Visudyne 15 mg powder for solution for infusion

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.

You should not be given Visudyne

• if you are allergic (hypersensitive) to verteporfin or any of the other ingredients of Visudyne (for a full list of ingredients, see section 6 ?What Visudyne contains?).
• if you have porphyria (a rare condition that may increase sensitivity to light).
• if you have any severe liver problems.

If any of these apply to you, tell your doctor. You should not be given Visudyne.

Take special care with Visudyne

• If you experience any problems or symptoms during the treatment such as chest pain, sudden loss of consciousness, sweating, dizziness, rash, breathlessness, flushing, irregular heart beat, please tell your doctor or nurse.
• If you have any liver problems or a blockage of your bile duct, please tell your doctor before starting Visudyne therapy.
• If, during the infusion, Visudyne goes outside the vein, and especially if the affected area is exposed to light, this can cause pain, swelling, blistering and a change in skin colour in the area of the leakage. If this happens, the infusion needs to be stopped and the skin treated with cold compresses and thoroughly protected from light until the skin colour returns to normal. You may need to take a painkiller.
• You will be sensitive to bright light for 48 hours after the infusion. During that time, avoid exposure to direct sunlight, bright indoor lights such as in tanning salons, bright halogen lighting, high power lighting as used by surgeons or dentists, or light from light-emitting medical devices such as pulse oximeters (used to measure oxygen in blood). If you have to go outdoors during daylight in the first 48 hours after treatment, you must protect your skin and eyes by wearing protective clothing and dark sunglasses. Sunscreens offer no protection. Normal indoor lighting is safe.
• Do not stay in the dark because exposure to normal indoor lighting will help your body to eliminate Visudyne more quickly.
• If you experience any eye problems after the treatment, such as a vision loss, talk to your doctor.

Using other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are taking any of the following medicines:

• tetracyclines or sulphonamides (used to treat bacterial infection),
• phenothiazines (used to treat psychiatric disorders, or nausea and vomiting),
• sulfonylurea (used to treat diabetes),
• medicines used to lower blood sugar,
• thiazide diuretics (used to reduce high blood pressure),
• griseofulvin (used to treat fungal infection) tell your doctor or pharmacist. This is important because taking these medicines may increase your sensitivity to light.

Pregnancy and breastfeeding

• Visudyne has not been studied in pregnant women. It is important to tell your doctor if you are pregnant, if you think you may be pregnant or if you plan to become pregnant. You should only be given Visudyne if your doctor considers it absolutely essential.
• Verteporfin is excreted in human milk in low amounts. Please tell your doctor if you are breastfeeding. He/she will decide whether you should be given Visudyne. It is recommended that, if you are given Visudyne, you do not breastfeed for 48 hours after administration.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

After Visudyne treatment you may have some vision problems, such as abnormal or decreased vision, which may be temporary. If this happens to you, do not drive or use any tools or machines until your vision improves.

Important information about some of the ingredients of Visudyne

Visudyne contains small amounts of butylated hydroxytoluene (E321). This ingredient is irritant to eyes, skin and mucous membranes.

If you come into direct contact with Visudyne, you must therefore wash it off extensively with water.

Treatment with Visudyne is a two-step process

First your doctor or the pharmacist will prepare the Visudyne infusion solution. It will be administered by your doctor or nurse into a vein using a drip intravenous infusion.

The second step is the activation of Visudyne in the eye 15 minutes after the start of the infusion. Your doctor will put a special contact lens onto your eye and treat your eye using a special laser. It takes 83 seconds to deliver the laser dose required to activate Visudyne. During this time, you will have to follow your doctors instructions and keep your eyes still.

If necessary, Visudyne therapy can be repeated every 3 months, up to 4 times per year.

Use in children

Visudyne is a treatment for adults only and not indicated for the use in children.

If you are given more Visudyne than you should be

Overdose of Visudyne may prolong the time during which you are sensitive to light and you may need to follow the protection instructions given in section 2 for longer than 48 hours. Your doctor will advise you.

Overdose of Visudyne and light in the treated eye may result in severe vision decrease.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Visudyne can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very rare affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data.

