Betaloc 1 mg/ml solution for injection

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

METOPROLOL TARTRATE

Dostupno od:

Recordati Ireland Limited

ATC koda:

C07AB; C07AB02

INN (International ime):

METOPROLOL TARTRATE

Doziranje:

1 milligram(s)/millilitre

Farmaceutski oblik:

Solution for injection

Područje terapije:

Beta blocking agents, selective; metoprolol

Status autorizacije:

Marketed

Datum autorizacije:

1983-05-02

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BETALOC 1 MG/ML SOLUTION FOR INJECTION
metoprolol tartrate
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.
•
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 Betaloc Injection is and what it is used for
2.
What you need to know before you use Betaloc Injection
3.
How to use Betaloc Injection
4.
Possible side effects
5.
How to store Betaloc Injection
6.
Contents of the pack and other information
1.
WHAT BETALOC INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Betaloc 1 mg/ml Solution for Injection
(called Betaloc Injection
in the rest of this leaflet). Betaloc Injection contains a medicine
called metoprolol tartrate. This
belongs to a group of medicines called beta-blockers.
Betaloc Injection is used:
•
To treat uneven heart beats (arrhythmias).
•
After a heart attack (myocardial infarction).
It works by making your heart beat more slowly and with less force.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BETALOC INJECTION
DO NOT HAVE BETALOC INJECTION
•
If you are allergic to metoprolol tartrate or any of the other
ingredients of this medicine
(listed in Section 6).
•
If you are allergic to any other beta-blocker medicines (such as
atenolol or propranolol).
•
If you have ever had any of the following heart problems:
- heart attack with shock
- heart failure which is not under control (this usually makes you
breathless and causes
your ankles to swell)
- second- or third-degree heart block (a condition which may be
treated by a pacemaker)
- very slow or very uneven heart beats (unless a permanent pacemaker
is in place).
•
If you have low blood pressure which may make you feel faint.
•
If you have very poor circulation.
•
If you ha

Svojstava lijeka

Health Products Regulatory Authority
06 March 2024
CRN00F4X4
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betaloc 1 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 1 mg metoprolol tartrate.
Each ampoule of 5 ml contains 5 mg metoprolol tartrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection. (Injection)
Clear, colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Control of tachyarrhythmias, especially supraventricular
tachyarrhythmias. The electrocardiogram should be monitored while
undergoing treatment.
Early intervention with Betaloc Injection in acute myocardial
infarction reduces infarct size and the incidence of ventricular
fibrillation. Pain relief may also decrease the need for opiate
analgesics. Betaloc Injection has been shown to reduce mortality
when administered to patients with acute myocardial infarction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose must always be adjusted to the individual requirements of the
patient. The following are guidelines:
Cardiac arrhythmias: Initially up to 5 mg injected intravenously at a
rate of
1–2 mg per minute. The injection can be repeated at 5 minute
intervals until a satisfactory response has been obtained. A
total dose of 10–15 mg generally proves sufficient.
Because of the risk of a pronounced drop of blood pressure, the i.v.
administration of Betaloc to patients with a systolic blood
pressure below 100 mmHg should only be given with special care.
During anaesthesia: 2-4 mg injected slowly i.v. at induction is
usually sufficient to prevent the development of arrhythmias
during anaesthesia. The same dosage can also be used to control
arrhythmias developing during anaesthesia. Further
injections of 2 mg may be given as required to a maximum overall dose
of 10 mg.
Myocardial infarction: Early intervention. To achieve optimal benefits
from intravenous Betaloc, suitable patients should present
with