PACKAGE LEAFLET: INFORMATION FOR THE USER
Macugen 0.3 mg solution for injection Pegaptanib sodium
Read all of this leaflet carefully before your treatment with Macugen begins
In this leaflet:
1. WHAT MACUGEN IS AND WHAT IT IS USED FOR
Macugen is an ophthalmic product, which means it is for eye treatment only. It is a solution for injection contained within a glass pre-filled syringe. Your doctor will administer the injection.
Macugen is used for the treatment of the wet form of age-related macular degeneration (AMD). This disease leads to vision loss resulting from damage to the central part of the retina (called the macula), at the back of the eye. The macula enables the eye to provide the fine central vision that is needed for activities such as driving a car, reading fine print and other similar tasks.
In the wet form of AMD, abnormal blood vessels grow under the retina and macula. These new blood vessels may bleed and leak fluid, causing the macula to bulge or lift up, thus distorting or destroying central vision. Under these circumstances vision loss may be rapid and severe. Macugen works by inhibiting the growth of these abnormal blood vessels and by stemming the bleeding and leakage. Macugen is used for the treatment of all types of abnormal blood vessels growth in AMD patients.
Each pack of Macugen contains one pre-filled syringe, an elastomeric plunger stopper, and a pre-attached plunge-rod inside a sealed pouch. The pre-filled syringe will be used once and then thrown away.
2. BEFORE MACUGEN IS USED
Macugen must not be used: If you are hypersensitive (allergic) to pegaptanib sodium or any of the other ingredients. If you have an infection in or around the eye.
Take special care with Macugen: Please contact your doctor if you are allergic to any substance.
Macugen is given as an injection into the eye. Occasionally, an infection in the internal portion of the eye can occur after Macugen treatment (in the next two weeks). It is important to identify and treat this type of infection as soon as possible. Please tell your doctor immediately if you notice any of the following symptoms: eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, increased sensitivity to light, increased number of small particles in your vision. If your doctor cannot be reached for any reason, an alternate should be contacted immediately. In some patients the pressure inside the treated eye may increase for a short period directly after the injection. Your doctor may monitor this after each injection.
Taking other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines obtained without a prescription.
Pregnancy: There is no experience of using Macugen in pregnant women; therefore the potential risks are unknown. If you are pregnant or planning to become pregnant, please discuss this with your doctor before Macugen treatment.
Breast-feeding: It is not known whether Macugen is excreted in human milk. Macugen is not recommended during breast-feeding. Ask your doctor or pharmacist for advice before Macugen treatment.
Driving and using machines: You may experience temporary visual blurring after receiving Macugen. If you are affected you should not drive or use machines until this resolves.
3. HOW THE INTRAVITREAL INJECTION OF MACUGEN IS ADMINISTERED
All injections of Macugen will be administered by your doctor.
Macugen is administered as a single injection into your eye at intervals of 6 weeks (i.e. 9 times per year). The injection is given into the vitreous of the eye, which is the jelly-like substance inside the eye. Your doctor will monitor your condition and recommend how long you should be treated with Macugen.
Before the treatment is given your doctor may ask you to use antibiotic eye drops, or to wash your eyes carefully. Please tell your doctor if you are known to be allergic to any substance. Please follow these instructions carefully.
Before the injection, your doctor will give you some local anaesthetic (numbing medication). This will reduce or prevent any pain you might have with the injection, which is a simple and rapid procedure.
After each injection you might be asked to use antibiotic eye drops (or another type of antibiotic treatment) to guard against eye infection.
If you forget to attend an appointment: Contact the hospital or clinic as soon as possible to re-schedule your appointment.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Macugen can have side effects although not everybody gets them. The most commonly reported side effects (occurring in more than one of 10 patients in clinical trials) are most probably caused by the injection procedure rather than the drug, and include: eye inflammation, eye pain, increased pressure inside the eye, small marks on the eye surface (punctate keratitis), small particles or spots in your vision (vitreous floaters or opacities).
Occasionally, an infection in the internal portion of the eye can occur after Macugen treatment in the next two weeks. The symptoms you might experience are described in Section 2 of this leaflet ("Take special care with Macugen"). Please read Section 2. It tells you what to do if you have any of these symptoms.
Other common eye side effects reported to be possibly caused by the drug or by the injection procedure include (occurring in more than one in 100 patients in clinical trials): blurred vision, visual disturbance, eye discomfort, decreased vision, increased sensitivity to light, appearance of flashing lights, bleeding that occurs around the eye (periorbital bleeding), bloodshot eye (conjunctival haemorrhage), disorder of the jelly portion inside the eye (vitreous disorder), such as displacement or tear (vitreous detachment), clouding of the lens (cataract), disorder of the surface of the eye (cornea), swelling or inflammation of the eyelid, swelling of the area on the inside of the eyelid or the outer surface of the eye (conjunctiva), eye inflammation, tears, inflammation of the conjunctiva (conjunctivitis), dryness, eye discharge, eye irritation, itching of the eye, eye redness or enlargement of the pupil.
Other common non-visual side effects reported to be possibly caused by the drug or by the injection procedure includes (occurring in more than one in 100 patients in clinical trials): headache or nasal discharge.
