Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
morphine sulfate pentahydrate, Quantity: 10 mg
Pfizer Australia Pty Ltd
morphine sulfate pentahydrate
Injection, solution
Excipient Ingredients: water for injections; sodium chloride; hydrochloric acid
Intravenous, Intramuscular, Subcutaneous
5x10mg/1mL, 50x10mg/1mL
(S8) Controlled Drug
INDICATIONS AS AT 7 JULY 2020: DBL Morphine Sulfate Injection is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. DBL Morphine Sulfate Injection may also be used as a pre-operative medication and as an analgesic adjunct in general anaesthesia.
Visual Identification: Clear colourless to slightly yellow solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2004-07-21
DBL™ MORPHINE SULFATE INJECTION D B L ™ M O R P H I N E S U L F A T E I N J E C T I O N C M I CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I BEING TREATED WITH DBL MORPHINE SULFATE INJECTION? DBL Morphine Sulfate Injection contains the active ingredient morphine sulfate pentahydrate. DBL Morphine Sulfate Injection is a pain reliever that belongs to a group of medicines called opioid analgesics. It is most commonly used for short-term relief of severe pain. It may also be used just before or during an operation to help the anaesthetic work better. For more information, see Section 1. Why am I being treated with DBL Morphine Sulfate Injection? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE TREATMENT WITH DBL MORPHINE SULFATE INJECTION? You should not be given DBL Morphine Sulfate Injection if you have ever had an allergic reaction to morphine or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before treatment with DBL Morphine Sulfate Injection? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DBL Morphine Sulfate Injection and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS DBL MORPHINE SULFATE INJECTION GIVEN? Your doctor will decide what dose of morphine you will receive. This depends on your condition and other factors, such as your weight. More instructions can be found in Section 4. How is DBL Morphine Sulfate Injection given? in the full CMI. 5. WHAT SHOULD I KNOW DURING TREATMENT WITH DBL MORPHINE SULFATE INJECTION? THING Read the complete document
Version: pfpmorpi10822 Supersedes: pfpmorpi10321 Page 1 of 23 AUSTRALIAN PRODUCT INFORMATION – DBL ™ MORPHINE SULFATE INJECTION ( MORPHINE SULFATE PENTAHYDRATE ) 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 opioids analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics, general anaesthetics, tranquilisers, beta blocker, 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. NAME OF THE MEDICINE Morphine sulfate pentahydrate Version: pfpmorpi1 Read the complete document