MESNA STADA® CONCENTRATE SOLUTION FOR INJECTION 400MG4ML

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Mesna

Dostępny od:

DCH AURIGA SINGAPORE

Kod ATC:

V03AF01

Forma farmaceutyczna:

INJECTION, SOLUTION, CONCENTRATE

Skład:

Mesna 400 mg/4 ml

Droga podania:

INTRAVENOUS

Typ recepty:

Prescription Only

Wyprodukowano przez:

Haupt Pharma Wolfratshausen GmbH

Status autoryzacji:

ACTIVE

Data autoryzacji:

2016-04-25

Charakterystyka produktu

MESNA STADA
®
400 MG/4ML CONCENTRATED SOLUTION FOR INJECTION
recommended
that
after
administration
of
20%
MESNA
Stada
(related
to
the
total
dose of oxazaphosphorine) at time 0, the
remaining calculated dose should be given
continuously IV over a period of 24 hrs with
a
perfusor.
Alternatively,
an
intermittent
bolus injection is possible: For adults 3 x
40% (at times 0, 4, 8 hrs) or 4 x 40% (at
times
0,
3,
6,
9
hrs),
respectively.
For
children due to more frequent micturition,
the bolus injections should always be given
in 3-hr intervals (eg, 20% at times 0, 1, 3, 6,
9, 12 hrs). Instead of a bolus injection, short
infusions of 15-min duration are possible.
With
a
continuous
infusion
of
ifosfamide
(Holoxan),
it
has
been
shown
to
be
of
benefit to give MESNA Stada at time zero
following the initial 20% bolus injection (start
of infusion, time 0), followed by infusion to
up to 100% of the ifosfamide dose, and to
continue uroprotection for a further 6 to 12
hours
after
termination
of
the
ifosfamide
infusion.
CONTRAINDICATIONS
Known hypersensitivity to mesna, other thiol
compounds or to any of the excipients.
As mesna is only indicated in combination
with
oxazaphosphorines,
the
contraindications
which
apply
to
cyclophosphamide,
ifosfamide
and
trofosfamide should also be observed.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The
protective
effect
of
MESNA
Stada
applies
only
to
the
urinary
tract.
Other
precautions
and
concomitant
measures
recommended
for
the
use
of
oxazaphosphorines
(ifosfamide,
cyclo-
phosphamide,
trofosfamide)
are
not
affected and should be continued.
A
false-positive
detection
of
urinary
ketones may arise during the treatment
with MESNA Stada. The colour is red-
violet rather than violet, it is less stable
and it will fade immediately on the addition
of glacial acetic acid.
This medicinal product contains less than
1 mmol sodium (23 mg) per 1ml solution
for injection.
The
occurrence
of
hypersensitivity
reactions
(hyperegic
reactions) following
MESNA Stada therapy has been reported
more
frequently
in
patie