البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Haloperidol decanoate 100 mg/mL
Janssen-Cilag (New Zealand) Ltd
Haloperidol decanoate 100 mg/mL
100 mg/mL
Injection (depot)
Active: Haloperidol decanoate 100 mg/mL
Ampoule, glass, 1mL, 5 dose units
Prescription
Prescription
Janssen Pharmaceutica NV
The maintenance therapy of psychoses, particularly for patients requiring prolonged parenteral neuroleptic therapy.
Package - Contents - Shelf Life: Ampoule, glass, 1mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light
1991-06-19
1 Haldol (211029) ACMI HALDOL INJECTION _Haloperidol decanoate _ 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 is used to control the symptoms of mental illnesses in adults with disturbances in thinking, feelings and behaviour. Haldol is a long-acting antipsychotic. It works by correcting the chemical imbalances in the brain, which may cause mental illness. Your doctor may have prescribed Haldol for another use. Ask your doctor 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 • suffer from severe depression • have or have ever had muscle stiffness, restricted or uncontrollable movement due to certain medical conditions, such as spastic diseases or Parkinson’s disease • have senility with pre-existing Parkinson like symptoms • suffer from Lewy body dementia • suffer from progressive supranuclear palsy • have an allergy to Haldol or any of the ingredients. See PRODUCT DESCRIPTION at the end of this leaflet for a list of ingredients. Signs of allergy may include skin rash, itching, shortness of breath, and/or swollen face that may lead to difficulty breathing or swallowing. If you think you are having an allergic reaction, tell your doctor immediately or go to accid اقرأ الوثيقة كاملة
CCDS(180302) Page 1 of 15 HALDOL(211029)ADS HALDOL ® HALOPERIDOL DECANOATE NEW ZEALAND DATA SHEET 1. PRODUCT NAME HALDOL haloperidol decanoate 50 mg/mL Injection HALDOL CONCENTRATE haloperidol decanoate 100 mg/mL Injection 2. QUANTITATIVE AND QUALITATIVE COMPOSITION HALDOL 50 mg/ml Haloperidol decanoate 70.52 mg, equivalent to 50 mg haloperidol base, per millilitre. HALDOL CONCENTRATE 100 mg/ml Haloperidol decanoate 141.04 mg, equivalent to 100 mg haloperidol base, per millilitre. Excipient(s) of known effect: Contains sesame seed products. For a full list of excipients, see SECTION 6.1. 3. PHARMACEUTICAL FORM Injection (depot) HALDOL Injection (long acting) is a slightly amber, slightly viscous solution, free from visible foreign matter, filled in 1 mL amber glass ampoules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HALDOL 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 should be administered by deep intramuscular injection into the gluteal region. It is recommended to alternate between the two gluteal muscles for subsequent injections. 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. DO NOT ADMINISTER INTRAVENOUSLY. Patients must be previously stabilised on oral haloperidol before converting to HALDOL. Treatment initiation and dose titration must be carried out under close clinical supervision. The starting dose of HALDOL should be based on the patient's clinical history, severity of symptoms, physical condition and response to the current oral haloperidol dose. Patients must always be maintained on the lowest effective dose. CCDS(180302) Page 2 of 15 HALDOL(211029)ADS 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 اقرأ الوثيقة كاملة