPARIN SODIUM

Commercializzato da:

SHENZHEN TECHDOW PHARMACEUTICAL CO., LTD.

Codice ATC:

B01AB05

INN (Nome Internazionale):

ENOXAPARIN

Dosaggio:

100MG

Forma farmaceutica:

SOLUTION

Composizione:

ENOXAPARIN SODIUM 100MG

Via di somministrazione:

INTRAVENOUS

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

HEPARINS

Dettagli prodotto:

Active ingredient group (AIG) number: 0131860001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-12-07

Scheda tecnica

                                Product Monograph
REDESCA
®
(
Enoxaparin sodium solution for injection)
Page 1 of 78
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
REDESCA®
Enoxaparin sodium solution for injection
Solution for subcutaneous or intravenous injection, 100 mg/mL
30 mg/0.3 mL
40 mg/0.4 mL
60 mg/0.6 mL
80 mg/0.8 mL
100 mg/mL
300 mg/3 mL
(manufacturer’s standard)
Pr
REDESCA HP®
Enoxaparin sodium solution for injection
Solution for subcutaneous or intravenous injection, 150 mg/mL (High
Potency)
120 mg/0.8 mL
150 mg/mL
(manufacturer’s standard)
ATC Code: B01AB05
Anticoagulant/Antithrombotic Agent
Shenzhen Techdow Pharmaceutical Co., Ltd.
No. 1 Rongtian South, Kengzi Sub-district,
Pingshan New District, Shenzhen City 518122
People’s Republic of China
Date of Initial Authorization:
December 7, 2020
Date of Revision:
March 16, 2021
Submission Control Number: 231767
Product Monograph
REDESCA
®
(Enoxaparin sodium solution for injection)
Page 2 of 78
RECENT MAJOR LABEL CHANGES
Not Applicable
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed
.
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
4
DOSAGE AND ADMINISTRATION
..............................
                                
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