Furosemide 250mg in 25ml Solution for Inj/Inf 10mg/ml

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

FUROSEMIDE

Beschikbaar vanaf:

Mercury Pharmaceuticals (Ireland) Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

ATC-code:

C03CA01

INN (Algemene Internationale Benaming):

FUROSEMIDE 10 mg/ml

farmaceutische vorm:

SOLUTION FOR INFUSION OR INJECTION

Samenstelling:

FUROSEMIDE 10 mg/ml

Prescription-type:

POM

Therapeutisch gebied:

DIURETICS

Autorisatie-status:

Withdrawn

Autorisatie datum:

2006-11-28

Bijsluiter

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

Productkenmerken

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 micrometer screw-
gauge adjustment; the rate of administration should st