UROMITEXAN mesna 600mg tablet blister pack

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

mesna, Quantity: 600 mg

Mevcut itibaren:

Baxter Healthcare Pty Ltd

Farmasötik formu:

Tablet, film coated

Kompozisyon:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; calcium hydrogen phosphate dihydrate; maize starch; povidone; magnesium stearate; hypromellose; macrogol 6000; titanium dioxide; simethicone

Uygulama yolu:

Oral

Paketteki üniteler:

50 tablets, 10 tablets, 20 tablets

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

For the reduction and prevention of urinary tract toxicity (haemorrhagic cystitis) of oxazaphosphorines (see Adverse Effects section of the cyclophosphamide and ifosfamide Product Information)

Ürün özeti:

Visual Identification: White, oblong, biconvex, film-coated tablet, scored on one side, marked M6; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

1996-08-28

Bilgilendirme broşürü

UROMITEXAN TAB (mesna)
Consumer Medicine Information
UROMITEXAN TAB CMI 060405
Page 1 of 4
Baxter
UROMITEXAN TABLETS
_Mesna _
CONSUMER MEDICINE INFORMATION_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
UROMITEXAN Tablets.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
UROMITEXAN Tablets against
the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT UROMITEXAN TABLETS
IS USED FOR
UROMITEXAN Tablets is a
protective agent which is used to
prevent damage to your bladder
and urinary system, that may be
caused by some drugs used to
treat cancer or auto-immune
diseases. These drugs can cause
a condition of the bladder, with
pain in the bladder or back and
blood in the urine.
UROMITEXAN Tablets can
help prevent this.
Your doctor may have
prescribed UROMITEXAN
Tablets for another reason. Ask
your doctor if you have any
questions about why
UROMITEXAN Tablets has
been prescribed for you.
Your doctor may decide to give
you some of your doses in the
form of UROMITEXAN
Injection instead of
UROMITEXAN Tablets. Both
work just as well.
UROMITEXAN Tablets is not
addictive.
This medicine is available only
with a doctor‟s prescription.
BEFORE YOU TAKE
UROMITEXAN TABLETS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE UROMITEXAN
TABLETS IF YOU HAVE AN ALLERGY
TO UROMITEXAN TABLETS OR
ANY RELATED PRODUCTS (THIOLS),
OR TO ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Symptoms of an allergic
reaction to UROMITEXAN
Tablets may include:

shortness of breath,
wheezing, difficulty
breathing or a tight feeling in
your chest

swelling of the face, lips,
tongue or other parts of the
body

rash, itching, hives or
flushed, red skin

dizziness or light-headedness

fast heart beat
DO NOT TAKE U

Ürün özellikleri

Uromitexan (Mesna) Tablet
Version 1.1
1 of 13
AUSTRALIAN PRODUCT INFORMATION –
UROMITEXAN (MESNA) TABLET
1
NAME OF THE MEDICINE
Mesna.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient, mesna, is a synthetic sulphydryl compound
designated as sodium 2-
mercapto-ethane sulphonate.
Excipients: Calcium hydrogen phosphate, cellulose microcrystalline,
hypromellose, lactose,
Macrogol
6000,
magnesium
stearate,
povidone,
simethicone,
starch-maize
and
titanium
dioxide.
3
PHARMACEUTICAL FORM
Uromitexan tablets are white, oblong, biconvex film-coated tablets,
scored on one side and
marked “M 4” or “M 6”, containing 400 mg or 600 mg
(respectively) of mesna.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For
the
reduction
and
prevention
of
urinary
tract
toxicity
(haemorrhagic
cystitis)
of
oxazaphosphorines (see section 4.8 Adverse Effects (Undesirable
Effects) sections of the
cyclophosphamide and ifosfamide Product Information).
4.2
DOSE AND METHOD OF ADMINISTRATION
Sufficient mesna must be given to protect the patient adequately 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. When calculating the dose of mesna, the quantity
should be rounded down
to the nearest whole tablet. 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.
_FOR INTERMITTENT OXAZAPHOSPHORINE THERAPY _
Oral mesna, 40% (w/w) of the oxazaphosphorine dose, should be given 2
hours prior to the
oxazaphosphorine
dose,
and
repeated
at
2
and
at
6
hours
after
oxazaphosphorine
administration. Alternatively,
an initial intravenous dose of mesna (20% (w/w) of the
oxazaphosphorin