ETOPOPHOS Pdr for Soln for Injection 100 Milligram
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
07-05-2024
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Ingredient activ:
ETOPOSIDE PHOSPHATE
Disponibil de la:
Bristol-Myers Squibb Pharmaceuticals Ltd
Dozare:
100 Milligram
Forma farmaceutică:
Pdr for Soln for Injection
Data de autorizare:
1996-10-10
Caracteristicilor produsului
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etopophos 100mg Powder for Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains etoposide phosphate equivalent to 100mg etoposiode.
Each vial also contains 7.64 mg (0.33mmol) sodium.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white lyophilised powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Etopophos is an anti-neoplastic drug for intravenous use, which can be used alone or in combination with other
cytotoxic drugs.
Present data indicate that Etopophos is applicable in the therapy of: small cell lung cancer, resistant non-seminomatous
testicular carcinoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Etopophos should be administered intravenously. The usual dose for etoposide is 50 to 100 mg/m2/day, days 1 to 5 or
100 mg/m2, days 1, 3, and 5 every 3 to 4 weeks in combination with other drugs indicated in the disease to be treated.
Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the
effects of prior radiation therapy or chemotherapy, which may have compromised bone marrow reserve. Etopophos
may be infused over 5 minutes to 3.5 hours.
In patients with impaired renal function, the following initial dose modification should be considered based on
measured creatinine clearance:
Subsequent dosing should be based on patient tolerance and clinical effect. Data are not available in patients with
creatinine clearance <15 ml/min and further dose reductions should be considered in these patients.
As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of
Etopophos. Skin reactions as
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