Other safety alerts
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| The United Kingdom: Class 4 Drug Alert (caution in use): Genotropin 5.3mg and 12mg powder for solution for injection (GoQuick pre-filled pen) - manufacturing defect of some pens used to administer somatropin |
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Pfizer Limited has notified MHRA of a manufacturing defect in the dosing mechanism of some Genotropin GoQuick pens which are used to administer somatropin. The defect has been found to create the possibility of the dose being set to one extra click beyond the dose selected and indicated in the memory window when the patient turns the dose knob with excessive force. This may result in a small increase in the dosage administered compared to the preset dose:
•An additional 0.05mg of Genotropin for the 5.3mg Go Quick pre-filled pen
•An additional 0.15mg of Genotropin for the 12mg GoQuick pre-filled pen
All unexpired batches of Genotropin GoQuck are within the scope of this issue although not all pens within these batches are affected. No complaints or adverse reactions relating to this issue have been received by the company to date.
In order to avoid product shortages, affected batches are not being recalled in the United Kingdom. Healthcare professionals are asked to remind patients to follow the instruction to align the dose settings in order to avoid the potential for an incorrect dose being administered.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/genotropin-5-3mg-and-12mg-powder-for-solution-for-injection-goquick-pre-filled-pen-manufacturing-defect-of-some-pens-used-to-administer-somatropin
In Hong Kong, Genotropin 12mg is not a registered pharmaceutical product, while Genotropin 5.3mg, registered as Genotropin For Inj 5.3mg (HK-35414) by Pfizer Corporation Hong Kong Limited (Pfizer), is a prescription-only medicine. So far, Department of Health (DH) has not received any adverse drug reaction case related to Genotropin. Pfizer confirmed with DH that Genotropin For Inj 5.3mg has not been marketed in Hong Kong for several years.
Ends/ Thursday, December 10, 2015
Issued at HKT 15:30 |
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