Uromitexan 100mg/ml Solution for Injection or infusion (10ml ampoule)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MESNA

Available from:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC code:

V03AF01

INN (International Name):

MESNA 100 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

MESNA 100 mg/ml

Prescription type:

POM

Therapeutic area:

ALL OTHER THERAPEUTIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2007-03-02

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
UROMITEXAN 100 MG/ML SOLUTION FOR INJECTION OR INFUSION
(MESNA)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, nurse or
pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
Throughout this leaflet, UROMITEXAN 100 mg/ml Solution for Injection
or infusion will be called
UROMITEXAN.
WHAT IS IN THIS LEAFLET:
1. What UROMITEXAN is and what it is used for
2. What you need to know before you are given UROMITEXAN
3. How UROMITEXAN is given
4. Possible side effects
5. How UROMITEXAN is stored
6. Contents of the pack and other information
1 WHAT UROMITEXAN IS AND WHAT IT IS USED FOR
The name of your medicine is UROMITEXAN.
UROMITEXAN is used to help reduce and prevent bleeding in the bladder
(haemorrhagic
cystitis) caused by cyclophosphamide and ifosfamide. UROMITEXAN helps
to protect the lining of
the bladder from damage caused by these two drugs. The body breaks
down these two drugs to form
products that can harm the bladder. UROMITEXAN works by helping to
make these breakdown
products less harmful. UROMITEXAN should only be given when you are
also given
cyclophosphamide or ifosfamide.
The damage to your bladder may show up as blood in your urine. Very
small amounts of blood
may not be seen, so your doctor or nurse will test your urine with a
‘dipstick’ or microscope to
check for blood. If a larger amount of blood is in your urine, you
will notice that it is red and very
occasionally you may be able to see blood clots in it.
2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN UROMITEXAN
YOU WILL NOT BE GIVEN UROMITEXAN IF:
•
yo

Summary of Product characteristics

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Uromitexan 100 mg/ml Solution for Injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mesna 100 mg/ml.
Each 4ml ampoule contains 400 mg mesna.
Each 10ml 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
are used.
Page 2 of 13
Example dosage schedule:
0 hrs