PhotoBarr
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
07-05-2012
Charakterystyka produktu
(SPC)
07-05-2012
Sprawozdanie z oceny publicznego
(PAR)
07-05-2012
Składnik aktywny:
porfimer sodium
Dostępny od:
Pinnacle Biologics B.V.
Kod ATC:
L01XD01
INN (International Nazwa):
porfimer sodium
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Barrett Esophagus
Wskazania:
Photodynamic therapy (PDT) with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)
Podsumowanie produktu:
Revision: 9
Status autoryzacji:
Withdrawn
Data autoryzacji:
2004-03-25
Ulotka dla pacjenta
Medicinal product no longer authorised
42
B. PACKAGE LEAFLET
Medicinal product no longer authorised
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
PHOTOBARR 15 MG POWDER FOR SOLUTION FOR INJECTION
Porfimer sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again
-
If you have any further questions, please ask your doctor or
pharmacist.
-
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 PhotoBarr is and what it is used for
2.
Before you use PhotoBarr
3.
How to use PhotoBarr
4.
Possible side effects
5
How to store PhotoBarr
6.
Further information
1.
WHAT PHOTOBARR IS AND WHAT IT IS USED FOR
PhotoBarr
is a light-activated medicine used in photodynamic therapy (PDT) in
combination with a
non-burning red laser light. PDT specifically targets and destroys
abnormal cells.
PhotoBarr is used to remove high-grade dysplasia (cells with atypical
changes that increase the risk of
developing cancer) in patients with Barrett's oesophagus (gullet).
2.
BEFORE YOU USE PHOTOBARR
DO NOT USE PHOTOBARR
-
if you are allergic (hypersensitive) to porfimer sodium, other
porphyrins or any of the other
ingredients of PhotoBarr (listed in section 6, ‘
_What PhotoBarr contains’_
)
-
if you have porphyria
-
if you have an opening (fistula) between the oesophagus and the
airways
-
if you suffer from varices of your oesophageal veins or erosion of
other major blood vessels
-
if you have ulcers in your oesophagus
-
if you have severe liver or kidney problems
TAKE SPECIAL CARE WITH PHOTOBARR
Tell your doctor if any of the following applies to you:
-
you are taking any other medicines (see below),
-
you have a liver or kidney problems
-
you have a family history of cataracts
-
you are 75 years or older,
-
you have or have had heart or lung disease
PhotoBarr should not be used in children and adolescents below 18
years of age, due to lack of
experience.
Medi
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Charakterystyka produktu
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
PhotoBarr 15 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each vial contains 15 mg porfimer sodium. After reconstitution, each
ml solution contains 2.5 mg
porfimer sodium.
For a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
A dark red to reddish brown lyophilised powder or cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Photodynamic therapy (PDT) with PhotoBarr is indicated for ablation of
high-grade dysplasia (HGD)
in patients with Barrett's Oesophagus (BO).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Photodynamic therapy with PhotoBarr should be performed only by, or
under the supervision of, a
physician with experience in endoscopic laser procedures. The
medicinal product should only be
administered when material and personnel experienced in evaluating and
treating anaphylaxis are
immediately available.
Posology
The recommended dose of PhotoBarr is 2 mg/kg body weight.
Reconstituted PhotoBarr solution (ml) = Patient's weight (kg) x 2
mg/kg
= 0.8 x patient's weight
2.5 mg/ml
After reconstitution, PhotoBarr is a dark red to reddish brown, opaque
solution.
Only a solution without particles should be used and without visible
signs of deterioration.
Photodynamic therapy with PhotoBarr is a two-stage process requiring
administration of both
medicinal product and light. One course of PDT consists of one
injection plus one or two light
applications.
In case of persistence of HGD, further treatment courses (up to a
maximum of three courses) may be
given (separated by a minimum of 90 days) to increase the response
rate. This has to be balanced
against the increased rate of stricture formation (see section 4.8 and
section 5.1).
Progression to cancer was related to the number of PDT courses
administered. Patients who received
one course of PDT had a greater risk of progressi
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