DBL™ Morphine Sulfate Injection

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Morphine sulfate pentahydrate 5 mg/mL

Tilgængelig fra:

Pfizer New Zealand Limited

INN (International Name):

Morphine sulfate pentahydrate 5 mg/mL

Dosering:

5 mg/mL

Lægemiddelform:

Solution for injection

Sammensætning:

Active: Morphine sulfate pentahydrate 5 mg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection

Enheder i pakken:

Ampoule, glass, 1mL, 5 dose units

Klasse:

Class B1 Controlled Drug

Recept type:

Class B1 Controlled Drug

Fremstillet af:

Macfarlan Smith Ltd

Terapeutiske indikationer:

Latest Regulatory Activity

Produkt oversigt:

Package - Contents - Shelf Life: Ampoule, glass, 1mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours opened stored at or below 25°C

Autorisation dato:

1983-04-27

Produktets egenskaber

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