国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ZOLEDRONINEZUUR 1-WATER SAMENSTELLING overeenkomend met ; ZOLEDRONINEZUUR 0-WATER
Alvogen IPCo S.ar.l 5, rue Heienhaff 1736 SENNINGERBERG (LUXEMBURG)
M05BA08
Zoledronic acid 1-WATER COMPOSITION corresponding to ; zoledronic acid 0-WATER
Concentraat voor oplossing voor infusie
MANNITOL (D-) (E 421) ; STIKSTOF (HEAD SPACE) (E 941) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE,
Intraveneus gebruik
Zoledronic Acid
Hulpstoffen: MANNITOL (D-) (E 421); STIKSTOF (HEAD SPACE) (E 941); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE;
2012-09-25
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ DESINOBON 4 MG/5 ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE Zoledronic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What DESINOBON is and what it is used for 2. What you need to know before you are given DESINOBON 3. How DESINOBON is used 4. Possible side effects 5. How to store DESINOBON 6. Contents of the pack and other information 1. WHAT DESINOBON IS AND WHAT IT IS USED FOR The active substance in Desinobon 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. It is used: TO PREVENT BONE COMPLICATIONS, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone). TO REDUCE THE AMOUNT OF CALCIUM in the blood in adult patients where it is too high due to the presence of a tumour. Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increased. This condition is known as tumour-induced hypercalcaemia (TIH). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DESINOBON Follow carefully all instructions given to you by your doctor. Your doctor will carry out blood tests before you start treatment with Desinobon and will check your response to treatment at regular intervals. YOU SHOULD NOT BE GIVEN DESINOBON: - if you are breast-feeding. - if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Desinobon belongs), or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor befor 阅读完整的文件
1 _Version 4, 02/2016_ SUMMARY OF PRODUCT CHARACTERISTICS 2 1 NAME OF THE MEDICINAL PRODUCT Desinobon 4 mg/5 ml, concentraat voor oplossing voor infusie 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. Excipient with known effect: 5 ml concentrate contains 0.0816 mmol of sodium citrate dihydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion _ _ Clear, colourless solution, free from visible particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. - Treatment of adult patients with tumour-induced hypercalcaemia (TIH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Desinobon must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. Patients treated with Desinobon should be given the package leaflet and the patient reminder card. Posology _Prevention of skeletal related events in patients with advanced malignancies involving bone _ _Adults and older people _ The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone 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 TIH _ _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. 3 _Renal impairment _ _TIH: _ Des 阅读完整的文件