Furosemide 20 mg/2 ml solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Furosemide

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

C03CA; C03CA01

INN (International Name):

Furosemide

Dosage:

20 mg/2ml

Pharmaceutical form:

Solution for injection

Therapeutic area:

Sulfonamides, plain; furosemide

Authorization status:

Not marketed

Authorization date:

2008-02-01

Patient Information leaflet

UK-IE PIL Furosemide V006
PACKAGE LEAFLET: INFORMATION FOR THE USER
Furosemide 20mg/2ml
solution for injection/infusion
furosemide
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 relieve symptoms caused when your body contains
too much fluid (also
called oedema). Too much fluid can be caused by:
•
heart problems
•
liver problems
•
kidney problems
Your doctor has prescribed Furosemide for one of the following
reasons:
•
When quick and effective removal of excess fluid is needed.
•
You are not able to take this kind of medicine by mouth or in an
emergency.
•
You have too much fluid around your heart, lungs, liver or kidneys.
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)
▪
if you are allergic to sulphonamide antibiotics
▪
if you are severely dehydrated (you have lost lots of body fluid for
example by
suffering from severe diarrhoe

Summary of Product characteristics

Health Products Regulatory Authority
03 November 2023
CRN00DDZX
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide 20 mg/2 ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml ampoule contains 20 mg of furosemide corresponding to 10 mg
furosemideper ml.
Excipient with known effect:
This medicinal product contains 3.7 mg sodium per ml.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless to almost colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Oedema and/or ascitescaused by cardiac or hepatic diseases
- Oedema caused by renal diseases (in case of nephroticsyndrome,
treatment of the underlying disease is essential)
- Pulmonaryoedema (e.g. in case of acute heart failure)
- Hypertensivecrisis (in addition to other therapeutic measures)
The parenteral administration of furosemide is indicated for use
incases where a prompt and effective diuresis is required or
oral administrationis 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 pref