Betaloc I.V. 5mg/5ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metoprolol tartrate

Available from:

Recordati Pharmaceuticals Ltd

ATC code:

C07AB02

INN (International Name):

Metoprolol tartrate

Dosage:

1mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5014162002715

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BETALOC
® IV 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 IV is and what it is used for
2.
What you need to know before you use Betaloc IV
3.
How to use Betaloc IV
4.
Possible side effects
5.
How to store Betaloc IV
6.
Contents of the pack and other information
1.
WHAT BETALOC IV INJECTION IS AND WHAT IT IS USED FOR
Betaloc IV Injection contains a medicine called metoprolol tartrate.
This belongs to a group of
medicines called beta-blockers. Betaloc IV Injection is used:

To treat uneven heart beat (arrhythmia).

After a heart attack.
It works by making your heart beat more slowly and with less force.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BETALOC IV
DO NOT HAVE BETALOC IV 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 propanolol).

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 have a tumour called phaeochromocytoma that is not being
treated. This is usually
near your kidney and can cause high blood pressure. If you are being
treated for
phaeochromocytoma your docto

Summary of Product characteristics

OBJECT 1
BETALOC I.V. INJECTION
Summary of Product Characteristics Updated 14-Mar-2017 | AstraZeneca
UK Limited
1. Name of the medicinal product
Betaloc I.V. Injection
2. Qualitative and quantitative composition
Each ampoule of 5 ml contains 5 mg Metoprolol tartrate Ph. Eur.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection
4. Clinical particulars
4.1 Therapeutic indications
Control of tachyarrhythmias, especially supraventricular
tachyarrhythmias.
Early intervention with Betaloc I.V. 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 I.V. 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 I.V.
Injection 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:
Intravenous Betaloc I.V. Injection should be initiated in a coronary
care or similar unit when the patient's
haemodynamic condition has stabilised. Therapy should commence with 5
mg I.V. every 2 minutes to a
maximum of 15 mg total as determined by blood p