SOLIAN 100 MG

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

AMISULPRIDE

제공처:

SANOFI ISRAEL LTD

ATC 코드:

N05AL05

약제 형태:

TABLETS

구성:

AMISULPRIDE 100 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

DELPHARM DIJON, FRANCE

치료 그룹:

AMISULPRIDE

치료 영역:

AMISULPRIDE

치료 징후:

Treatment of schizophrenia .

승인 날짜:

2021-12-31

환자 정보 전단

ربكأ
ً
ايئاود
ً
ارادقم أطخلاب تلوانت اذإ
،ءاودلا نم أطخلاب لفط علب اذإ وأ
ً
اطرفم
ً
ايئاود
ً
ارادقم تلوانت اذإ
رضحأو ،ىفشتسملا يف ئراوطلا ةفرغل وأ
بيبطلا ىلإ
ً
لااح هجوت
ضارعلأا رهظت دق .تلوانت اذام بيبطلا
فرعي يكل ،ءاودلا ةبلع كعم
ساعنب روعشلا ،يلضع بلصت ،فاجترإ وأ
ةحار مدعب روعشلا :ةيلاتلا
.يعولا نادقف ىلإ يدؤي دق يذلا رملأا
مونلل ليم وأ
ءاودلا لوانت تيسن اذإ
كركذت دعب
ً
لااح هلوانت بجيف ،ءاودلا نم
ً
ايئاود
ً
ارادقم لوانت تيسن اذإ
مقف ،يلاتلا يئاودلا رادقملا لوانت
دعوم
ً
ابيرقت ناح دق اذإ نكل .كلذب
ً
ايئاود
ً
ارادقم لوانت زوجي لا .هتيسن يذلا
يئاودلا رادقملا تيوفتب
.يسنملا يئاودلا رادقملا نع ضيوعتلل
ً
افعاضم
.بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا
بجي
ءاودلا لوانت نع تفقوت اذإ
.فقوتلاب كبيبط كدشري نأ ىلإ ،نايلوس
لوانت لصاو
ولو ىتح بيبطلا ةراشتسإ نودب ءاودلاب
جلاعلا نع فقوتلا زوجي لا
.ةيحصلا كتلاح ىلع نسحت أرط
لوانت نع فقوتلا زوجي لا .مقافتي وأ دوعي
دق كضرم نإف ،تفقوت اذإ
.كبيبط نم ةحضاو تاميلعت تيقلت اذإ لاإ
،ئجافم لكشب نايلوس
:لثم ماطف ضارعأ ىلإ يدؤي دق لامعتسلإا
نع ئجافملا فقوتلا نإ
.ؤيقت وأ نايثغ •
.قرعت •
.ةحار ةلقب روعشلا وأ مونلا يف تابوعص •
.ةذاش مسج تاكرح وأ يلضع بلصت •
.كضرم ضارعأ ةدوع زئاجلا نم • ءاودلا عباط صي�

제품 특성 요약

1
_ _
_Solian version SOLI-SPC-100MG-400MG-24.0- update according to the UK
SPC dated 09.2021 _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SOLIAN 100 MG
SOLIAN 400 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Solian 100mg tablet contains 100mg of the active substance,
amisulpride
Also contains 69.6mg of lactose monohydrate
Each Solian 400mg tablet contains 400mg of the active substance,
amisulpride
Also contains 130.25mg of lactose monohydrate
For the complete list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solian 100 mg tablet.
White to off-white, round, flat-faced tablet engraved AMI 100 on one
face and with a breakable bar on
the other face.
Solian 400mg film coated tablet
White, film coated, scored oblong tablet, engraved 'AMI 400' on one
face.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of schizophrenia
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Usually, if the daily dose is ≤ 400 mg, it is to be administered as
a once-daily dose. If the daily dose
exceeds 400 mg, it is to be administered as two divided doses.
PREDOMINANTLY NEGATIVE EPISODES:
Doses between 50 mg/day and 300 mg/day are recommended. Doses should
be adjusted individually.
The optimum dosage is about 100 mg/day.
For patients with mixed positive and negative symptoms, doses should
be adjusted to obtain optimal
control of positive symptoms.
2
ACUTE PSYCHOTIC EPISODES:
_When initiating treatment _
•
it is possible to start via the IM route for a few days, at a maximum
dose of 400 mg/day, switching
thereafter to oral treatment,
•
oral doses between 400 mg/day and 800 mg/day are recommended. The
maximum dose should
never exceed 1200 mg. Given that there has been no large-scale safety
assessment of doses
higher than 1200 mg/day, these doses should not be used.
_Thereafter _
•
the dosage should then be maintained or adjusted according to the
patient's individual response.
In all cases, the maintenance treatment should be established
individually with the minimum effective
dose.
ELDE