País: Malta
Idioma: anglès
Font: Medicines Authority
LORAZEPAM
Medochemie Iberia S.A
N05BA06
LORAZEPAM
SOLUTION FOR INJECTION
LORAZEPAM 4 milligram(s)/millilitre
POM
PSYCHOLEPTICS
Authorised
2019-08-06
PACKAGE LEAFLET: INFORMATION FOR THE USER TEMELOR 4 MG/ML SOLUTION FOR INJECTION lorazepam 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 nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Temelor is and what it is used for 2. What you need to know before you use Temelor 3. How to use Temelor 4. Possible side effects 5. How to store Temelor 6. Contents of the pack and other information 1. WHAT TEMELOR IS AND WHAT IT IS USED FOR Temelor belongs to a certain group of sedative-hypnotic medicines, called benzodiazepines. Temelor is used as a sedative to initiate certain interventions (premedication), such as small or large surgical procedures or certain extensive physical examinations. Temelor is also used for people who suffer from severe fears or tension and for any reason can not take any tablets. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TEMELOR DO NOT USE TEMELOR: - If you are allergic to the active substance, other benzodiazepines, benzodiazepine-like substances or any of the other ingredients of this medicine (listed in section 6); - If you suffer from myasthenia gravis (a disease in which muscle weakness occurs due to the impairment of the transfer of nerve impulses to muscles); - If you suffer from severe respiratory distress; - If you suffer from sleep apnoea syndrome (severe respiratory disturbances may occur during sleep); - If you have severe liver problems. Temelor may not be injected into an artery. CHILDREN Children under 12 years old are not allowed to use Temelor. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Temelor: - If Llegiu el document complet
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Temelor 4 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule contains 4 mg/ml lorazepam (4 mg per 1 ml ampoule). Excipients with known effect: benzyl alcohol, propylene glycol. Each ml contains 21 mg benzyl alcohol. Each ml contains 840 mg propylene glycol. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection A clear, colourless or almost colourless hypertonic solution, free from visible particles. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Temelor is indicated in adults and adolescents above 12 years of age: • As premedication , before surgical procedures or prior to diagnostic procedures. • For symptomatic treatment of pathological anxiety and tension in patients who, for some reason, are unable to take oral medication. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology Premedication For a maximum beneficial effect, the dose should be calculated based on body weight (the usual dose is 2-4 mg) and administered as follows: _a) I.V. administration: _ For an optimal effect, doses of 0.044 mg / kg to a maximum of 2 mg should be used, 15-20 minutes before the procedure. This dose (I.V. administered) will be adequate for sedation of most adult patients and should not normally be exceeded in patients over 50 years of age. Higher doses, up to 0.05 mg / kg with a maximum of 4 mg, can be administered. The necessary airway equipment must be available immediately prior to the intravenous administration of Temelor. _b) I.M. administration: _ The optimal effect is reached by administrating 0.05mg/kg to a maximum 4mg, with minimum 2 hours before the forecasted procedure. The dose is individually adjusted. In elderly or debilitated patients or in patients with impaired renal or hepatic function or with severe respiratory or cardiovascular disease, a dose reduction is recommended. In case of local anesthesia and in diagnostic procedures requiring patient invo Llegiu el document complet