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D R U G A L E R T CLASS 4 MEDICINES DEFECT INFORMATION |
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Saturday, 13 December 2008 |
Defective Medicines Report Centre
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Telephone: +44 (0)20 7084 2574 Fax: +44 (0)20 7084 2676
MHRA Distribution:
Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts (England)
D R U G A L E R T CLASS 4 MEDICINES DEFECT INFORMATION
Caution in Use
Distribute to Community and Hospital Pharmacist Level
Date: 11 December 2008 EL (08)A/20 Our Ref: MDR 70-11/08
___________________________________________________________ ______________
Dear Healthcare Professional,
Merck Serono UK - Gonal-F 900 IU/1.5ml solution for injection in pre-filled pen EU/1/95/001/035
(follitropin alfa, recombinant human follicle stimulating hormone)
Batch Number Expiry Date Pack Size First Distributed
Y10B0063 03/2010 1 06/06/2008
Y10B2052 03/2010 1 25/07/2008
Y10B4293 04/2010 1 18/08/2008
Y10B7228 04/2010 1 12/09/2008
Y10B8889 04/2010 1 17/10/2008
Y11B2580 05/2010 1 31/10/2008
Y11B3841 06/2010 1 11/11/2008
The MHRA has been informed that there is an error in the title of the package leaflet for some batches of Gonal-F 900 IU/1.5ml solution for injection in pre-filled pens. Details of the affected batches are shown above.
The actual concentration of Gonal-F in the pre-filled pen device is 900 IU/1.5ml and this is correctly stated on both the label of the pen injection device and the external packaging.
It is also stated correctly in the body of the text of the package leaflet in section 6. However the title of the package leaflet indicates a concentration of 900 IU/0.5ml.
The error in the package leaflet should not affect the dosage of Gonal-F administered to the patient as the package leaflet clearly specifies that the dose on the pen should be set in IU and not by volume.
We have been asked to advise pharmacists that this information should be relayed to patients when dispensing, and should be conveyed to all pharmacists working within their pharmacy. To avoid stock disruption, distribution of affected stock will continue, therefore further deliveries over the next few months will display this error. Corrected package leaflets are being produced but it is unlikely that these will be supplied to the market before January
2009.
Further Information
For further enquiries, please telephone Merck Serono Medical Information on 0208 8187373 Primary Care Trusts are asked to bring this information to the attention of Community Pharmacists and other concerned Health Professionals by copy of this letter.
Yours faithfully
Alison Bunce
Pharmaceutical Assessor
DMRC |
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Thursday, 20 November 2008 |
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 Have your say - HFEA consultation on presenting clinic performance and outcome data
The HFEA would like your views on how to present clinic performance and outcome data to best inform patient choice, promote good clinical practice and support HFEA policies.
A discussion document will review ways to present success rates in the most useful and meaningful way and consider the benefits of adopting a more holistic approach such as providing information about patient experience, clinical safety and quality of service of clinics.
Taking part
The HFEA consultation on presenting clinic performance and outcome data is split over two parts:
Part one
Read the discussion document and respond to our online questionnaire below by 15th December 2008.
Discussion document
Respond to the online questionnaire
Part two
Your feedback from part one will help us develop a range of models that will illustrate different options for presenting clinic performance. In part two of this consultation we will seek further feedback on these models. This will take place in January and February 2009. Public events and focus groups
Public meetings
Clinicians, fertility sector professionals and public are invited to attend one of our consultation meetings which will cover the presentation of clinic data consultation and the draft 8th Code of Practice and consent forms consultation: - Manchester - 14th January 2009
- Bristol - 29th January 2009
- London - 11th February 2009
For more information and to register for one of these events, contact
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Focus groups for patients
Engaging with patients is important to us and we have been developing our proposals with help from patient and donor groups. We also plan to hold two patient focus groups in December 2008. These meetings will help us to find out more about how we should present information about clinics in order to best inform patient choice.
Two early evening events are taking place:
- London - Tuesday 9 December (6.30 - 8.30pm)
- Birmingham - Wednesday 10 December (6.30 - 8.30pm)
To register, please email
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Questions and comments about the consultation
If you have any questions or comments about the consultation, contact Jacky Moran on 020 7291 8268 or via email at
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Related links
Draft 8th Code of Practice and consent forms consultation
http://www.hfea.gov.uk/en/1743.html
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Friday, 10 October 2008 |
CAN YOU HELP US?
I am seeking a very special person who is willing to donate her eggs anonymously to enable us to have the chance of fulfilling our dream of having a baby.
My husband and I have been together for 15 years and trying for a baby for the last 3 years. After extensive testing and failed fertility treatment, I have now been diagnosed with Premature Ovarian Failure (commonly known as Premature Menopause).
Being only 31 years old, this was devastating news for both of us. There is no explanation for my diagnosis and I still find it hard to accept that my body does not function as it should.
We have been told that our only option in achieving the family we desire so much is to use donor eggs.
We've gone on the waiting list at The Nuffield Hospital in Woking but have been told it will take about two years to find a donor match. The only way that we could get treatment within a six month period would be to find someone who would be willing to provide eggs to the donation pool either as part of an egg share or just because they want to help other women like me have a baby.
If you are aged 35 and under and you would like more information about egg donation and egg sharing please contact Mrs Caroline Lewis (Assisted Conception Unit Manager) or any of the other nurses at The Nuffield Hospital in Woking on 01483 227859.
If by any chance you do decide to go ahead, I would be really grateful if you would quote my hospital number to the nurses - 276666.
We are aware that this would take a very special person who is willing to do such an unselfish act for someone they do not know.
Thank you for taking the time to read this message. |
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