Furosemide Solution for Inj/Inf 10mg/ml (250mg/25ml)

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

FUROSEMIDE

Beschikbaar vanaf:

Wockhardt UK Limited

ATC-code:

C03CA01

INN (Algemene Internationale Benaming):

FUROSEMIDE

farmaceutische vorm:

SOLUTION FOR INJECTION/INFUSION

Samenstelling:

FUROSEMIDE 10 mg/ml

Prescription-type:

POM

Therapeutisch gebied:

DIURETICS

Autorisatie-status:

Authorised

Autorisatie datum:

2015-03-12

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUROSEMIDE 10MG/ML SOLUTION FOR INJECTION OR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
- Keep this leaflet. You may need to read it again while you are
receiving your treatment.
- If you have any further questions, please ask your doctor or nurse.
- This medicine has been prescribed for you. Do not pass it onto
others. It may harm them, even if their symptoms
are the same as yours.
- If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor
or pharmacist.
The active ingredient in this medicine is furosemide. This is the new
name for frusemide. The ingredient itself has
not changed.
The name of your medicine is furosemide 10mg/ml solution for injection
or infusion. In the rest of this leaflet it is
called furosemide injection.
IN THIS LEAFLET:
1.
What furosemide injection is and what it is_ _used for
2.
Before you are given furosemide injection
3.
How furosemide injection should be given
4.
Possible side effects
5.
How to store furosemide injection
6.
Further information
1.
WHAT FUROSEMIDE INJECTION IS AND WHAT IT IS_ _USED FOR
Furosemide belongs to a group of medicines called loop diuretics which
are used to get rid of excess water from the
body.
Furosemide injection is used to get rid of excess fluid from the body,
which has accumulated due to problems
with the heart, lungs, liver or kidneys. It is used in emergency
situations or in situations when you are unable to
take medicines by mouth.
2.
BEFORE YOU ARE GIVEN FUROSEMIDE INJECTION
FUROSEMIDE INJECTION SHOULD NOT BE GIVEN_ _IF:

you have been told you are allergic to furosemide or any of the other
ingredients in the injection_ _(see ‘What
furosemide injection contains’ below)

you have been told you are allergic to certain antibiotics, called
sulphonamides

you are suffering from dehydration or have lost a lot of blood

you have kidney failure caused by certain drugs

you have reduced conscio

Productkenmerken

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Furosemide 10mg/ml Solution for Injection or Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10mg of furosemide. Each 25ml vial contains 250mg of
furosemide.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection or infusion
The solution is colourless or almost colourless.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Furosemide 10mg/ml Injection is a diuretic indicated for use when a
prompt
and effective diuresis is required. The intravenous formulation is
appropriate
for use in emergencies or when oral therapy is precluded. Indications
include
cardiac, pulmonary, hepatic and renal oedema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: intramuscular or intravenous use.
_Adults _
Intravenous furosemide must be injected or infused slowly; a rate of 4
mg per
minute must not be exceeded. 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 (approximately four hours) is to be preferred
to a
regimen with higher bolus doses at longer intervals.
Page 2 of 12
Doses of 20 to 50 mg intramuscularly or intravenously may be given
initially.
If larger doses are required, they should be given by 20 mg increments
and not
given more often than every two hours. If doses greater than 50 mg