Furosemide 250mg in 25ml Solution for Injection/Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Furosemide

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

C03CA; C03CA01

INN (International Name):

Furosemide

Dosage:

250/25 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

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

Therapeutic area:

Sulfonamides, plain; furosemide

Authorization status:

Not marketed

Authorization date:

1990-05-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FUROSEMIDE 250MG IN 25ML SOLUTION FOR INJECTION/INFUSION
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 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.
This product will be referred to as Furosemide Injection/Infusion from
here onwards.
WHAT IS IN THIS LEAFLET
1. What Furosemide Injection/Infusion is and what it is used for
2. What you need to know before you are given Furosemide Injection
/Infusion
3. How Furosemide Injection/Infusion
is given to you
4. Possible side effects
5. How to store Furosemide Injection/Infusion
6. Contents of the pack and other information
1. WHAT FUROSEMIDE INJECTION/INFUSION IS AND WHAT IT IS USED FOR
Furosemide is a strong diuretic. Diuretics help you to pass more water
(urine).
Furosemide Injection/Infusion may be used to help you to pass more
water when your kidneys are not
producing enough urine.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FUROSEMIDE INJECTION
/INFUSION
YOU SHOULD NOT BE GIVEN FUROSEMIDE IF-
-you are allergic to furosemide or any of the other ingredients of
this medicine (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips,
face, throat or tongue
-you are allergic to amiloride, sulfonamides or sulphonamide
derivatives, such as sulfadiazine or
cotrimoxazole
-you have a low blood volume or are dehydrated (with or without
accompanying low blood pressure)
-you have too little potassium or sodium in your blood (shown in blood
test)
-you have severe liver problems (cirrhosis)
-you have already taken Furosemide in the past to treat failure to
pass urine or kidney failure or if you
have kidney failure that is due to medicines or chemicals that are
prone to cause ki

Summary of Product characteristics

Health Products Regulatory Authority
16 November 2020
CRN009W5D
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide 250mg in 25ml Solution for Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains Furosemide 10mg.
Each 25ml ampoule contains Furosemide 250mg
Excipient with known effect: Each 25ml contains 91 mg (4mmol) sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection/Infusion.
Clear, colourless or almost colourless sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Furosemide Injection 250mg/25ml is for use in the management of
oliguria due to acute or chronic renal insufficiency with a
glomerular filtration rate below 20ml/minute.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doses of 20 to 50 mg intramuscularly or intravenously may be given
initially. If larger doses are required, they should be given
increasing by 20 mg increments and not given more often than every two
hours. If doses greater than 50 mg are required it is
recommended that they be given by slow intravenous infusion. The
recommended maximum daily dose of furosemide
administration is 1,500 mg.
The recommended initial dose is one 25ml ampoule (250mg) diluted in
225ml Sodium Chloride Injection BP or Ringer's
solution for injection, administered over one hour. If urine output is
insufficient within the next hour, a dose of two 25ml
ampoules (500mg) in an appropriate infusion fluid may be given over
two hours. The total volume of the infusion should be
governed by the patient's state of hydration. If a satisfactory urine
output has still not been achieved within one hour of the
end of the second infusion, a third infusion containing four 25ml
ampoules (1,000mg) may be given. The rate of infusion
should not exceed 4mg/minute.
In oliguric or anuric patients with significant fluid overload, the
injection may be given without dilution directly into the vein,
using a constant-rate infusion pump with a mic