Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
padeliporfin di-potassium
STEBA Biotech S.A
L01XD07
padeliporfin
Antineoplastic agents
Prostatic Neoplasms
Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and:Clinical stage T1c or T2a;Gleason Score ≤ 6, based on high-resolution biopsy strategies;PSA ≤ 10 ng/mL;3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm³.
Revision: 6
Authorised
2017-11-10
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE USER TOOKAD 183 MG POWDER FOR SOLUTION FOR INJECTION TOOKAD 366 MG POWDER FOR SOLUTION FOR INJECTION padeliporfin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 TOOKAD is and what it is used for 2. What you need to know before TOOKAD is used 3. How TOOKAD is used 4. Possible side effects 5. How TOOKAD is stored 6. Contents of the pack and other information 1. WHAT TOOKAD IS AND WHAT IT IS USED FOR TOOKAD is a medicine that contains padeliporfin (as potassium salt). It is used to treat adult men who have low-risk, localised prostate cancer in only one lobe, using a technique called Vascular-Targeted Photodynamic (VTP) therapy. The treatment is carried out under general anaesthetic (medicines that send you to sleep to prevent pain and discomfort). Hollow needles are used to insert the fibres into the right place in the prostate. Once it has been given, TOOKAD has to be activated by laser light shone along a fibre that targets the light onto the cancer. The activated medicine then causes the death of the cancer cells. 2. WHAT YOU NEED TO KNOW BEFORE TOOKAD IS USED _ _ TOOKAD MUST NOT BE USED IF - You are allergic to padeliporfin or any of the other ingredients of this medicine (listed in section 6). - You have undergone a procedure for treating benign prostatic hypertrophy including Trans-Urethral Resection of the Prostate (TURP). - You are having or have previously had any treatment for prostate cancer. - You have been diagnosed with a problem with the liver called cholestasis. - You are having an exacerbation of rectal inflammatory bowel disease. - You are not able to hav Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TOOKAD 183 mg powder for solution for injection Each vial contains 183 mg of padeliporfin (as di-potassium salt). TOOKAD 366 mg powder for solution for injection Each vial contains 366 mg of padeliporfin (as di-potassium salt). 1 mL of reconstituted solution contains 9.15 mg of padeliporfin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. The powder is a dark lyophilisate. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TOOKAD is indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and: - Clinical stage T1c or T2a, - Gleason Score ≤ 6, based on high-resolution biopsy strategies, - PSA ≤ 10 ng/mL, - 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm 3 . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TOOKAD is restricted to hospital use only. It should only be used by personnel trained in the Vascular-Targeted Photodynamic therapy (VTP) procedure. Posology The recommended posology of TOOKAD is one single dose of 3.66 mg/kg of padeliporfin. TOOKAD is administered as part of focal VTP. The VTP procedure is performed under general anaesthetic after rectal preparation. Prophylactic antibiotics and alpha-blockers may be prescribed at the physician’s discretion. Retreatment of the same lobe or sequential treatment of the contralateral lobe of the prostate are not recommended (see section 4.4). 3 Special populations _ _ _ _ _Hepatic impairment _ No data are available in patients with hepatic impairment. Exposure to padeliporfin is expected to be increased and/or prolonged in patients with hepatic Lesen Sie das vollständige Dokument