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EMEA Recommends A New Warning For Epoetins For Their Use In Cancerpatients, Europe
The European Medicines Agency (EMEA) has recommended updating the
product information for epoetin-containing medicines with a new warning
for their use in cancer patients stating that blood transfusion should
be the preferred method of correcting anaemia in patients suffering
cancer. Epoetin-containing medicines are indicated in patients with
chronic renal failure and for the treatment of anaemia in symptomatic
patients with non-myeloid tumours receiving chemotherapy.
The Agency's Committee for Medicinal Products for Human Use (CHMP) had
reviewed new data from studies that showed an increased risk of tumour
progression, venous thromboembolism and shorter overall survival in
cancer patients who received epoetins compared to patients who did not
receive them. Following this review, the CHMP concluded, at its June
2008 meeting, that the benefits of epoetins continue to outweigh their
risks in the approved indications.
However, in cancer patients with a reasonably long life-expectancy, the
benefit of using epoetins does not outweigh the risk of tumour
progression and shorter overall survival and therefore the Committee
concluded that in these patients anaemia should be corrected with blood
transfusions.
Doctors and patients are advised that the decision to administer
epoetin-containing medicines should be based on an informed assessment
of the benefits against the risks on individual basis, taking into
account the type and stage of tumour, the degree of anaemia, the
patient's life-expectancy, the environment in which the patient is being
treated and patient preference.
The Committee agreed that there is no consequence of the new information
on the use of epoetin-containing medicines for the treatment of anaemia
in patients with chronic renal failure.
The Agency is closely monitoring the safety of epoetin-containing
medicines. In September 2007 a full safety review of all epoetins was
finalised. As a consequence, the product information was updated and the
indication for all the epoetin-containing medicines was changed to state
that epoetins should be used in the treatment of anaemia only if
associated with symptoms such as weakness and lack of energy.
The CHMP will continue to review the safety profile of the epoetins
within the terms of their currently authorised indications in the EU as
additional data become available.
The CHMP also requested that the marketing authorisation holders for
epoetin-containing medicines should carry out, as a priority, additional
studies to clarify the risks and benefits of epoetins in the treatment
of patients with cancer under the new treatment recommendations.
Notes:
1. More information is available in a question-and-answer document .
2. Epoetin-containing medicines are approved at the level of Member
States. Medicines available in the European Union contain epoetin alfa
(Abseamed, Binocrit, Epoetin Alfa Hexal, Eprex, Erypo), darbepoetin alfa
(Aranesp, Nespo), epoetin beta (NeoRecormon), methoxy polyethylene
glycol-epoetin beta (Mircera), epoetin delta (Dynepo) and epoetin zeta
(Retacrit, Silapo). All of these medicines, except Mircera and Dynepo,
are approved for the treatment of anaemia in cancer patients and
patients with chronic renal failure.
3. Further information on the outcome of the review of epoetins
finalised in September 2007 can be found here.
European Medicines Agency
View drug information on Mircera.
EMEA recomandã un nou avertisment pentru Epoetins pentru utilizarea lor în Cancerpatients, Europa - EMEA Recommends A New Warning For Epoetins For Their Use In Cancerpatients, Europe - articole medicale engleza - startsanatate