Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
temoporfin
Biolitec Pharma Ltd
L01XD05
temoporfin
Antineoplastic agents
Head and Neck Neoplasms; Carcinoma, Squamous Cell
Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.
Revision: 18
Authorised
2001-10-24
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FOSCAN 1 MG/ML SOLUTION FOR INJECTION Temoporfin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Foscan is and what it is used for 2. What you need to know before you use Foscan 3. How to use Foscan 4. Possible side effects 5. How to store Foscan 6. Contents of the pack and other information 1. WHAT FOSCAN IS AND WHAT IT IS USED FOR The active ingredient in Foscan is temoporfin. Foscan is a porphyrin photosensitising medicine, which increases your sensitivity to light and is activated by light from a laser in a treatment called photodynamic therapy. Foscan is used for the treatment of head and neck cancer in patients who cannot be treated with other therapies. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FOSCAN DO NOT USE FOSCAN - if you are allergic to temoporfin or any of the other ingredients of this medicine (listed in section 6), - if you are hypersensitive (allergic) to porphyrins, - if you have porphyria, or any other disease that is made worse by light, - if the tumour being treated goes through a large blood vessel, - if you are going to have an operation in the next 30 days, - if you have an eye disease which needs examination with bright light in the next 30 days, - if you are already being treated with a photosensitising agent. 21 WARNINGS AND PRECAUTIONS Foscan will make you sensitive to light for about 15 days after your injection. This means that normal daylight or bright indoor lighting could give you skin burns. To stop this, you MUST follow carefully the instructions for gradual exposure to increasing light levels indoors over the first week and outdoor, shaded light d Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Foscan 1 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 1 mg of temoporfin. _Excipients with known effect_ Each ml contains 376 mg of ethanol anhydrous and 560 mg of propylene glycol. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection Dark purple solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Foscan photodynamic therapy must only be administered in specialist oncology centres in which a multidisciplinary team assesses patient treatment and under the supervision of physicians experienced in photodynamic therapy. Posology The dose is 0.15 mg/kg body weight. _Paediatric population_ There is no relevant use of Foscan in the paediatric population. Method of administration Foscan is administered via an in-dwelling intravenous cannula in a large proximal limb vein, preferably in the antecubital fossa, as a single slow intravenous injection over not less than 6 minutes. The patency of the in-dwelling cannula should be tested before injection and every precaution taken against extravasation (see section 4.4). The dark purple colour of the solution, together with the amber vials makes a visual check for particulates impossible. Thus, an in-line filter must be used as a precautionary measure and is provided in the package. Foscan shall not be diluted nor flushed with sodium chloride or any other aqueous solution. The required dose of Foscan is administered by slow intravenous injection, over not less than 6 minutes. 96 hours after the administration of Foscan, the treatment site is to be illuminated with light at 652 nm from an approved laser source. Light must be delivered to the entire surface of the tu Pročitajte cijeli dokument