FUROSEMIDE

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

FUROSEMIDE

Tilgjengelig fra:

Fresenius Kabi Limited

ATC-kode:

C03CA01

INN (International Name):

FUROSEMIDE

Dosering :

20 mg/2ml

Legemiddelform:

Solution for Injection

Resept typen:

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

Terapeutisk område:

furosemide

Autorisasjon status:

Not Marketed

Autorisasjon dato:

2008-02-01

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Furosemide 20mg/2ml solution for injection
(Furosemide)
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.

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 or nurse. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Furosemide is and what it is used for
2.
What you need to know before you use Furosemide
3.
How to use Furosemide
4.
Possible side effects
5.
How to store Furosemide
6.
Contents of the pack and other information
1. WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR
Furosemide belongs to a group of medicines called diuretics.
Furosemide increases
the amount of urine produced by your body.
Furosemide is used to rid the body of too much fluid (also called
oedema). Too much
fluid can be caused by:

heart problems

liver problems

kidney problems
Furosemide is also used:

in periods with extremely high blood pressure that may lead to
life-threatening
conditions (hypertensive crisis).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FUROSEMIDE
DO NOT USE FUROSEMIDE IF:

You are allergic to Furosemide, or any of the other ingredients of
this
medicine (listed in section 6)

You are allergic to sulphonamide antibiotics

You are severely dehydrated (you have lost lots of body fluid for
example by
suffering from severe diarrhoea or being sick)

You have kidney failure and are not producing urine, despite treatment
with
furosemide

You have kidney failure as a consequence of poisoning with kidney or
liver
toxic substances

You have very low levels of potassium or sodium in your blood

The patient is in a coma caused by liver failure

You are bre

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide 20 mg/2 ml solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml ampoule contains 20 mg of Furosemide corresponding to 10 mg
furosemide per ml.
Excipients 7.4 mg of sodium per ampoule (3.7 mg per ml)
_For the full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to almost colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Oedema and/or ascites caused by cardiac or hepatic diseases
-
Oedema caused by renal diseases (in case of nephrotic syndrome,
treatment of the underlying disease is essential)
-
Pulmonary oedema (e.g. in case of acute heart failure)
-
Hypertensive crisis (in addition to other therapeutic measures)
The parenteral administration of furosemide is indicated in cases
where a prompt and effective diuresis is required and
oral administration is not feasible or not efficient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
The lowest dose with which the desired effect is achieved should
always be used.
The duration of the treatment should be determined by the doctor and
be appropriate to the type and severity of the
disease.
The parenteral administration of furosemide is indicated in cases
where oral administration is not feasible or not
efficient (for example in case of reduced intestinal absorption) or
when a quick effect is required. In cases where
parenteral administration is used, the switch to oral administration
is recommended, as soon as possible.
To achieve optimum efficacy and suppress counter-regulation, a
continuous furosemide infusion is generally to be
preferred to repeated bolus injections.
Where continuous furosemide infusion is not feasible for follow-up
treatment after one or several acute bolus doses, a
follow-up regimen with low doses given at short intervals (approx. 4
hours) is to be preferred to a regimen with higher
bolus doses at longer intervals.
Intravenous administration of furosemide must be slow; a