Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
calamine, Quantity: 50 mg/g
JMAC (WA) Pty Ltd trading as PharmAust Manufacturing
Lotion
Excipient Ingredients: Arachis Oil; quaternium-15; calcium hydroxide; Wool fat; purified water; oleic acid
Topical
100mL, 2 Litres
Medicine Registered
Not scheduled. Not considered by committee
This product accepted for registration/listing as 'currently supplied' at the time of commencement of the Act. Indications held in ARTG paper records. (Old code) For the temporary relief of insect bites and stings
Visual Identification: Oily opaque pink lotion; Container Type: Bottle; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-10-25
HALDOL ® Injection (210920) ACMI 1 HALDOL ® DECANOATE _Haloperidol decanoate solution for injection (IM OILY INJECTION) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Haldol injection. 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 treating you with Haldol against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING TREATED WITH HALDOL, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT HALDOL IS USED FOR Haldol contains the active substance haloperidol (as haloperidol decanoate). This belongs to a group of medicines called ‘antipsychotics’. Haldol is a long-acting antipsychotic. It works by correcting the chemical imbalances in the brain, which may cause mental illness. Haldol is used in adults whose condition has previously been treated with haloperidol taken by mouth. It is used for illnesses affecting the way you think, feel or behave. These include mental health problems (such as schizophrenia). These illnesses may make you: • Feel confused (delirium) • See, hear, feel or smell things that are not there (hallucinations) • Believe things that are not true (delusions) • Feel unusually suspicious (paranoia) • Feel very excited, agitated, enthusiastic, impulsive or hyperactive • Feel very aggressive, hostile or violent. Your doctor may have prescribed Haldol for another use. ASK YOUR DOCTOR OR HEALTHCARE PROFESSIONAL IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Haldol is not addictive. BEFORE YOU ARE GIVEN HALDOL _WHEN YOU MUST NOT BE GIVEN _ _IT: _ DO NOT GIVE HALDOL TO ANYONE WHO IS UNCONSCIOUS OR IN A COMA. YOU MUST NOT BE GIVEN HALDOL IF YOU: • have severe drowsiness and slowness due to illness or the use of alcohol or medicine • feel unusually confused, dizz Pročitajte cijeli dokument
CCDS180302 Page 1 of 17 HALDOL(210920)API AUSTRALIAN PRODUCT INFORMATION HALDOL ® DECANOATE HALOPERIDOL DECANOATE SOLUTION FOR INJECTION (IM OILY INJECTION) 1. NAME OF THE MEDICINE Haloperidol decanoate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL injection contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg) and each 3 mL injection contains 150 mg haloperidol (present as haloperidol decanoate 211.56 mg). Excipient(s) of known effect: Contains sesame seed products. For the full list of excipients, see Section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM The oily injection for intramuscular injection (IM) is a slightly amber, slightly viscous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HALDOL DECANOATE is indicated for the maintenance therapy of psychoses in adults; particularly for patients requiring prolonged parenteral neuroleptic therapy. 4.2 DOSE AND METHOD OF ADMINISTRATION ADMINISTRATION HALDOL DECANOATE should be administered by deep intramuscular injection into the gluteal region. A 2-inch-long, 21-gauge needle is recommended. The maximum volume per injection site should not exceed 3 mL. The recommended interval between doses is 4 weeks. It is recommended to alternate between the two gluteal muscles for subsequent injections. DO NOT ADMINISTER INTRAVENOUSLY Patients must be previously stabilised on oral haloperidol before converting to HALDOL DECANOATE. Treatment initiation and dose titration must be carried out under close clinical supervision. The starting dose of HALDOL DECANOATE should be based on the patient's clinical history, physical condition and response to the current oral haloperidol dose. Patients must always be maintained on the lowest effective dose. CCDS180302 Page 2 of 17 HALDOL(210920)API DOSAGE - ADULTS Table 1. Haloperidol decanoate dose recommendations for adults aged 18 years and above TRANSITION FROM ORAL HALOPERIDOL • A haloperidol decanoate dose of 10 to 15 times the previous daily dose of oral haloperidol is recommended. • Based Pročitajte cijeli dokument