DBL™ Morphine Sulfate Injection

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Morphine sulfate pentahydrate 15 mg/mL

Tersedia dari:

Pfizer New Zealand Limited

INN (Nama Internasional):

Morphine sulfate pentahydrate 15 mg/mL

Dosis:

15 mg/mL

Bentuk farmasi:

Solution for injection

Komposisi:

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

Unit dalam paket:

Ampoule, glass, 1mL, 5 dose units

Kelas:

Class B1 Controlled Drug

Jenis Resep:

Class B1 Controlled Drug

Diproduksi oleh:

Macfarlan Smith Ltd

Indikasi Terapi:

Latest Regulatory Activity

Ringkasan produk:

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

Tanggal Otorisasi:

1983-04-27

Karakteristik produk

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