Lanoxin 500 micrograms/2ml Solution for Injection

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Digoxin

Disponível em:

Aspen Pharma Trading Limited

Código ATC:

C01AA; C01AA05

DCI (Denominação Comum Internacional):

Digoxin

Dosagem:

0.25 percent volume/volume

Forma farmacêutica:

Solution for injection

Tipo de prescrição:

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

Área terapêutica:

Digitalis glycosides; digoxin

Status de autorização:

Not marketed

Data de autorização:

1980-04-01

Folheto informativo - Bula

1/8
PACKAGE LEAFLET: INFORMATION FOR THE USER
LANOXIN 500 MICROGRAMS/2ML SOLUTION FOR INJECTION
(DIGOXIN)
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, 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 Lanoxin Solution for Injection is and what it is used for
2.
What you need to know before you use Lanoxin Solution for Injection
3.
How to use Lanoxin Solution for Injection
4.
Possible side effects
5.
How to store Lanoxin Solution for Injection
6.
Contents of the pack and other information
1.
WHAT LANOXIN SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Lanoxin contains the active substance digoxin, which belongs to a
group of medicines called cardiac
glycosides. It is used to treat arrhythmias and heart failure. An
arrhythmia is an irregularity in the heart-
beat, which causes the heart to skip a beat, beat irregularly or beat
at the wrong speed. This medicine
works by correcting irregular heartbeats to a normal rhythm and
strengthens the force of the heart-beat,
which is why it is useful in heart failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LANOXIN SOLUTION FOR INJECTION
DO NOT USE LANOXIN SOLUTION FOR INJECTION IF YOU:
-
Are allergic to digoxin, other cardiac glycosides or any of the other
ingredients of this medicine
(listed in section 6).
-
Have serious heart problems, such as those with the conduction of the
electrical impulses in the
heart, especially if you have a history of Stokes-Adams attacks
(abrupt, short-lived loss of
consciousness caused by a sudden change in heart rate or rhythm).
-
Have an irregular heart-be

Características técnicas

Health Products Regulatory Authority
01 September 2022
CRN00D3Y6
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lanoxin 500 micrograms/2ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 250 micrograms Digoxin (500 micrograms per 2ml
ampoule).
Excipients with known effect:
Each 2ml ampoule contains 166mg of ethanol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
Lanoxin Injection is a clear, colourless, sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cardiac failure
Digoxin is indicated in the management of chronic cardiac failure
where the dominant problem is systolic dysfunction. Its
therapeutic benefit is greatest in those patients with ventricular
dilatation.
Digoxin is specifically indicated where cardiac failure is accompanied
by atrial fibrillation.
Supraventricular arrhythmias
Digoxin is indicated in the management of certain supraventricular
arrhythmias, particularly chronic atrial flutter and fibrillation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The dose of digoxin for each patient has to be tailored individually
according to age, lean body weight and renal function.
Suggested doses are intended only as an initial guide.
In cases where cardiac glycosides have been taken in the preceding two
weeks the recommendations for initial dosing of a
patient should be reconsidered and a reduced dose is advised.
The difference in bioavailability between injectable digoxin and oral
formulations must be considered when changing from one
dosage form to another. For example if patients are switched from oral
to the I.V. formulation the dosage should be reduced
by approximately 33%.
Adults and paediatric populations over 10 years
_Parenteral loading:_
Parenteral loading should only be used in patients who have not been
given cardiac glycosides within the preceding two weeks.
The total loading dose of parenteral digoxin is 500 to 1000micrograms
(0.5 to 1.0mg) dependi