Temelor 4mg/ml solution for injection

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

LORAZEPAM

Disponibil de la:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Codul ATC:

N05BA06

INN (nume internaţional):

LORAZEPAM 4 mg/ml

Forma farmaceutică:

SOLUTION FOR INJECTION

Compoziție:

LORAZEPAM 4 mg/ml

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

PSYCHOLEPTICS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2019-08-06

Prospect

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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 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.
Temelor is used for adults and adolescents above 12 years who suffer
from severe fears or tension and for
any reason can not take any tablets.
Temelor 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 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);
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-
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

Caracteristicilor produsului

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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.
Temelor 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.
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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 sev