מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
PROPRANOLOL HYDROCHLORIDE
ABIC LTD.
C07AA05
CAPSULES
PROPRANOLOL HYDROCHLORIDE 160 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
PROPRANOLOL
PROPRANOLOL
Management of angina pectoris. Control of essential and renal hypertension and essential tremor.As an adjunct in the management of tachycardias and arrhythmias due to thyrotoxicosis and thyrotoxic crises. Migraine prophylaxis.
2010-05-31
Deralin-07-05-12-AH/JO ® ! " ® #! " Propranolol HCl 10 mg Propranolol HCl 40 mg Lactose monohydrate, magnesium stearate, gelatin, carmine powder. ® ! " ® ! " ! ! ! ! Propranolol HCl 80 mg Propranolol HCl 160 mg In a sustained release form In a sustained release form Microcrystalline cellulose, ethylcellulose, hypromellose, erythrosine, black iron oxide, red iron oxide, titanium dioxide, water, gelatin. ! ! " " ! " # $ # % & Beta- blockers ' & ! # # % & ' ( ) ( # $ & " " ! & ! & & ! # ! ( ! # ( ! ( ) * # ( ( # ! & % # ' !*# + phaechromocytoma # % & * ! " ) ' !*# + " % & " ' " #*# % # *# !*# + & ! # & % ! ' ( + ( ( + & ( ! & % ' ( ! * "*# + & & $ # & # & & ( # ! # & # & & ( # & Deralin-07-05-12-AH/JO 2 ' * & ) ( ( ( *# + ( ## * & & * & , # + # ) & & # & ( # & )& * & & & * # & *# + ! # & % # # ' ( # & & * & & " #*# + !# ( & ( ! # ( * & # ! & # $ & # & $ ( " # % ) ' ( " ! % ! ( ( # ( # ( ' ( ! % ' ( % ' ( # % ) ' ( " # % ' ( % # ' ( % ! & ' ( " % ' ( !# ( ( ! # % # ' ( % ( # ( ( !# ( # ( ! ( " ' ( % ) ' # % ! ' & & & " & ,!# ( ! ( & " " # & % Raynaud ' ( # & + ! ( & ( ( ! ( " # + # ! % ! ! ' ( ! % ( ! ( & & ' ( ! $ & ( % ! *# + ' ( & # ( " # ( ( ( # % ! ' ( ( ( ( #& ( ! & % ! ! ' ( & # ! % ! ' ( & & ! ( % myasthenia gravis ' ( , # , % & & & ' # ! % ! # ! " & ( ( & ( ( ( ( ! # # ( # " " ( # ! ' # ! & # ! % $ & ' # + # % # ' # + & ( ! # ( ( % # ' # + - *# + & # " & ( * # ( )& * & & " # & & # # " # # & * $ # & # # & % ' ) !& - " " # & & & & Deralin-07-05-12-AH/JO 3 ........................................ ... . $ . ........................................... & "& ! * " & # ( ) ! + # * & # & & & # # ( # + ( + * + - * # % ' ( & & ' ) & & * * - + # & #*# + + *# + * ( $ 25 C # + " #! ( # * # - ! ( * ! )& * & # ! + 023 52 21382 00 105 37 21381 00 ! / 048 34 23318 00 ! 0 048 35 23320 00 & " & " & & ( 1 ( $ ( & ( / ( # # קרא את המסמך השלם
SLOW DERALIN CAPSULES 3. 4. 2012, RH " ע עבקנ הז ןולע טמרופ " רשואו קדבנ ונכותו תואירבה דרשמ י ." רשואמ ןולע : לירפא 2012 . “This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved.” Date of approval: April 2012. PHYSICIANS’ PRESCIBING INFORMATION SLOW DERALIN CAPSULES 1. NAME OF THE MEDICINAL PRODUCT `SLOW DERALIN' 80 Capsules `SLOW DERALIN' 160 Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Propranolol Hydrochloride 80mg, or 160mg. in a sustained-release formulation. 3. PHARMACEUTICAL FORM CLEAR PINK BODY AND OPAQUE LAVENDER CAP; CAPSULES CONTAINING WHITE TO PALE CREAM COLOURED SPHEROIDS. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Management of angina pectoris. 2. Control of essential and renal hypertension, and essential tremor. 3. As an adjunct in the management of tachycardias and arrhythmias due to thyrotoxicosis and thyrotoxic crises. 4. Migraine prophylaxis. 4.2 DOSAGE AND METHOD OF ADMINISTRATION Since the half-life may be increased in patients with significant hepatic or renal impairment, care should be taken when starting treatment and selecting the initial dose. As with any other potent beta-blocking agent, the optimum dosage of Slow Deralin has to be determined individually for each patient. Food may slow the hepatic metabolism of propranolol therapy, enhancing its bioavailability. In order to standardize conditions, it is recommended that Slow Deralin should be taken with meals. As a guide for the correct dosage, bradycardia (usually less than 45 beats/minute) is indicative that dosage should not be further increased. SLOW DERALIN CAPSULES 3. 4. 2012, RH Page 2 of 10 2 If patients are switched from Deralin to Slow Deralin, care should be taken to assure that the desired therapeutic effect is maintained. Slow Deralin should not be considered a simple mg-for mg substitute for Deralin. Slow Deralin has different kinetics and produces lower blood levels. Re קרא את המסמך השלם