Χώρα: Νέα Ζηλανδία
Γλώσσα: Αγγλικά
Πηγή: Medsafe (Medicines Safety Authority)
Morphine sulfate pentahydrate 15 mg/mL
Pfizer New Zealand Limited
Morphine sulfate pentahydrate 15 mg/mL
15 mg/mL
Solution for injection
Active: Morphine sulfate pentahydrate 15 mg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection
Ampoule, glass, 1mL, 5 dose units
Class B1 Controlled Drug
Class B1 Controlled Drug
Macfarlan Smith Ltd
Latest Regulatory Activity
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
1983-04-27
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 Διαβάστε το πλήρες έγγραφο