Quốc gia: Hà Lan
Ngôn ngữ: Tiếng Hà Lan
Nguồn: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LORAZEPAM 4 mg/ml
LORAZEPAM 4 mg/ml
Oplossing voor injectie
BENZYLALCOHOL (E 1519) 21 mg/ml ; MACROGOL 400 ; PROPYLEENGLYCOL (E 1520) 840 mg/ml ; STIKSTOF (HEAD SPACE) (E 941)
Intraveneus gebruik, Intramusculair gebruik
1900-01-01
pillorainj_DCP PACKAGE LEAFLET: INFORMATION FOR THE USER LAMBUTRIX 4 MG/ML OPLOSSING VOOR INJECTIE 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 Lambutrix is and what it is used for 2. What you need to know before you use Lambutrix 3. How to use Lambutrix 4. Possible side effects 5. How to store Lambutrix 6. Contents of the pack and other information 1. WHAT LAMBUTRIX IS AND WHAT IT IS USED FOR Lambutrix belongs to a certain group of sedative-hypnotic medicines, called benzodiazepines. Lambutrix is used for adults and adolescents above 12 years as a sedative to initiate certain interventions (premedication), such as small or large surgical procedures or certain extensive physical examinations. Lambutrix is used for adults and adolescents above 12 years who suffer from severe fears and agitation and for any reason can not take any tablets. Lambutrix is used for adults, adolescents, children and infants aged 1 month and older in the control of status epilepticus. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LAMBUTRIX DO NOT USE LAMBUTRIX: - 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 slee Đọc toàn bộ tài liệu
spclorainj_DCP 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lambutrix 4 mg/ml oplossing voor injectie 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 Lambutrix 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 acute anxiety states and agitation in patients who, for some reason, are unable to take oral medication. Lambutrix is indicated in adults, adolescents, children and infants from 1 month of age: • For the control of status epilepticus. 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 [Product name]. _b) I.M. administration: _ spclorainj_DCP 2 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 Đọc toàn bộ tài liệu