Uncommon eye side effects reported to be possibly caused by the drug or by the injection procedure include (occurring in less than one in 100 but more than one in 1000 patients in clinical trials): inflammation of your eye or of the outer surface of the eye, bleeding in the eye or the internal portion of the eye (vitreous), eye strain, inflammation of the central part of the surface of the eye (keratitis), small deposits on the eye or on the surface of the eye (cornea), deposits in the back of the eye, itching of the eyelids, disturbance in your eye’s reaction to the light (pupillary reflex impaired), small erosion on the central part of the surface of the eye (cornea), drooping eyelid, scar inside the eye (retinal scar), small lump on your eyelid due to inflammation (chalazion), decreased pressure inside the eye, injection site reaction, injection site vesicles, displacement or tear of a layer in the back of the eye (retina), disorder of the pupil, of the coloured part of the eye (iris), retinal artery occlusion, eversion of the eyelid, eye movement disorder, eyelid irritation, blood in your eye, discoloured eye, deposit eye, inflammation of the eye (iritis), optic nerve cupping, deformation of the pupil, occlusion of the vein at the back of the eye, discharge of inner jelly of the eye.
Uncommon non-visual side effects reported to be possibly caused by the drug or by the injection procedure include: (occurring in less than one in 100 but more than one in 1000 patients in clinical trials): nightmare, depression, deafness, vertigo, palpitations, high blood pressure, dilatation of the aorta (the main blood vessel), inflammation of the higher respiratory tract, vomiting, indigestion, irritation and inflammation of the skin, hair colour changes, rash, itching night sweats, back pain, fatigue, shivering, tenderness, chest pain, sudden fever, generalised aches and pains, elevation of the liver enzymes, abrasion.
In some rare cases, serious allergic reaction has been reported soon after the injection. Please seek immediate medical help if you experience any of the following soon after the injection: sudden onset of breathing difficulty or wheezing, swollen mouth, face, hands or feet, itching skin, fainting, rapid pulse, stomach cramps, nausea, vomiting or diarrhoea.
If you notice other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. HOW TO STORE MACUGEN
Keep out of the reach and sight of children.
Store in a refrigerator (2°C -8°C). Do not freeze.
Macugen should be discarded if kept at room temperature for more than two weeks.
Do not use after the expiry date stated which is on the label and carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What MACUGEN contains
What MACUGEN looks like and contents of the pack
Macugen is supplied in a single dose pack.
Each pack contains a pouch in a carton, containing a 1 ml pre-filled syringe, Type I glass, sealed with an elastomeric plunger stopper and a pre-attached plunger rod, held by a plastic clip. The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric tip cap. The pack is supplied without a needle.
Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich CT13 9NJ United Kingdom
Manufacturer Pfizer Ireland Pharmaceuticals Pottery Road Dun Laoghaire Co Dublin Ireland
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Pfizer S.A. / N.V. Tél/Tel: +32 (0)2 554 62 11
Luxembourg/Luxemburg Pfizer S.A. Tél/Tel: +32 (0)2 554 62 11
България Pfizer HCP Corporation Тел.: +359 2 970 4333
Magyarország Pfizer Kft. Tel. + 36 1 488 37 00
Česká republika Pfizer s.r.o. Tel: +420 283 004 111
Malta V.J. Salomone Pharma Ltd. Tel: + 356 21 22 01 74
Danmark Pfizer ApS Tlf: +45 44 20 11 00
Nederland Pfizer bv Tel: +31 (0)10 406 42 00
Deutschland Pfizer Pharma GmbH Tel: +49(0) 30 550055 51000
Norge Pfizer AS Tlf: +47 67 52 61 00
Eesti Pfizer Luxembourg SARL, Eesti filiaal Tel: +372 6 405 328
Österreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0
Ελλάδα Pfizer Hellas A.E. Τhλ: +30 210 678 5800
Polska Pfizer Polska Sp. z o.o. Tel.: + 48 22 335 61 00
España Pfizer S.A. Tel: +34 91 490 99 00
Portugal Laboratórios Pfizer, Lda. Tel: +351 21 423 5500
France Pfizer Tél: +33 (0)1 58 07 34 40
România Pfizer Romania S.R.L. Tel: +40 (0)21 207 2800
Ireland Pfizer Healthcare Ireland Tel: +44 (0)1304 616161
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Ísland Vistor hf Sími: +354 535 7000
Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: +421–2–5941 8500
Italia Pfizer Italia S.r.l. Tel: +39 06 33 18 21
Suomi/Finland Pfizer Oy Puh./Tel: +358 (0)9 43 00 40
Κύπρος GEO. PAVLIDES & ARAOUZOS LTD Τηλ: +35722818087
Sverige Pfizer AB Tel: +46 (0)8 550 520 00
Latvija Pfizer Luxembourg SARL, filiāle Latvijā Tel: +371 670 35 775
United Kingdom Pfizer Limited Tel: +44 (0)1304 616161
Lietuva Pfizer Luxembourg SARL, filialas Lietuvoje Tel. +3705 2514000
This leaflet was last approved in 03/2009
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Link to this document from your website:http://www.medicines.ie/medicine/10898/PIL/Macugen+0.3+mg+solution+for+injection/