Xilmac 4 mg/ml Solution for injection

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Lorazepam

Disponível em:

Macure Healthcare Limited

Código ATC:

N05BA; N05BA06

DCI (Denominação Comum Internacional):

Lorazepam

Forma farmacêutica:

Solution for injection

Área terapêutica:

Benzodiazepine derivatives; lorazepam

Status de autorização:

Not marketed

Data de autorização:

1977-06-27

Folheto informativo - Bula

Page 1 of 10 2021-0074032, 2021-0074033
PATIENT LEAFLET: INFORMATION FOR THE USER
XILMAC
® 4 MG/ML SOLUTION FOR INJECTION
lorazepam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT XILMAC INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN XILMAC INJECTION
3.
HOW TO TAKE XILMAC INJECTION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE XILMAC INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT XILMAC INJECTION IS AND WHAT IT IS USED FOR
This medicine contains lorazepam, which is a member of a group of
medicines called benzodiazepines.
It helps to relieve anxiety and muscle tension.
Xilmac Injection is usually prescribed as premedication before surgery
or uncomfortable or prolonged
investigations. It may also be used to relieve acute anxiety states,
acute excitement or acute mania, and
in the control of convulsions.
You must talk to a doctor if you do not feel better or if you feel
worse.
Xilmac Injection is not recommended for use in children under the age
of 12 years except for status
epilepticus where Xilmac Injection can be used in adults and children
1 month of age and older.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE XILMAC INJECTION
Tell your doctor or pharmacist if you have been given Xilmac Injection
before taking any other
medicine, if you become pregnant or if you enter hospital for
treatment.
YOU SHOULD NOT BE GIVEN XILMAC INJECTION:
•
If you have severe breathing or chest problems
•
If you have been prescribed benzodiazepines before an

Características técnicas

Health Products Regulatory Authority
25 January 2023
CRN00DCZR
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xilmac 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:
Each ampoule with 1 ml solution contains 20.9 mg benzyl alcohol, 822.6
mg propylene glycol and 202.5 mg polyethylene
glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection).
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Premedication for dental or general surgery or for minor invasive
investigations, e.g. bronchoscopy, arteriography, endoscopy
in adults and paediatric patients 12 years of age and older.
The treatment of acute anxiety states, acute excitement or acute mania
in adults and paediatric patients 12 years of age and
older.
The control of status epilepticus in adults, adolescents, children and
infants from 1 month of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Dosage and duration of therapy should be individualised. The lowest
effective dose should be prescribed for the shortest time
possible. The risk of withdrawal and rebound phenomena is greater
after abrupt discontinuation; therefore, the drug should be
discontinued gradually in all patients (see section 4.4).
Method of administration
Xilmac Injection can be given intravenously or intramuscularly.
However, the intravenous route is to be preferred. Care should
be taken to avoid injection into small veins and intra‑arterial
injection.
Absorption from the injection site is considerably slower if the
intramuscular route is used and as rapid an effect may be
obtained by oral administration of Lorazepam tablets.
Xilmac should not be used for long-term chronic treatment.
PREPARATION OF THE INJECTION
Intramuscular administration:
A 1:1 dilution of Xilmac Injection with normal saline or Sterile Water
for Injection BP is recommended in orde