Treosulfan Powder for Solution for Injection or Infusion 5 g

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Treosulfan

Available from:

Medac Gesellschaft fur Klinische Spezialpraparate mbH

ATC code:

L01AB; L01AB02

INN (International Name):

Treosulfan

Dosage:

5 gram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Alkyl sulfonates; treosulfan

Authorization status:

Not marketed

Authorization date:

1984-03-05

Patient Information leaflet

Treosulfan · 80310-VBIL · BA · 04.17 · Pharma-Code: 452
Format: 444 x 150 mm · HKS 44 · Corrective action: KV01_osc_27.04.16
/ KV02_osc_18.11.16 / KV03_osc_07.04.17
PACKAGE LEAFLET: INFORMATION FOR THE USER
TREOSULFAN
POWDER FOR SOLUTION FOR INJECTION OR INFUSION 5 G
Treosulfan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE
GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Treosulfan Powder for Solution for Injection or
Infusion 5 g is and what it is used for
2. What you need to know before you are given
Treosulfan Powder for Solution for Injection or
Infusion 5 g
3. How you are given Treosulfan Powder for Solution for
Injection or Infusion 5 g
4. Possible side effects
5. How to store Treosulfan Powder for Solution for
Injection or Infusion 5 g
6. Contents of the pack and other information
1.
WHAT TREOSULFAN POWDER FOR SOLUTION FOR INJECTION OR
INFUSION 5 G IS AND WHAT IT IS USED FOR
Treosulfan belongs to the group of anticancer medicines
called bifunctional alkylating agents. These agents inhibit
tumour growth.
Treosulfan has been prescribed by your doctor for the
treatment of ovarian cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TREOSULFAN
POWDER FOR SOLUTION FOR INJECTION OR INFUSION 5 G
YOU ARE NOT GIVEN TREOSULFAN POWDER FOR SOLUTION FOR
INJECTION OR INFUSION 5 G
• if you are allergic to treosulfan.
• if you do not have enough blood cells (severe bone
marrow depression).
Before each administration, you will have blood tests to
check that you have enough blood cells to receive treosulfan.
WARNINGS AND PRECAUTIONS
Tal

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Treosulfan Powder for Solution for Injection or Infusion 5 g
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 5 g of treosulfan, intended for reconstitution with
100 ml water for injection resulting in a 50 mg/ml
solution.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
A white crystalline odourless powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treosulfan is indicated for the palliative treatment of epithelial
ovarian cancer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage of treosulfan as monotherapy is 8 g/m² in patients who
have not undergone previous chemotherapy. The
dose should be reduced to 6 g/m² or less in patients with risk
factors such as pre-treatment with myelosuppressive
agents or radiotherapy and reduced performance status.
The therapy should be repeated every three to four weeks.
In combination with cisplatin, treosulfan should be dosed at 5 g/m²,
with cycles repeated every 3
-
4 weeks.
_Duration of treatment_
In general, 6 courses of treatment with treosulfan are given.
In the case of a progressive clinical picture and/or occurrence of
non-tolerable adverse events, the treatment must be
stopped.
_Dose modification_
If, following administration of treosulfan, the white cell count falls
below 1,000/µl and/or the platelet count falls below
25,000/µl, the following dose must be reduced by 1 g/m².
Treatment should not be given if the white blood cell count is less
than 3,500/µl or the thrombocyte count less than
100,000/µl after three weeks.
A repeat blood count should be made after a week interval, when
treatment may be restarted if haematological parameters
are satisfactory. If the values after this are still unchanged, the
treosulfan dose must be reduced to 6 g/m² in case of
monotherapy and to 3 g/m² in combination with cisplatin.
If during treatment the white cell count does not fall below 3,500/µl
and/or the platelet count does not fall below
100,000/µl, the dos