国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxycodone hydrochloride
Wockhardt UK Ltd
N02AA05
Oxycodone hydrochloride
1mg/1ml
Oral solution
Oral
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5012727906669
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 artwork.leicester@MULTIPKG.com CLEARLY MARK ANY AMENDMENTS ON ONE PROOF AND RETURN TO MPS 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. Process Black Keyline (non-printing) Text free area (non-printing) Wockhardt UK Limited Oxycodone oral 5mg/ml 105259/4 n-a 297 x 210mm matt.pirie-scott 1 08/08/2016 675313 n-a 8.5pt (Main Body) / 6pt (Variables) UK English PACKAGE LEAFLET: INFORMATION FOR THE USER Oxycodone Hydrochloride 5mg/5ml Oral Solution (referred to as Oxycodone 5mg/5ml Solution in this leaflet) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, please ask your doctor or pharmacist. − This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. − If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Oxycodone 5mg/5ml Solution is and what it is used for 2. What you need to know before you take Oxycodone 5mg/5ml Solution 3. How to take Oxycodone 5mg/5ml Solution 4. Possible side effects 5. How to store Oxycodone 5mg/5ml Solution 6. Contents of the pack and other information 1. WHAT OXYCODONE 5MG/5ML SOLUTION IS AND WHAT IT IS USED FOR This medicine has been prescribed for you by your doctor to relieve moderate to severe pain. It contains the active ingredient oxycodone which belongs to a group of medicines c 阅读完整的文件
OBJECT 1 OXYCODONE HYDROCHLORIDE 5MG/5ML ORAL SOLUTION Summary of Product Characteristics Updated 03-Jan-2017 | Wockhardt UK Ltd 1. Name of the medicinal product Oxycodone Hydrochloride 5mg/5ml Oral Solution 2. Qualitative and quantitative composition Each 5ml contains oxycodone hydrochloride 5 mg (equivalent to 4.5 mg of oxycodone base). This medicinal product contains approximately 3.5mg sodium per 5ml. For full list of excipients, see Section 6.1. 3. Pharmaceutical form A clear, colourless oral solution. 4. Clinical particulars 4.1 Therapeutic indications For the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid. 4.2 Posology and method of administration _Route of administration:_ Oral use. _Post-operative pain: _ In common with other strong opioids, the need for continued treatment should be assessed at regular intervals. _Elderly and adults over 18 years:_ Oxycodone solution should be taken at 4-6 hourly intervals. The dosage is dependent on the severity of the pain, and the patient's previous history of analgesic requirements. Increasing severity of pain will require an increased dosage of Oxycodone solution. The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. The usual starting dose for opioid naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 5 mg, 4-6 hourly. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. The majority of patients will not require a daily dose greater than 400 mg. However, a few patients may require higher doses. Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasi 阅读完整的文件