HYDROMORPHONE HYDROCHLORIDE INJECTION USP SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

HYDROMORPHONE HYDROCHLORIDE

Commercializzato da:

SANDOZ CANADA INCORPORATED

Codice ATC:

N02AA03

INN (Nome Internazionale):

HYDROMORPHONE

Dosaggio:

2MG

Forma farmaceutica:

SOLUTION

Composizione:

HYDROMORPHONE HYDROCHLORIDE 2MG

Via di somministrazione:

INTRAMUSCULAR

Confezione:

10X1ML

Tipo di ricetta:

Narcotic (CDSA I)

Area terapeutica:

OPIATE AGONISTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0108698003; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2005-10-04

Scheda tecnica

_HYDROmorphone Hydrochloride Injection USP 1mg/mL and 2 mg/mL _
_Page 1 of 36 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORM ATION
N HYDROMORPHONE HYDROCHLORIDE INJECTION USP
1 mg/mL and 2 mg/mL Sterile Solution
For subcutaneous (SC), intramuscular (IM) and intravenous (IV)
injection
Opioid Analgesic
Sandoz Canada Inc.
110 de Lauzon Street
Boucherville,
Québec
J4B 1E6
Date of revision:
April 1, 2021
Submission Control No.: 237401
_HYDROmorphone Hydrochloride Injection USP 1mg/mL and 2 mg/mL _
_Page 2 of 36 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Life-Threatening Respiratory
Depression,
Mar 2018
4 DOSING AND ADMINISTRATION, 4.2 Recommended Dose and Dose Adjustment,
Patients
Currently Receiving Opioids, Mar 2018
4 DOSING AND ADMINISTRATION, 4.3 Administration, Mar 2018
7 WARNINGS AND PRECAUTIONS, Use in Drug and Alcohol Addiction, Mar
2018
7 WARNINGS AND PRECAUTIONS, Neurologic, Serotonin toxicity / Serotonin
syndrome
July 2020
7 WARNINGS AND PRECAUTIONS, Respiratory, Sleep Apnea, July 2020
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women, Mar 2018
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding, Mar 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
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............