Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
dexrazoxane hydrochloride
Clinigen Healthcare B.V.
V03AF02
dexrazoxane
All other therapeutic products
Extravasation of Diagnostic and Therapeutic Materials
Savene is indicated for the treatment of anthracycline extravasation.
Revision: 14
Authorised
2006-07-27
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SAVENE 20 MG/ML POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION Dexrazoxane 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 Savene is and what it is used for 2. What you need to know before you use Savene 3. How to use Savene 4. Possible side effects 5 How to store Savene 6. Contents of the pack and other information 1. WHAT SAVENE IS AND WHAT IT IS USED FOR Savene contains the active substance dexrazoxane, which acts as an antidote to anti-cancer medicines called anthracyclines. Most anti-cancer medicines are administered intravenously (into a vein). Occasionally an accident occurs and the medicine is infused outside the vein and into the surrounding tissue or leaks from the vein into the surrounding tissue. This event is called extravasation. It is a serious complication as it can cause severe tissue damage. Savene is used to treat anthracyline extravasation in adults. It can reduce the amount of tissue damage caused by anthracycline extravasation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SAVENE DO NOT USE SAVENE: - If you are allergic to dexrazoxane or any of the other ingredients of this medicine (listed in section 6) - If you are planning to become pregnant and do not use adequate contraceptive measures - If you are breast-feeding - If you are given yellow-fever vaccine WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Savene: - Savene should only be given to you if you have an extravasation in connection with anthracycline-containing chemotherapy. - During treatment with Savene the area where the extravasation has occurred will be examined on a regula Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Savene 20 mg/ml powder and solvent for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride). Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of Savene solvent. Excipients with known effects: Solvent bottle: Potassium 98 mg/500 ml or 5.0 mmol/l Sodium 1.61 g/500 ml or 140 mmol/l For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion. Powder vial: White to off-white lyophilisate. Solvent bottle: Clear isotonic solution (295 mOsml/l, pH approx. 7.4). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Savene is indicated in adults for the treatment of anthracycline extravasation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Savene must be administered under the supervision of a physician experienced in the use of anti- cancer medicinal products. Posology Treatment should be given once daily for 3 consecutive days. The recommended dose is: Day 1: 1000 mg/m 2 Day 2: 1000 mg/m 2 Day 3: 500 mg/m 2 The first infusion should be initiated as soon as possible, within the first six hours after the accident. Treatment Day 2 and Day 3 should start at the same hour (+/- 3 hours) as Day 1. For patients with a body surface area of more than 2 m 2 the single dose should not exceed 2000 mg. _Renal impairment _ In patients with moderate to severe renal impairment (creatinine clearance <40 mL/min) the Savene dose should be reduced by 50% (see section 4.4 and 5.2). 3 _Hepatic impairment _ Dexrazoxane has not been studied in patients with impaired hepatic function and its use in such patients is not recommended (see section 4.4). _Elderly _ Safety and efficacy have not been evaluated in the elderly and the use of dexrazoxane in such patients is not recommended. _Paediatric population _ The safety and efficacy of Savene in children below the age of 18 years hav Lesen Sie das vollständige Dokument