Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxycodone hydrochloride
Qdem Pharmaceuticals Ltd
N02AA05
Oxycodone hydrochloride
50mg/1ml
Solution for injection
Subcutaneous; Intravenous
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5060307920161
PACKAGE LEAFLET: INFORMATION FOR THE USER _SHORTEC_ _®_ 50 MG/ML, SOLUTION FOR INJECTION OR INFUSION Oxycodone hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4. IN THIS LEAFLET : 1. What _SHORTEC _ injection is and what it is used for 2. What you need to know before you use _SHORTEC _ injection 3. How to use _ SHORTEC _ injection 4. Possible side effects 5. How to store _SHORTEC _ injection 6. Contents of the pack and other information 1. WHAT _SHORTEC _INJECTION IS AND WHAT IT IS USED FOR This injection 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 called strong analgesics or ‘painkillers’. The other ingredients are listed in section 6 of this leaflet. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE_ SHORTEC _INJECTION DO NOT USE_ SHORTEC _INJECTION IF YOU: are allergic to oxycodone, or any of the other ingredients of _SHORTEC_ injection (listed in section 6); have breathing problems, such as severe obstructive lung disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected; have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen; have a heart problem after long-term lung disease (cor pulmonale); have moderate to severe liver problems. If you have o Lees het volledige document
OBJECT 1 SHORTEC 50 MG/ML, SOLUTION FOR INJECTION OR INFUSION Summary of Product Characteristics Updated 07-Feb-2017 | Qdem Pharmaceuticals Limited 1. Name of the medicinal product _SHORTEC_ 50 mg/ml, solution for injection or infusion 2. Qualitative and quantitative composition Oxycodone hydrochloride 50 mg/ml (equivalent to 45 mg/ml oxycodone). For the full list of excipients, see Section 6.1. 3. Pharmaceutical form Solution for injection or infusion. 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 _Posology_: The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication. _Adults over 18 years_: The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases. i.v. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1-2 minutes in opioid naïve patients. Doses should not be administered more frequently than every 4 hours. i.v. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended for opioid naïve patients. . i.v. (PCA): Dilute in 0.9% saline, 5% dextrose or water for injections. Bolus doses of 0.03 mg/kg should be administered with a minimum lock-out time of 5 minutes for opioid naïve patients. s.c. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for injections. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required for opioid naïve patients. s.c. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for injections if required. A starting dose of 7.5 mg/day is recommended in opioid naïve patients, titrating gradually according to symptom control. Cancer patients transferring from oral ox Lees het volledige document