Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pamidronate disodium
Wockhardt UK Ltd
M05BA03
Pamidronate disodium
15mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 5012727904511
MPS READ DIRECTION WOCKHARDT TRAVEL DIRECTION Pharmacode: Process Black Keylines MEASURE BAR SHOULD BE 150MM AT 100% SCALE Customer Description Item Code Profile Size Min. Point Size Market Language Proof By Proof No. Date Artwork No. Pharma Code Colours Used WARNING! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clientʼs brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT. artwork.leicester@CIRRUS-ARTWORK.com Wockhardt UK Limited DISODIUM PAMIDRONATE CONCENTRATE FOR SOLUTION FOR INFUSION 104228/5 See uploaded pdf 210 x 420mm MPI 4 19/12/2017 914495 n/a 5pt (Main Body) / 6pt (Variables) UK English SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Disodium pamidronate 15mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSTION 1ml of concentrate contains 15mg disodium pamidronate. One ampoule of 1ml contains 15mg disodium pamidronate. One ampoule of 2ml contains 30mg disodium pamidronate. One ampoule of 4ml contains 60mg disodium pamidronate. One ampoule of 6ml contains 90mg disodium pamidronate. Excipient: Sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Colourless solution, free from particles. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of conditions associated with increased osteoclast activity: • Tumour-induced hypercalcaemia • Osteolytic lesions and bone pain in patients with bone metastases associated with breast cancer or multiple myeloma • Paget’s disease of bone. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Disodium pamidronate concentrate must never be given as a bolus injection (see “Warnings”). The concentrate of disodium pamidronate concentrate in ampoules should be diluted in a calcium-free infusion solution (0.9 % Sodium Chloride Intravenous Infusion B.P. is recommended) and i Olvassa el a teljes dokumentumot
OBJECT 1 DISODIUM PAMIDRONATE 15MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION (90MG STRENGTH) Summary of Product Characteristics Updated 23-Jan-2018 | Wockhardt UK Ltd 1. Name of the medicinal product Disodium Pamidronate 15mg/ml Concentrate for Solution for Infusion 2. Qualitative and quantitative composition 1ml of concentrate contains 15mg disodium pamidronate. One ampoule of 6ml contains 90mg of disodium pamidronate. Excipient with known effect Sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion Colourless solution, free from particles. 4. Clinical particulars 4.1 Therapeutic indications Treatment of conditions associated with increased osteoclast activity: • Tumour-induced hypercalcaemia • Osteolytic lesions and bone pain in patients with bone metastases associated with breast cancer or multiple myeloma • Paget's disease of bone. 4.2 Posology and method of administration Disodium pamidronate concentrate must never be given as a bolus injection (see "Warnings"). The concentrate of disodium pamidronate concentrate in ampoules should be diluted in a calcium-free infusion solution (0.9 % Sodium Chloride Intravenous Infusion B.P. is recommended) and infused slowly. The infusion rate should never exceed 60mg/hour (1mg/min), and the concentration of disodium pamidronate concentrate in the infusion solution should not exceed 90mg /250ml. A dose of 90mg should normally be administered as a 2-hour infusion in 250mL infusion solution. However, in patients with multiple myeloma and in patients with tumour-induced hypercalcaemia, it is recommended not to exceed 90mg in 500mL over 4 hours. In patients with established or suspected renal impairment (e.g. those with tumour-induced hypercalcaemia or multiple myeloma) it is recommended that the infusion rate does not exceed 20mg/h (see also "Renal Impairment"). In order to minimise local reactions at the infusion site, the cannula should be inserted carefully into a relatively large vein. Until further exp Olvassa el a teljes dokumentumot