HALDOL DECANOAS

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

HALOPERIDOL AS DECANOATE

Dostupné z:

J-C HEALTH CARE LTD

ATC kód:

N05AD01

Forma lieku:

SOLUTION FOR INJECTION

Zloženie:

HALOPERIDOL AS DECANOATE 100 MG/ML

Spôsob podávania:

I.M

Typ predpisu:

Required

Výrobca:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Terapeutické oblasti:

HALOPERIDOL

Terapeutické indikácie:

Maintainance therapy of chronic schizophrenic patients.

Dátum Autorizácia:

2020-08-13

Príbalový leták

يبطلا مقاطلل تامولعم
יאופרה תווצל עדימ
PHARMACEUTICAL PARTICULARS
1. LIST OF EXCIPIENTS
Benzyl alcohol, sesame oil refined.
2. INCOMPATIBILITIES
Not applicable.
3. SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C.
Protect from light.
Keep out of the sight and reach of children.
4. NATURE AND CONTENTS OF CONTAINER
HALDOL DECANOAS 100 mg/ml is supplied in 1 ml amber-coloured type I
glass ampoules.
Packs of 5 ampoules.
INSTRUCTIONS FOR USE AND HANDLING
• Before using the ampoule, roll it briefly between both hand palms
to warm up
the product.
• Hold the ampoule between the thumb and index finger, leaving the
tip of the
ampoule free.
• With the other hand, hold the tip of ampoule putting the index
finger against
the neck of ampoule, and the thumb on the coloured point parallel to
the
identification coloured rings.
• Keeping the thumb on the point, sharply break the tip of ampoule
while holding
firmly the other part of the ampoule in the hand.
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 INTRAMUSCULAR INJECTION
Each ampoule contains 1 ml.
Each 1 ml contains:
Haloperidol 100 mg )equivalent to 141.04 mg haloperidol decanoate(
Inactive and allergenic ingredients in the preparation – see 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.
The medicine is not intended for children.
1. WHAT IS THE MEDICINE INTENDED FOR?
Maintenance treatment in patients with schizophrenia.
THERAPEUTIC GROUP: Antipsychotics from the butyrophenone group.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You

Súhrn charakteristických

1
Haldol decanoas_100mg/ml_PI_2-2021
1.
NAME OF THE MEDICINAL PRODUCT
HALDOL DECANOAS
100 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 mg/ml solution:
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 therapy of chronic
schizophrenic
patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HALDOL DECANOAS Injection is intended for use in chronic psychotic
patients who require
prolonged parenteral antipsychotic therapy. These patients should be
previously stabilised on
antipsychotic medication before considering a conversion to HALDOL
DECANOAS.
HALDOL DECANOAS is for use in adults only and has been formulated to
provide a one month's
therapy for most patients following a single deep intramuscular
injection in the
gluteal region.
HALDOL DECANOAS SHOULD NOT BE ADMINISTERED INTRAVENOUSLY.
As the administration of
volumes greater than 3 ml are uncomfortable for the patient, such
large injection volumes are not
recommended.
Since individual response to neuroleptic drugs is variable, dosage
should be individually determined
and is best initiated and titrated under close clinical supervision.
The individual starting dose will
depend on both the severity of the symptomatology and the amount of
oral medication required to
maintain the patient before starting depot treatment.
It is recommended that the initial dose of HALDOL DECANOAS be 10-15
times the previous daily
dose of oral haloperidol. For most patients, this means a starting
dose ranging between
25 and 75 mg
of HALDOL DECANOAS. A maximum starting dose of 100 mg should not