SINTREDIUS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PREDNISOLONE AS SODIUM PHOSPHATE

متاح من:

KAMADA LTD, ISRAEL

ATC رمز:

H02AB06

الشكل الصيدلاني:

SOLUTION

تركيب:

PREDNISOLONE AS SODIUM PHOSPHATE 1 MG/ML

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GENETIC S.P.A., ITALY

المجال العلاجي:

PREDNISOLONE

الخصائص العلاجية:

Sintredius oral solution is indicated for the treatment of:- Rheumatological disorders and connective tissue diseases such as: • rheumatoid arthritis (for primary chronic disease and maintenance therapy), • systemic lupus erythematosus (non-organ threatening disease), • mild-moderate juvenile dermatomyositis.- Severe or debilitating allergic conditions, not treatable in a conventional manner such as: • bronchial asthma in children, • bronchial asthma in adults (for maintenance therapy).- Sarcoidosis in children and for maintenance therapy in adults.- Acquired haemolytic anaemia (autoimmune, for maintenance therapy).

تاريخ الترخيص:

2021-12-09

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
The medicine is dispensed with a doctor’s prescription only
SINTREDIUS
Oral solution
ACTIVE SUBSTANCE AND QUANTITY IN UNIT DOSE:
prednisolone )as sodium phosphate( 1mg/ml
INACTIVE INGREDIENTS AND ALLERGENS IN THE PRODUCT: see
section 2 “Important information about some of the ingredients
of the medicine” and section 6 “additional information”
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine.
If you have further questions, please refer to the doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them even if it seems to you that their
medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Sintredius is indicated for the treatment of:
• Rheumatological disorders and connective tissue diseases
such as: rheumatoid arthritis )for primary chronic disease
and maintenance therapy(, systemic lupus erythematosus
)non-organ threatening disease(, mild-moderate juvenile
dermatomyositis.
• Severe or debilitating allergic conditions, not treatable in a
conventional manner such as: bronchial asthma in children,
bronchial asthma in adults )for maintenance therapy(.
• Sarcoidosis in children and for maintenance therapy in adults.
• Acquired haemolytic anaemia )autoimmune, for maintenance
therapy(.
Therapeutic group: glucocorticosteroids
Sintredius contains the active ingredient prednisolone, which
belongs to a group of medicines called corticosteroids or
“steroids”. Steroids work by reducing inflammation and lowering
the body’s immune response.
SINTREDIUS – BENEFIT INFORMATION
Corticosteroids occur naturally in the body and help to
maintain health and well-being. Boosting your body with extra
corticosteroids )such as prednisolone( is an effective way
to treat various illnesses involving inflammation in the body.
Prednisolone reduces this inflammation, which could otherwise
go

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sintredius
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of Sintredius is prednisolone as the sodium
phosphate ester.
Each 1 ml oral solution contains 1 mg prednisolone (as sodium
phosphate).
Each 5 ml single-dose container contains 5 mg of prednisolone (as
sodium
phosphate).
Each 5 ml single-dose container contains 0.5 mmole sodium per dose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral Solution.
The solution is a clear, light brown solution free from particulate
matters.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sintredius oral solution is indicated for the treatment of:
Rheumatological disorders and connective tissue diseases such as:
•
rheumatoid arthritis
(for primary chronic disease and maintenance therapy)
•
systemic lupus erythematosus (non-organ threatening disease)
•
mild-moderate juvenile dermatomyositis
Severe or debilitating allergic conditions, not treatable in a
conventional manner such
as:
•
bronchial asthma in children
•
bronchial asthma in adults (for maintenance therapy)
Sarcoidosis in children and for maintenance therapy in adults
Acquired haemolytic anaemia (autoimmune, for maintenance therapy)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lowest dosage that will produce an acceptable result should be
used (See section
4.4); when it is possible to reduce the dosage, this must be
accomplished by stages.
During prolonged therapy any intercurrent illness, trauma or surgical
procedure will
require a temporary increase in dosage; if corticosteroids have been
stopped following
prolonged therapy they may need to be temporarily re-introduced.
The medicinal product should preferably be taken as a single dose in
the morning.
However, divided daily dosages may be employed if required.
_NOTE TO THE PRESCRIBER: _
This 5 ml single-dose unit presentation should not be prescribed for
doses exceeding
30 mg daily, because opening more than 6 containers in a day may
incr