HALDOL AMPOULES

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

HALOPERIDOL

MAH:

J-C HEALTH CARE LTD

ATC_code:

N05AD01

pharmaceutical_form:

SOLUTION FOR INJECTION

composition:

HALOPERIDOL 5 MG/ML

administration_route:

I.M

prescription_type:

Required

manufactured_by:

GLAXO SMITH KLINE MANUFACTURING SPA,ITALY

therapeutic_group:

HALOPERIDOL

therapeutic_area:

HALOPERIDOL

therapeutic_indication:

Psychomotor agitation encountered in different neuropsychotic affections, prophylaxis and therapy of acute and chronic vomiting.

authorization_date:

2012-02-28

SPC

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)
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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