Temelor 4 mg/ml oplossing voor injectie

Ország: Hollandia

Nyelv: holland

Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktív összetevők:

LORAZEPAM 4 mg/ml

Beszerezhető a:

Medochemie Limited Constantinopelstreet 1-10 3011 LIMASSOL (CYPRUS)

ATC-kód:

N05BA06

INN (nemzetközi neve):

LORAZEPAM 4 mg/ml

Gyógyszerészeti forma:

Oplossing voor injectie

Összetétel:

BENZYLALCOHOL (E 1519) 21 mg/ml ; MACROGOL 400 ; PROPYLEENGLYCOL (E 1520) 840 mg/ml ; STIKSTOF (HEAD SPACE) (E 941)

Az alkalmazás módja:

Intraveneus gebruik, Intramusculair gebruik

Terápiás terület:

Lorazepam

Engedély dátuma:

1900-01-01

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMELOR 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,
evenif 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);
-
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 severe liver problems.
Te

Termékjellemzők

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Temelor 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
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.
[Product name] 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 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