Trandate 5mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Labetalol hydrochloride

Available from:

RPH Pharmaceuticals AB

ATC code:

C07AG; C07AG01

INN (International Name):

Labetalol hydrochloride

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

Alpha and beta blocking agents; labetalol

Authorization status:

Marketed

Authorization date:

1993-07-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRANDATE 5MG/ML SOLUTION FOR INJECTION
labetalol hydrochloride
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 or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects
not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1. What Trandate injection is and what it is used for
2. What you need to know before you are given Trandate injection
3. How you will be given Trandate injection
4. Possible side effects
5. How to store Trandate injection
6. Contents of the pack and further information
1. WHAT TRANDATE INJECTION IS FOR
In this leaflet Trandate 5 mg/ml Solution for Injection will be called
Trandate injection.
Trandate injection belongs to a group of medicines called beta
blockers.
Trandate injection works by causing the heart to beat more slowly and
with less force. It also widens
the arteries in the body. This helps to lower the pressure of the
blood as it travels around the body.
The result is a rapid lowering of a person’s blood pressure.
Trandate injection is given in hospital and
can be used to:
• Lower very high blood pressure, especially in pregnant women
• Keep your blood pressure down during an operation
• Lower high blood pressure after a heart attack.
It is very important that the doctor treats your high blood pressure,
because left untreated it can
cause damage to your blood vessels in the long-term. This could lead
to heart attacks, kidney failure,
stroke or blindness.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TRANDATE INJECTION
DO NOT USE TRANDATE INJECTION :
• if you are allergic to labetalol hydrochloride or any of the other
ingredients of this medicine (listed
in section 6
• if your heart cannot maintain adequate circulation of blood
(cardiogenic shock)
• if you have heart fa

Summary of Product characteristics

Health Products Regulatory Authority
09 March 2023
CRN00DFXS
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trandate 5mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 5mg labetalol hydrochloride.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection
A colourless or very pale yellow solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Trandate Injection is indicated for the treatment of:-
1. Severe hypertension, including severe hypertension of pregnancy,
when rapid control of blood pressure is essential.
2. Anaesthesia when a hypotensive technique is indicated.
3. Hypertensive episodes following acute myocardial infarction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS:_
Trandate Injection is intended for intravenous use in hospitalised
patients. The plasma concentrations achieved after
intravenous dose of Trandate in severe hypertension are substantially
greater than those following oral administration of the
drug and provide a greater degree of blockade of alpha-adrenoceptors
necessary to control the more severe disease. Patients
should, therefore, always receive the drug whilst in the supine or
left lateral position. Raising the patient into the upright
position, within three hours of intravenous Trandate administration,
should be avoided since excessive postural hypotension
may occur.
_BOLUS INJECTION_
If it is essential to reduce blood pressure quickly, as for example,
in hypertensive encephalopathy, a dose of 50mg of Trandate
should be given by intravenous injection over a period of at least one
minute. If necessary, doses of 50mg may be repeated at
five minute intervals until a satisfactory response occurs. The total
dose should not exceed 200mg. After bolus injection, the
maximum effect usually occurs within five minutes and the effective
duration of action is usually about six hours but may be as
long as eighteen hours.
_INTRAVENOUS INFUSION_
An alternative method