DILAUDID TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

HYDROMORPHONE HYDROCHLORIDE

Disponível em:

PURDUE PHARMA

Código ATC:

N02AA03

DCI (Denominação Comum Internacional):

HYDROMORPHONE

Dosagem:

1MG

Forma farmacêutica:

TABLET

Composição:

HYDROMORPHONE HYDROCHLORIDE 1MG

Via de administração:

ORAL

Unidades em pacote:

25/100

Tipo de prescrição:

Narcotic (CDSA I)

Área terapêutica:

OPIATE AGONISTS

Resumo do produto:

Active ingredient group (AIG) number: 0108698004; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2008-08-07

Características técnicas

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_DILAUDID_
_®_
_ (HYDROmorphone hydrochloride) Page 1 of 37 _
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PRODUCT MONOGRAPH
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INCLUDING PATIENT MEDICATION INFORMATION
N
DILAUDID
®
HYDROmorphone* hydrochloride
Tablets, 1 mg, 2 mg, 4 mg and 8 mg, Oral
Sterile Solution for Injection, 2 mg/mL, Intramuscular, Intravenous,
Subcutaneous
USP Standard
Opioid Analgesic
ATC code:
N02AA03
Purdue Pharma
3381 Steeles Avenue East Suite 310
Toronto, ON
M2H 3S7
Date of Initial Approval:
August 8, 2008
_ _
Date of Revision:
August 29, 2023
Submission Control No: 273917
DILAUDID
® is a registered trademark of Purdue Pharma
*HYDROmorphone is the name of the active chemical ingredient
(hydromorphone) and is not a
brandname/tradename.
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_DILAUDID_
_®_
_ (HYDROmorphone hydrochloride) Page 2 of 37 _
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RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION
08/2023
7 WARNINGS AND PRECAUTIONS
08/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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6
4.1 Dosing Considerations
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6
4.2 Recommended Dose and Dosage Adjustment
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