Country: Israel
Language: English
Source: Ministry of Health
POVIDONE-IODINE
RAFA LABORATORIES LTD
R02AA15
CONCENTRATED SOLUTION
POVIDONE-IODINE 7.5 %
MOUTHWASH, , , , , GARGLE, ,
Not required
MUNDIPHARMA GMBH, GERMANY
POVIDONE-IODINE
For the treatment of infectious/inflammatory diseases of oropharyngeal mucosa and gingiva caused by fungi, viruses and bacteria (oral thrush, aphthae, superinfected and herpetic ulcers, gingivitis, stomatitis, pharyngitis, supportive treatment of tonsillitis) ;treatment oral or pharyngeal injuries ; antiseptic treatment of the oral mucosa (e.g. prior to surgery), in particular in immunocompromised patients with a risk of endocarditis (prevention of bacteremia) ;prevention of radiation-induced mucositis in patients undergoing radiotherapy or radiochemotherapy.
2018-03-08
1 The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in March 2018 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is sold with a doctor's prescription only BETADINE ® GARGLE CONCENTRATED SOLUTION GARGLE AND MOUTHWASH ACTIVE INGREDIENT: 7.5% Povidone Iodine (equivalent to 0.75% available iodine). For a list of the other ingredients, please see section 6. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, refer to your doctor or pharmacist. This medicine was prescribed for your treatment, do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? This medicine is intended for infections in the mouth and throat: For the treatment of infections/inflammations in the mouth, throat and gums, caused by fungi, bacteria or viruses. For the treatment of mouth and throat injuries. For disinfection of the oral cavity before surgeries. Prevention of radiotherapy-induced mouth inflammations and ulcers. THERAPEUTIC GROUP: Antiseptics 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: Do not use if you are sensitive (allergic) to the active ingredient, to iodine, or to any of the other ingredients this medicine contains (for a list of the other ingredients, please see section 6). Do not use if you suffer from overactive thyroid gland (hyperthyroidism) or other thyroid disorders. Do not use if you suffer from dermatitis herpetiformis (Duhring disease), which is an autoimmune disease with blisters. Do not use before and after treatment with radioactive iodine (until conclusion of the treatment). SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: Inform your attending doctor if you suffer from latent thyroid gland diseases (especially in elderly patients) particularly with prolong Read the complete document
Betadine Gargle -DL-March 2018-01 THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH AND ITS CONTENT WAS CHECKED AND APPROVED BY IT IN MARCH 2018 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Betadine Gargle Concentrated Solution Gargle and Mouthwash 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Betadine Gargle contains 7.5% povidone-iodine (0.75% available iodine). For the a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Concentrated Solution Gargle and Mouthwash 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of infectious-inflammatory diseases of the mucous membranes in the mouth, throat and the gingiva caused by fungi, viruses and bacteria (e. g. thrush, aphthae, superinfected and herpetic ulcers, gingivitis, stomatitis, pharyngitis, supporting treatment in the case of tonsillitis). For the treatment of injuries in the mouth and throat region. For antiseptic treatment of the oral mucous membrane (e. g. prior to surgery), especially in patients with immunodeficiency and patients at risk for endocarditis (prevention of bacteremia). Prevention of radiation-induced mucositis in patients undergoing radiotherapy or radio-chemotherapy. Betadine Gargle may be used in adults, infants, toddlers, children and adolescents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Betadine Gargle is used undiluted or diluted with lukewarm water. The screw cap may be used for dosing. The screw cap has a volume of 5 ml. DOSAGE: FOR INFECTIOUS INFLAMMATORY DISEASES AND INJURIES IN THE MOUTH AND THROAT REGION A dilution of 1:8 to 1:16 (approx. 2-4 caps in 125 ml water) is recommended. Rinse mouth and/or gargle for at least 30 seconds every 1-4 hours until the disease subsides. ANTISEPSIS PRIOR TO SURGERY Apply Betadine Gargle undiluted to the area of the planned surgery for at least 30 seconds. PREVENTION OF RADIATION-INDUCED MUCOSITIS A dilution of 1:8 (approx. 4 caps in 125 ml water) is recommended. The treatment should be repeated several times dai Read the complete document