The Pharmaceutical
Journal
Vol 269 No 7211 p212
17 August 2002
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The Pharmaceutical
Journal |
Products |
Recall BCG vaccines |
Prescription ProductsRisperdal Consta (risperidone) injection has been launched (Janssen-Cilag); net price, 25mg 1 £82.92, 37.5mg 1 £115.84 and 50mg 1 £148.55. The product should be administered every two weeks by deep intramuscular gluteal injection. The maximum dose should not exceed 50mg every two weeks. |
SPC changesThe summaries of product characteristics for Zomig (zolmitriptan) tablets and Zomig Rapimelt orodispersible tablets have been updated. Both products are contraindicated in patients with a history of cerebrovascular accident or transient ischaemic attack. The following statement has been added to the special warnings and precautions for use section: "Migraneurs may be at risk of certain cerebrovascular events. Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5HT1B/1D agonists." In very rare cases angina pectoris has been reported in patients taking zolmitriptan. The following rare adverse reactions (>0.01 per cent, <0.1 per cent) have been added to the undesirable effects section: hypersensitivity reactions including urticaria and angioedema, head-ache, tachycardia and palpitations. See SPC. The licensed indications for Zometa (zoledronic acid) infusion have been extended (Novartis Pharmaceuticals). Zometa infusion is now additionally licensed for the prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone. The recommended dose is 4mg given as an infusion every 3–4 weeks. The posology and method of administration section states that renal function should be monitored in all patients receiving Zometa and possible deterioration in remal function should be assessed before retreatment. The special warnings and precautions for use section states that patients must be assessed before administration of Zometa to assure that they are adequately hydrated. It also states that if hypocalcaemia, hypophosphataemia or hypomagnesaemia occur, short-term supplemental therapy may be necessary. The following common (Ž1 per cent, <10 per cent) undesirable effects have been added: anaemia, bone pain, myalgia, renal impairment, influenza-like syndrome, increased blood creatinine and blood urea. See SPC for uncommon and rare adverse effects. The instructions for use section has been updated and states that reconstituted solution should be further diluted with 100ml of 0.9 per cent w/v sodium chloride solution or 5 per cent w/v glucose solution instead of 50ml. See SPC. The summary of product characteristics for Xenical (orlistat) capsules has been updated (Roche). Additional data on the use of Xenical capsules have been added to the pharmacodynamic properties section. See SPC. |
Discontinued productsAstraZeneca has informed us that only 7-tablet packs of Losec MUPS 10mg, 20mg and 40mg tablets for use in hospitals have been discontinued. A 7-day community pack of Losec MUPS 40mg tablets remains available (PJ, 10 August, p189). |
Supply problemsAspav (aspirin 500mg, papaveretum 7.71mg) tablets, pack size 30, are currently out of stock (Alpharma). New stock is expected to be available by the end of the year. Alpharma's norethisterone 5mg tablets, pack size 30, are now back in stock. |
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