DBL™ Morphine Sulfate Injection

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Morphine sulfate pentahydrate 15 mg/mL

可用日期:

Pfizer New Zealand Limited

INN（国际名称）:

Morphine sulfate pentahydrate 15 mg/mL

剂量:

15 mg/mL

药物剂型:

Solution for injection

组成:

Active: Morphine sulfate pentahydrate 15 mg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection

每包单位数:

Ampoule, glass, 1mL, 5 dose units

类:

Class B1 Controlled Drug

处方类型:

Class B1 Controlled Drug

厂商:

Macfarlan Smith Ltd

疗效迹象:

Latest Regulatory Activity

產品總結:

Package - Contents - Shelf Life: Ampoule, glass, 1mL - 5 dose units - 30 months from date of manufacture stored at or below 25°C - Ampoule, glass, 1mL - 50 dose units - 30 months from date of manufacture stored at or below 25°C

授权日期:

1983-04-27

产品特点

Version: pfdmorpi11123
Supercede: pfdmorpi10522
Page 1 of 24
NEW ZEALAND DATA SHEET
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, morphine
should only be used in
patients for whom other treatment options, including non-opioid
analgesics, are ineffective,
not tolerated or otherwise inadequate to provide appropriate
management of pain (see SECTION
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
HAZARDOUS AND HARMFUL USE
Morphine poses risks of hazardous and harmful use which can lead to
overdose and death.
Assess the patient’s risk of hazardous and harmful use before
prescribing and monitor the
patient regularly during treatment (see
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE
).
LIFE-THREATENING RESPIRATORY DEPRESSION
Serious, life-threatening or fatal respiratory depression may occur
with the use of morphine.
Be aware of situations which increase the risk of respiratory
depression, modify dosing in
patients at risk and monitor patients closely, especially on
initiation or following a dose
increase (see
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
CONCOMITANT
USE
OF
BENZODIAZEPINES
AND
OTHER
CENTRAL
NERVOUS
SYSTEM
(CNS)
DEPRESSANTS, INCLUDING ALCOHOL
Concomitant use of opioids with other opioid analgesics,
benzodiazepines, gabapentinoids,
cannabis,
sedatives,
hypnotics,
tricyclic
antidepressants,
antipsychotics,
antihistamines,
centrally-active anti-emetics, general anaesthetics, tranquilisers,
beta blockers, or other
central nervous system (CNS) depressants, including alcohol, may
result in profound
sedation, respiratory depression, coma, and death. Limit dosages and
durations to the
minimum required and monitor patients for signs and symptoms of
respiratory depression
and sedation. Caution patients not to drink alcohol while using
morphine (see
SECTION 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
1. PRODUCT NAME
DBL
™
Morphine Sulfate Injection, 5 mg/mL, solution for injection
DBL
™
Morphine Sulfate Injection, 10 mg/mL, solution for injection
DB