Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
flupentixol decanoate, Quantity: 100 mg
Lundbeck Australia Pty Ltd
Injection, concentrated
Excipient Ingredients: fractionated coconut oil
Intramuscular
5 x 1mL
(S4) Prescription Only Medicine
Flupenthixol is indicated for the maintenance treatment of chronic schizophrenia and other related chronic psychoses, in patients intolerant of and/or refractory to other depot preparations. Flupenthixol is intended for maintenance therapy and not for short term use (less than 3 months).
Visual Identification: Clear, yellow to yellowish oil, pratically free from particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1994-01-10
FLUANXOL ® _(FLU-ANK-SOL); FLUANXOL_ _®_ _ DEPOT 20 MG/ML; FLUANXOL_ _®_ _ CONCENTRATED DEPOT 100 MG/ML_ _Flupentixol decanoate (flu-PEN-tic-sol deck-can-OH-ate)_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet contains answers to some common questions about Fluanxol. It does not contain all the information that is known about Fluanxol. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects 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 FLUANXOL IS USED FOR Fluanxol is used for the long-term treatment of schizophrenia, a mental illness with disturbances in thinking, emotional reactions and behaviour, and other chronic mental conditions. Fluanxol belongs to a group of medicines called thioxanthene neuroleptics. It helps to correct chemical imbalances in the brain, which may cause mental illness. Your doctor, however, may prescribe it for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. Fluanxol is not addictive. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT USE FLUANXOL IF YOU ARE ALLERGIC TO IT, TO ANY OTHER SIMILAR MEDICINES (SUCH AS THIOXANTHENES OR PHENOTHIAZINES), OR THE INGREDIENT FRACTIONATED COCONUT OIL. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, or rash, itching or hives on the skin. DO NOT USE FLUANXOL IF YOU HAVE: • diminished consciousness due to any cause • collapse due to very low blood pressure • brain damage • diseases of the blood with a reduced number of red or white blood cells or platelets • phaeochromocytoma, a rare tumour of the adre Baca dokumen lengkap
FLUANXOL ® ( flupentixol decanoate ) 1 of 15 AUSTRALIAN PRODUCT INFORMATION – FLUANXOL ® DEPOT AND FLUANXOL ® CONCENTRATED DEPOT SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Flupentixol decanoate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fluanxol Depot • Solution for injection containing 20 mg/mL flupentixol decanoate. Fluanxol Concentrated Depot • Concentrated injection containing 100 mg/mL flupentixol decanoate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Flupentixol decanoate is insoluble in water, soluble in alcohol, ether and chloroform. Fluanxol Depot injection presents as a clear, colourless to slightly yellowish oil. Fluanxol Concentrated Depot injection presents as a clear, yellowish to yellow oil. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flupentixol is indicated for the maintenance treatment of chronic schizophrenia and other related chronic psychoses, in patients intolerant of and/or refractory to other depot preparations. Flupentixol is intended for maintenance therapy and not for short-term use (less than 3 months). 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS Fluanxol (flupentixol decanoate) is administered by intramuscular injection, in the gluteus maximus. Fluanxol is NOT for intravenous use. It is not intended for short-term therapy (less than 3 months). As a long-acting depot preparation, Fluanxol has been found useful in the maintenance treatment of non-agitated chronic schizophrenic patients who have been stabilised with short- acting neuroleptics and might benefit from transfer to a longer-acting injectable medication. FLUANXOL ® ( flupentixol decanoate ) 2 of 15 The changeover of medication should aim at maintaining a clinical outcome similar to or better than that obtained with the previous therapy. To achieve and maintain the optimum dose, the changeover from other neuroleptic medication should proceed gradually and constant supervision is required during the period of dosage adjustment in order to minimise the risk of ov Baca dokumen lengkap