MUPHORAN POWDER & SOLVENT FOR INFUSION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FOTEMUSTINE

Available from:

MEDILINE LTD.

ATC code:

L01AD05

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

FOTEMUSTINE 208 MG / 4 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

CENEXI - LABORATOIRES THISSEN SA., BELGIUM

Therapeutic group:

FOTEMUSTINE

Therapeutic area:

FOTEMUSTINE

Therapeutic indications:

Disseminated malignant melanoma.

Authorization date:

2010-03-31

Summary of Product characteristics

This leaflet format has been determined by the Ministry of Health and
the content has been checked and approved in March 2010.
Physician Package Insert
=======================================
MUPHORAN
®
———————————————————————
POWDER AND SOLVENT FOR INFUSION
1. NAME OF THE MEDICINAL PRODUCT
MUPHORAN
Powder and solution to be diluted for parenteral use (infusion).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Powder:
Fotemustine
.....................................................................
208.00 mg
for one vial
Solvent:
96 percent (v/v) ethyl alcohol
................................................ 3,35 ml
Water for injections
...................................................... q.s.f. 4,00 ml
for an ampoule
The reconstituted solution represents a volume of 4.16 ml, i.e. 200
mg of fotemustine in 4 ml of solution.
For the excipients, refer to 6.1.
3. PHARMACEUTICAL FORM
Powder and solution to be diluted for parenteral use (infusion).
4. CLINICAL DATA
4.1 THERAPEUTIC INDICATIONS
Disseminated malignant melanoma.
4.2 DOSAGE AND ADMINISTRATION
Prepare the solution immediately prior to administration.
Dissolve the contents of the fotemustine vial with the 4 ml ampoule
of sterile alcoholic solution, then after having calculated the dose
to
be injected, dilute the solution in 5 % isotonic glucose solution for
administration as an intravenous infusion.
THE SOLUTION ONCE PREPARED MUST BE PROTECTED FROM LIGHT:
Administer by intravenous infusion over a period of one hour.
- IN SINGLE AGENT CHEMOTHERAPY, the treatment consists of:
➢
Induction treatment: 3 consecutive administrations at weekly
intervals followed by a 4 to 5 week therapeutic rest period.
➢
Maintenance treatment: one administration every 3 weeks.
The usual dose is 100 mg/m
2
.
- IN COMBINATION CHEMOTHERAPy, the 3
rd
administration of the induction
treatment is cancelled. The dose remains 100 mg/m
2
.
ASSOCIATION WITH DACARBAZINE
Rare cases of pulmonary toxicity (acute adult respiratory distress
syndrome)