The Pharmaceutical Journal
Vol 279 No 7466 p203
25 August 2007

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Products

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

Prescription Products
• Aranesp
SPC changes
• Durogesic DTrans
• Gardasil
Discontinued products
• Moditen
Supply issues
• Fortipine LA 40
• Navridex
• Stelazine
• Synarel

Recall Flucloxacillin capsules 500mg

Prescription Products

Aranesp
Aranesp (darbepoetin alfa) is now available from Amgen in 130µg/0.65ml syringe and 130µg/0.65ml SureClick presentations. 4 x prefilled syringe, £810.42; 1 x SureClick prefilled pen £202.61. Legal category: POM.

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SPC changes

Durogesic DTrans
Information about use in paediatrics has been added to the summary of product characteristics for Durogesic DTrans (fentanyl; Janssen-Cilag) transdermal patch. The SPC now advises that patches should be applied to the upper back of children, to minimise the chances of the child removing them.

The special warnings and precautions in use section also now warns: that the product should not be administered in opioid-naive children; that the potential for serious or life-threatening hypoventilation exists regardless of the dose of Durogesic DTrans administered; that caution should be used when choosing the application site for the patch; and that adhesion of the patch should be monitored closely.

Gardasil
The following adverse events (reported from post-marketing surveillance) have been added to the summary of product characteristics for Gardasil (human papillomavirus vaccine, recombinant adsorbed; Sanofi Pasteur MSD): nausea, vomiting, hypersensitivity reactions (including anaphylaxis), dizziness and syncope.

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Discontinued products

Moditen
Sanofi-Aventis will discontinue Moditen (fluphenazine) tablets 1mg at the end of June 2008. The company advises that patients being treated with Moditen should be reviewed by their prescribing doctor to co-ordinate gradual withdrawal and switching to an alternative treatment while stocks remain.

Medical information on 01483 505515.

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Supply issues

Fortipine LA 40
Fortipine LA 40 (nifedipine) tablets are available again from Goldshield after being out of stock.

Navridex
Navridex (cyclopenthiazide) tablets are available again from Goldshield after being out of stock.

Stelazine
Stelazine (trifluoperazine) tablets 112 x 1mg are available again from Goldshield after being out of stock.

Synarel
Synarel (nafarelin acetate) nasal spray 30 dose (4ml) and 60 dose (8ml) are currently unavailable from Pfizer. New stock is expected to be available at the end of September. Further information on 01304 616161.

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