Burinex Injection 0.5mgml (4ml)

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

BUMETANIDE

Disponibil de la:

DKSH MALAYSIA SDN BHD

INN (nume internaţional):

BUMETANIDE

Unități în pachet:

4ml mL

Produs de:

CENEXI

Caracteristicilor produsului

1.
NAME OF THE MEDICINAL PRODUCT
Burinex®
Bumetanide
Carefully read this insert before administering this product. It
contains information about your
treatment. If you have any doubt or you are not sure about something,
please ask your physician or
Pharmacist chemist.
Keep this insert as you might need to read it again.
Verify this product fully corresponds to the one prescribed by your
physician.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bumetanide 0.50 mg/ml
Pack size: 5x4ml ampoules
For the full list of excipients, see section 6.1.
Not all pack sizes, strengths and formulations may be marketed
Sale under prescription
3.
PHARMACEUTICAL FORM
Solution for injection
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Burinex® is indicated whenever diuretic therapy is required in the
treatment of oedema e.g. associated
with congestive heart failure, cirrhosis of the liver, renal diseases
including the nephrotic syndrome.
Acute pulmonary oedema, drug induced fluid retention, and drug
poisoning that can be treated by
forced diuresis. Hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Usually 1–2 mg intravenously or intramuscularly.
Pulmonary oedema:
Initially 2 mg by intravenous injection.
This can be repeated, if necessary, after 20 minutes. In those
conditions in which an infusion
appropriate, 2–5 mg may be given in 500 ml infusion fluid over
30–60 minutes.
Renal failure:
2–10 mg in 500 ml infusion fluid given over a period of 30–60
minutes. Repeated, if required, at
intervals of 6–8 hours.
Drug poisoning with salicylates or barbiturates:
Initially, 2 mg intravenously, followed by 1 mg every 4 hours.
Totally, 7 mg in the course of 24 hours.
The usual procedure for forced alkaline diuresis should be followed.
Burinex® injection may be
added to the commonly used infusion fluids based on glucose, sodium
chloride, sodium bicarbonate,
or potassium chloride.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to formaldehyde (see Section 4.4).
•
Hypersensitivity to active substan