Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dexmedetomidine hydrochloride
Orion Pharma (UK
Dexmedetomidine hydrochloride
100microgram/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 6432100020857
PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ DEXDOR 100 MICROGRAMS/ML CONCENTRATE FOR SOLUTION FOR INFUSION Dexmedetomidine 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 or nurse. - 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 Dexdor is and what it is used for 2. What you need to know before you are given Dexdor 3. How to use Dexdor 4. Possible side effects 5. How to store Dexdor 6. Contents of the pack and other information 1. WHAT DEXDOR IS AND WHAT IT IS USED FOR Dexdor contains an active substance called dexmedetomidine which belongs to a medicine group called sedatives. It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care settings. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DEXDOR _ _ YOU MUST NOT BE GIVEN DEXDOR - if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6). - if you have some disorders of heart rhythm (heart block grade 2 or 3). - if you have very low blood pressure which does not respond to treatment. - if you have recently had a stroke or other serious condition affecting blood supply to the brain. WARNINGS AND PRECAUTIONS Before you have this medicine, tell your doctor or nurse if any of the following apply as Dexdor should be used cautiously: - if you have an abnormally slow heart rate (either due to illness or high levels of physical fitness) - if you have low blood pressure - if you have low blood volume, for example after bleeding - if you have certain heart disorders - if you are elderly - if you have a neurological disorder (for instance head or spinal cord injury or stroke) - if you have severe liver problems - if you have ever developed a serious fever after some m Прочетете целия документ
OBJECT 1 DEXDOR 100 MICROGRAMS/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 16-Sep-2016 | Orion Pharma (UK) Limited 1. Name of the medicinal product Dexdor 100 micrograms/ml concentrate for solution for infusion 2. Qualitative and quantitative composition Each 1 ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine. Each 2 ml ampoule contains 200 micrograms of dexmedetomidine. Each 2 ml vial contains 200 micrograms of dexmedetomidine. Each 4 ml vial contains 400 micrograms of dexmedetomidine. Each 10 ml vial contains 1000 micrograms of dexmedetomidine. The concentration of the final solution after dilution should be either 4 micrograms/ml or 8 micrograms/ml. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colourless solution, pH 4.5 7.0 4. Clinical particulars 4.1 Therapeutic indications For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3). 4.2 Posology and method of administration For hospital use only. Dexdor should be administered by healthcare professionals skilled in the management of patients requiring intensive care. Posology Patients already intubated and sedated may switch to dexmedetomidine with an initial infusion rate of 0.7 micrograms/kg/h which may then be adjusted stepwise within the dose range 0.2 to 1.4 micrograms/kg/h in order to achieve the desired level of sedation, depending on the patient's response. A lower starting infusion rate should be considered for frail patients. Dexmedetomidine is very potent and the infusion rate is given per HOUR. After dose adjustment, a new steady state sedation level may not be reached for up to one hour. _Maximum dose_ The maximum dose of 1.4 micrograms/kg/h should not be exceeded. Patients failing to achi Прочетете целия документ