Furosemide Solution for Injection 10mg/ml (2ml)

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

FUROSEMIDE

Beschikbaar vanaf:

Accord Healthcare Limited

ATC-code:

C03CA01

INN (Algemene Internationale Benaming):

FUROSEMIDE

farmaceutische vorm:

SOLUTION FOR INJECTION

Samenstelling:

FUROSEMIDE 10 mg/ml

Prescription-type:

POM

Therapeutisch gebied:

DIURETICS

Autorisatie-status:

Authorised

Bijsluiter

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
FUROSEMIDE 10 MG/ML SOLUTION FOR INJECTION OR INFUSION
FUROSEMIDE
The name of your medicine is ‘Furosemide 10 mg/ml Solution for
Injection or Infusion’ but in the
rest of the leaflet it will be called “Furosemide Injection
10mg/ml”.
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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
-
WHAT IS IN THIS LEAFLET
1. What Furosemide Injection 10 mg/ml is and what it is used for
2. What you need to know before you use Furosemide Injection 10 mg/ml
3. How to use Furosemide Injection 10 mg/ml
4. Possible side effects
5. How to store Furosemide Injection 10 mg/ml
6. Contents of the pack and other information
1.
WHAT FUROSEMIDE INJECTION 10 MG/ML IS AND WHAT IT IS USED FOR
Furosemide Injection 10 mg/ml contains the active ingredient
furosemide.
Furosemide is one of a group of medicines called diuretics. Furosemide
works by helping to
produce more urine. This helps to relieve symptoms caused when your
body contains too much
fluid.
YOUR DOCTOR HAS PRESCRIBED FUROSEMIDE FOR ONE OF THE FOLLOWING
REASONS:
•When quick and effective removal of excess fluid is needed.
•You are not able to take this kind of medicine by mouth or in an
emergency.
•You have too much fluid around your heart, lungs, liver or kidneys.
• in periods with extremely high blood pressure that may lead to
life-threatening conditions
(hypertensive crisis)
FUROSEMIDE INJECTION MUST ONLY BE USED UNDER MEDICAL SUPERVISION.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FUROSEMIDE INJECTION 10 MG/ML
DO NOT USE FUROSEMIDE INJEC

Productkenmerken

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Furosemide 10 mg/ml Solution for Injection or Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 10 mg Furosemide.
Each 2 ml ampoule contains 20 mg Furosemide (20mg/2ml).
Each 4 ml ampoule contains 40 mg Furosemide (40mg/4ml).
Each 5 ml ampoule contains 50 mg Furosemide (50mg/5ml).
Excipients:
Each 2 ml of sterile solution contains approximately 7 mg of sodium.
Each 4 ml of sterile solution contains approximately 15 mg of sodium.
Each 5 ml of sterile solution contains approximately 19 mg of sodium.
For the full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless or almost colourless solution (pH: 8.0 to 9.3).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
When a prompt diuresis is required. Use in emergencies or when oral
therapy is precluded.
Indications include:
_- Oedema and/or ascites caused by cardiac or hepatic diseases _
- _Oedema caused by renal diseases (in case of nephrotic syndrome,
treatment of the _
_underlying disease is essential) _
_- Pulmonary oedema (e.g. in case of acute heart failure) _
_ _
-_ Hypertensive crisis (in addition to other therapeutic measures) _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: intravenous or (in exceptional cases)
intramuscular
General:
The parenteral administration of furosemide is indicated in cases
where oral administration
is not feasible or not efficient (for example in case of reduced
intestinal absorption) or when
a quick effect is required. To achieve optimum efficacy and suppress
counter-regulation, a
continuous furosemide infusion is generally to be preferred to
repeated bolus injections.
Consideration should be given to current clinical guidelines where
available.
Page 2 of 15
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 ho