Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
pegaptanib
PharmaSwiss Ceska Republika s.r.o
S01LA03
pegaptanib
Ophthalmologicals
Wet Macular Degeneration
Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).
Revision: 15
Withdrawn
2006-01-31
22 B. PACKAGE LEAFLET Medicinal product no longer authorised 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MACUGEN 0.3 MG SOLUTION FOR INJECTION Pegaptanib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START YOUR TREATMENT WITH 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. - 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 Macugen is and what it is used for 2. What you need to know before you are given Macugen 3. How you will be given Macugen 4. Possible side effects 5. How to store Macugen 6. Contents of the pack and other information 1. WHAT MACUGEN IS AND WHAT IT IS USED FOR Macugen is a solution which is injected into the eye. Pegaptanib, the active substance of this medicine, inhibits the activity of the factor involved in the abnormal formation of new blood vessels in the eye, known as Vascular Endothelial Growth Factor 165 (VEGF 165 ). 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. The medicine is used for the treatment of all types of abnormal blood vessels growth in adult AMD patients. 2. WHAT YOU NEED TO Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Macugen 0.3 mg solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe provides a usable amount to deliver a single dose of 90 microlitres containing pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). The solution is clear and colourless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Macugen should only be administered by ophthalmologists experienced in intravitreal injections. Posology The patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4). The recommended dose is 0.3 mg pegaptanib, equivalent to 90 microliters, administered once every six weeks (9 injections per year) by intravitreal injection into the affected eye. Following the injection, transient increases in intraocular pressure were seen in Macugen treated patients. Therefore, the perfusion of the optic nerve head and intraocular pressure should be monitored. Moreover patients should be closely monitored for vitreous haemorrhage and endophthalmitis in the two weeks following the injection. Patients should be instructed to report any symptoms suggestive of these conditions without delay (see section 4.4). After 2 consecutive injections of Macugen, if a patient does not demonstrate a treatment benefit (loss of less than 15 letters of visual acuity) at the 12-week visit, consideration should be given to stopping or withholding Macugen therapy. Special populations _Elderly _ No special considerations are needed. _Hepatic impairment _ Macugen has not been studied in patients with hepatic impa Lestu allt skjalið