Visudyne
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
16-09-2020
Charakterystyka produktu
(SPC)
16-09-2020
Sprawozdanie z oceny publicznego
(PAR)
24-02-2016
Składnik aktywny:
verteporfin
Dostępny od:
CHEPLAPHARM Arzneimittel GmbH
Kod ATC:
S01LA01
INN (International Nazwa):
verteporfin
Grupa terapeutyczna:
Ophthalmologicals
Dziedzina terapeutyczna:
Myopia, Degenerative; Macular Degeneration
Wskazania:
Visudyne is indicated for the treatment of:adults with exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV) or;adults with subfoveal choroidal neovascularisation secondary to pathological myopia.
Podsumowanie produktu:
Revision: 35
Status autoryzacji:
Authorised
Data autoryzacji:
2000-07-27
Ulotka dla pacjenta
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
VISUDYNE 15 MG POWDER FOR SOLUTION FOR INFUSION
verteporfin
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Visudyne is and what it is used for
2.
What you need to know before you are given Visudyne
3.
How Visudyne is used
4.
Possible side effects
5.
How to store Visudyne
6.
Contents of the pack and other information
1.
WHAT VISUDYNE IS AND WHAT IT IS USED FOR
WHAT VISUDYNE IS
Visudyne contains the active substance verteporfin, which is activated
by light from a laser in a
treatment called photodynamic therapy. When you are given an infusion
of Visudyne, it is distributed
within your body through the blood vessels, including the blood
vessels at the back of the eye. When
the laser light is shone into the eye, Visudyne is activated.
WHAT VISUDYNE IS USED FOR
Visudyne is used to treat the wet form of age-related macular
degeneration and pathological myopia.
These diseases lead to vision loss. Vision loss is caused by new blood
vessels (choroidal
neovascularisation) that damage the retina (the light-sensitive
membrane that lines the back of the
eye). There are two types of choroidal neovascularisation: classic and
occult.
Visudyne is used for the treatment of predominantly classic choroidal
neovascularisation in adults
with age-related macular degeneration, and also for the treatment of
all types of choroidal
neovascularisation in adults with pathological myopia.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VISUDYNE
YOU S
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Visudyne 15 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 15 mg of verteporfin.
After reconstitution, 1 ml contains 2 mg of verteporfin. 7.5 ml of
reconstituted solution contains 15 mg
of verteporfin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion
Dark green to black powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Visudyne is indicated for the treatment of
-
adults with exudative (wet) age-related macular degeneration (AMD)
with predominantly
classic subfoveal choroidal neovascularisation (CNV) or
-
adults with subfoveal choroidal neovascularisation secondary to
pathological myopia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Visudyne should be administered only by ophthalmologists experienced
in the management of patients
with age-related macular degeneration or with pathological myopia.
Posology
_Adults, including the elderly (_
_≥_
_65 years old) _
Visudyne photodynamic therapy (PDT) is a two-step process:
The first step is a 10-minute intravenous infusion of Visudyne at a
dose of 6 mg/m
2
body surface area,
diluted in 30 ml infusion solution (see section 6.6).
The second step is the light activation of Visudyne at 15 minutes
after the start of the infusion (see
“Method of administration”).
Patients should be re-evaluated every 3 months. In the event of
recurrent CNV leakage, Visudyne
therapy may be given up to 4 times per year.
_Treatment of the second eye with Visudyne _
There are no clinical data to support concomitant treatment of the
second eye. However, if treatment
of the second eye is deemed necessary, light should be applied to the
second eye immediately after
light application in the first eye but no later than 20 minutes from
the start of the infusion.
3
_Special populations _
_Hepatic impairment _
Visudyne therapy should be considered carefully in patients with
moderate hepatic dysfunction or
b
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