Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Morphine sulfate pentahydrate 30mg
Teva Pharma (New Zealand) Limited
Morphine sulfate pentahydrate 30 mg
30 mg
Modified release tablet
Active: Morphine sulfate pentahydrate 30mg Excipient: Hyetellose Hypromellose Lactose monohydrate Magnesium stearate Opadry violet 0Y-6708 Povidone Purified talc
Blister pack, 1 tablet
Class B1 Controlled Drug
Class B1 Controlled Drug
Macfarlan Smith Ltd
ARROW-MORPHINE LA tablets are indicated for the prolonged relief of opioid responsive severe and intractable pain in adults. Use in Non-Malignant Pain: The use of ARROW-MORPHINE LA tablets for the treatment of pain which is not due to malignancy should be restricted to situations where: · All other conservative methods of analgesia have been tried and have failed; · The pain is having a significant impact on the patient's quality of life; · There is no psychological contraindication, drug seeking behaviour or history of drug abuse.
Package - Contents - Shelf Life: Blister pack, - 1 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, - 1000 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, Polypropylene with LDPE lid - 10 tablets - 36 months from date of manufacture stored at or below 25°C
1993-02-16
CONSUMER MEDICINE INFORMATION ARROW – MORPHINE LA MORPHINE SULPHATE 10 MG, 30 MG, 60 MG AND 100 MG LONG ACTING TABLETS WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ARROW – MORPHINE LA tablets. 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 weighed the risks of you taking ARROW – MORPHINE LA tablets against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT ARROW – MORPHINE LA IS USED FOR Morphine is a pain reliever that belongs to a group of medicines called opioid analgesics. It acts mainly on the central nervous system and on smooth muscle. The special tablet core is designed to prolong the release of the active over time (L.A. stands for “long acting”). ARROW – MORPHINE LA is used for prolonged relief of opioid responsive severe pain. Your doctor, however, may have prescribed ARROW – MORPHINE LA tablets for another purpose. Ask your doctor if you have any questions why ARROW – MORPHINE LA tablets have been prescribed for you. This medicine is a controlled drug (Class B1) and can only be obtained on prescription from your doctor. BEFORE YOU TAKE ARROW – MORPHINE LA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ARROW – MORPHINE LA IF YOU HAVE HAD AN ALLERGIC REACTION TO: • morphine sulphate • other opioids • any ingredients listed at the end of this leaflet Symptoms of an allergic reaction 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 DO NOT TAKE ARROW – MORPHINE LA IF YOU ARE PREGNANT OR BREASTFEEDING. DO NOT GIVE ARROW – MORPHINE LA TABLETS TO CHILDREN. DO NOT TAKE ARROW – MORPHINE LA IF YOU HAVE THE FOLLOWING MEDICAL CONDITIONS: • Breathing problem Lesen Sie das vollständige Dokument
Version 3.0 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Arrow – Morphine LA, 10 mg, 30 mg, 60 mg and 100 mg long acting tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each controlled release tablet contains 10 mg, 30 mg, 60 mg or 100 mg of morphine sulphate. Excipient with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Each 10 mg controlled release tablet is a smooth biconvex buff coloured film coated round tablet embossed with 10 on one side and contains 10 mg Morphine Sulphate Ph.Eur. Each 30 mg controlled release tablet is a smooth biconvex violet coloured film coated round tablet embossed with 30 on one side and contains 30 mg Morphine Sulphate Ph.Eur. Each 60 mg controlled release tablet is a smooth biconvex orange coloured film coated round tablet embossed with 60 on one side and contains 60 mg Morphine Sulphate Ph.Eur. Each 100 mg controlled release tablet is a smooth biconvex grey coloured film coated round tablet embossed with 100 on one side and contains 100 mg Morphine Sulphate Ph.Eur. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arrow – Morphine LA tablets are indicated for the prolonged relief of opioid responsive severe and intractable pain in adults. USE IN NON-MALIGNANT PAIN The use of Arrow – Morphine LA tablets for the treatment of pain which is not due to malignancy should be restricted to situations where: • All other conservative methods of analgesia have been tried and have failed; • The pain is having a significant impact on the patient’s quality of life; • There is no psychological contraindication, drug seeking behaviour or history of drug misuse 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE _Adults _ The dosage is dependent upon the severity of the pain and the patients previous history of analgesic requirements. The tablets should normally be administered twice daily at 12 hourly intervals. One or two 10 mg tablets twice daily is the recommended starting dosage for a patient presenting with severe pain. With Lesen Sie das vollständige Dokument