Furosemide 50mg in 5ml Solution for Injection

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Furosemide

Beschikbaar vanaf:

Mercury Pharmaceuticals (Ireland) Ltd

ATC-code:

C03CA; C03CA01

INN (Algemene Internationale Benaming):

Furosemide

Dosering:

50 mg/5ml

farmaceutische vorm:

Solution for injection

Prescription-type:

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

Therapeutisch gebied:

Sulfonamides, plain; furosemide

Autorisatie-status:

Marketed

Autorisatie datum:

1990-05-28

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FUROSEMIDE 20MG IN 2ML SOLUTION FOR INJECTION
FUROSEMIDE 50MG IN 5ML 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 further questions, please 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 from here
onwards.
WHAT IS IN THIS LEAFLET
1. What Furosemide Injection is and what it is used for
2. What you need to know before you are given Furosemide Injection
3. How Furosemide Injection is given to you
4. Possible side effects
5. How to store Furosemide Injection
6. Contents of the pack and other information
1. WHAT FUROSEMIDE INJECTION IS AND WHAT IT IS USED FOR
Furosemide is a strong diuretic. Diuretics help you to pass more water
(urine).
Furosemide Injection may be used to help you pass more water, promptly
and effectively. Excess
fluid can build up in certain conditions which affect the heart,
lungs, kidneys and liver.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FUROSEMIDE INJECTION
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
co-trimoxazole
-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

Productkenmerken

Health Products Regulatory Authority
16 November 2020
CRN009W5D
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide 50mg in 5ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of sterile solution for injection contains Furosemide 10mg.
Each 5ml ampoule contains Furosemide 50mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless or almost colourless sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Furosemide is a potent diuretic and is recommended for use when prompt
and effective diuresis is required Furosemide
Injection 50mg/5ml is appropriate for use in emergencies or where oral
therapy is not feasible. The indications include cardiac,
pulmonary, hepatic and renal oedema.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
Initially, doses of 20 - 50mg may be administered by the intramuscular
route, or by slow intravenous injection at a rate not
exceeding 4mg/minute. The diuretic effect of furosemide is
proportional to the dosage and, if larger doses are required, they
should be given as a controlled infusion at a rate not exceeding
4mg/minute and titrated according to the response.
Elderly: Elimination of furosemide is generally slower in the elderly.
Dosage should be titrated until the required effect is
achieved.
_Paediatric population: _Dosages for children range from 0.5 -
1.5mg/kg weight daily up to a maximum total daily dose of 20mg
Method of administration
Furosemide Injection 50mg/5ml are for intramuscular or for intravenous
administration and must always be given slowly.
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.

Hypersensitivity to amiloride, sulphonamides or sulphonamide
derivatives.

Hypovolaemia and dehydration (with or without accompanying
hypotension) (see section 4.4).

Severe hypokalaemia: severe hyponatraemia (see section 4.4).

Comatose or pre-comatose