Land: Ísrael
Tungumál: enska
Heimild: Ministry of Health
PROMETHAZINE HYDROCHLORIDE
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
R06AD02
SYRUP
PROMETHAZINE HYDROCHLORIDE 5 MG / 5 ML
PER OS
Required
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
PROMETHAZINE
PROMETHAZINE
Antihistaminic, Antiemetic, Sedative.
2014-08-31
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 ّ ماه تامولعم" ىلع ةرشنلا هذه يوتحت .ءاودلل كلامعتسا لبق اهتياهن ى ّ تح ناعمإب ةرشنلا أرقا وأ بيبطلا عجارف ،ة ّ يفاضإ ةلئسأ كيدل تر ّ فوت اذإ .ءاودلا نع ةص ّ خلم تامولعم . ّ يلديصلا ول ى ّ تح ءاودلا مه ّ رضي دق .نيرخلآل هطعت لا .كضرم جلاعل ءاودلا اذه فص ُ و دقل .هباشم مهضرم ّ نأ كل ادب .مايأ 7 دعب ن ّ سحتت مل وأ ضرملا ضارعأ تمقافت اذإ بيبطلا ةعجارم كيلع ب ّ جوتي .نيماع نم ّ لقأ مهرمع نيذلا دلاولأل ص ّ صخم ريغ ءاودلا ؟ءاودلا اذه ص ّ صخم ضرغ يلأ .1 فيفختو عنمل ةئدهم ةيلاعف يذ نيماتسيهلل داضم رضحتسم نع ةرابع نيزايتورپ دض لمعتس ُ ي كلذكو ءودهلا مدعو قلقلا تلااح يف ةئدهتلل ،ةيسسحتلا لعفلا دودر .نايثغلاو تاؤيقتلا .)تانيزايثونيف( نيماتسيهلا تاداضم ةليصفل ةلاعفلا ةداملا يمتنت :ة ّ يجلاعلا ةليصفلا :ءاودلا لامعتسا لبق .2 :اذإ ءاودلا لامعت Lestu allt skjalið
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 Lestu allt skjalið