البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
PELARGONIUM SIDOIDES ROOTS (1: 8- 10) (EPS® 7630) DRIED LIQUID EXTRACT; EXTRACTING AGENT : ETHANOL 11% (W/W)
DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL
R05FB01
SYRUP
PELARGONIUM SIDOIDES ROOTS (1: 8- 10) (EPS® 7630) DRIED LIQUID EXTRACT; EXTRACTING AGENT : ETHANOL 11% (W/W) 20 MG / 7.5 ML
PER OS
Not required
DR. WILLMAR SCHWABE GMBH &CO. KG, GERMANY
COUGH SUPPRESSANTS AND MUCOLYTICS
Symptomatic treatment of acute bronchitis for adults and children form age of 1 years. Traditional herbal medicinal product for use in the common cold for adults and children form age of 1 years
2019-05-29
1 1. NAME OF THE MEDICINAL PRODUCT Kaloba® Syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Pelargonium sidoides roots (1:8-10) (EPs 7630®) dried liquid extract 20mg / 7.5ml Extracting agent: ethanol 11% (W/W) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Kaloba® Syrup is an orange to light brown, viscous syrup. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Symptomatic treatment of acute bronchitis for adults and children from age of 1 years. • Traditional herbal medicinal product for use in the common cold for adults and children from age of 1 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and adolescents over the age of 12: 7.5 ml syrup three times per day. Children aged between 6-11 years: 5 ml syrup three times per day. Children aged between 1 - 5 years: 2.5 ml syrup three times per day. Use in children under the age of one is not recommended as there are no adequate data. Method of administration Oral administration. Kaloba® Syrup is to be taken mornings, at midday and evenings. A measuring cup with various markings is enclosed for dosing Kaloba® Syrup. The cup should be cleaned appropriately after use. _ _ Continuation of treatment is recommended for several days after relief of symptoms, in order to prevent a relapse. If the symptoms become worse or no improvement occurs after 7 days, a doctor must be consulted. Treatment should not exceed 3 weeks. 2 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Kaloba® syrup should not be taken in cases of severe hepatic diseases, as no sufficient experience is available in this area. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE A doctor must be consulted if the condition does not improve within one week, with liver dysfunctions of different origin, or if fever, shortness of breath or bloody sputum occur. Cases of liver damage and hepatitis have been reported in connection with the use of medicinal products containing Pelargonium, Paediatr اقرأ الوثيقة كاملة