Burinex 0.5mg/ml, solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUMETANIDE

Available from:

KARO Pharma AB Box 16184, 103 24, Stockholm, Sweden

ATC code:

C03CA02

INN (International Name):

BUMETANIDE 0.5 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

BUMETANIDE 0.5 mg/ml

Prescription type:

POM

Therapeutic area:

DIURETICS

Authorization status:

Authorised

Authorization date:

2012-11-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BURINEX
® 0.5 MG/ML, SOLUTION FOR INJECTION
Bumetanide
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
•
In this leaflet Burinex 0.5mg/mL solution for injection will be called
Burinex.
WHAT IS IN THIS LEAFLET
1.
What Burinex is and what it is used for
2.
What you need to know before you use Burinex
3.
How to take Burinex
4.
Possible side effects
5.
How to store Burinex
6.
Contents of the pack and other information
1.
WHAT BURINEX
® IS AND WHAT IT IS USED FOR
Burinex is available as a solution for injection, containing 0.5 mg
bumetanide per ml.
Burinex
®
belongs to a group of medicine called diuretics.
Burinex
®
works by removing any excess water from your body. It will make you go
to the toilet more.
Burinex is used:
•
To treat high blood pressure, fluid retention (oedema) in the body,
_e.g_
. if you have disturbed
heart function, if you have impared renal function or if, for some
other reason you need to
increase the production of urine.
•
To treat drug poisoning with salicylates (painkillers) or barbiturates
(hypnotics).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BURINEX
®
DO NOT USE BURINEX
•
if you are allergic to bumetanide, formaldehyde or any of the other
ingredients in this medicine
(listed in section 6).
•
if you have been told that you have very low levels of potassium,
sodium or chloride in your
blood.
•
if you cannot make urine at all.
•
if you have severe liver problems or are in a coma caused by this
(hepatic encephalopathy).
WARNINGS

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Burinex 0.5 mg/ml, solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Burinex ampoule contains 0.5 mg bumetanide per millilitre.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Burinex 0.5 mg/ml, solution for injection is indicated in the
management of acute oedema due to
congestive heart failure, including pulmonary oedema, cirrhosis of the
liver and renal disease
including nephrotic syndrome in adults. Drug intoxication where forced
diuresis is desirable in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
If oral administration is not feasible, of if a rapid effect is
desired, bumetanide may be
administered intramuscularly or intravenously. Usual dose is 0.5-1 mg.
Pulmonary oedema:
In less serious cases 0.5 mg intravenously. Repeat, if necessary,
after 20 minutes. In acute cases 2
mg intravenously. Repeat, if necessary, 2 to 3 times at 20 minute
intervals.
_Paediatric population: _
The medicinal product is not recommended for children as there is
limited information on the
safety, efficacy and dosage in children.
_Elderly _
Due to changed pharmaco-kinetics and pharmaco-dynamics the diuretic
effect may decrease in
elderly, increasing the risk of side effects. Therefore, the dosage
must be determined in accordance
with the efficiency and any adverse reactions to the medicinal
product.
_Patients with hepatic or renal impairment _
Page 1 of 9
Due to changed pharmaco-kinetics and/or pharmaco-dynamics the diuretic
effect may decrease in
patients with hepatic or renal insufficiency, increasing the risk of
side effects. Therefore, the
dosage must be determined in accordance with the efficiency and any
adverse reactions to the
medicinal product.
_Renal impairment: _
2-5 mg, repeat, if necessary, every 6 to 8 hours, or 2-5 mg in 500 ml
solution for infusion
administered over 30 to 60 minutes. Repe