Land: Israel
Språk: engelsk
Kilde: Ministry of Health
BENZYDAMINE HYDROCHLORIDE
ABIC MARKETING LTD, ISRAEL
A01AD02
LOZENGES
BENZYDAMINE HYDROCHLORIDE 3 MG
PER OS
Not required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
BENZYDAMINE
Rogaron is used for symptomatic local treatment of acute sore throat in adults and children over 6 years of age.
2020-04-02
DOR-Rog-Lem-Orng-PIL-0520-07 DOR-Rog-Lem-Orng-PIL-0520-07 دنع مدصت لا .نيمدختسملا نم مسق ىدل ة ّ يبناج ا ً ضارعأ نم يناعت ّ لاأ لمتحملا نم .ة ّ يبناجلا ضارعلأا ةمئاق ةءارق .اهنم ٍ ّ يأ هجوت .ةريطخ نوكت دق اهنكل ةردان ة ّ يسسحتلا ضارعلأا ،ةرجنحلا/مفلا يف يئاجف خافتنا رهظ اذإ بيبطلا ىلإ ا ً روف تناك اذإ ةصاخ ،ةكح وأ يدلج حفط ،سفنتلا يف تابوعص .هلمكأب مسجلا ىلع رثؤت نم 1 ىتح ىلع رثؤت نأ نكمم( ةعئاش ريغ ة ّ يبناج ضارعأ :)لمعتسم 100 نيب • وأ يدلج حفط ىلإ يدؤ ُ ت( سمشلا ةعشلأ دلجلا ةيساسح .)قرح نيب نم 1 ىتح ىلع رثؤت نأ نكمم( ةردان ةيبناج ضارعأ :)لمعتسم 1,000 • نكمي ،ةلاحلا هذه يف .مفلا يف فافج وأ ةقرحلاب ساسحإ .ضارعلأا هذه فيفختل ءام سأك برش نم 1 ىتح ىلع رثؤت نأ نكمم( ا ً دج ةردان ةيبناج ضارعأ :)لمعتسم 10,000 نيب • ةيطاخملا ةجسنلأا يفو ةرجنحلا/مفلا يف يئاجف خافتنا (Angioedema - ةيئاعو ةمذو( • .سفنتلا يف تابوعص مل ة ّ يبناج ضارعأ( فورعم ريغ اهعويش ة ّ يبناج ضارعأ :)دعب اهعويش ديدحت ّ متي • مفلا يف ةيطاخملا ةجسنلأا يف يعضوم ساسحإ نادقف • )ةطرفم ةيساسح( ة ّ يسسحت لعف دودر • تاملاعلا لمشت دق :)ةيقأت ةمدص( ريطخ ي ّ سسحت لعف در ،ردصلا يف طغض وأ ردصلا يف ملأ ،سفنتلا يف تابوعص وأ دلجلا يف ةداح ةكح ،فعضلاب/راودلاب ساسحإ وأ/و وأ/و ناسللا ،نيتفشلا ،هجولا خافتنا ،دلجلا ىلع ةزراب لتك .ةايحلا ىلع Les hele dokumentet
Rogaron lozenges, HS/SZ 04/2020 Approved SUMMARY OF PRODUCT CHARACTERISTICS ROGARON ® ORANGE-HONEY FLAVOR ROGARON ® LEMON FLAVOR 1 NAME OF THE MEDICINAL PRODUCT Rogaron ® Orange-Honey Flavor Rogaron ® Lemon Flavor 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 3 mg of benzydamine hydrochloride (equivalent to 2.68 mg of benzydamine). Excipients with known effects: ROGARON ORANGE-HONEY: each lozenge contains 2464.420 mg of Isomalt (E-953) and 3.409 mg of Aspartame (E-951) and 0.013 mg of Cochenille red colorant (E-124). ROGARON LEMON: each lozenge contains 2457.316 mg of Isomalt (E-953) and 3.409 mg of Aspartame (E-951) (lemon flavor). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Lozenge. Rogaron Orange-Honey: Round orange lozenges, 19 mm diameter, with orange and honey flavor. Rogaron Lemon: Round yellow lozenges, 19 mm diameter, with lemon flavor. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rogaron is indicated for symptomatic local treatment of acute sore throat in adults and children over 6 years of age. POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children over 6 years of age: one lozenge 3 times a day. The treatment must not exceed 7 days. Pediatric population Children 6-11 years of age: The medicinal product should be administered under adult supervision. Children below 6 years of age: Due to the type of the pharmaceutical form, the administration should be restricted to children of more than 6 years of age. Method of administration For oropharyngeal use. Lozenge should be dissolved slowly in the mouth patients should not swallow or chew the lozenges. 4.2 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Rogaron lozenges, HS/SZ 04/2020 Approved 4.3 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Benzydamine use is not advisable in patient with hypersensitivity to salicylic acid or other NSAIDs. Bronchospasm may be precipitated in patients suffering from or with a previous history o Les hele dokumentet