HALDOL DECANOAS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HALOPERIDOL AS DECANOATE

Available from:

J-C HEALTH CARE LTD

ATC code:

N05AD01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

HALOPERIDOL AS DECANOATE 100 MG/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

GLAXO SMITH KLINE MANUFACTURING S.P.A., ITALY

Therapeutic group:

HALOPERIDOL

Therapeutic area:

HALOPERIDOL

Therapeutic indications:

indicated for the maintenance treatment of schizophrenia and schizoaffective disorder in adult patients currently stabilized with oral haloperidol.

Authorization date:

2023-01-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
HALDOL
® DECANOAS
SOLUTION FOR INJECTION
Each ampoule contains 1 ml.
Each 1 ml contains:
Haloperidol 100 mg (as decanoate)
Inactive and allergenic ingredients in the preparation
–
See section 2
“Important
information regarding some of the ingredients of the
medicine” and section 6
“Further information”
.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to
others. It may harm them even if it seems to you that their ailment is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Haldol Decanoas is intended for maintenance treatment of schizophrenia
and
schizoaffective disorder in adult patients currently stabilized with
oral haloperidol.
THERAPEUTIC GROUP:
Haloperidol belongs to the anti-psychotics group
of the
butyrophenone family.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient (haloperidol) or
to any of
the additional ingredients contained in the medicine, (
see section 6 “Further
information”
).
•
You are less aware of things around you or your reactions become
unusually
slow.
•
You have
Parkinson’s disease.
•
You have a type of dementia called ‘Lewy body dementia’
.
•
You have progressive supranuclear palsy (PSP).
•
You have a heart condition called ‘prolonged QT interval’, or any
other
problem with your heart rhythm that shows as an abnormal tracing on an
ECG (electrocardiogram).
•
You have heart failure or recently had a heart attack.
•
You have a low level of potassium in your blood, which has not been
treated.
•
You are taking one of the medicines appearing on the list of medicines
that
should not be taken with Haldol Decanoas
(se

Summary of Product characteristics

1
Haldol decanoas_100mg/ml_PI_01-2023
1.
NAME OF THE MEDICINAL PRODUCT
HALDOL DECANOAS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 141.04 mg of haloperidol decanoate,
equivalent to 100 mg of haloperidol
base.
Excipients with known effect:
100 mg/ml solution: Each ml of solution contains 15 mg of benzyl
alcohol and up to 1 ml of sesame
oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Slightly amber, slightly viscous solution, free from visible foreign
material.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HALDOL DECANOAS is indicated for the maintenance treatment of
schizophrenia and schizoaffective
disorder in adult patients currently stabilized with oral haloperidol.
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment initiation and dose titration must be carried out under
close clinical supervision.
Posology
The individual dose will depend on both the severity of the symptoms
and the current oral haloperidol
dose. Patients must always be maintained on the lowest effective dose.
As the initial dose of haloperidol decanoate is based on a multiple of
the daily oral haloperidol dose,
specific guidance on switching from other antipsychotics cannot be
provided (see section 5.1).
_Adults aged 18 years and above_
TABLE 1: HALOPERIDOL DECANOATE DOSE RECOMMENDATIONS FOR ADULTS AGED 18
YEARS AND ABOVE
2
Haldol decanoas_100mg/ml_PI_ 01-2023
TRANSITION FROM ORAL HALOPERIDOL
•
A haloperidol decanoate dose of 10 to 15 times the previous daily dose
of oral haloperidol is
recommended.
•
Based on this conversion, the haloperidol decanoate dose will be 25
to150 mg for most patients.
CONTINUATION OF TREATMENT
•
It is recommended to adjust the haloperidol decanoate dose by up to 50
mg every 4 weeks
(based on individual patient response) until an optimal therapeutic
effect is obtained.
•
The most effective dose is expected to range between 50 and 200 mg.
•
It is recommended to assess the individual benefit-risk when