देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
CLODRONIC ACID AS DISODIUM TETRATHYDRATE
BIOAVENIR LTD, ISRAEL
M05BA02
FILM COATED TABLETS
CLODRONIC ACID AS DISODIUM TETRATHYDRATE 800 MG
PER OS
Required
ABOIGEN PHARMA S.P.A, ITALY
CLODRONIC ACID
Treatment of hypercalcemia due to malignancy. Palliative treatment of osteolysis due to malignancy.
2022-01-31
Page 1 of 6 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only CLASTEON 800 MG, FILM-COATED TABLETS Active ingredient and its quantity in each film-coated tablet: 800 mg disodium clodronate (as tetrahydrate) For the list of inactive ingredients and allergens, please see section 2 sub-section "Important information about some of this medicine’s ingredients" and section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. The medicine is intended for adults above the age of 18. 1. WHAT IS THIS MEDICINE INTENDED FOR? • For treatment of bone lysis or destruction (osteolysis) in patients suffering from enhanced bone breakdown as a result of tumors. • For treatment of hypercalcemia (excess calcium in blood) in case of malignancy (cancer). THERAPEUTIC GROUP: bisphosphonates. 2. BEFORE USING THIS MEDICINE: DO NOT USE THIS MEDICINE IF: • you are sensitive (allergic) to the active ingredient (sodium clodronate), similar medicines or any of the other ingredients contained in the medicine (listed in section 6) • you have severe kidney dysfunction • you are taking other medicines of the bisphosphonates group SPECIAL WARNINGS ABOUT USING THIS MEDICINE: BEFORE TREATMENT WITH CLASTEON 800 MG, TELL YOUR DOCTOR IF: • you have kidney problems • you have or have previously had pain, swelling or numbness of the jaw or a heavy jaw feeling or loosening of a tooth. Page 2 of 6 If you are undergoing DENTAL TREATMENT or are expected to undergo DENTAL SURGERY, tell your dentist that you are being treated with a bisphosphonate. Certain dental treatments are not recommended while taking bisphosphonates. DRUG INTE पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CLASTEON ® 800 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains 800 mg disodium clodronate. In the preparation, the active ingredient is in the form of disodium clodronate tetrahydrate. Each tablet contains 128.24 mg sodium. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Film coated tablets. White, oval, convex tablet with breakline. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypercalcemia due to malignancy. Palliative treatment of osteolysis due to malignancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Clodronate is mainly eliminated via the kidneys. Therefore, adequate fluid intake must be maintained during clodronate treatment. _Pediatric patients: _Safety and efficacy in children have not been established. Elderly _patients: _ There are no special dosage recommendations for the elderly. Clinical trials have included patients over 65 years and no adverse effects specific to this age group have been reported. CLASTEON ® 800 mg tablets should be swallowed whole. A CLASTEON ® 800 mg tablet may be divided into two to ease swallowing, but the halves have to be taken at the same time of administration. CLASTEON ® 800 mg tablets must not be crushed or dissolved before intake. A daily dose of 1600 mg should be taken as a single dose. When higher daily doses are used, the part of the dose exceeding 1600 mg should be taken separately (as a second dose) as recommended below. The single daily dose and the first dose of two, should preferably be taken in the morning on an empty stomach together with a glass of water. The patient should then refrain from eating, drinking (other than plain water), and taking any other oral drugs for one hour. When twice daily dosing is used the first dose should be taken as recommended above. The second dose should be taken between meals, more than two hours aft पूरा दस्तावेज़ पढ़ें