Examples of using Dacogen in English and their translations into German
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Colloquial
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Official
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Ecclesiastic
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Medicine
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Financial
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Ecclesiastic
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Political
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Computer
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Programming
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Official/political
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Political
What is Dacogen?
How Dacogen is given.
Other medicines and Dacogen.
Dacogen contains potassium and sodium.
Myelosuppression caused by Dacogen is reversible.
Your doctor, nurse or pharmacist is responsible for storing Dacogen.
Dacogen administration must be initiated under the supervision of physicians experienced in the use of chemotherapeutic agents.
In clinical studies, approximately one-third of patients receiving Dacogen required a dose-delay.
Dacogen was administered as a 1-hour intravenous infusion of 20 mg/m2 once daily for 5 consecutive days repeated every 4 weeks.
The most common adverse drug reactions(≥ 35%)reported during treatment with Dacogen are pyrexia, anaemia and thrombocytopaenia.
Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia(AML), a type of cancer affecting the white blood cells.
Talk to your doctor or nurse if you have any questions about how Dacogen works or why this medicine has been prescribed for you.
If you are not sure if any of the above applies to you, talk to your doctor,pharmacist or nurse before using Dacogen.
Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine.
Table 3: Summary of population PK analysis for a typicalpatient receiving daily 1-hour infusions of Dacogen 20 mg/m2 over 5 days every 4 weeks.
Dacogen is contraindicated during lactation; therefore if treatment with Dacogen is required, breast-feeding must be discontinued see section 4.3.
Caution should be exercised in the administration of Dacogen to patients with hepatic impairment and patients should be monitored closely see sections 4.2 and 5.2.
Myelosuppression and complications of myelosuppression, including infections andbleeding that occur in patients with AML may be exacerbated with Dacogen treatment.
The most commonly reportedhaematologic adverse drug reactions associated with Dacogen treatment included febrile neutropaenia, thrombocytopaenia, neutropaenia, anaemia and leukopaenia.
As it is not known whether the active substance is excreted in breast milk, in the event that a patient is breastfeeding,they must discontinue breastfeeding if they require treatment with Dacogen.
In the presence of myelosuppression or its complications, treatment with Dacogen may be interrupted and/or supportive measures instituted see sections 4.2 and 4.8.
Treatment with Dacogen may be resumed once these conditions have improved or have been stabilised with adequate treatment anti-infective therapy, transfusions, or growth factors.
In an analysis with an additional 1 year of mature survival data, the effect of Dacogen on overall survival demonstrated a clinical improvement compared to the TC arm 7.7 months vs.
Dacogen was compared with either supportive care(any medicine or technique to help patients, excluding cancer medicines or surgery) or low-dose cytarabine another cancer medicine.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dacogen have been included in the summary of product characteristics and the package leaflet.
Caution should be exercised in the administration of Dacogen to patients with severe renal impairment(Creatinine Clearance[CrCl]< 30 ml/min) and these patients should be monitored closely see section 4.2.
Patients with a history of severe congestive heart failure or clinically unstable cardiac disease were excluded from clinical studies andtherefore the safety and efficacy of Dacogen in these patients has not been established.
In a treatment cycle, Dacogen is administered at a dose of 20 mg/m2 body surface area by intravenous infusion over 1 hour repeated daily for 5 consecutive days i.e., a total of 5 doses per treatment cycle.
In clinical studies, 30% of patients treated with Dacogen and 25% of patients treated in the comparator arm had adverse events with an outcome of death during treatment or within 30 days after the last dose of study drug.
Dacogen(n 242) was compared to treatment choice(TC, n 243) which consisted of patient's choice with physician's advice of either supportive care alone(n 28, 11.5%) or 20 mg/m2 cytarabine subcutaneously once daily for 10 consecutive days repeated every 4 weeks n 215, 88.5.