Uromitexan 100mg/ml Solution for Injection or Infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Mesna

Dostopno od:

Baxter Holding B.V.

Koda artikla:

V03AF; V03AF01

INN (mednarodno ime):

Mesna

Odmerek:

100 milligram(s)/millilitre

Farmacevtska oblika:

Solution for injection/infusion

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

Detoxifying agents for antineoplastic treatment; mesna

Status dovoljenje:

Marketed

Datum dovoljenje:

1996-09-25

Lastnosti izdelka

Health Products Regulatory Authority
22 October 2019
CRN009233
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Uromitexan 100mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mesna 100 mg/ml
Each 4 ml ampoule contains 400 mg mesna
Each 10 ml ampoule contains 1 g mesna
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.(Oral solution)
Clear, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention of urothelial toxicity including haemorrhagic
cystitis, microhaematuria and macrohaematuria in patients
treated with ifosfamide and cyclophosphamide, in doses considered to
be urotoxic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Sufficient mesna must be given to adequately protect the patient from
the urotoxic effects of the oxazaphosphorine.
The duration of mesna treatment should equal that of the
oxazaphosphorine treatment plus the time taken for the urinary
concentration of oxazaphosphorine metabolites to fall to non-toxic
levels. This usually occurs within 8-12 hours after the end
of oxazaphosphorine treatment but may vary depending on the scheduling
of oxazaphosphorine. Urinary output should be
maintained at 100 ml/hr (as required for oxazaphosphorine treatment)
and the urine monitored for haematuria and proteinuria
throughout the treatment period.
Parenteral drug products should be inspected visually for particulate
matter and discolouration prior to administration.
Any solutions which are discoloured, hazy, or contain visible
particulate matter should not be used.
Where ifosfamide or cyclophosphamide is used as an iv bolus: Mesna is
given by intravenous injection over 15-30 minutes at
20% of the simultaneously administered oxazaphosphorine on a weight
for weight basis (w/w). The same dose of mesna is
repeated after 4 and 8 hours. The total dose of mesna is 60% (w/w) of
the oxazaphosphorine dose. This is repeated on each
occasion that the cytotoxic agents a