Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
ZOLEDRONIC ACID AS MONOHYDRATE
NEOPHARM (ISRAEL) 1996 LTD
M05BA08
CONCENTRATE FOR SOLUTION FOR INFUSION
ZOLEDRONIC ACID AS MONOHYDRATE 4 MG
I.V
Required
FRESENIUS KABI AUSTRIA GmbH
ZOLEDRONIC ACID
Treatment of hypercalcaemia of malignancy. Treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors , in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.
2021-07-31
1986 - PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) This medicine is dispensed with a doctor’s prescription only ZOLEDRONIC ACID FRESENIUS 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION ACTIVE INGREDIENT One 5 ml vial contains 4 mg zoledronic acid. INACTIVE INGREDIENTS AND ALLERGENS: see section 2 under 'Important information about some of this medicine's ingredients', and section 6 'Additional Information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have 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. 1. WHAT IS THIS MEDICINE INTENDED FOR? Zoledronic Acid Fresenius 4 mg/5 ml is used to: − Treat patients with multiple myeloma and patients with documented bone metastases from solid tumours (where cancer spreads from the primary site to the bone), together with standard anticancer therapy. − For prostate cancer, treatment is given if there is progression after at least one hormonal treatment. − Reduce the amount of calcium in the blood in patients where the level is too high due to presence of a tumour. THERAPEUTIC GROUP: Bisphosphonates The active substance in Zoledronic Acid Fresenius 4 mg/5 ml is zoledronic acid, which belongs to a group of substances called bisphosphonates. Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change. 2. BEFORE USING THIS MEDICINE - Carefully follow all the instructions given to you by the doctor. DO NOT USE THIS MEDICINE IF: - you are sensitive (allergic) to zoledronic acid, to another bisphosphonate (the group of substances to which zoledronic acid belongs) or to any of the other ingredients that this medicine contains (listed in section 6, in the list of inactive ingredients). - you are breastfeeding. SPECIAL WARNINGS ABOUT USING THIS MEDICI Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS ZOLEDRONIC ACID FRESENIUS 4 MG/ 5 ML 1. NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Fresenius 4 mg/5 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate. One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion ) sterile concentrate) Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Treatment of hypercalcaemia of malignancy 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zoledronic Acid Fresenius must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. Patients treated with Zoledronic Acid Fresenius should be given the package leaflet. Posology _Multiple Myeloma and bone metastases from solid tumors _ _Adults and older people _ The recommended dose is 4 mg zoledronic acid every 3 to 4 weeks. Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily. The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months. _Treatment of hypercalcemia of malignancy (HCM) _ _Adults and older people _ The recommended dose in hypercalcaemia (albumin-corrected serum calcium 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid. Patients must be maintained well hydrated prior to and following administration of Zoledronic Acid Fresenius. _Renal impairment _ _Patients with hypercalcemia of malignancy (HCM): _ Zoledronic Acid Fresenius treatment in Lugege kogu dokumenti