TRICLONAM ELIXIR

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

TRICLOFOS SODIUM

제공처:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC 코드:

N05CM07

약제 형태:

ELIXIR

구성:

TRICLOFOS SODIUM 500 MG / 5 ML

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

CTS CHEMICAL INDUSTRIES LTD

치료 그룹:

TRICLOFOS

치료 영역:

TRICLOFOS

치료 징후:

Insomnia, daytime sedation and pre-medication in EEC.

승인 날짜:

2020-04-30

환자 정보 전단

ّ
يئاجف لكشب ة
ّ
يئاودلا ةعرجلا
َ
تل
ّ
لق وأ ءاودلا لوانت نع تف
ّ
قوت اذإ
تابون لثم باحسنلاا ضارعأب رعشت دقف
،لصاوتملا لامعتسلاا دعب
بجي ،جلاعلا فاقيإ دنع .كلذ ىلإ امو قلق
،فاجترا ،تاسوله ،تاجلاتخا
جئاتن ةشقانم بجي جلاعلا فاقيإ لبق .
ّ
يجيردت لكشب ة
ّ
يئاودلا ةعرجلا ليلقت
.بيبطلا عم كلذ يف ةعرجلا نم د
ّ
كأتو قصل
ُ
ملا عجار !ةمتعلا يف ةيودلأا لوانت زوجي
لا
.اهيلإ ةجاحب تنك اذإ ة
ّ
ي
ّ
بطلا تارا
ّ
ظنلا عض .ءاودلا اهيف لوانتت ة
ّ
رم
ّ
لك بيبطلا رشتساف ،ءاودلا لامعتسا لوح ة
ّ
يفاضإ ةلئسأ كيدل تر
ّ
فوت اذإ
.
ّ
يلديصلا وأ
4 .
:ة
ّ
يبناجلا ضارعلأا
دنع ة
ّ
يبناج ضارعأ ءوشن ىلإ مانولكيرت
لامعتسا ي
ّ
دؤي دق ،ءاود
ّ
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يناعت لا دق .ة
ّ
يبناجلا ضارعلأا ةمئاق ةءارق دنع قلقت
لا .نيلمعتسملا ضعب
.اهنم دحاو
ّ
يأ نم
:اذإ بيبطلا ىلإ ا
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ّ
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ّ
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طغض طوبه ،ة
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ّ
فنت ةقئاض ،ةمذو ،ة
ّ
كح :ة
ّ
يقأت ةمدص نم تيناع
،ىمام
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ح ،
ّ
يدلج حفط :ةطرفملا ة
ّ
يساسحلا لعف
ّ
در وأ قار
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ز ،مدلا
.ى
ّ
مح ،ة
ّ
كح ،تلاصيوح
.ة
ّ
يبلق ةتكس ناب
ّ
بسي دق نيذ
ّ
للا س
ُّ
فنتلا طيبثت وأ س
ُّ
فنتلا ف
ُّ
قوت نم تيناع
ة
ّ
لق ،تا
ّ
ينيزويلا ةرثك( ءاضيبلا مدلا ايلاخ
ّ
دع يف تار
ّ
يغت ترهظ
.)ءاضيبلا تا
ّ
يركلا
:)فورعم ريغ اهعويش ىدم( ةريطخ ة
ّ
يبناج ضارعأ
.دامتعلاا
:

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
TRICLONAM ELIXIR
TRICLOFOS SODIUM 500 MG / 5 ML
TREATMENT MATTERS
1. THERAPEUTIC INDICATIONS
Insomnia, daytime sedation and pre-medication in EEC.
2. DOSAGE AND ADMINISTRATION
For insomnia:
Adults and children over 12 years: 10 ml daily, in certain cases a
higher dosage
may be required - up to 20 ml daily.
Children 6-12 years: 5-10 ml daily.
Children 1-5 years: 2.5-5 ml daily.
Infants up to 1 year: 1-2.5 ml daily.
As a sedative:
Adults and children over 12 years: 5 ml twice daily.
Children 6-12 years: 5 ml daily.
Children 1-5 years: 2.5 ml daily.
Infants up to 1 year: 1 ml daily.
3. CLINICAL RESULTS
(1) CLINICAL DATA PACKAGE
None
(2) CLINICAL EFFECTS
Clinical results judging by sleeping effects were 84.3% (321/381). (3) CLINICAL PHARMACOLOGICAL TEST
No applicable data
(4) EXPLORATORY TEST
No applicable data
(5) VERIFICATION TEST
1) RANDOMIZED PARALLEL DOSAGE RESPONSE STUDY
No applicable data
2) COMPARATIVE TEST
The following results were obtained comparing chloral hydrate
(22mg/kg) and
triclofos sodium (33mg/kg) in 71 children aged 4 to 14 years old who
require
sedation during EEG. EEG was used for the sleep start monitor.
Triclofos Sodium syrup (37 subjects)
Chloral hydrate (34 subjects)
Dosage*
Average 1 g (480 mg to 1960 mg)
Average: 680 mg (300mg to 1,510mg)
Sleep introduction time
37.3 ± 12.1 minutes
36.6 ± 14.4 minutes
Ineffective cases
6 cases
4 cases
Taste
Aversion
2 cases (5%)
9 cases (27%)
Good
14 cases (33%)
11 cases (32%)
Very good
21 cases (51%)
14 cases (41%)
Adverse reactions
16 types in 9 people (24%)
16 types in 9 people (26%)
*: Dosage is expressed in the amount of the active ingredient.
Triclofos Sodium Syrup active ingredient: Triclofos sodium
Chloral hydrate active ingredient
3) SAFETY TEST
No applicable data
4) TESTING BY PATIENT/CONDITION
No applicable data
(6) THERAPEUTIC USE
1) TREATMENT OUTCOME STUDY AND RESEARCH OF SPECIFIC USES (SPECIAL
SURVEY)/CLINICAL
STUDIES AFTER MANUFACTURING AND SALES (POST-MARKETING CLINICAL
RESULTS)
No applicable uses
2) APP