Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fentanyl citrate; Bupivacaine hydrochloride
Sandoz Ltd
N01AH51
Fentanyl citrate; Bupivacaine hydrochloride
2microgram/1ml ; 1.25mg/1ml
Solution for infusion
Epidural
Schedule 2 (CD)
Valid as a prescribable product
BNF: ; GTIN: 5099602001756 05021691001539
• constipation • chills, cold (hypothermia), sweating, micturition difficulties • airway complication of anaesthesia. RARE: MAY AFFECT UP TO 1 In 1,000 PEOPLE • weakness, loss of sensation (persistent anasthesia), bowel incontinence (loss of sphincter control), weakness or numbness in peripheral nerves (neuropathy), peripheral nerve injury, a pain disorder caused by inflammation of one of the membranes that surrounds and protects the nerves of the spinal cord. It is characterized by severe stinging, burning pain and neurological problems (arachnoiditis), muscular weakness caused by nerve damage (paresis), paralysis of legs and lower body (paraplegia) • double vision (diplopia). NOT KNOWN: FREQUENCY CANNOT BE ESTIMATED FROM THE AVAILABLE DATA • loss of consciousness, involuntary twitching of a muscle (myoclonus), impairment of voluntary movement (Dyskinesia), rise in the pressure inside the skull that can result from or cause brain injury (raised intracranial pressure) • cough. If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE BUFYL Keep this medicine out of the sight and reach of children. You should not be given Bufyl after the expiry date which is stated on the container label after EXP. The doctor or nurse will check that the expiry date on the label has not been passed before administering the infusion to you. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENT Lees het volledige document
OBJECT 1 BUFYL 1.25MG/ML AND 2MICROGRAM/ML SOLUTION FOR INFUSION Summary of Product Characteristics Updated 07-Apr-2017 | Concordia International - formerly AMCo 1. Name of the medicinal product BUFYL 1.25mg/ml and 2microgram/ml Solution for Infusion Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml Solution for infusion 2. Qualitative and quantitative composition Each 1ml of solution contains 1.25mg bupivacaine hydrochloride and 2 micrograms fentanyl (as fentanyl citrate) Excipient with known effect Contains up to 3.5mg sodium per ml. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for epidural infusion. Clear, colourless aqueous sterile solution. 4. Clinical particulars 4.1 Therapeutic indications Bufyl/ Bupivacaine and Fentanyl solution for infusion is indicated for: (i) maintaining analgesia post-operatively and (ii) for maintaining epidural analgesia during labour. 4.2 Posology and method of administration _Posology _ ADULTS: The length of continuous epidural infusions given post-operatively should be minimized, due to the increased risks of reaching a toxic plasma concentration, inducing local neural injury or local infection. Administration of bupivacaine with fentanyl epidural infusion has not been adequately studied for more than 72 hours. The dosages in the following table are recommended as a guide for use in healthy adults during labour and in the post operative period. It should not be necessary to exceed an infusion dosage of 20mg/hour for bupivacaine. Standard textbooks should be consulted for factors affecting specific block techniques; dosing should be titrated to meet the individual patient requirements and the lowest dose required to provide adequate analgesia should be used. Bufyl/ Bupivacaine 1.25mg/mL + Fentanyl 2 microgram/mL solution for infusion Indication Administration by continuous epidural infusion Volume mL/hour Dosage / hour Bupivacaine (mg) Dosage / hour Fentanyl (microgram) Analgesia in labour Lumbar epidural 8 - 15 10 – 1 Lees het volledige document