Revision Year: 2011 Publisher: RS & M Consulting GmbH, Industriestrasse 8, D-82194 Groebenzell, GERMANY
Sedalor 2 mg/10 ml solution for injection or for infusion is indicated:
In children from 2 years and adolescents Sedalor 2 mg/10 ml solution for injection or for infusion is only indicated for administration prior to diagnostic or surgical interventions (anaesthesia, intensive care).
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.
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 2 mg/10 ml solution for injection or for infusion |
| 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 2 mg/10 ml solution for injection or for infusion |
| 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 2 mg/10 ml solution for injection or for infusion |
| 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 basic sedation before intervention under local anaesthesia
Prior to anaesthesia:
| Recommended Dosage of Lormetazepam | Equivalent Dosage of Sedalor 2 mg/10 ml solution for injection or for infusion |
| 0.4–1.0 mg Lormetazepam, equivalent to 0.006 – 0.015 mg/kg body weight | 2-5 ml |
And additionally during the intervention depending on the intended depth of sedation:
| Recommended Dosage of Lormetazepam | Equivalent Dosage of Sedalor 2 mg/10 ml solution for injection or for infusion |
| up to a total dose of 2.0 mg Lormetazepam | up to 10 ml |
e) Symptomatic treatment of acute attacks of tension, excitation and anxiety during interventions for diagnostic purposes
| Recommended Dosage of Lormetazepam | Equivalent Dosage of Sedalor 2 mg/10 ml solution for injection or for infusion |
| 0.6–1.0 mg Lormetazepam, equivalent to 0.009–0.015 mg/kg body weight | 3-5 ml |
f) Basic sedation during intensive care
Up to a depth of sedation of RASS 0 / − 1, if required, up to RASS-3.
| Recommended Dosage of Lormetazepam | Equivalent Dosage of Sedalor 2 mg/10 ml solution for injection or for infusion |
| 0.2–0.4 mg Lormetazepam | 1–2 ml |
Administer and dose carefully – especially if cardiac and respiratory performance is inadequate (cardiorespiratory insufficiency). Often, excretion is delayed in elderly patients, whereas the effects of benzodiazepines may be enhanced.
Patients in a poor general condition, especially those with organic brain changes, circulatory or respiratory insufficiency:
| Recommended Dosage of Lormetazepam | Equivalent Dosage of Sedalor 2 mg/10 ml solution for injection or for infusion |
| 0.2–1.0 mg Lormetazepam, equivalent to 0.003–0.015 mg/kg body weight | 1-5 ml |
Children from 2 to 10 years of age:
| Recommended Dosage of Lormetazepam | Equivalent Dosage of Sedalor 2 mg/10 ml solution for injection or for infusion |
| 0.1–0.8 mg Lormetazepam, equivalent to 0.0015–0.012 mg/ kg body weight | 0.5-4 ml |
Taking the respective age group into account, slowly administer into large calibre veins (not faster than 5 ml injection solution/min). Observe the recommended dosage and continuously pay close attention to respiration, blood pressure and heart rate.
The daily dose in children should not exceed 3.5 mg (see also below “Maintenance of the effect”).
Children from 10 to 12 years follow the posology of the adults.
The dosage recommendations for children under 10 years are based on very limited clinical experience in this age group.
Repeated administration of Sedalor 2 mg/10 ml solution for injection or for infusion is possible. In general however, daily doses should not exceed 5 mg Lormetazepam in adults, 4 mg in risk patients and 3.5 mg in children and adolescents.
Generally, slowly administer (approx. 5 ml injection solution/min) into large calibre veins. Thereby, pay close attention to respiration, blood pressure and heart rate.
Sedalor 2 mg/10 ml solution for injection or for infusion may be administered without dilution and it may be administered together with the named solutions for infusion (see below).
Sedalor 2 mg/10 ml solution for injection or for infusion is administered without dilution.
Sedalor 2 mg/10 ml solution for injection or for infusion has to be administered exclusively intravenously. It is not suitable for intramuscular injection. Intraarterial application should be avoided. In case of an unintended intraarterial injection of Sedalor 2 mg/10 ml solution for injection or for infusion, flush the concerning artery with 50 ml physiologic saline solution by the indwelling needle. Afterwards pull out the needle and bandage up the puncture by a pressure bandage. For further information please refer to section 6.6.
