Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ziconotide acetate
Intrapharm Laboratories Ltd
N02BG08
Ziconotide acetate
100microgram/1ml
Solution for infusion
Intrathecal
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5036519000328
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PRIALT 100 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. WARNINGS AND PRECAUTIONS 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 necessary (as decided by your doctor). - If you are receiving Prialt via a pump worn outside your body, it is important you check once daily for any signs of infection at the point where the tube enters your body. - If you observe any signs of infection around the tube, such as skin redness, swelling, pain or discharge, you must tell your doctor immediately and seek treatment for the infection. - If you develop any t Přečtěte si celý dokument
OBJECT 1 PRIALT SOLUTION FOR INFUSION Summary of Product Characteristics Updated 07-Mar-2017 | Eisai Ltd 1. Name of the medicinal product Prialt 100 micrograms/ml solution for infusion 2. Qualitative and quantitative composition One ml solution contains 100 μg ziconotide (as acetate). Each 1 ml vial contains 100 μg ziconotide (as acetate). Each 5 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 Ziconotide 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. Posology _Adults (including the elderly ≥ 65 years of age)_ Dosing of ziconotide should be initiated at 2.4 μg/day and titrated on an individual patient basis according to the patient's analgesic response and adverse reactions. Patients should 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. If necessary the dose can be decreased by any amount (including stopping the infusion) for the management of adverse reactions. Approximately 75% of patients who respond satisfactorily to treatment require a dose of ≤ 9.6 μg/day. _Renal impairment_ Studies have not been conducted in patients with impaired renal function. Caution should be exercised when ziconotide is administered to patients with impaired renal function. _Hepatic impairment_ Studies have not been conducted in patients with impaired hepatic function. Caution should be exercised when ziconotide is administered to patients with impaired hepatic function. _Paediatric population_ The safety and efficacy of ziconotide in children age Přečtěte si celý dokument