Burinex 0.5mg/ml, solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUMETANIDE

Available from:

LEO Pharma A/S

ATC code:

C03CA02

INN (International Name):

BUMETANIDE

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

148 mm
Page 1
315 mm
128 BARCODE
Value: SAP number
256.05
15
00000000
Univers 55 - 6 pt, kerning 0
1,5 x
8 mm
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 AND PRECAUTIONS
Formaldehyde is a degradation product which occurs in
Burinex in trace amounts during storage. Because
formaldehyde may cause a severe allergic reaction
caution should be taken when Burinex is administered.
Talk to your doctor, pharmacist or nurse before using
Burinex.
•
If you have severe liver problems.
•
If you have low blood pressure.
•
If you have been told that you have abnormal levels of
potassium in your blood. Your doctor may test your blood
regularly.
•
If you use drugs called proton pump inhibitors as this
may cause magnesium in your blood to fall.
•
If you have gout.
•
If you suffer fro

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. Drug intoxication where forced diuresis
is desirable.
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: _
Burinex is not indicated for use in children until further experience
from paediatrics is available.
_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 _
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: _
1
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. Repeat, if necessary, every 6 to 8
hours.
_Drug intoxication with salicylates or barbiturates: _
2 mg