Lorazepam Macure 4 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lorazepam

Available from:

Macure Pharma ApS

ATC code:

N05BA06

INN (International Name):

Lorazepam

Dosage:

4 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

lorazepam

Authorization status:

Marketed

Authorization date:

2021-11-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LORAZEPAM MACURE 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 Lorazepam Macure is and what it is used for
2.
What you need to know before you use Lorazepam Macure
3.
How to use Lorazepam Macure
4.
Possible side effects
5.
How to store Lorazepam Macure
6.
Contents of the pack and other information
1.
WHAT LORAZEPAM MACURE IS AND WHAT IT IS USED FOR
Lorazepam Macure belongs to a certain group of sedative-hypnotic
medicines, called benzodiazepines.
Lorazepam Macure is used as a sedative to initiate certain
interventions (premedication), such as small or
large surgical procedures or certain extensive physical examinations.
Lorazepam Macure is also used for people who suffer from severe fears
or tension and for any reason can
not take any tablets.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LORAZEPAM MACURE
DO NOT USE LORAZEPAM MACURE:
-
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.
Lorazepam Macure may not be injected into an artery.
CHILDREN
Children under 12 years old are

Summary of Product characteristics

Health Products Regulatory Authority
16 October 2023
CRN00DSD3
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lorazepam Macure 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
Lorazepam Macure 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.
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 Lorazepam Macure.
_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 recommende