MESNA-CLARIS mesna 400 mg/4 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mesna, Quantity: 100 mg/mL

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

Mesna

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

25 ampoules, 10 ampoules, 5 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Clear colourless aqueous solution free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-08-01

Patient Information leaflet

MESNA-CLARIS INJ
(mesna)
Consumer Medicine Information
MESNA-CLARIS INJ CMI
060405
Page
1
of
4
Baxter
MESNA-CLARIS
_Mesna_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Mesna-Claris. 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 Mesna-
Claris 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 MESNA-CLARIS IS USED FOR
Mesna –Claris 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.
Mesna-Claris can help prevent this.
Your doctor may have prescribed Mesna-Claris for another reason. Ask
your doctor if you have any
questions about why Mesna-Claris has been prescribed for you.
Mesna-Claris is not
addictive.
This medicine is available only with a doctor’s prescription
.
BEFORE YOU ARE GIVEN MESNA-CLARIS
_WHEN YOU MUST NOT BE GIVEN MESNA-CLARIS _
DO NOT HAVE MESNA-CLARIS IF YOU HAVE AN ALLERGY TO MESNA OR ANY
RELATED PRODUCTS (THIOLS), OR TO ANY
OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction to Mesna-Claris 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 lightheadedness
•
fast heart beat
IF YOU ARE NOT SURE WHETHER YOU SHOULD START HAVING MESNA-CLARIS, TALK
TO YOUR DOCTOR OR
PHARMACIST.
_BEFORE YOU ARE GIVEN IT _
Tell your doctor or pharmacist if you have allergies to:
•
any other medicines
•

Summary of Product characteristics

PRODUCT INFORMATION
MESNA-CLARIS
Claris Lifesciences Australia Pty Ltd
NAME OF THE MEDICINE
Mesna 200 mg/2 mL, 400 mg/4 mL and 1000 mg/10 mL, concentrated
solution for infusion.
The chemical name of mesna is sodium 2-sulfanylethanesulfonate.
The CAS number is 19767-45-4
The empirical formula is C
2
H
5
NaO
3
S
2
The molecular weight is 164.2
DESCRIPTION
Mesna is a white or slightly yellow, hygroscopic crystalline powder.
It is freely soluble in water,
slightly soluble in alcohol and practically insoluble in cyclohexane.
M e s n a - C l a r i s is a c l e a r , c o l o u r l e s s ,
sterile, aqueous solution for intravenous
administration. M e s n a - C l a r i s contains 100 mg/mL mesna,
edetate disodium, sodium
hydroxide for pH adjustment and water for injections. The solution has
a pH range of 6.50 -7.30.
PHARMACOLOGY
Mesna was developed as a prophylactic agent to prevent and reduce the
urothelial
toxicity
(haemorrhagic cystitis) induced by oxazaphosphorine alkylating
agents such as ifosfamide or
cyclophosphamide.
Analogous to the physiological cysteine-cystine system, following
intravenous
administration,
mesna is rapidly and easily converted by autoxidation to its only
metabolite, disodium 2,2’-
dithio-bisethane sulphonate (mesna disulphide, dimesna) forming a
disulphide link. Following
I.V. injection, only a small portion of the administered dose is
detected in the blood as a
reduced thiol compound (mesna). Mesna disulphide remains in the
intravascular space and
is rapidly delivered to the kidney. In the renal tubular epithelium a
considerable proportion
of mesna disulphide
is again reduced to a free thiol compound, presumably mediated by
glutathione reductase. Acrolein or other urotoxic oxazaphosphorine
metabolites are detoxified
by chemical reaction with the free thiol compound i.e. mesna.
The first and most important step towards detoxification is the
reaction of mesna with
the
double bond of acrolein, resulting in the formation of a stable
thioether which can be detected
in the urine by chromatography.