Visudyne 15mg powder for solution for infusion vials

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Verteporfin

זמין מ:

Novartis Pharmaceuticals UK Ltd

קוד ATC:

S01LA01

INN (שם בינלאומי):

Verteporfin

כמות:

15mg

טופס פרצבטיות:

Powder for solution for infusion

מסלול נתינה (של תרופות):

Intravenous

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 11080200; GTIN: 5016833008316

עלון מידע

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 SHOULD NOT BE GIVEN VIS

מאפייני מוצר

OBJECT 1
VISUDYNE 15 MG, POWDER FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 20-Nov-2017 | Novartis
Pharmaceuticals UK Ltd
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.
_Special populations _
_Hepatic impairment_
Visudyne t