Therapeutic indications. For the treatment of acute variceal bleeding and prevention of rebleeding related to portal hypertension. [*]
Therapeutic indications. Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Therapeutic indications. Ertapenem is indicated in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to Ertapenem and when parenteral therapy is required: • Intra-abdominal infections • Community acquired pneumonia • Acute gynaecological infections • Diabetic foot infections of the skin and soft tissue Contraindications: • Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics (SPC). • Hypersensitivity to any other carbapenem antibacterial agent. • Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins or cephalosporins). Ertapenem - Dose and Route of Administration Usual dosing regimen: 1g ONCE DAILY Reconstitution and Administration: Reconstitute the contents of a 1 g vial of Ertapenem with 10 ml of water for injection or sodium chloride 0.9 % solution to yield a reconstituted solution of approximately 100 mg/ml. Shake well to dissolve. For a 1 g dose, immediately transfer contents of the reconstituted vial to a 50 - 100 ml bag of sodium chloride 0.9 % solution. Infuse over a period of 30 minutes. Duration of treatment: The duration of treatment should be decided based on the clinical response. Variable – from 7 days to 6 weeks depending on indication. Renal impairment: Ertapenem may be used for the treatment of infections in adult patients with mild to moderate renal impairment. In patients whose creatinine clearance is > 30 ml/min, no dosage adjustment is necessary. For Creatinine Clearance (GFR) 10 – 30ml/min: 500mg ONCE DAILY can be prescribed (unlicensed dose). The UK manufacturer does not recommend its use in renal impairment, but the US data sheet does recommend this dose3. The patient’s U + E and Creatinine will be monitored weekly for any deterioration in renal function. Haemodialysis: The UK manufacturer does not recommend using Ertapenem in haemodialysis. However there is data supporting its use. Approximately 30% of the dose is dialysed after a 4 hour haemodialysis session. The Renal Handbook recommends 500mg once daily or 1g three times a week in haemodialysis patients (unlicensed dose). Give at least 6 hours before haemodialysis session if unable to give post dialysis3. Hepatic impairment: No dosage adjustment is recommended in patients with impaired hepatic function. Ertapenem - Special warnings and precautions for use: Hypersensitivity reactions S...
Therapeutic indications. For the treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon.
Therapeutic indications. Induction of remission in patients with mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon. -Symptomatic relief of chronic diarrhoea due to collagenous colitis Please note: Treatment with Budenofalk 3 mg does not appear useful in patients with Crohn’s disease affecting the upper gastro-intestinal tract. Extraintestinal symptoms, e.g. involving the skin, eyes or joints, are unlikely to respond to Budenofalk 3 mg because of its local action.
Therapeutic indications. Note: For products authorised in paediatric patients only: <“Codeine is indicated in children older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone).”> Note: For products authorised without a specified age range: <“Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone).”>
