PROTHIAZINE SYRUP

国家: 以色列

语言: 英文

来源: Ministry of Health

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下载 资料单张 (PIL)
26-09-2021
下载 产品特点 (SPC)
28-02-2023
下载 公众评估报告 (PAR)
01-11-2021

有效成分:

PROMETHAZINE HYDROCHLORIDE

可用日期:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC代码:

R06AD02

药物剂型:

SYRUP

组成:

PROMETHAZINE HYDROCHLORIDE 5 MG / 5 ML

给药途径:

PER OS

处方类型:

Required

厂商:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

治疗组:

PROMETHAZINE

治疗领域:

PROMETHAZINE

疗效迹象:

Antihistaminic, Antiemetic, Sedative.

授权日期:

2014-08-31

资料单张

                                1986 )تارضحتسم( ةلدايصلا ةمظنأ بجومب
كلهتسملل ة
ّ
ي
ّ
بط ةرشن
طقف بيبط ةفصو بسحب ءاودلا اذه ق
ّ
وس
ُ
ي
PROTHIAZINE SYRUP بارش نيزايتورپ
:ىلع )للم 5( ةريغص ةقعلم لك يوتحت
ديرولكورديه نيزاتيمورپ( Promethazine
Hydrochloride 5 mg
)غلم 5
PROTHIAZINE TABLETS صارقأ نيزايتورپ
:ىلع صرق
ّ
لك يوتحي
ديرولكورديه نيزاتيمورپ( Promethazine
Hydrochloride 25 mg
)غلم 25
2 دنبلا رظنا - رضحتسملا يف ةيجرلأا تاب
ّ
بسمو ةلاعفلا ريغ داوملا ىلع علاطلال
.6 دنبلاو "ءاودلا تاب
ّ
كرم ضعب نع ة
ّ
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لبق اهتياهن ى
ّ
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وأ بيبطلا عجارف ،ة
ّ
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ّ
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ّ
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.
ّ
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ول ى
ّ
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ّ
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ءاودلا اذه فص
ُ
و دقل
.هباشم مهضرم
ّ
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.مايأ 7 دعب ن
ّ
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ّ
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ّ
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ّ
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؟ءاودلا اذه ص
ّ
صخم ضرغ يلأ .1
فيفختو عنمل ةئدهم ةيلاعف يذ
نيماتسيهلل داضم رضحتسم نع ةرابع
نيزايتورپ
دض لمعتس
ُ
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ّ
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:ءاودلا لامعتسا لبق .2
:اذإ ءاودلا لامعت
                                
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产品特点

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Prothiazine 25 mg Tablets
Prothiazine Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg of the active substance Promethazine
hydrochloride.
Each 5ml syrup contains 5mg of the active substance Promethazine
hydrochloride.
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Prothiazine tablets are purple, round, and biconvex.
Prothiazine syrup is a clear orange-colored liquid.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antihistaminic, Antiemetic, Sedative.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
Not for use in children under the age of 2 years (see section 4.3).
FOR TREATMENT OF ALLERGIES:
Children aged 2-5 years:
5-15 ml of syrup in one dose, to be taken at night or 5 ml two to
three times a day. Do not
administer more than 15 ml per day.
Children aged 6-12 years:
10-25 ml of syrup in one dose to be taken at night, or 10 ml twice a
day. Do not administer
more than 25 ml per day.
Children above the age of 12 and adults:
Begin treatment by taking one tablet at night. The dosage can be
increased to a maximum of
one tablet twice a day, as required.
FOR TREATMENT AND PREVENTION OF NAUSEA AND VOMITING:
Children aged 2-5 years:
5 ml of syrup every 4-6 hours up to a maximum of 15 ml per day.
Children aged 6-12 years:
A dose of 10 ml of syrup; wait 4-6 hours before administering another
dose. Up to two doses
per day can be administered (a total of 20 ml per day).
Children above the age of 12 and adults:
One tablet every 4-6 hours, up to a maximum of 4 tablets per day.
FOR SHORT-TERM USE AS A SEDATIVE, WITH THE DOCTOR’S INSTRUCTION
ONLY:
Children aged 2-5 years:
5-15 ml of syrup as a single dose to be taken at night, at bedtime.
Children aged 6-12 years:
10-20 ml of syrup as a single dose to be taken at night, at bedtime.
Children above the age of 12 and adults:
One to three tablets as a single dose, to be taken at night, at
bedtime.
4.3 CONTRAINDICATIONS
Prothiazine should
                                
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