Ativan 4 mg/ml Solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lorazepam

Available from:

Pfizer Healthcare Ireland

ATC code:

N05BA; N05BA06

INN (International Name):

Lorazepam

Dosage:

4 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Benzodiazepine derivatives; lorazepam

Authorization status:

Not marketed

Authorization date:

1977-06-27

Patient Information leaflet

Page 1 of 10
2020-0061924, 2020-
0061726
PATIENT LEAFLET: INFORMATION FOR THE USER
ATIVAN
®
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 ATIVAN INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ATIVAN INJECTION
3.
HOW TO TAKE ATIVAN INJECTION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ATIVAN INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ATIVAN 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.
Ativan 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.
Ativan Injection is not recommended for use in children under the age
of 12 years except for status
epilepticus where Ativan Injection can be used in adults and children
1 month of age and older.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ATIVAN INJECTION
Tell your doctor
or pharmacist if you have been given Ativan Injection before taking
any other
medicine, if you become pregnant or if you enter hospital for
treatment.
YOU SHOULD NOT BE GIVEN ATIVAN INJECTION:

If you have severe breathing or chest problems

If you have been prescribed benzodiazepines before a

Summary of Product characteristics

Health Products Regulatory Authority
05 November 2021
CRN009ZT0
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ativan 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:
Ativan 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 Ativan tablets.
Ativan should not be used for long-term chronic treatment.
PREPARATION OF THE INJECTION
Intramuscular administration:
A 1:1 dilution of Ativan Injection with normal saline or Sterile Water
for Injection BP is recommended in order