Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Haloperidol 0.5mg
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Haloperidol 0.5 mg
0.5 mg
Tablet
Active: Haloperidol 0.5mg Excipient: Acacia Acid green 50 Calcium hydrogen phosphate dihydrate Lactose monohydrate Magnesium stearate Maize starch Quinoline yellow
Bottle, plastic, 100 tablets
Prescription
Prescription
RPG Life Sciences Ltd
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: Bottle, plastic, 30mL white opaque HPDE bottle with PP white opaque CR closure - 100 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 100 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 500 tablets - 24 months from date of manufacture stored at or below 30°C
1969-12-31
1 SERENACE TABLETS AND LIQUID NEW ZEALAND CONSUMER MEDICINE INFORMATION SERENACE TABLETS AND LIQUID 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 TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. 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. This medicine is only available with a doctor’s prescription. • Brain damage • Parkinson’s Disease • Severe depression • Alcohol or drug intoxication • Spasticity, where a group of muscles are stiff and restricted in movement • Parkinsonian-like symptoms together with senility • Breast cancer DO NOT GIVE SERENACE TO ANYONE WHO IS UNCONSCIOUS OR IN A COMA. DO NOT GIVE SERENACE TO CHILDREN UNDER 12 YEARS OF AGE, UNLESS DIRECTED BY THE CHILD’S DOCTOR. SERENACE is not recommended for use in children under 3 years of age. SERENACE is not recommended DO NOT TAKE SERENACE AFTER THE WHAT SERENACE IS USED FOR SERENACE is used to treat mental illnesses such as: for use in children under the age of 3 years, as there is not enough information on its effects in this age group. EXPIRY DATE _(EXP) _PRINTED ON THE PACK. DO NOT TAKE SERENACE IF THE • schizophrenia, an illness with PACK Leggi il documento completo
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 Leggi il documento completo