Lasix 20mg/2ml Solution for Injection or Infusion

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Preparatomtale Preparatomtale (SPC)
24-02-2023

Aktiv ingrediens:

Frusemide

Tilgjengelig fra:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC-kode:

C03CA; C03CA01

INN (International Name):

Frusemide

Dosering :

20 mg/2ml

Legemiddelform:

Solution for injection/infusion

Resept typen:

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

Terapeutisk område:

Sulfonamides, plain; furosemide

Autorisasjon status:

Marketed

Autorisasjon dato:

1977-04-01

Informasjon til brukeren

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
LASIX 20MG/2ML
SOLUTION FOR INJECTION OR INFUSION
_FUROSEMIDE _
SANOFI LOGO
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE 01 403 5600 FOR HELP
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 pharmacist.
• 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 Lasix Injection is and what it is used for
2. What you need to know before you take Lasix Injection
3. How Lasix Injection is given
4. Possible side effects
5. How to store Lasix Injection
6. Contents of the pack and other information
1. WHAT LASIX INJECTION IS AND WHAT IT IS USED FOR
WHAT LASIX INJECTION IS
The name of your medicine is Lasix 20mg/2ml Solution for Injection or
Infusion (called Lasix Injection
throughout this leaflet). Lasix Injection contains a medicine called
furosemide. Lasix Injection belongs to
a group of medicines called diuretics (water tablets).
WHAT LASIX INJECTION IS USED FOR
Lasix Injection can be used to help you lose extra water in your body
very quickly. It is given when you
cannot take a tablet or when you have a lot of extra water in your
body. Lasix Injection is often used
when you have too much water around your heart, lungs, liver or
kidneys.
HOW LASIX INJECTION WORKS
Lasix Injection works by helping you to pass more water (urine) than
you usually do. If the extra water in
your body is not removed, it can put extra strain on the heart, blood
vessels, lungs, kidneys or liver. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LASIX INJECTION
DO NOT TAKE LASIX INJECTION IF:
• You are allergic (hypersensitive) to furosemide or any of the
other ingredients of Lasix Injection (listed
in Section 6 below) Signs of an allergic reaction include: a rash,
swallowing or breathing problems,
s
                                
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Preparatomtale

                                Health Products Regulatory Authority
23 February 2023
CRN00CPW7
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lasix 20mg/2ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Furosemide 20mg in 2ml aqueous solution.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection or Infusion.
Clear, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lasix is used for the management of fluid retention and for the
management of mild to moderate hypertension, either alone or
as an adjunct.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
General: The dose used must be the lowest that is sufficient to
achieve the desired effect.
Route of administration: intramuscular or intravenous
Furosemide is given intravenously only when oral administration is not
feasible or is ineffective (e.g. in impaired intestinal
absorption) or if a rapid effect is required. If intravenous therapy
is used, it is recommended that transfer to oral therapy be
carried out as soon as possible.
Intravenous furosemide must always be injected or infused slowly, a
rate of 4mg per minute must not be exceeded. The
diuretic effect of Lasix is proportional to the dosage.
In patients with severe impairment of renal function (serum creatinine
>5 mg/dl), it is recommended that an infusion rate of 2.5
mg per minute is not exceeded.
Intramuscular administration must be restricted to exceptional cases
where neither oral nor intravenous administration are
feasible. It must be noted that intramuscular injection is not
suitable for the treatment of acute conditions such as pulmonary
oedema.
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 
                                
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