देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Midazolam maleate 10.2mg equivalent to 7.5 mg midazolam;
Roche Products (NZ) Ltd
Midazolam maleate 10.2 mg (equivalent to 7.5 mg midazolam)
7.5 mg
Tablet
Active: Midazolam maleate 10.2mg equivalent to 7.5 mg midazolam Excipient: Hypromellose Lactose Magnesium stearate Microcrystalline cellulose Purified talc Starch Titanium dioxide
Blister pack, PVC/PVDC, 100 tablets
Class C5 Controlled Drug
Class C5 Controlled Drug
F.I.S. Fabbrica Italiana Sintetici SpA
Short-term treatment of insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 100 tablets - 60 months from date of manufacture stored at or below 30°C
1986-11-26
_ _ Hypnovel Tablets170918 1 NEW ZEALAND CONSUMER MEDICINE INFORMATION HYPNOVEL ® MIDAZOLAM TABLETS 7.5 MG WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Hypnovel 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 your using Hypnovel against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT HYPNOVEL IS USED FOR Hypnovel tablets are used for the short term treatment of serious insomnia (inability to sleep). Hypnovel tablets may also be given to you before an operation to produce sleepiness or drowsiness and to relieve anxiety. Hypnovel belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals. Hypnovel tablets will cause sedation and help you sleep. Your doctor, however, may have prescribed Hypnovel for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY HYPNOVEL HAS BEEN PRESCRIBED FOR YOU. If you will be receiving Hypnovel before minor surgery, your doctor will give you the medicine and closely follow your progress. This medicine is available only with a doctor’s prescription. BEFORE YOU RECEIVE HYPNOVEL _DO NOT USE HYPNOVEL TABLETS IF _ § YOU HAVE HAD AN ALLERGIC REACTION TO HYPNOVEL, ANY OTHER BENZODIAZEPINE MEDICINE, OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET § YOU HAVE SEVERE MUSCLE WEAKNESS, ALSO KNOWN AS MYASTHENIA GRAVIS § YOU HAVE RESPIRATORY PROBLEMS § YOU HAVE A CONDITION CALLED SLEEP APNOEA SYNDROME § YOU HAVE SEVERE LIVER DAMAGE OR LIVER DISEASE § YOU ARE SUFFERING FROM SHOCK, COMA OR ACUTE ALCOHOLIC INTOXICATION § YOU ARE TAKING ANTIFUNGAL MEDICINES SUCH AS KETOCONAZOLE, ITRACONAZOLE OR VORICONAZOLE § YOU ARE TAKING HIV PROTEASE INHIBITORS INCLUDING RITONAVIR BOOSTED PROTEASE INHIBITORS § YOU AR पूरा दस्तावेज़ पढ़ें
NEW ZEALAND DATA SHEET 1 Hypnovel 170717 1. PRODUCT NAME Hypnovel ® 7.5mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: midazolam as the maleate Tablets containing midazolam maleate equivalent to 7.5 mg of midazolam. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Midazolam 7.5mg tablets are white, oval, cylindrical, biconvex. Imprint above is ROCHE 7.5 and below is a single break bar. Dimensions of the tablets are length 11.6mm, width 6.1mm, thickness 3.6mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS • Short-term treatment of insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. • Sedation in premedication before surgical or diagnostic procedures. 4.2 DOSE AND METHOD OF ADMINISTRATION In order to minimise the risk of dependence, benzodiazepines should only be prescribed after careful consideration of the indication and should be taken for the shortest possible duration. Generally the duration of treatment varies from a few days to a maximum of 2 weeks. Treatment with Hypnovel should not be terminated abruptly. The tapering-off process should be tailored to the individual. The necessity of continuing treatment should be closely monitored. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status. DOSE The standard dosage range: 7.5-15 mg. NEW ZEALAND DATA SHEET 2 Hypnovel 170717 Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded because of the increased risk of CNS adverse effects possibly including clinically relevant respiratory and cardiovascular depression. PREMEDICATION _ADULTS _ In premedication, 15mg of Hypnovel should be given 30-60 minutes before the procedure. SPECIAL POPULATIONS_ _ _Elderly and/or debilitated patients _ In elderly and/or debilitated patients the recommended dose is 7.5 mg. In eld पूरा दस्तावेज़ पढ़ें