Paxene
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
22-03-2010
Karatteristiċi tal-prodott
(SPC)
22-03-2010
Rapport ta 'Valutazzjoni Pubblika
(PAR)
22-03-2010
Ingredjent attiv:
paclitaxel
Disponibbli minn:
Norton Healthcare Ltd.
Kodiċi ATC:
L01CD01
INN (Isem Internazzjonali):
paclitaxel
Grupp terapewtiku:
Antineoplastic agents
Żona terapewtika:
Sarcoma, Kaposi; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Breast Neoplasms
Indikazzjonijiet terapewtiċi:
Paxene is indicated for the treatment of patients with:• advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy;• metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy;• advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment;• metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment;• non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. Limited efficacy data supports this indication (see section 5.1).
Sommarju tal-prodott:
Revision: 14
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
1999-07-19
Fuljett ta 'informazzjoni
B. PACKAGE LEAFLET
32
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
PAXENE 6 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Paclitaxel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE:
-
Keep this leaflet safe as you may need to read it again.
-
If you have further questions, please ask your doctor or your
pharmacist.
-
This medicine has been prescribed for you personally and you should
not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
-
If any of the
side effects gets serious, or if you notice any side effects not
listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Paxene is and what it is used for
2.
Before you use Paxene
3.
How to use Paxene
4.
Possible side effects
5
How to store Paxene
6.
Further information
1.
WHAT PAXENE IS AND WHAT IT IS USED FOR
Paxene belongs to a group of medicines known as antineoplastic agents.
These agents are used to treat
cancer.
_ _
Paxene concentrate for solution for infusion is used to treat:
•
Advanced AIDS-related Kaposi’s sarcoma when certain other treatments
(liposomal
anthracyclines) have been tried but have not worked. This is a tumour
that arises from blood
vessels in the skin or internal organs and typically appears as flat
or raised, purple to dark brown
patches on the skin.
•
Advanced breast cancer when certain other treatments (standard
anthracycline-containing
therapy) have been tried but have not worked or when the patient is
unsuitable for these
treatments.
•
Advanced ovarian cancer or remaining tumour (> 1 cm) after initial
surgery, in combination
with cisplatin as first-line treatment.
•
Advanced ovarian cancer when certain other treatments
(platinum-containing combination
therapy without taxanes) have been tried but have not worked (as
second-line treatment).
•
Advanced non-small cell lung cancer if potentially curative surgery
and/or radiation therapy are
not possible, in combination with cisplatin. There is limited
inf
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Karatteristiċi tal-prodott
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Paxene 6 mg/ml concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 6 mg/ml of paclitaxel (30 mg of paclitaxel in 5 ml
or 100 mg of paclitaxel in 16.7 ml
or 150 mg of paclitaxel in 25 ml or 300 mg of paclitaxel in 50 ml).
Excipients
One vial contains polyoxyl castor oil: 527 mg/ml and ethanol
anhydrous; 49.7 v/v%
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to slightly yellow, viscous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paxene
is indicated for the treatment of patients with:
–
advanced AIDS-related Kaposi’s sarcoma (AIDS-KS) who have failed
prior liposomal
anthracycline therapy;
–
metastatic carcinoma of the breast (MBC) who have failed, or are not
candidates for standard
anthracycline-containing therapy;
–
advanced carcinoma of the ovary (AOC) or with residual disease (
>
1 cm) after initial
laparotomy, in combination with cisplatin as first-line treatment;
–
metastatic carcinoma of the ovary (MOC) after failure of
platinum-containing combination
therapy without taxanes as second-line treatment;
–
non-small cell lung carcinoma (NSCLC) who are not candidates for
potentially curative surgery
and/or radiation therapy, in combination with cisplatin. Limited
efficacy data supports this
indication (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Paxene should only be administered under the supervision of a
qualified oncologist in units specialised
in the administration of cytotoxic agents (see section 6.6).
All patients must be pre-medicated with corticosteroids,
antihistamines and H
2
antagonists prior to
Paxene. The following is a recommended pre-medication regimen:
dexamethasone (8 - 20 mg) given
orally (12 and 6 hours) or intravenously (30 - 60 mins) prior to
Paxene, chlorpheniramine 10 mg
intravenously or an equivalent ant
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