Foscan
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
18-04-2016
Karatteristiċi tal-prodott
(SPC)
18-04-2016
Rapport ta 'Valutazzjoni Pubblika
(PAR)
18-04-2016
Ingredjent attiv:
temoporfin
Disponibbli minn:
Biolitec Pharma Ltd
Kodiċi ATC:
L01XD05
INN (Isem Internazzjonali):
temoporfin
Grupp terapewtiku:
Antineoplastic agents
Żona terapewtika:
Head and Neck Neoplasms; Carcinoma, Squamous Cell
Indikazzjonijiet terapewtiċi:
Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.
Sommarju tal-prodott:
Revision: 18
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2001-10-24
Fuljett ta 'informazzjoni
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOSCAN 1 MG/ML SOLUTION FOR INJECTION
Temoporfin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Foscan is and what it is used for
2.
What you need to know before you use Foscan
3.
How to use Foscan
4.
Possible side effects
5.
How to store Foscan
6.
Contents of the pack and other information
1.
WHAT FOSCAN IS AND WHAT IT IS USED FOR
The active ingredient in Foscan is temoporfin.
Foscan is a porphyrin photosensitising medicine, which increases your
sensitivity to light and is
activated by light from a laser in a treatment called photodynamic
therapy.
Foscan is used for the treatment of head and neck cancer in patients
who cannot be treated with other
therapies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FOSCAN
DO NOT USE FOSCAN
-
if you are allergic to temoporfin or any of the other ingredients of
this medicine (listed in
section 6),
-
if you are hypersensitive (allergic) to porphyrins,
-
if you have porphyria, or any other disease that is made worse by
light,
-
if the tumour being treated goes through a large blood vessel,
-
if you are going to have an operation in the next 30 days,
-
if you have an eye disease which needs examination with bright light
in the next 30 days,
-
if you are already being treated with a photosensitising agent.
21
WARNINGS AND PRECAUTIONS
Foscan will make you sensitive to light for about 15 days after your
injection. This means that
normal daylight or bright indoor lighting could give you skin burns.
To stop this, you MUST
follow carefully the instructions for gradual exposure to increasing
light levels indoors over
the first week and outdoor, shaded light d
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Foscan 1 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1 mg of temoporfin.
_Excipients with known effect_
Each ml contains 376 mg of ethanol anhydrous and 560 mg of propylene
glycol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
Dark purple solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Foscan is indicated for the palliative treatment of patients with
advanced head and neck squamous cell
carcinoma failing prior therapies and unsuitable for radiotherapy,
surgery or systemic chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Foscan photodynamic therapy must only be administered in specialist
oncology centres in which a
multidisciplinary team assesses patient treatment and under the
supervision of physicians experienced
in photodynamic therapy.
Posology
The dose is 0.15 mg/kg body weight.
_Paediatric population_
There is no relevant use of Foscan in the paediatric population.
Method of administration
Foscan is administered via an in-dwelling intravenous cannula in a
large proximal limb vein,
preferably in the antecubital fossa, as a single slow intravenous
injection over not less than 6 minutes.
The patency of the in-dwelling cannula should be tested before
injection and every precaution taken
against extravasation (see section 4.4).
The dark purple colour of the solution, together with the amber vials
makes a visual check for
particulates impossible. Thus, an in-line filter must be used as a
precautionary measure and is provided
in the package. Foscan shall not be diluted nor flushed with sodium
chloride or any other aqueous
solution.
The required dose of Foscan is administered by slow intravenous
injection, over not less than 6
minutes. 96 hours after the administration of Foscan, the treatment
site is to be illuminated with light
at 652 nm from an approved laser source. Light must be delivered to
the entire surface of the tu
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