국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
haloperidol, Quantity: 5 mg/mL
Aspen Pharmacare Australia Pty Ltd
Haloperidol
Injection, solution
Excipient Ingredients: water for injections; sodium hydroxide; (S)-lactic acid
Intravenous, Intramuscular
10 ampoules
Medicine Registered
(S4) Prescription Only Medicine
Chronic Therapy: The management of manifestations of psychotic disorders such as schizophrenia, psychosis due to organic brain damage or mental deficiency, the manic phase of manic depressive illness, Gilles de la Tourette syndrome. Short Term Therapy: The treatment of acute alcoholism for the relief of delusions, hallucinations and confused states, and for the control of accompanying tremulousness and aggressive behaviour. In the treatment of intractable nausea and vomiting associated with radiation or malignancy and not responding to other therapy. Neuroleptanalgesia
Visual Identification: A clear, colourless liquid practically free of visible contamination.; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2011-10-31
SERENACE injection – Consumer Medicine Information Page 1 of 5 SERENACE INJECTION _haloperidol _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SERENACE. 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 using SERENACE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SERENACE IS USED FOR SERENACE contains haloperidol as the active ingredient and belongs to a group of medicines called antipsychotics. SERENACE helps to correct chemical imbalances in the brain and is used to treat mental illnesses such as: • schizophrenia, an illness with disturbances in thinking, feelings and behaviour • mania, an illness where the patient experiences episodes of overactivity, elation or irritability • severe anxiety, tension or excitement and severe agitation, hyperactivity or aggression in patients with mental or emotional illness. It is also used to treat: • behavioural problems in children with mental retardation or mental illness • nausea and vomiting (caused by cancer treatment) • anxiety and pain during surgery _(neurolept anaesthesia) _ • Tourette’s Syndrome, a condition with uncontrolled vocal outbursts and body movements (tics). • Before you receive SERENACE, your doctor may recommend that you have an electrocardiogram or ECG. • Your doctor may also recommend that you have an ECG on a regular basis while taking SERENACE. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SERENACE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. There is no evidence that this medicine is addictive. SERENACE is only available with a doctor’s prescription. SERENACE is not recommended for use in children under the ag 전체 문서 읽기
Serenace ampoules – Product information Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION SERENACE INJECTION (HALOPERIDOL) 1. NAME OF THE MEDICINE Haloperidol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SERENACE injections contain haloperidol as the active ingredient – present as haloperidol 5 mg/1 mL, haloperidol 10 mg/1 mL and haloperidol 20 mg/2 mL. Excipients include (S)-lactic acid (5 mg/1 mL injection only), lactic acid (10 mg/1 mL & 20 mg/2 mL injection only), sodium hydroxide and water for injections. 3. PHARMACEUTICAL FORM A clear, colourless solution practically free of visible particles in amber coloured glass ampoules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CHRONIC THERAPY The management of manifestations of psychotic disorders such as schizophrenia, psychosis due to organic brain damage or mental deficiency, the manic phase of manic depressive illness, Gilles de la Tourette syndrome. SHORT TERM THERAPY The treatment of acute alcoholism for the relief of delusions, hallucinations and confused states, and for the control of accompanying tremulousness and aggressive behaviour. In the treatment of intractable nausea and vomiting associated with radiation or malignancy and not responding to other therapy. Neuroleptanalgesia. 4.2 DOSE AND METHOD OF ADMINISTRATION WARNING Higher doses and intravenous administration of haloperidol appear to be associated with a higher risk of QT prolongation and Torsades de Pointes (see PRECAUTIONS and ADVERSE EFFECTS). Haloperidol solution for injection is recommended for intramuscular administration only. However, if administered intravenously, continuous ECG monitoring must be performed for QTc interval prolongation and for ventricular arrhythmias. Where rapid control of an acutely disturbed patient is required, or where heavier than usual dosages are envisaged, or when parenteral administration, particularly repeated parenteral administration, is required, then the patient should be transferred as soon as possible to a situation where, ECG monitoring, parentera 전체 문서 읽기