METHOTREXATE EBEWE 100 Mg/Ml Concentrate for Soln for Inf
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
01-06-2024
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Viambatanisho vya kazi:
METHOTREXATE
Inapatikana kutoka:
Ebewe Pharma Ges.m.b.H Nfg. KG
INN (Jina la Kimataifa):
METHOTREXATE
Kipimo:
100 Mg/Ml
Dawa fomu:
Concentrate for Soln for Inf
Dawa ya aina:
Product subject to prescription which may not be renewed (A)
Idhini hali ya:
Authorised
Idhini ya tarehe:
0000-00-00
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate Ebewe 100mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 100 mg methotrexate
Each vial with 5 ml of concentrate contains 500 mg methotrexate
Each vial with 10 ml of concentrate contains 1000 mg methotrexate
Each vial with 50 ml of concentrate contains 5000 mg methotrexate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, dark yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Methotrexate is indicated in the treatment of different malignant diseases such as acute lymphatic leukaemia (ALL),
breast cancer and osteosarcoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with methotrexate should be initiated by or in consultation with a doctor with considerable experience of cytostatic
treatment.
Methotrexate 100 mg/ml is given intravenously.
Methotrexate 100 mg/ml concentrate for infusion is not suitable for intrathecal, intramuscular or intraarterial administration, as an
extreme dilution would be necessary. For these purposes a preparation with lower concentration should be used
High-dose treatment:
Methotrexate can be used at very high doses (> 1 g) in certain neoplastic conditions. Disease states that have been successfully
treated with high-dose methotrexate either alone or in combination with other cytostatics are acute lymphatic leukaemia,
osteogenic sarcoma and certain solid tumours. High-dose therapy is usually given as an infusion over 24 h.
The dose is usually calculated per m
2
body surface.
Calcium folinate rescue is necessary when methotrexate is given at doses exceeding 500 mg/m2 body surface and has to be
considered with doses of 100 m
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