Examples of using Mifamurtide in English and their translations into Finnish
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It contains the active substance mifamurtide.
Mifamurtide was not mutagenic and did not cause teratogenic effects in rats and rabbits.
One vial contains 4 mg mifamurtide.
Mifamurtide is, therefore, not expected to interact with the metabolism of substances that are hepatic cytochrome P450 substrates.
Each ml reconstituted suspension contains 0.08 mg mifamurtide.
These data indicate that neither total nor free mifamurtide accumulated during the treatment period.
Powder for concentrate for dispersion for infusion 4 mg mifamurtide.
Anaemia has very commonly been reported when mifamurtide is used in conjunction with chemotherapeutic agents.
After reconstitution, each ml suspension in the vial contains 0.08 mg mifamurtide.
Mifamurtide treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of osteosarcoma.
Hyperhidrosis(11%) was very common in patients receiving mifamurtide in uncontrolled studies.
One patient in the phase III study experienced 2 episodes of Grade 4 seizure while on study therapy with chemotherapy and mifamurtide.
Mifamurtide is not recommended for use during pregnancy and in women of childbearing potential not using effective contraception.
Mepact should not be used in people who may be hypersensitive(allergic) to mifamurtide or any of the other ingredients.
The exact mechanism by which mifamurtide activation of monocytes and macrophages leads to antitumour activity in animals and humans is not yet known.
One serious incident of subacute thrombosis was reported in early studies, butno serious cardiac events were associated with mifamurtide in a large randomised controlled study see section 4.4.
Because mifamurtide acts through stimulation of the immune system, the chronic or routine use of corticosteroids should be avoided during treatment with mifamurtide. .
Continued monitoring of the kidney and liver function is recommended if mifamurtide is used beyond completion of chemotherapy until all therapy is completed.
The precise way that mifamurtide works in osteosarcoma is not fully understood, but it is thought to cause the white blood cells to release chemicals that kill the cancerous cells.
In 28 osteosarcoma patients aged 6 to 39 years serum total(liposomal and free) mifamurtide concentrations declined rapidly with a mean half-life of 2.04± 0.456 hours.
Mifamurtide was studied as a single agent in 248 patients with mostly advanced malignancies during the early, single arm phase I and II clinical studies.
In vitro interaction studies showed that liposomal and non-liposomal mifamurtide do not inhibit the metabolic activity of cytochrome P450 in pooled human liver microsomes.
An osteosarcoma patient in a phase II study who had high creatinine level at enrolment showed an increase in blood urea andblood creatinine which was associated with mifamurtide use.
Liposomal and non-liposomal mifamurtide do not induce the metabolic activity or the transcription of cytochrome P450 in primary cultures of freshly isolated human hepatocytes.
At 6 hours after injection of radiolabelled liposomes containing 1 mg mifamurtide, radioactivity was found in liver, spleen, nasopharynx, thyroid, and, to a lesser extent, in lung.
Mifamurtide significantly increased the overall survival of patients with newly-diagnosed resectable high-grade osteosarcoma when used in conjunction with combination chemotherapy when compared to chemotherapy alone.
Data from a six month dog study of daily intravenous injections of up to 0.5 mg/kg(10 mg/m2) mifamurtide provide an 8- to 19-fold cumulative exposure safety margin for overt toxicity for the intended clinical dose in humans.
As no pharmacokinetic data of mifamurtide is available in patients with severe renal or hepatic impairment, caution when administering mifamurtide to these patients is recommended.
Gastrointestinal disorders were frequently associated with mifamurtide administration, including nausea(57%) and vomiting(44%) in about half of patients, constipation(17%), diarrhoea(13%) and abdominal pain see section 4.4.
In 21 healthy adult subjects mifamurtide was cleared rapidly from serum(minutes)with a half-life of 2.05± 0.40 hours, resulting in a very low serum concentration of total(liposomal and free) mifamurtide.