Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
ziconotide
Esteve Pharmaceuticals GmbH
N02BG08
ziconotide
Analgesics
Injections, Spinal; Pain
Ziconotide is indicated for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia.
Revision: 30
Authorised
2005-02-21
46 B. PACKAGE LEAFLET 47 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PRIALT 25 MICROGRAMS/ML SOLUTION FOR INFUSION Ziconotide 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Prialt is and what it is used for 2. What you need to know before you are given Prialt 3. How to use Prialt 4. Possible side effects 5. How to store Prialt 6. Contents of the pack and other information 1. WHAT PRIALT IS AND WHAT IT IS USED FOR Prialt contains the active substance ziconotide which belongs to a group of medicines, called analgesics or ‘painkillers’. Prialt is used for the treatment of severe, long-term pain in adults who need a painkiller by intrathecal injection (injection into the space that surrounds the spinal cord and the brain). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PRIALT YOU SHOULD NOT BE GIVEN PRIALT - if you are allergic to ziconotide or any of the other ingredients of this medicine (listed in section 6). - if you are receiving an anticancer medicine into the space around your spinal cord. - if you have a history of suicidal attempt or suicidal ideation with ziconotide WARNINGS AND PRECAUTIONS Patients should undergo a neuropsychiatric evaluation before, after starting and during intrathecal ziconotide, and immediately when any depressive signs or symptoms appear. Caregivers should contact a physician immediately if the patient experiences symptoms of potentially life-threatening adverse event. Talk to your doctor before you are given Prialt - The effects of long-term treatment of Prialt are uncertain at this time and the possibility of toxic effects on the spinal cord have not yet been ruled out. In case of a need for long term treatment, monitoring may be necessar Baca dokumen lengkapnya
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Prialt 25 micrograms/mL solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL solution contains 25 μg ziconotide (as acetate). Each 20 mL vial contains 500 μg ziconotide (as acetate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion (infusion). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prialt is indicated for the treatment of severe, chronic pain in adults who require intrathecal (IT) analgesia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with ziconotide should only be undertaken by physicians experienced in intrathecal (IT) administration of medicinal products. Patients should undergo a neuropsychiatric evaluation before, after starting and during intrathecal ziconotide and immediately when any depressive signs or symptoms appear. (See Section 4.3, 4.4, 4.8 and 5.1). Posology _Dose initiation _ Dosing of ziconotide should be initiated at _no more than_ 2.4 μg/day and titrated on an individual patient basis according to analgesic response and adverse reactions. _Dose titration _ For each dose titration, assess the dosing requirements and adjust the pump infusion flow rate as required to achieve the new dosing. Patients may be titrated in dose increments of ≤ 2.4 μg/day, up to a maximum dose of 21.6 μg/day. The minimal interval between dose increases is 24 hours; the recommended interval, for safety reasons, is 48 hours or more. The maximum daily dose is 21.6 µg/day (0.9 µg/h). The median dose at response is approximately 6.0 μg/day and approximately 75% of responsive patients required ≤ 9.6 μg/day in placebo-controlled clinical trials. However, to limit the occurrence of 3 serious adverse reactions, reports from clinical practice indicate that responsive patients may require a smaller daily dose of approximately 3.0 - 4.5 µg/d or lower. Adjust the dose of intrathecal ziconotide according to the severity of pain, Baca dokumen lengkapnya