Most of the side effects are mild to moderate and will usually disappear a few days to a few weeks after treatment.

Common side effects
- Eye disorders: severe decrease of vision (loss of 4 lines or more within 7 days of treatment), visual disturbances such as blurred, hazy or fuzzy vision, flashes of light, decreased vision, and a change in the field of vision in the treated eye such as grey or dark shadows, blind spots or black spots.
- Infusion site side effects: as with other types of injections, some patients experienced pain, swelling, inflammation, and weeping from the infusion site.
- General disorders: feeling sick (nausea), sunburn-like reactions, tiredness, infusion-related reaction, primarily presented as back pain which may radiate to other areas, including but not limited to, the pelvis, shoulders or rib cage, and increased cholesterol.

Uncommon side effects
- Eye disorders: bleeding of the retina or into the vitreous humour (the clear gel-like substance that fills the eyeball behind the lens), and displacement of the retina in the treated eye. - Infusion site side effects: as with other types of injections, some patients experienced bleeding at the infusion site, change in skin colour and hypersensitivity. If this happens to you, there will be increased sensitivity to light in that part of the skin until the green discolouration disappears. - General disorders: pain, increased blood pressure, increased sensation, and fever.

Rare frequency side effects

- Eye disorders: lack of blood circulation to the retina or choroids (the vascular layer of the eye) in the treated eye.

Not known frequency side effects
- Eye disorders: tear in the coloured layer of the retina.
- Infusion site side effects: as with other types of injections, some patients experienced blistering. - General disorders: vasovagal reactions (light-headedness and fainting) and allergic reactions, which on rare occasions can be severe, have been reported. General symptoms can include headache, malaise (feeling unwell), fainting, sweating, dizziness, rash, hives, itching, breathlessness, flushing, or changes in blood pressure and heart rate. Infusion-related reaction, primarily presented as chest pain which may radiate to other areas, including but not limited to, the pelvis, shoulders or rib cage.
- Heart attack has been reported, particularly in patients with a history of heart disease, sometimes within 48 hours after treatment with Visudyne. In the event of suspected heart attack, seek medical attention immediately.

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 nurse.

Keep out of the reach and sight of children.

Do not use Visudyne after the expiry date which is stated on the carton and vial after ?EXP-. The expiry date refers to the last day of that month.

Do not store above 25-C. Keep the vial in the outer carton in order to protect from light.

Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C. From a microbiological point of view, the medicine should be used immediately. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and would normally not last longer than 4 hours below 25°C protected from light.

What Visudyne contains

• The active substance is verteporfin. 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.
• The other ingredients are dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, butylated hydroxytoluene (E321) and lactose monohydrate.

What Visudyne looks like and contents of the pack

Visudyne is supplied as a dark green to black powder in a clear glass vial. The powder is reconstituted in water prior to use to form an opaque dark green solution.

Visudyne is available in packs containing 1 vial of powder.

Marketing Authorisation Holder
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer
Novartis Pharma S.A.S.
26, rue de la Chapelle
F-68333 Huningue Cedex
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH TélTel 49 911 273 0

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

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Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

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Lietuva

Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in

The following information is intended for medical or healthcare professionals only:

Reconstitute Visudyne in 7.0 ml water for injections to produce 7.5 ml of a 2.0 mg/ml solution. Reconstituted Visudyne is an opaque dark green solution. It is recommended that reconstituted Visudyne be inspected visually for particulate matter and discoloration prior to administration. For a dose of 6 mg/m 2 body surface (the dose recommended for the treatment) dilute the required amount of Visudyne solution in glucose 50 mg/ml (5 %) solution for infusion to a final volume of 30 ml. Do not use sodium chloride solution. Use of a standard infusion line filter with hydrophilic membranes (such as polyethersulfone) of a pore size of not less than 1.2 ?m is recommended .

For storage conditions, please see section 5 of this leaflet.

The vial and any unused portion of reconstituted solution should be discarded after single use.

If material is spilled, it should be contained and wiped up with a damp cloth. Eye and skin contact should be avoided. Use of rubber gloves and eye protection is recommended. Any unused medicine or waste material should be disposed of in accordance with local requirements.