Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Midazolam
SERB S.A.,
N05CD08
Midazolam
Oromucosal solution
midazolam
Marketed
2022-10-28
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 Aqra d-dokument sħiħ
Health Products Regulatory Authority 25 September 2023 CRN00DQY1 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epistatus 7.5 mg oromucosal solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled oral syringe (0.75 ml) contains midazolam maleate corresponding to 7.5 mg midazolam. Excipients with known effect Ethanol 148 mg/dose. Maltitol, liquid 506 mg/dose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal solution. Clear colourless to pale yellow solution, practically free from visible particles. pH 4.8 - 5.6 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epistatus is indicated for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents aged from 3 months to less than 18 years. Epistatus must only be used by parents / caregivers where the patient has been diagnosed to have epilepsy. For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. See section 4.4. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Standard doses are indicated below: Age range Dose Labelled packaging colour 3 to 6 months hospital setting 2.5 mg (0.25 ml) Yellow > 6 months to < 1 year 2.5 mg (0.25 ml) Yellow 1 year to < 5 years 5 mg (0.5 ml) Blue 5 years to < 10 years 7.5 mg (0.75 ml) Purple 10 years to < 18 years 10 mg (1 ml) Orange 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 Aqra d-dokument sħiħ