البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
hydromorphone hydrochloride, Quantity: 16 mg
Janssen-Cilag Pty Ltd
hydromorphone hydrochloride
Tablet, modified release
Excipient Ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; hypromellose; lactose; macrogol 3350; lactose monohydrate; titanium dioxide; triacetin; iron oxide yellow; macrogol 400; propylene glycol; isopropyl alcohol; purified water
Oral
Blister packs of 10 tablets, Blister packs of 60 tablets, Blister packs of 7 tablets, Blister packs of 30 tablets, Blister packs
(S8) Controlled Drug
JURNISTA 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. JURNISTA is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. JURNISTA is not indicated as an as-needed (PRN) analgesia. Not for use in opioid na?ve patients.
Visual Identification: Yellow, round, biconvex tablet with 'HM16' printed in black on one side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2008-07-29
JURNISTA ® 1 JURNISTA ® _Hydromorphone hydrochloride _ CONSUMER MEDICINE INFORMATION WARNING LIMITATIONS OF USE JURNISTA 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 JURNISTA 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 JURNISTA 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 JURNISTA 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 JURNISTA USING JURNISTA 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 JURNISTA. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about JURNISTA prolonged-release 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 JURNISTA against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING JURNISTA, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT JURNISTA IS TAKEN FOR JURNISTA is taken to relieve modera اقرأ الوثيقة كاملة
CCDS v10 200417 1 JURNISTA (201012)API AUSTRALIAN PRODUCT INFORMATION JURNISTA ® HYDROMORPHONE HYDROCHLORIDE P ROLONGED - RELEASE T ABLETS WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, JURNISTA 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 JURNISTA 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 JURNISTA. 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 JURNISTA. 1. NAME OF THE MEDICINE Hydromorphone hydrochloride CCDS v10 200417 2 JURNISTA(201012)API 2. QUALITATIVE AND QUANTITATIVE COMPOSITION JURNISTA is available as prolonged-release tablets containing 4, 8, 16, 32 and 64 mg hydromorphone hydrochloride. Excipient(s) with known effect: Lactose Fo اقرأ الوثيقة كاملة