UROMITEXAN 400 mg injection

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

UROMITEXAN 400 mg injection

COMPOSITION:
Per 1 mL:
Mesna (2-mercaptoethanesulphonate sodium (100 mg)

PHARMACOLOGICAL CLASSIFICATION:
A 18 Medicines acting on genital-urinary system

PHARMACOLOGICAL ACTION:
UROMITEXAN (Mesna) may reduce lesions of the urinary bladder mucosa by binding to reactive metabolites of the oxazaphosphorines; MESNA is excreted as free thiol in the urine and the total urinary excretion is 59,1 per cent after four hours. Therefore it is excreted, with an elimination half life of about one hour, more quickly than oxazaphosphorines and their reactive metabolites.

INDICATIONS:
UROMITEXAN (Mesna) is an aid in the reduction of toxicity in the urinary passages caused by oxazaphosphorines (Endoxan, Holoxan).

CONTRA-INDICATIONS:
No hypersensitivity interactions have been reported with doxorubicin, BCNU, methotrexate and vincristine.

WARNINGS:
The protective effect of Mesna is restricted to the urinary passages. All other prophylactic measures and concomitant therapy recommended for oxazaphosphorine treatment are not affected and should be continued as before.

DOSAGE AND DIRECTIONS FOR USE:
Unless otherwise prescribed UROMITEXAN (Mesna) should be injected intravenously at a dosage of 20 per cent of the oxazaphosphorine doses, at the times 0 hours (i.e. concurrently with the oxazaphosphorines), four hours and eight hours thereafter.

Example
  08h00 12h00 16h00
Oxazaphosphorine (Endoxan, Holoxan) 2 000 mg – –
Uromitexan 400 mg (4 mL)  400 mg (4 mL)  400 mg (4 mL)

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Single doses above 60 mg per kg body mass cause nausea, vomiting, diarrhoea, fatigue, pain in the legs, arthralgia and hypersensitivity reactions.
A false positive test for ketone bodies may arise during treatment with Mesna. However, the colour is usually red-violet, rather than violet, less stable, and disappears immediately after the addition of glacial acetic acid.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, colourless liquid in a 5 mL clear glass ampoule with double colour coding; upper ring blue; lower ring green

PRESENTATION:
Ampoules
15 x 5 mL ampoules containing 400 mg per 4 mL
50 x 5 mL ampoules containing 400 mg per 4 mL

STORAGE INSTRUCTIONS:
Store below 25°C
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
S/18/306

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
NORISTAN LIMITED
326 MARKS STREET, WALTLOO, PRETORIA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 November 1989

NORISTAN LABORATORIES
Division of
NORISTAN LIMITED, WALTLOO, PRETORIA
Under Licence to SATA Pharma AG, Frankfurt, Germany