XEPLION 100 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PALIPERIDONE AS PALMITATE

متاح من:

J-C HEALTH CARE LTD

ATC رمز:

N05AX13

الشكل الصيدلاني:

SUSPENSION FOR INJECTION EXTENDED RELEASE

تركيب:

PALIPERIDONE AS PALMITATE 100 MG / 1 ML

طريقة التعاطي:

I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

المجال العلاجي:

PALIPERIDONE

الخصائص العلاجية:

Xeplion is indicated for the acute and maintenance treatment of schizophrenia in adults.Xeplion is indicated for the treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and antidepressants

تاريخ الترخيص:

2022-02-02

نشرة المعلومات

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
XEPLION
®
50 mg, 75 mg, 100 mg, 150 mg
Extended-release suspension for intramuscular injection
The active ingredient and its quantity:
Xeplion 50 mg contains Paliperidone (as palmitate) 50 mg
Xeplion 75 mg contains Paliperidone (as palmitate) 75 mg
Xeplion 100 mg contains Paliperidone (as palmitate) 100 mg
Xeplion 150 mg contains Paliperidone (as palmitate) 150 mg
Inactive ingredients and allergens 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 for the treatment of 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 to treat children and adolescents below
18 years of
age.
The medicine is not intended for use in patients with dementia-related
psychosis.
Clinical studies have shown that elderly patients who used
antipsychotics similar
to Xeplion had a higher risk of stroke and death.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is intended for:
●
treatment of schizophrenia in adults.
●
treatment of schizoaffective disorder as monotherapy or as an adjunct
therapy
to mood stabilizers or antidepressants.
Therapeutic group: atypical antipsychotic
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
●
You are sensitive (allergic) to the active ingredient paliperidone or
to any of
the additional ingredients contained in the medicine.
●
You
are
sensitive
(allergic)
to
other
antipsychotic
medicines
including
risperidone-containing medicine.
Special warnings regarding use of the medicine
Before treatment with Xeplion, tell the doctor if you suffer from any
of the
following conditions:
All medicines have side

خصائص المنتج

1
1.
NAME OF THE MEDICINAL PRODUCT
XEPLION® 50 mg, 75 mg, 100 mg, 150 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
50 mg prolonged release suspension for injection
Each pre-filled syringe contains 78 mg paliperidone palmitate in 0.5
mL equivalent to 50 mg
paliperidone.
75 mg prolonged release suspension for injection
Each pre-filled syringe contains 117 mg paliperidone palmitate in 0.75
mL equivalent to 75 mg
paliperidone.
100 mg prolonged release suspension for injection
Each pre-filled syringe contains 156 mg paliperidone palmitate in 1 mL
equivalent to 100 mg
paliperidone.
150 mg prolonged release suspension for injection
Each pre-filled syringe contains 234 mg paliperidone palmitate in 1.5
mL equivalent to 150 mg
paliperidone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Extended release suspension for injection.
The suspension is white to off-white. The suspension is pH neutral
(approximately 7.0).
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
XEPLION® (paliperidone as palmitate) is indicated for the treatment
of:
•
Acute and maintenance treatment of schizophrenia in adults. [see 5.1
Pharmacodynamic
properties ].
•
Schizoaffective disorder as monotherapy and as an adjunct to mood
stabilizers or antidepressants
4.2
Posology and method of administration
4.2.1 Administration instructions
Each injection must be administered only by a health care
professional.
Parenteral drug products should be inspected visually for foreign
matter and discoloration prior to
administration, whenever product and container permit.
XEPLION® is intended for intramascular use only. Do not administer by
any other route. Avoid
inadvertent injection into a blood vessel. Administer the dose in a
single injection; do not administer
the dose in divided injections. Inject slowly, deep into the muscle.
The recommended needle size for administration of XEPLION® into the
deltoid muscle is determined
by the patient’s weight:
•
For patients weighing 90 Kg or more, the 1 ½ -inch, the 22 gauge
needle