PERICATE

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

HALOPERIDOL AS DECANOATE

متاح من:

UNIPHARM TRADING LTD, ISRAEL

ATC رمز:

N05AD01

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

HALOPERIDOL AS DECANOATE 100 MG/ML

طريقة التعاطي:

I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

UNIPHARM TRADING LTD, ISRAEL

المجموعة العلاجية:

HALOPERIDOL

المجال العلاجي:

HALOPERIDOL

الخصائص العلاجية:

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

تاريخ الترخيص:

2022-08-31

نشرة المعلومات

0321A
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with
a doctor’s prescription only
PERICATE
SOLUTION FOR INTRAMUSCULAR INJECTION
COMPOSITION:
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 2 “Important information about 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.
The medicine is not intended for children.
1. WHAT IS THE MEDICINE INTENDED FOR?
Maintenance treatment in schizophrenic patients.
THERAPEUTIC
GROUP:
Antipsychotics
from
the
butyrophenones group.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive )allergic( to the active ingredient 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 suffer from Parkinson’s disease.
• You have Lewy body-type dementia.
• You have progressive supranuclear palsy )PSP(.
• You have a heart disorder called prolonged QT
interval syndrome, or any other problem with your
heart rhythm that appears as an abnormal finding on
an ECG tracing (electrocardiogram).
• You have heart failure or have recently had a heart
attack.
• You are suffering, or have suffered in the past, from
heart rhythm disturbances or an especially slow heart
rate.
• You are taking certain medicines that affect the heart
rate.
• You have a low level of blood potassium, which has
not been treated.
• You suffer

خصائص المنتج

The format of this leaflet was determined by the Ministry of Health
that checked and approved
its content
1. NAME OF THE MEDICINAL PRODUCT
PERICATE
International Non-Proprietary Name (INN)
Haloperidol decanoate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of PERICATE 100 mg/ml is expressed in terms of the haloperidol
content and is equivalent to 141.04
mg haloperidol decanoate.
For excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Appearance:
100 mg/ml injectable solutions.
Slightly amber, slightly viscous solution. Free from visible foreign
material.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
PERICATE is indicated for the maintenance therapy of chronic
schizophrenic patients.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
PERICATE 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 PERICATE.
PERICATE 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.
PERICATE 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 PERICATE 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 PERICATE. A maximum starting
dose of 100 mg should not be exceeded.
Depending on the individual patient’s response