Sedalor 2 mg/10 ml solution for injection or for infusion may be added to 5% glucose solution, 0.9% physiologic sodium chloride solution or to Ringer’s solution, respectively. The application of further medicines or infusions into an ongoing infusion of Lormetazepam should be carried out by a three-way connection or an ypsiloid connection immediately next to the infusion tube.
For further information please refer to section 6.6.
Duration of administration:
The designated starting dose of Sedalor 2 mg/10 ml solution for injection or for infusion should be administered within 2 minutes, to obtain the desired effect. The choice of the maintenance dose depends on the required degree of effect and on the compliance of the patient.
Without a compelling reason, Sedalor 2 mg/10 ml solution for injection or for infusion should not be used longer than about a week.
Thereby, the duration of administration and treatment depends on the medical necessities and is decided by the responsible attending doctor.
As with other benzodiazepines, overdose of Lormetazepam should not present a threat to life unless combined with other CNS depressants (including alcohol).
Overdose of benzodiazepines is usually – in relation to the applied dose – manifested by degrees of central nervous system depression that may range from somnolence, mental confusion, lethargy, visual disorders and dystonia up to ataxia, unconsciousness, central respiratory and circulatory depression and coma. Other symptoms may include: depression of consciousness, paradoxical reactions, agitation and hallucinations.
Treatment of overdose is mainly symptomatic:
Patients with milder symptoms of intoxication should be allowed to sleep them off under observation of respiratory and circulatory functions. In severe cases further measures should be taken, such as gastric lavage, stabilisation of cardiovascular functions and close observation in intensive care.
If necessary, the specific benzodiazepine antagonist, flumazenil, may be useful in hospitalised patients for the management of benzodiazepine overdose. Flumazenil product information should be consulted prior to use.
Due to pronounced plasma protein binding and the high volume of distribution, forced diuresis or haemodialysis is only of limited benefit in cases of intoxication with Lormetazepam solely.
Unopened ampoules: 24 months.
Diluted in tested solutions for infusion: 24 hours.
The compatibility of a mixture of Sedalor 2 mg/10 ml solution for injection or for infusion with common solutions for infusion (5% glucose, 0.9% physiologic sodium chloride, Ringer’s solution) has been demonstrated for up to 24 hours at room temperature.
Do not store above 25°C.
Do not freeze.
For storage conditions after mixture of the medicinal product with solutions for infusion, see section 6.3.
Cardboard boxes containing:
5 glass ampoules of 10 ml
25 glass ampoules of 10 ml
50 glass ampoules of 10 ml
100 glass ampoules of 10 ml
Not all pack sizes may be marketed.
Do not use Sedalor 2 mg/10 ml solution for injection or for infusion, if the solution shows any turbidity or has been frozen.
Before opening the ampoule, wipe off the neck of the ampoule with medical alcohol (spray or alcohol pads). Discard the broken ampoules after administration of the medicinal product.
Sedalor 2 mg/10 ml solution for injection or for infusion does not contain any antimicrobial preservatives. Therefore, immediately after opening and under aseptic conditions, the contents of the ampoule has to be transferred into a sterile syringe for injection or into a sterile infusion set, in case of infusions.
Administration of Sedalor 2 mg/10 ml solution for injection or for infusion has to be started immediately. The contents of each ampoule containing Sedalor 2 mg/10 ml solution for injection or for infusion, must only be administered as single administration for one patient.
In case of infusion of Sedalor 2 mg/10 ml solution for injection or for infusion, use a burette, a drop counter, a syringe pump with infusion lines or a volumetric pump to control the infusion rate.
During infusion, strictly observe aseptic conditions for Sedalor 2 mg/10 ml solution for injection or for infusion itself as well as for the infusion device.
The contents of each ampoule or each syringe or each infusion system containing Sedalor 2 mg/10 ml solution for injection or for infusion, must only be administered as single administration for one patient.
After administration of injection or after termination of infusion or change of the infusion system, all remains of the solution have to be discarded.
Addition to solutions for infusion:
Sedalor 2 mg/10 ml solution for injection or for infusion may be added to 5 % glucose solution, 0.9% physiologic sodium chloride solution or to Ringer’s solution, respectively.
The ampoules of Sedalor 2mg/10 ml solution for injection or for infusion are intended for single use. 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.
