Примери за използване на Mylotarg на Английски и техните преводи на Български
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Other medicines and MYLOTARG.
Discontinue MYLOTARG(see section 4.4).
MYLOTARG daunorubicin cytarabine hydroxyurea.
Dosing regimens for MYLOTARG in combination with chemotherapy.
Mylotarg can only be obtained with a prescription.
Nervous system effects have not been observed in animals after administration of MYLOTARG.
Why is Mylotarg authorised in the EU?
The company also stated that it will continue to supply Mylotarg for use in existing, ongoing clinical trials.
What is Mylotarg and what is it used for?
What are the consequences of the refusal for patients in clinical trials orcompassionate use programmes using Mylotarg?
MYLOTARG contains no bacteriostatic preservatives.
At that point in time,the CHMP was of the opinion that there was insufficient evidence to establish the effectiveness of Mylotarg in the treatment of acute myeloid leukaemia, and therefore that the medicine's benefits did not outweigh its risks.
MYLOTARG+ daunorubicin+ cytarabine daunorubicin+ cytarabine.
On 20 September 2007, the Committee for Medicinal Products for Human Use(CHMP) adopted a negative opinion,recommending the refusal of the marketing authorisation for the medicinal product Mylotarg 5 mg powder for solution for infusion, intended for the treatment of acute myeloid leukaemia.
MYLOTARG should not be administered during second induction.
Although some side effects with Mylotarg can be serious, they were considered acceptable in light of the severity of the patients' condition.
Mylotarg vials contain 5 mg of drug product with no overfill.
However, it was difficult to compare the effectiveness of Mylotarg and other treatments used for this disease, in terms of how long remission would last, how long it would take until the disease got worse, or what the medicines' effects would be on survival.
MYLOTARG has not been studied in patients with severe renal impairment.
AML is rare, and Mylotarg was designated an‘orphan medicine'(a medicine used in rare diseases) on 18 October 2000.
Mylotarg was not compared to any other treatment in any of the studies.
The active substance in Mylotarg, gemtuzumab ozogamicin, is a cytotoxic(cell-killing) substance that is linked to a monoclonal antibody.
Mylotarg contains the active substance gemtuzumab ozogamicin.
The active substance in Mylotarg, gemtuzumab ozogamicin, consists of two parts: a cytotoxic(cellkilling) substance and a monoclonal antibody(a type of protein).
MYLOTARG 5 mg powder for concentrate for solution for infusion gemtuzumab ozogamicin.
Mylotarg was designated as an orphan medicinal product on 18 October 2000 for acute myeloid leukaemia.
Mylotarg was expected to be used to treat acute myeloid leukaemia, a type of cancer of the white blood cells.
Mylotarg infusions must be given in a place(such as a hospital) where the patient can be resuscitated if there are severe reactions.
Mylotarg is used in patients with a protein called CD33 on their cancer cells(which is the case in most patients with AML).
The effects of Mylotarg were studied in three main studies involving a total of 277 patients with CD33-positive acute myeloid leukaemia, whose disease had come back after one previous course of treatment.