BAR-HYDROMORPHONE CR CAPSULE (EXTENDED RELEASE)
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
22-08-2018
Unele documente pentru acest produs nu sunt disponibile în prezent, puteți trimite o solicitare la serviciul nostru pentru clienți și vă vom anunța de îndată ce vom putea să le obținem.
Trimite cerere.
Trimite cerere.
Ingredient activ:
HYDROMORPHONE HYDROCHLORIDE
Disponibil de la:
BARD PHARMACEUTICALS (1990) INC
Codul ATC:
N02AA03
INN (nume internaţional):
HYDROMORPHONE
Dozare:
4.5MG
Forma farmaceutică:
CAPSULE (EXTENDED RELEASE)
Compoziție:
HYDROMORPHONE HYDROCHLORIDE 4.5MG
Calea de administrare:
ORAL
Unități în pachet:
100
Tip de prescriptie medicala:
Narcotic (CDSA I)
Zonă Terapeutică:
OPIATE AGONISTS
Rezumat produs:
Active ingredient group (AIG) number: 0108698018; AHFS:
Statutul autorizaţiei:
APPROVED
Data de autorizare:
2018-08-29
Caracteristicilor produsului
Page 1 of 44
PRODUCT MONOGRAPH
N
BAR-HYDROMORPHONE CR
HYDROmorphone* Hydrochloride Controlled Release Capsules
3, 4.5, 6, 9, 12, 18, 24 and 30 mg
Mfr. Std.
Opioid Analgesic
Bard Pharmaceuticals (1990) Inc.
580 Granite Court
Pickering, Ontario
L1W 3W8
Date of Revision:
August 22, 2018
Control No: 216202
* HYDROmorphone is the name of the active chemical ingredient
(hydromorphone) and is not a
brandname/tradename.
DILAUDID
®
is a trademark of Purdue Pharma
Page 2 of 44
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................. 3
INDICATIONS AND CLINICAL USE
........................................................................
3
CONTRAINDICATIONS
.............................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................
5
ADVERSE REACTIONS
............................................................................................
15
DRUG INTERACTIONS
............................................................................................
18
DOSAGE AND ADMINISTRATION
........................................................................
19
OVERDOSAGE
...........................................................................................................
23
ACTION AND CLINICAL
PHARMACOLOGY....................................................... 24
STORAGE AND STABILITY
....................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
................................................................. 26
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................... 27
PART II: SCIENTIFIC INFORMATION
..............................................................................
28
PHARMACEUTICAL INFORMATION
..............................................................
Citiți documentul complet
