MESNA-CELL 100 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MESNA

Available from:

MBI PHARMA LTD., ISRAEL

ATC code:

V03AF01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

MESNA 100 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

STADAPHARM GMBH, GERMANY

Therapeutic area:

MESNA

Therapeutic indications:

Prevention of urinary tract toxicity of oxazaphosphorines (ifosfamide, cyclophosphamide or trofosfamide) in particular patients at risk. Risks are in particular previous radiation therapy in the area of the true pelvis, cystitis following previous therapy with ifosfamide, cyclophosphamide or trofosfamide and a history of uropathy.

Authorization date:

2020-06-30

Summary of Product characteristics

THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH
AND ITS CONTENT WAS
CHECKED AND APPROVED BY IT ON 07.2015
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MESNA-cell
®
400 mg solution for injection
Active substance: Mesna
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ampoule with 4 ml solution contains 400 mg mesna (100 mg/ml).
Excipient with known effect: 1 ml solution contains 14.3 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution, free from particles
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of urinary passage toxicity of oxazaphosphorines (the
active components of
Ifosfamide , Cyclophosphamide, Trofosamide), in particular in
high-risk patients
with previous radiation therapy in the area of the lesser pelvis,
cystitis with previous
Ifosfamide, Cyclophosphamide or Trofosamide , urinary passage diseases
in anamnesis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Unless otherwise prescribed, MESNA-cell
®
is usually administered in adults intravenously at
time 0 (time of oxazaphosphorine administration), after 4 hours and
after 8 hours, with each
dose being 20% of the oxazaphosphorine dose.
Example of MESNA-cell
®
administration in oxazaphosphorine injection:
Hours
(Time)
0
(8 a.m.)
4
(12 a.m.)
8
(4 p.m.)
Oxazaphosphorine dose
40 mg/kg BW
--
--
Mesna dose
8 mg/kg BW
8 mg/kg BW
8 mg/kg BW
Therapeutic
experience
in
children
has
shown
that
a
more
frequent
(e.g.
six
times)
administration at shorter intervals (e.g. 3 hours) is useful.
In the case of continuous infusions of ifosfamide, it has proven
effective to administer a
mesna bolus injection (20% of the ifosfamide dose) at time 0 (start of
infusion) and to add
MESNA-cell
®
to the continous infusion at a dose of up to 100% of the ifosfamide
dose. To
maintain the uroprotection after the end of the ifosfamide infusion, a
mesna dose equivalent
to up to 50 % of the ifosfamide dose should be given for further 6 -
12 hours.
Exampl