Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
HALOPERIDOL
J-C HEALTH CARE LTD
N05AD01
SOLUTION FOR INJECTION
HALOPERIDOL 5 MG/ML
I.M
Required
GLAXO SMITH KLINE MANUFACTURING SPA,ITALY
HALOPERIDOL
HALOPERIDOL
Psychomotor agitation encountered in different neuropsychotic affections, prophylaxis and therapy of acute and chronic vomiting.
2012-02-28
1 Haldol Ampoules_PI_Safety + other updates_5.1.2021 HALDOL ® AMPOULES 1. NAME OF THE MEDICINAL PRODUCT HALDOL AMPOULES ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Contains 5 mg haloperidol per ml. For excipients, see Section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution, free from visible foreign material. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Psychomotor agitation encountered in different neuropsychotic affections. Prophylaxis and therapy of acute and chronic vomiting. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION There is considerable variation from patient to patient in the amount of medication required for treatment. As with all antipsychotic drugs, dosage should be individualized according to the needs and response of the individual patient. When initiating treatment, consideration should be given to the following factors: age of the patient, severity of the disease, history of response to other antipsychotic drugs, concomitant medication or disease state. Haldol Injection is reserved for prompt control of the acutely agitated patient with moderately severe to very severe symptoms. Haldol Injection is recommended for IM administration only. Haldol Injection should be substituted by Haldol Tablets as soon as feasible. The usual dosage is 2-5 mg (0.4-1 ml of a Haldol ampoule) administered intramuscularly. Depending on the response of the patient, subsequent doses may be given, administered as often as every hour, although 4- to 8-hour intervals may be satisfactory. Acute and Chronic Vomiting: 5 mg administered IM. TREATMENT WITHDRAWAL Gradual withdrawal of haloperidol is advisable (see Warnings and Precautions – Additional considerations) 2 Haldol Ampoules_PI_Safety + other updates_5.1.2021 4.3. CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Comatose state • Central Nervous system (CNS) • Parkinson's diseaseDementia with Lewy bodies. • Progressive supranuclear palsy. • Known QTc int Prečítajte si celý dokument