Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Medochemie Iberia, S.A., Rua Jose Maria Nicolau, no 6, 7oB, São Domingos de Benfica, Lisboa 1500 662, Portugal
Temelor is indicated in adults and adolescents above 12 years of age:
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 involvement, the simultaneous use of an analgesic may be appropriate.
The dose should be reduced in case of concomitant administration of central nervous system depressants.
Temelor should not be mixed with other drugs in the same syringe.
Symptomatic treatment of pathological anxiety and tension in patients who, for some reason, are unable to take oral medication.
The recommended initial dose is 2-4 mg I.V. or 0.05 mg/kg I.M. (intravenous administration is preferred). If necessary, the dose may be repeated after 2 hours. As soon as the acute symptomatology is controlled, the patient must receive appropriate treatment for the underlying condition.
The use of lorazepam tablets may be considered if further treatment with benzodiazepines is required.
The use of Temelor in children under 12 years is contraindicated (see section 4.3).
Clinical studies have shown that patients over 50 years of age have a deeper and prolonged sedation when lorazepam is administered intravenously.
In normal conditions, a starting dose of 2 mg should be sufficient unless a greater degree of sedation and/or preoperative impairment of memory is desired.
For elderly and debilitated patients reduce the initial dose by approximately 50% and adjust the dosage as needed and tolerated (see section 4.4).
Temelor is not recommended for use in patients with severe hepatic insufficiency. When Temelor is used in patients with mild to moderate hepatic or renal insufficiency, a starting dose of 0.05 mg/kg (but not more than 2 mg) is recommended.
For instructions on dilution of the medicinal product before administration, see section 6.6.
As with other benzodiazepines, an overdose will not cause a life-threatening situation, except in combination with other drugs with inhibitory effects on the central nervous system (including alcohol).
In the treatment of overdose with any drug, one should keep in mind that the patient may have taken different medicines.
Particular attention should be paid to respiratory and cardiovascular functions on the intensive care.
Overdose with benzodiazepines usually results in different degrees of central nervous system dampening, ranging from sleepiness to coma. In mild cases, symptoms include sleepiness, mental confusion and lethargy.
In severe cases, symptoms may occur such as ataxia, hypotension, hypotonia, respiratory depression, rarely coma (stages 1 to 3) and, very rarely, the patient’s death.
Flumazenil may be useful as antidote.
Cases of lactic acidosis, hyperosmolality, hypotension possibly related to propylene glycol (excipient) were reported on administration of injectable lorazepam in higher than the recommended doses. The risk of these symptoms is greater in patients with renal insufficiency and in children (see section 4.4).
Unopened: 18 months.
Stability after dilution: Chemical and physical in-use stability has been demonstrated for 1 hour at 2-8⁰C. From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Store and transport refrigerated (2°C–8°C). Keep in the outer carton to protect from light.
For storage conditions after dilution/first opening of the medicinal product, see section 6.3.
Temelor is packed in Type I (Ph.Eur), clear glass ampoule of 2 ml filling capacity. The ampoules are placed in moulded polyvinyl chloride trays, which are then sealed by a protective PE transparent foil.
The polyvinyl chloride trays are inserted in a carton box together with a leaflet.
Box of 5 and 10 ampoules of 1 ml solution.
Not all pack sizes may be marketed.
Temelor is slightly viscous when cool.
In order to facilitate intramuscular administration, dilution with an equal volume of a compatible solution is recommended, such as 0.9% NaCl, 5% Glucose, Bacteriostatic Water for injection with Benzyl alcohol, Bacteriostatic NaCl for injection- with Benzyl alcohol, Bacteriostatic Water for injection with paraben and Water for injection.
Temelor can be also administered undiluted, if given deeply in a large muscle mass.
In case of intravenous administration, Temelor should always be diluted with an equal volume of one of the following diluents: 0.9% NaCl, 5% Glucose, Bacteriostatic Water for injection with Benzyl alcohol, Bacteriostatic NaCl for injection with Benzyl alcohol, Bacteriostatic Water for injection with paraben and Water for injection.
The injection rate should not exceed 2 mg/min. Parenteral medicines must be inspected visually for the presence of particles or discolourations prior to administration.
Extract the desired amount of Temelor into the syringe, then slowly suck the desired volume of diluent. Retract the piston slightly to provide an additional mixing space. Immediately mix the contents by repeatedly twisting the syringe until a homogeneous solution has formed. Do not shake vigorously as this will cause air bubbles.
Temelor should not be mixed with other drugs in the same syringe. Do not use if solution has developed a colour or a precipitate (see section 4.2).
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
