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The Pharmaceutical Journal
Vol 270 No 7253 p823
14 June 2003

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Products

    Prescription Products SPC changes Discontinued products Supply problems

Prescription Products

Metvix cream

Metvix (methyl aminolevulinate) 160mg/g cream has been launched by Galderma (tel 01923 291033). The cream is used as part of photodynamic therapy for the treatment of actinic keratosis and superficial basal cell carcinoma. A layer of the cream is applied to the affected area and its surroundings and is activated by specific red light. Application should only be made by health care professionals with appropriate training. Treatment is normally applied in two sessions one week apart. See SPC. Price, 2g £208.06.

Fluconazole infusion

Fluconazole 2mg/ml intravenous infusion for the treatment of fungal infections has been launched by PLIVA Pharma (tel 01730 710910). Price, 25ml infusion vial £7.31, 100ml vial £29.27.

Testogel

Testogel (testosterone) 50mg in 5g gel has been launched by Schering Health Care (tel 0845 609 6767). The gel is indicated as testosterone replacement therapy in confirmed hypogonadism in men. The gel should be applied to clean, dry skin on the shoulders, arms or abdomen once a day. Care should be taken to avoid transfer of the gel to partners or children. Skin reactions at the application site were reported in 10 per cent of trial patients. Use of the gel may increase the effect of oral anticoagulants. See SPC. Price, 30 x 5g sachets £33.

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SPC changes

Enbrel safety information

The summary of product characteristics for Enbrel (etanercept) has been updated (Wyeth). Safety information regarding concurrent use of etanercept with anakinra (Kineret) is now included. The special warnings and precautions for use section now says that the combined use of Enbrel and anakinra is not recommended. "Concurrent administration of Enbrel and anakinra has been associated with an increased risk of serious infections and neutropenia compared to Enbrel alone. This combination has not demonstrated increased clinical benefit," it states. Other sections of the SPC have been updated accordingly. See SPC.

Xenical and anticoagulants

The summary of product characteristics for Xenical (orlistat) has been updated (Roche). The special warnings and precautions for use section now states: "Coagulation parameters should be monitored in patients treated with concomitant oral anticoagulants." The following statement has been added to the undesirable effects section: "Reports of decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in variations of haemostatic parameters have been reported in patients treated with anticoagulants in association with orlistat."

NeoRecormon dosage and administration

The summaries of product characteristics for NeoRecormon (epoetin beta) multidose vials, cartridges and prefilled syringes have been updated (Roche). The sections on posology and method of administration for maintenance treatment of anaemic patients with chronic renal failure now read: "In the case of subcutaneous administration, the weekly dose can be given as one injection per week or in divided doses three or seven times per week. Patients who are stable on a once weekly dosing regimen may be switched to once every two weeks administration. In this case dose increases may be necessary."

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Discontinued products

Exosurf Neonatal

Supplies of Exosurf Neonatal suspension (colfosceril palmitate) have now been exhausted (GlaxoSmith-Kline). For further information, customers should contact the GSK customer contact centre on 0800 221 441.

Mysoline

Mysoline (primidone) 250mg tablets will be discontinued in the United Kingdom on 1 December 2003. For further information, customers should contact AstraZeneca UK medical information on 0800 783 0033.

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Supply problems

Short-dated Tritace

Aventis advises that the only stock of the seven-capsule packs of Tritace (ramipril) 2.5mg it has available has an expiry date of November 2003. Since this is less than six months, the product is currently being supplied on a sale or return basis. Details from customer services on 0870 513 3347.

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