Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
zuclopenthixol acetate, Quantity: 100 mg (Equivalent: zuclopenthixol, Qty 90.5 mg)
Lundbeck Australia Pty Ltd
Injection, solution
Excipient Ingredients: fractionated coconut oil
Intramuscular
5 X 2mL
(S4) Prescription Only Medicine
Initial treatment of acute psychoses, mania and exacerbation of chronic psychoses.
Visual Identification: Clear yellowish oil.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1993-09-20
CLOPIXOL ® C L O P I X O L ® CLOPIXOL ® TABLETS 10 MG, CLOPIXOL ® ACUPHASE INJECTION 50 MG/ML, CLOPIXOL ® DEPOT INJECTION 200 MG/ML CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING CLOPIXOL? Clopixol Tablet, Acuphase and Depot contain the active ingredient Zuclopenthixol hydrochloride, Zuclopenthixol acetate and Zuclopenthixol decanoate, respectively. Clopixol tablets are used for the acute and long-term treatment of schizophrenia and other mental illnesses, and to treat the manic phase of manic-depressive illness. Clopixol Acuphase injection is used for the initial treatment of acute episodes of mental disorders and to treat mania. Clopixol Depot injection is used to prevent further episodes of your illness. For more information, see Section 1. Why am I using Clopixol? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CLOPIXOL? Do not use if you have ever had an allergic reaction to Zuclopenthixol hydrochloride, Zuclopenthixol acetate or Zuclopenthixol decanoate or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Clopixol? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Clopixol and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE CLOPIXOL? • Clopixol tablets: the usual dose is 10 to 50 mg per day; Clopixol Acuphase injection: the usual dose is 50 to 150 mg (1 to 3 mL) every 2 to 3 days; Clopixol Depot injection: the usual dose is 200 to 400 mg (1 to 2 mL) every second to fourth week. • Clopixol tablets should be swallowed whole with a full glass of water; Clopixol injections should only be given by a doctor, nurs Прочитајте комплетан документ
CLOPIXOL ® 1 of 21 AUSTRALIAN PRODUCT INFORMATION CLOPIXOL (ZUCLOPENTHIXOL HYDROCHLORIDE) FILM- COATED TABLETS CLOPIXOL ACUPHASE (ZUCLOPENTHIXOL ACETATE) INJECTION CLOPIXOL DEPOT (ZUCLOPENTHIXOL DECANOATE) INJECTION 1 NAME OF THE MEDICINE CLOPIXOL TABLETS CLOPIXOL ACUPHASE INJECTION CLOPIXOL DEPOT INJECTION Zuclopenthixol hydrochloride Zuclopenthixol acetate Zuclopenthixol decanoate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Clopixol tablets _ Film-coated tablets containing 10 mg zuclopenthixol as zuclopenthixol hydrochloride. _Clopixol Acuphase injection _ The 1 mL solution for injection contains 50 mg zuclopenthixol acetate equivalent to 45.25 mg zuclopenthixol. The 2 mL solution for injection containing 100 mg zuclopenthixol acetate equivalent to 90.50 mg zuclopenthixol. _Clopixol Depot injection _ The 1 ml solution for injection contains 200 mg zuclopenthixol decanoate equivalent to 144.4 mg zuclopenthixol. Excipients with known effect in the tablets: sugars as lactose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM _Clopixol tablets _ Film-coated tablets. Clopixol 10 mg tablets are light red brown, round biconvex film-coated tablets. CLOPIXOL ® 2 of 21 _Clopixol Acuphase injection _ Solution for injection. Clopixol Acuphase injection presents as a clear, yellowish oil. _Clopixol Depot injection _ Solution for injection. Clopixol Depot injection presents as a clear, yellowish oil. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Clopixol tablets _ Acute and chronic schizophrenia and other psychoses, especially those with symptoms such as hallucinations, delusions, thought disturbances, agitation, restlessness, hostility or aggressiveness. Manic phase of manic depressive illness. _Clopixol Acuphase injection _ Initial treatment of acute psychoses, mania and exacerbation of chronic psychoses. _Clopixol Depot injection _ Maintenance treatment. May be an advantage in the treatment of noncompliant patients. 4.2 DOSE AND METHOD OF ADMINISTRAT Прочитајте комплетан документ