Land: Malta
Språk: engelska
Källa: Medicines Authority
LORMETAZEPAM
Dr. Franz Kohler Chemie GmbH Werner-von-Siemens-Str. 22-28, D-64625, Bensheim, Germany
N05CD06
LORMETAZEPAM 2 mg
SOLUTION FOR INFUSION OR INJECTION
LORMETAZEPAM 2 mg
POM
PSYCHOLEPTICS
Authorised
2014-01-15
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SEDALOR 2 MG/10 ML SOLUTION FOR INJECTION OR FOR INFUSION Lormetazepam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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. - 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 Sedalor is and what it is used for 2. What you need to know before you receive Sedalor 3. How Sedalor is given 4. Possible side effects 5. How to store Sedalor 6. Contents of the pack and other information 1. WHAT SEDALOR_ _IS AND WHAT IT IS USED FOR Lormetazepam, the active substance in Sedalor _ _ is a sedative, anxiolytic and sleep inducing medicine belonging to the class of benzodiazepines. Adults: Sedalor _ _ is indicated ◦ for the symptomatic treatment of acute attacks of tension, excitation and anxiety during surgical intervention and during intervention for diagnostic purposes and also in intensive care ◦ for induction of anaesthesia Paediatric population: In children from 2 years and adolescents Sedalor _ _ is only indicated for administration prior to diagnostic or surgical interventions (anaesthesia, intensive care). 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE SEDALOR YOU WILL RECEIVE SEDALOR_ _ONLY FROM A PHYSICIAN OR UNDER THE SUPERVISION OF A PHYSICIAN. SEDALOR_ _SHOULD NOT BE GIVEN ◦ if you are allergic to Lormetazepam, to other benzodiazepines or to any of the other ingredients of this medicine (listed in section 6) ◦ in case of existing or a known history of dependence upon alcohol and other medicines or drugs ◦ in case of acute intoxication with alcohol, sleep-inducing drugs (hypnotics), pain relieving drugs (analgesics) or psychotropic drugs (neuroleptics, antidepressants, lithium) ◦ in case of certain forms of weakened muscles (myasthe Läs hela dokumentet
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sedalor 2 mg/10 ml solution for injection or for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule of 10 ml contains 2 mg Lormetazepam. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion. Clear to slightly opalescent, colourless to pale yellowish solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: Sedalor _ _ is indicated ◦ for the symptomatic treatment of acute attacks of tension, excitation and anxiety during surgical intervention and during intervention for diagnostic purposes and also in intensive care. ◦ for induction of anaesthesia. Paediatric population: In children from 2 years and adolescents Sedalor _ _ is only indicated for administration prior to diagnostic or surgical interventions (anaesthesia, intensive care). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage and duration of therapy must be individualised with respect to the patient’s individual ability to respond and the nature and severeness of illness. In general, the lowest effective dose should be administered for the shortest time possible. Page 2 of 12 Posology The following posology is recommended: a) Premedication before intervention under general anaesthesia On the previous days, on the previous evening and/or on the day of intervention: Recommended Dosage of Lormetazepam Equivalent Dosage of Sedalor _ _ 0.4 – 1.0 mg Lormetazepam 2 – 5 ml b) Sedation before surgical intervention under general anaesthesia Recommended Dosage of Lormetazepam Equivalent Dosage of Sedalor _ _ 0.4 – 2.0 mg Lormetazepam, equivalent to 0.006 – 0.03 mg/kg body weight 2 - 10 ml c) Sedation (induction of sleep) during intervention for diagnostic purposes Recommended Dosage of Lormetazepam Equivalent Dosage of Sedalor _ _ 1.0 – 2.0 mg Lormetazepam, equivalent to 0.015 – 0.03 mg/kg body weight 5 - 10 ml d) Symptomatic treatment of acute attacks of tension, excitation and anxiety and ba Läs hela dokumentet