Other safety alerts
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| The United Kingdom: Class 4 Drug Alert (caution in use): Diflucan powder for oral suspension (10 mg/ml and 40 mg/ml) - Pfizer Limited |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announced that Pfizer Limited has recently amended the labels and patient information leaflet (PIL) for Diflucan 10 mg/ml powder for oral suspension and Diflucan 40mg/ml powder for oral suspension. Pfizer Limited has informed MHRA that there may be some confusion resulting from the new packaging, as follows:
1. The PIL, which is common to both strengths, provides reconstitution instructions for a 175ml bottle. Pharmacists are asked to disregard these instructions as the 175ml presentation is not available in the UK. The only pack size in the UK is the 60ml bottle and instructions for reconstitution are provided in the PIL in the section containing information intended for medical or healthcare professionals.
2. For Diflucan 40mg/ml, batch A233306, the level mark on the label, which is referred to in the reconstitution instructions in the PIL, is missing. Pharmacists are asked to ensure that 24ml water is added. This produces 35ml of useable suspension.
MHRA informed that to ensure continuity of supply in UK, distribution of affected stock will continue and it will be necessary to release further batches. Steps are being taken to remedy this situation as quickly as possible, but it may be several months before the issue is resolved.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/Publications/Safetywarnings/../CON185158
In Hong Kong, Diflucan Oral Suspension 50mg/5ml (HK-38313) with the only pack size of 35ml, containing fluconazole, is registered by Pfizer Corporation Hong Kong Limited (Pfizer). It is a prescription-only medicine. Confirmed with Pfizer, the registered product in Hong Kong has not included the Patient information leaflet (PIL) of UK.
Ends/ Friday, September 21, 2012
Issued at HKT 16:00 |
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