PMS-HYDROMORPHONE TAB 2MG TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

HYDROMORPHONE HYDROCHLORIDE

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

N02AA03

INN (nume internaţional):

HYDROMORPHONE

Dozare:

2MG

Forma farmaceutică:

TABLET

Compoziție:

HYDROMORPHONE HYDROCHLORIDE 2MG

Calea de administrare:

ORAL

Unități în pachet:

100, 4 X 25 (CONTROL PACK)

Tip de prescriptie medicala:

Narcotic (CDSA I)

Zonă Terapeutică:

OPIATE AGONISTS

Rezumat produs:

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

Statutul autorizaţiei:

MARKETED

Data de autorizare:

1991-12-31

Caracteristicilor produsului

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
N
PMS-HYDROMORPHONE
HYDROmorphone Hydrochloride
Tablets, 1 mg, 2 mg, 4 mg and 8 mg, Oral
Syrup, 1 mg/mL, Oral
Suppositories, 3 mg, Rectal
USP Standard
Opioid Analgesic
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control No.: 243864
DATE OF REVISION:
October 14, 2020
_pms-HYDROmorphone Prescribing Information _
_Page 2 of 33_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 3
1
INDICATIONS
......................................................................................................................
3
1.1
Pediatrics
.................................................................................................................
3
1.2
Geriatrics
.................................................................................................................
3
2
CONTRAINDICATIONS
.......................................................................................................
3
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.3
Administration
..........................................................................................................
7
4.4
Missed Dose
............................................................................................................
7
5
OVERDOSAGE
...................................................................................................................
8
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
.............................. 9
7
WARNINGS AND PRECAUTIONS