Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
oxycodone hydrochloride, Quantity: 80 mg; naloxone hydrochloride dihydrate, Quantity: 43.6 mg (Equivalent: naloxone hydrochloride?, Qty 40 mg)
Mundipharma Pty Ltd
naloxone hydrochloride dihydrate,oxycodone hydrochloride
Tablet, modified release
Excipient Ingredients: ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; povidone; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide
Oral
28, 60, 20
(S8) Controlled Drug
TARGIN modified release tablet is indicated for the management of severe pain where:,- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and,- the pain is opioid-responsive; and,- requires daily, continuous, long term treatment.,TARGIN modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,TARGIN modified release tablet is not indicated as an as-needed (PRN) analgesia,The naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,TARGIN is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.
Visual Identification: Brown capsule shaped tablet OXN marked on one side and 80 on other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-07-20
TARGIN®TABLETS MFCTARGI10820 (SUPERSEDES MFCTARGI11219) 1 TARGIN ® tablets Oxycodone hydrochloride and naloxone hydrochloride Consumer Medicine Information WARNING: Limitations of use TARGIN should only be used when your doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them. Hazardous and harmful use TARGIN poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment. Life threatening respiratory depression TARGIN can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing) even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting Targin and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate. Use of other medicines while using TARGIN Using TARGIN with other medicines that can make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using TARGIN What is in this leaflet This leaflet answers some common questions about TARGIN 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 has weighed the risks of you taking this medicine against the benefits they expect it will 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 TARGIN tablets are t Lugege kogu dokumenti
TARGIN ® Modified Release Tablets Page 1 of 36 AUSTRALIAN PRODUCT INFORMATION – TARGIN ® MODIFIED RELEASE TABLETS WARNINGS Limitations of use Because of the risks associated with the use of opioids, TARGIN modified release tablets 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 TARGIN modified release tablets 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 TARGIN modified release tablets. 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 benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis 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 taking TARGIN modified release tablets. 1 NAME OF THE MEDICINE Oxycodone hydrochloride and naloxone hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TARGIN 2.5/1.25 modified release tablets contains oxycodone hydrochloride 2.5 mg/naloxone hydrochl Lugege kogu dokumenti