Sedalor 2mg/10 ml solution for injection or infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LORMETAZEPAM

Available from:

Dr. Franz Kohler Chemie GmbH Werner-von-Siemens-Str. 22-28, D-64625, Bensheim, Germany

ATC code:

N05CD06

INN (International Name):

LORMETAZEPAM 2 mg

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

LORMETAZEPAM 2 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2014-01-15

Patient Information leaflet

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

Summary of Product characteristics

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