DBL SODIUM NITROPRUSSIDE CONCENTRATED INJECTION sodium nitroprusside 25 mg/mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium nitroprusside, Quantity: 50 mg

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Sodium nitroprusside

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

Single Pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DBL? Sodium Nitroprusside Injection is indicated for:,1. Immediate reduction of blood pressure in patients with hypertensive crises. Concomitant oral antihypertensive medication should be started while the hypertensive emergency is being brought under control with sodium nitroprusside.,2. Producing controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures where surgeon and anaesthetist deem it appropriate.,3. Short term therapy of cardiac failure, to enhance cardiac output and lower myocardial oxygen requirements. Patients should be commenced on oral therapy as soon as possible.

Product summary:

Visual Identification: DBL Sodium Nitroprusside Concentrated Injection is a clear sterile solution, free from visible particulates, presented in a 2 mL amber, rubber stoppered vial; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-06-15

Patient Information leaflet

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DBL™ Sodium Nitroprusside Concentrated Injection
1
DBL™
SODIUM NITROPRUSSIDE
CONCENTRATED INJECTION
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_Sodium nitroprusside _(_Sodium Nitro-PRUSS-ide) _
CONSUMER MEDICINE INFORMATION
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WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL™
Sodium Nitroprusside
Concentrated Injection.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT DBL™
SODIUM
NITROPRUSSIDE
CONCENTRATED
INJECTION IS USED FOR
Sodium nitroprusside is known
as a vasodilator. It works by
widening blood vessels, which
causes a decrease in blood
pressure.
Sodium nitroprusside is used in
emergency situations to quickly
lower very high blood pressure
(also known as hypertensive
crisis).
It can also be used during
surgery to keep blood pressure
low in order to reduce bleeding
during the surgical procedure.
It may also be used in the short-
term treatment of heart failure.
Your doctor may have
prescribed DBL™ Sodium
Nitroprusside Concentrated
Injection for another reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
DBL™ SODIUM NITROPRUSSIDE
CONCENTRATED INJECTION HAS
BEEN PRESCRIBED FOR YOU.
Sodium nitroprusside is not
addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL™
SODIUM
NITROPRUSSIDE
CONCENTRATED
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN DBL™
SODIUM NITROPRUSSIDE
CONCENTRATED

Summary of Product characteristics

Version: pfpsodui10919
Supersedes: Version 3.0
Page 1
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
TM
SODIUM
NITROPRUSSIDE
50MG/2ML
CONCENTRATED INJECTION VIAL
(SODIUM
NITROPRUSSIDE)
1.
NAME OF THE MEDICINE
Sodium nitroprusside
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL™ Sodium Nitroprusside concentrated injection is a sterile
solution containing the
equivalent
of
50
milligram
of
sodium
nitroprusside
dihydrate
[sodium
nitrosylpentacyanoferrate (III)] per 2 mL.
3.
PHARMACEUTICAL FORM
DBL™ Sodium Nitroprusside concentrated injection is a clear solution
available in amber glass
vials containing the equivalent of 50 mg sodium nitroprusside
dihydrate in 2 mL solution
.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL™ Sodium Nitroprusside concentrated injection is indicated for:
1.
Immediate
reduction
of
blood
pressure
in
patients
with
hypertensive
crises.
Concomitant oral antihypertensive medication should be started while
the hypertensive
emergency is being brought under control with sodium nitroprusside.
2.
Producing controlled hypotension during anaesthesia in order to reduce
bleeding in
surgical procedures where surgeon and anaesthetist deem it
appropriate.
3.
Short term therapy of cardiac failure, to enhance cardiac output and
lower myocardial
oxygen requirements. Patients should be commenced on oral therapy as
soon as
possible.
4.2 DOSE AND METHOD OF ADMINISTRATION
SODIUM NITROPRUSSIDE IS ONLY TO BE USED AS AN INFUSION WITH
STERILE 5% GLUCOSE IN WATER. IT SHOULD NOT BE ADMINISTERED BY
DIRECT INJECTION.
Product is for single use in one patient only. Discard any residue.
Version: pfpsodui10919
Supersedes: Version 3.0
Page 2
DOSAGE
DILUTION TO PROPER STRENGTH FOR INFUSION:
Depending on the desired concentration, DBL™ Sodium Nitroprusside
concentrated injection
containing 50 mg/2 mL sodium nitroprusside must be further diluted in
500-1000 mL of sterile
5% glucose injection. The diluted solution should be protected from
light, using the supplied
opaque sleeve, aluminium foil, or other opaque material.