UROMITEXAN 400mg/4mL injection ampoule

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

mesna, Quantity: 100 mg/mL

Boleh didapati daripada:

Baxter Healthcare Pty Ltd

Borang farmaseutikal:

Injection, concentrated

Komposisi:

Excipient Ingredients: disodium edetate; sodium hydroxide; water for injections

Laluan pentadbiran:

Intravenous

Unit dalam pakej:

15 x 4mL

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

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

Ringkasan produk:

Visual Identification: A clear colourless solution; Container Type: Ampoule; Container Material: Glass; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Status kebenaran:

Registered

Tarikh kebenaran:

1993-10-21

Risalah maklumat

UROMITEXAN INJ (mesna)
Consumer Medicine Information
UROMITEXAN INJ CMI 060405
Page 1 of 4
Baxter
UROMITEXAN INJECTION
_Mesna _
CONSUMER MEDICINE INFORMATION_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
UROMITEXAN Injection.
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 being
given UROMITEXAN Injection
against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT HAVING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET IN A SAFE
PLACE.
You may need to read it again.
WHAT UROMITEXAN
INJECTION IS USED FOR
UROMITEXAN Injection 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 Injection can
help prevent this.
Your doctor may have
prescribed UROMITEXAN
Injection for another reason.
Ask your doctor if you have any
questions about why
UROMITEXAN Injection has
been prescribed for you.
Your doctor may decide to give
you some of your doses in the
form of UROMITEXAN Tablets
instead of UROMITEXAN
Injection. Both work just as
well.
UROMITEXAN Injection is not
addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
UROMITEXAN INJECTION
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT HAVE UROMITEXAN
INJECTION IF YOU HAVE AN
ALLERGY TO UROMITEXAN
INJECTION 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
Injection 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 lightheadedn

Ciri produk

Uromitexan (Mesna) Injection
Version 1.1
1 of 12
AUSTRALIAN PRODUCT INFORMATION –
UROMITEXAN (MESNA) INJECTION
1
NAME OF THE MEDICINE
Mesna.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: mesna 100 mg/mL
The active ingredient, mesna, is a synthetic sulphydryl compound
designated as sodium 2-
mercapto-ethane sulphonate.
Uromitexan contains 100 mg/mL mesna, 0.2 - 0.3 mg/mL edetate disodium
and sodium
hydroxide for pH adjustment. The solution has a pH range of 6.5 - 8.5.
Excipients: Disodium edetate, sodium hydroxide and water for
injections.
3
PHARMACEUTICAL FORM
Uromitexan is a sterile preservative-free aqueous solution of clear
and colourless appearance
in clear glass ampoules for intravenous administration.
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 urothelial toxic
effects of the oxazaphosphorine. When calculating the dose of mesna,
the quantity should be
rounded up to the nearest whole ampoule.
Parenteral drug products should be inspected visually for particulate
matter and discolouration
prior to administration. Any solutions which are discoloured or
contain visible particulate
matter should not be used.
Mesna injection should be administered intravenously only, over 15 -
30 minutes, usually at
20% of the respective oxazaphosphorine dose, at each of the times 0 (=
administration of the
cytostatic agent), 4 hours and 8 hours. The total dose of mesna is 60%
of the oxazaphosphorine
dose and is repeated on each occasion that the cytotoxic agents are
used.
Preparation - For intravenous administration. The drug can be diluted
by adding the contents
of a Uromitexan ampoule to any of the following fluids obtaining final
concentrations of 1.5
to 3 mg mesna/mL