Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
porfimer sodium
Pinnacle Biologics B.V.
L01XD01
porfimer sodium
Antineoplastic agents
Barrett Esophagus
Photodynamic therapy (PDT) with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)
Revision: 9
Withdrawn
2004-03-25
Medicinal product no longer authorised 42 B. PACKAGE LEAFLET Medicinal product no longer authorised 43 PACKAGE LEAFLET: INFORMATION FOR THE USER PHOTOBARR 15 MG POWDER FOR SOLUTION FOR INJECTION Porfimer sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again - If you have any further questions, please ask your doctor or pharmacist. - 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 pharmacist. IN THIS LEAFLET : 1. What PhotoBarr is and what it is used for 2. Before you use PhotoBarr 3. How to use PhotoBarr 4. Possible side effects 5 How to store PhotoBarr 6. Further information 1. WHAT PHOTOBARR IS AND WHAT IT IS USED FOR PhotoBarr is a light-activated medicine used in photodynamic therapy (PDT) in combination with a non-burning red laser light. PDT specifically targets and destroys abnormal cells. PhotoBarr is used to remove high-grade dysplasia (cells with atypical changes that increase the risk of developing cancer) in patients with Barrett's oesophagus (gullet). 2. BEFORE YOU USE PHOTOBARR DO NOT USE PHOTOBARR - if you are allergic (hypersensitive) to porfimer sodium, other porphyrins or any of the other ingredients of PhotoBarr (listed in section 6, ‘ _What PhotoBarr contains’_ ) - if you have porphyria - if you have an opening (fistula) between the oesophagus and the airways - if you suffer from varices of your oesophageal veins or erosion of other major blood vessels - if you have ulcers in your oesophagus - if you have severe liver or kidney problems TAKE SPECIAL CARE WITH PHOTOBARR Tell your doctor if any of the following applies to you: - you are taking any other medicines (see below), - you have a liver or kidney problems - you have a family history of cataracts - you are 75 years or older, - you have or have had heart or lung disease PhotoBarr should not be used in children and adolescents below 18 years of age, due to lack of experience. Medi Izlasiet visu dokumentu
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT PhotoBarr 15 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each vial contains 15 mg porfimer sodium. After reconstitution, each ml solution contains 2.5 mg porfimer sodium. For a full list of excipients, see 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. A dark red to reddish brown lyophilised powder or cake. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Photodynamic therapy (PDT) with PhotoBarr is indicated for ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Photodynamic therapy with PhotoBarr should be performed only by, or under the supervision of, a physician with experience in endoscopic laser procedures. The medicinal product should only be administered when material and personnel experienced in evaluating and treating anaphylaxis are immediately available. Posology The recommended dose of PhotoBarr is 2 mg/kg body weight. Reconstituted PhotoBarr solution (ml) = Patient's weight (kg) x 2 mg/kg = 0.8 x patient's weight 2.5 mg/ml After reconstitution, PhotoBarr is a dark red to reddish brown, opaque solution. Only a solution without particles should be used and without visible signs of deterioration. Photodynamic therapy with PhotoBarr is a two-stage process requiring administration of both medicinal product and light. One course of PDT consists of one injection plus one or two light applications. In case of persistence of HGD, further treatment courses (up to a maximum of three courses) may be given (separated by a minimum of 90 days) to increase the response rate. This has to be balanced against the increased rate of stricture formation (see section 4.8 and section 5.1). Progression to cancer was related to the number of PDT courses administered. Patients who received one course of PDT had a greater risk of progressi Izlasiet visu dokumentu