Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Haloperidol 5 mg/mL
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Haloperidol 5 mg/mL
5 mg/mL
Solution for injection
Active: Haloperidol 5 mg/mL Excipient: Lactic acid Sodium hydroxide Water for injection
Ampoule, glass, 10 dose units
Prescription
Prescription
Excella GmbH & Co KG
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.
Package - Contents - Shelf Life: Ampoule, glass, - 10 dose units - 36 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, - 25 dose units - 36 months from date of manufacture stored at or below 30°C protect from light
1969-12-31
SERENACE INJECTION 1 NEW ZEALAND CONSUMER MEDICINE INFORMATION SERENACE INJECTION _Haloperidol (Hal oh PER I doll) _ 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 taking 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 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) Your doctor may have prescribed SERENACE for another reason. Ask your doctor if you have any questions about why SERENACE has been prescribed for you. SERENACE belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness. _These _ _chemicals may also affect the parts _ _of the brain, which control nausea _ _and vomiting._ There is no evidence that SERENACE is addictive or habit forming. SERENACE is only available with Прочитать полный документ
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME SERENACE Haloperidol tablets - 0.5mg; 1.5mg; 5mg Haloperidol liquid – 2mg/mL Haloperidol injection – 5mg/mL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Serenace tablets contains 0.5mg, 1.5mg and 5mg haloperidol respectively. Serenace liquid contains 2mg/mL haloperidol Serenace injection contains 5mg/mL haloperidol For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM SERENACE 0.5mg tablet: (1/4" diameter), green, biconvex, scored, uncoated, plain on one side, each containing haloperidol BP 0.5mg. SERENACE 1.5mg tablet: (9/32" diameter), white, biconvex, scored, uncoated, plain on one side, each containing haloperidol BP 1.5mg. SERENACE 5mg tablet: (5/16" diameter), red, biconvex, scored, uncoated, plain on one side, each containing haloperidol BP 5mg. Liquid Clear, colourless liquid containing 2mg haloperidol BP per ml, in a bottle. Injection Ampoule 1ml amber coloured ampoule containing 5mg haloperidol BP per ml. 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. 2 4.2 DOSAGE AND METHOD OF ADMINISTRATION 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 REACTIONS). 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 Прочитать полный документ