البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Morphine hydrochloride trihydrate 10 mg/mL equivalent to morphine base 7.58 mg/mL
Juno Pharmaceuticals NZ Limited
Morphine hydrochloride trihydrate 10 mg/mL (equivalent to morphine base 7.58 mg/mL)
10 mg/mL
Solution for injection
Active: Morphine hydrochloride trihydrate 10 mg/mL equivalent to morphine base 7.58 mg/mL Excipient: Hydrochloric acid Water for injection
Class B1 Controlled Drug
S.A.L.A.R.S SpA
Morphine hydrochloride is indicated for: - the relief of moderate to severe pain not responsive to non-opioid analgesics - symptomatic relief of severe and intractable pains of various categories, in terminal cancer patients - use as a pre-operative medication and as an analgesic adjunct in general anaesthesia
Package - Contents - Shelf Life: Ampoule, glass, Type I - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, Type I - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light
2015-07-06
Page 1 MORPHINE JUNO Morphine hydrochloride injection _(MOR-feen)_ _ _ _ _ CONSUMER MEDICINE INFORMATION _Date of _ _Dispensing Consumer Name _ _Pharmacist Name_ _Consumer Address _ _Pharmacist Address_ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Morphine Juno morphine hydrochloride injection (Morphine). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits . Your doctor has weighed the risks of you being given Morphine Juno against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT MORPHINE JUNO IS USED FOR Morphine is a pain reliever that belongs to a group of medicines called opioid analgesics. Morphine acts in the brain and spinal cord. It is used most commonly for relief of severe pain. It may also be used just before or during an operation to help the anesthetic work better. Your doctor may have prescribed morphine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MORPHINE HAS BEEN PRESCRIBED FOR YOU. Morphine may produce physical dependency if used for a long time (ie more than two weeks). Physical dependency means you may experience unpleasant feelings if you stop morphine suddenly. However, it is also important to keep your pain under control. Your doctor can advise you on how to manage this. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN MORPHINE JUNO _ _ _WHEN YOU MUST NOT BE GIVEN IT_ _ _ YOU SHOULD NOT BE GIVEN MORPHINE IF YOU HAVE AN ALLERGY TO MORPHINE, OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction to morphine may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. YOU SHOULD NOT BE GIVE اقرأ الوثيقة كاملة
Datasheet – New Zealand MORPHINE JUNO _(MORPHINE HYDROCHLORIDE INJECTION) _ DATA SHEET 1. PRODUCT NAME The name of the medicine is Morphine Juno as morphine hydrochloride trihydrate, (10mg /mL, 20mg /mL, 50mg /5mL, 100mg/5mL) Solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION morphine hydrochloride trihydrate 10mg/mL, 20mg/mL, 50mg /5mL, 100mg/5mL For full list of excipients, see section 6.1 3. PHARMACEUTICALS FORM Morphine Juno injection is a clear, colourless to almost colourless, sterile solution for injection. The pH of the solution ranges between 3.0 and 5.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MORPHINE JUNO IS INDICATED FOR • the relief of moderate to severe pain not responsive to non-opioid analgesics • symptomatic relief of severe and intractable pains of various categories, in terminal cancer patients • use as a pre-operative medication and as an analgesic adjunct in general anaesthesia. 4.2 DOSE AND METHOD OF ADMINISTRATION NOTE : 1 . Opioid antagonists and facilities for administration of oxygen and control of respiration should be available during, and immediately after parenteral administration of morphine. 2 Morphine hydrochloride contains almost an equivalent amount of morphine base per milligram as morphine sulphate and morphine tartrate. Therefore, the two preparations may be used interchangeably. Datasheet – New Zealand Morphine Juno should be administered by subcutaneous, intramuscular or slow intravenous injection. ADULTS : The usual adult dose is 5 to 20 milligrams. Doses may be repeated every 4 to 6 hours. Morphine may be administered intravenously when a rapid onset of action is desired. The usual adult dose is 2.5 to 15 milligrams diluted in 4 to 5 mL of water for injections given slowly over 4 to 5 minutes. ELDERLY PATIENTS The dose should be reduced in elderly patients, those with respiratory impairment and in patients receiving other CNS depressant medication. In severe or chronic pain, the dose may need to be adjusted according to the response اقرأ الوثيقة كاملة