Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Midazolam
SERB S.A.,
N05CD08
Midazolam
10 milligram(s)
Oromucosal solution
midazolam
Not marketed
2020-08-07
PACKAGE LEAFLET: INFORMATION FOR THE USER EPISTATUS 2.5 MG OROMUCOSAL SOLUTION EPISTATUS 5 MG OROMUCOSAL SOLUTION EPISTATUS 7.5 MG OROMUCOSAL SOLUTION EPISTATUS 10 MG OROMUCOSAL SOLUTION midazolam 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 pharmacist. ▪ This medicine has been prescribed for your child or adolescent. Do not pass it on to others. It may harm them, even if their signs of illness are the same as those of the patient for whom this medicine has been prescribed. ▪ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Epistatus is and what it is used for 2. What you need to know before you use Epistatus 3. How to give Epistatus 4. Possible side effects 5. How to store Epistatus 6. Contents of the pack and other information 1. WHAT EPISTATUS IS AND WHAT IT IS USED FOR Epistatus oromucosal solution contains the medicine midazolam, which belongs to a group of medicines known as benzodiazepines. Epistatus is used to stop a prolonged, acute convulsive seizure (‘fit’) in infants, toddlers, children and adolescents aged from 3 months to less than 18 years. In infants from 3 months to less than 6 months, this medicine should only be used in a hospital setting where monitoring is possible and resuscitation equipment is available (see “Warnings and precautions” for more information). This medicine must only be given by parents or caregivers where the patient has been diagnosed with epilepsy. The patient’s doctor should give the parents or caregivers instructions on how to give Epistatus and what to do if the seizure does not stop (see also “How to give Epistatus”). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EPISTATUS DO NOT GIVE EPISTATUS IF THE PATIENT HAS ▪ an allergy to midazolam, an Przeczytaj cały dokument
Health Products Regulatory Authority 25 September 2023 CRN00DQY1 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epistatus 10 mg oromucosal solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled oral syringe (1 ml) contains midazolam maleate corresponding to 10 mg midazolam. Excipients with known effect Ethanol 197 mg/ml. Liquid maltitol qs to 1 ml (675 mg). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal solution. Clear colourless to pale yellow solution. pH 4.6 - 5.6 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epistatus is indicated for the treatment of prolonged, acute, convulsive seizures in children and adolescents aged 10 to less than 18 years. Epistatus must only be used by parents / caregivers where the patient has been diagnosed to have epilepsy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Children and adolescents aged 10 to less than 18 years of age The standard dose is 10 mg (1 ml). Carers should only administer a single dose of midazolam. If the seizure does not stop shortly after administration of midazolam, emergency medical assistance must be sought, taking into account prior instructions from the prescribing physician, or local guidelines. The empty syringe must be given to the healthcare professional to provide information on the dose and product received by the patient. After receiving midazolam, patients should be kept under supervision by a carer who remains with the patient. A second or repeat dose when seizures re-occur after an initial response should not be given without prior medical advice (see section 5.2). _Paediatric population_ This medicine should only be given to children and adolescents aged 10 years to less than 18 years. _Obesity_ No efficacy studies of midazolam in obese children have been reported. Therefore, no data are available. _Renal Impairment_ No efficacy studies of midazolam in children with chronic renal failure have been reported. Multiple doses of midazolam in patients with Przeczytaj cały dokument