Transcription of HALDOL Injection - Janssen
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HALDOL Injection - Janssen
CCDS180302 Page 1 of 17 HALDOL (190619)API HALDOL DECANOATE Haloperidol decanoate AUSTRALIAN PRODUCT INFORMATION 1. NAME OF THE MEDICINE Haloperidol decanoate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 50 mg haloperidol (present as haloperidol decanoate mg) in a sesame oil vehicle, with w/v benzyl alcohol as a preservative each mL contains 15 mg benzyl alcohol. For the full list of excipients, see Section List of Excipients. 3. PHARMACEUTICAL FORM HALDOL DECANOATE Injection contains haloperidol decanoate mg/mL (equivalent to 50 mg haloperidol) oily Injection for intramuscular Injection (IM) only in 1 mL (50 mg/mL solution for Injection ) or 3 mL (150mg/3mL for Injection ) ampoules. 4. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS HALDOL DECANOATE is indicated for the maintenance therapy of psychoses in adults; particularly for patients requiring prolonged parenteral neuroleptic therapy. DOSE AND METHOD OF ADMINISTRATION Administration HALDOL DECANOATE should be administered by deep intramuscular Injection into the gluteal region.
CCDS 170522 3 HALDOL(170907)API The mechanism for this increased risk is not known. An increased risk cannot be excluded for other patient
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