Country: Европска Унија
Језик: Енглески
Извор: EMA (European Medicines Agency)
sufentanil
FGK Representative Service GmbH
N01AH03
sufentanil
Anesthetics
Pain, Postoperative
Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.,
Revision: 7
Withdrawn
2015-09-18
30 B. PACKAGE LEAFLET Medicinal Product no longer authorised 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZALVISO 15 MICROGRAMS SUBLINGUAL TABLETS sufentanil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Zalviso is and what it is used for 2. What you need to know before you take Zalviso 3. How to take Zalviso 4. Possible side effects 5. How to store Zalviso 6. Contents of the pack and other information 1. WHAT ZALVISO IS AND WHAT IT IS USED FOR The active substance of Zalviso is sufentanil, which belongs to a group of strong pain-relieving medicines called opioids. Zalviso is used to treat acute moderate to severe pain after an operation in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZALVISO DO NOT TAKE ZALVISO: - if you are allergic to sufentanil or any of the other ingredients of this medicine (listed in section 6). - if you have severe breathing problems. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before taking Zalviso. Tell your doctor or nurse before treatment if you: - are suffering from any condition that affects your breathing (such as asthma, wheezing, or shortness of breath). As Zalviso may affect your breathing, your doctor or nurse will check your breathing during treatment; - have a head injury or brain tumour; - have problems with your heart and circulation, especially slow heart rate, irregular heart beats, low blood volume or low blood pressure; - have moderate to severe liver or severe kidney problems, as these organs have an effect on the way in which your body breaks down and eliminates the medicine; - have a history of medicine or alcohol abuse; - are regularly using a prescribed opioid medicine (e.g. codeine, fe Прочитајте комплетан документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Zalviso 15 micrograms sublingual tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sublingual tablet contains 15 micrograms sufentanil (as citrate). Excipient(s) with known effect Each sublingual tablet contains 0.074 mg sunset yellow FCF Aluminium Lake (E110). Each sublingual tablet contains 0.013 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sublingual tablet. Zalviso sublingual tablets of 3 mm diameter are orange-coloured flat-faced tablets with rounded edges. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zalviso is to be administered in a hospital setting only. Zalviso should only be prescribed by physicians who are experienced in the management of opioid therapy, particularly opioid adverse reactions such as respiratory depression (see section 4.4). Posology Zalviso sublingual tablets are to be self-administered by the patient in response to pain using the Zalviso administration device. The Zalviso administration device is designed to deliver a single sufentanil 15 micrograms sublingual tablet, on a patient-controlled as needed basis, with a minimum of 20 minutes (lockout interval) between doses, over a period of up to 72 hours, which is the maximum recommended treatment duration. See section “Method of administration”. _Elderly _ No special population studies were performed using sufentanil sublingual tablets in elderly patients. In clinical trials approximately 30 % of enrolled patients were 65 to 75 years of age. The safety and efficacy in elderly patients was similar to that observed in younger adults (see section 5.2). _Hepatic or renal impairment _ Medicinal Product no longer authorised 3 No special population studies were performed using sufentanil sublingual tablets in hepatic and re Прочитајте комплетан документ