Land: Storbritannien
Sprog: engelsk
Kilde: myHealthbox
Oxycodone Hydrochlorid
Ash Road North, Wrexham
N02AA05
Oxycodone Hydrochlorid
10mg/ml
Oral Solution
Oral use
125 ml bottle
POM - Prescription Only Medicine
CP Pharmaceuticals Ltd
Natural opium alkaloids
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.
Authorised
2011-05-25
MEASURE BAR SHOULD BE 150MM AT 100% SCALE Customer Description Item Code Profile Size Min. Point Size Market Lang uag e 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 mu st be taken by our client. IF YOU SI GN THI S PROOF Y OU ARE SIGNI FYI NG FULL APPROVAL OF DESI GN AN D TEXT. Wockhardt UK Lim ited Oxycodone 10mg /m l oral solution leaflet 105263- 4 148 x 210mm uk eng lish tom.robertson 2 19/05/2014 487228 5.5pt Process Black Keylin e (n on- printin g) N/A N/A • have an enlarged prostate gland • have a severe headache or feel sick as this may indicate that the pressure in your skull is increased (have raised intracranial pressure) • have kidney or liver disease • are intoxicated with alcohol • are suffering from withdrawal symptoms of alcohol SPECIAL CARE SHOULD BE TAKEN WITH ELDERLY, DEBILITATED AND WEAK PATIENTS AS WELL AS PATIENTS WITH A HISTORY OF DRUG OR ALCOHOL ABUSE. THIS MEDICINE CAN CAUSE DEPENDENCE, IF YOU HAVE ANY CONCERNS ABOUT WHETHER THIS MEDICINE IS SUITABLE FOR YOU SPEAK TO YOUR DOCTOR OR NURSE. IF YOU ARE GOING TO HAVE AN OPERATION, PLEASE TELL THE DOCTOR AT THE HOSPITAL THAT YOU ARE TAKING THIS MEDICINE. TAKING OTHER MEDICINES Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by treatment with Oxycodone 10mg/ml Solution: • tranquilisers and sleeping tablets • anaesthetics • anti-depressants • phenothiazines (often used to treat severe mental illness) • neuroleptic drugs (often used to treat severe mental illnesses such as psychosis and schizophrenia) • alcohol • other opioid painkillers • muscle relaxants • medicines to treat high blood pressure • quinid Læs hele dokumentet
Oxycodone Hydrochloride 10mg/ml Oral Solution Summary of Product Characteristics Updated 21Oct2014 | Wockhardt UK Ltd 1. Name of the medicinal product Oxycodone Hydrochloride 10mg/ml Oral Solution 2. Qualitative and quantitative composition Each 1ml contains oxycodone hydrochloride 10 mg (equivalent to 9 mg of oxycodone base). This medicinal product contains approximately 0.85mg sodium per ml. For full list of excipients, see Section 6.1. 3. Pharmaceutical form A clear, orange oral solution. 4. Clinical particulars 4.1 Therapeutic indications For the treatment of moderate to severe pain in patients with cancer and postoperative 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. _Postoperative 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 46 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, 46 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 Læs hele dokumentet