NITROPRUSSIDE-EMC sodium nitroprusside 50 mg/2 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium nitroprusside, Quantity: 50 mg

Available from:

Emcure Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous Infusion

Units in package:

1 vial (in carton with one leaflet and one protective sleeve in holder)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: Clear, reddish brown coloured solution, essentially free from visible particles.; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-11-12

Patient Information leaflet

Nitroprusside-EMC Sodium Nitroprusside Concentrated Injection 1
NITROPRUSSIDE-EMC
SODIUM NITROPRUSSIDE CONCENTRATED
INJECTION
_Sodium nitroprusside (Sodium Nitro-PRUSS-ide) _
CONSUMER MEDICINE INFORMATION
_Date of Dispensing _
_Consumer Name Pharmacist Name _
_Consumer Address Pharmacist Address _
_Consumer Address Pharmacist Address_
WHAT IS IN THIS LEAFLET?
This
leaflet
answers
some
common
questions
about
Nitroprusside-EMC
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
NITROPRUSSIDE-
EMC
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
Nitroprusside-EMC
Sodium
Nitroprusside
Concentrated
Injection
for
another reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
NITROPRUSSIDE-EMC
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
NITROPRUSSIDE-EMC
SODIUM
NITROPRUSSIDE
CONCENTRATED INJECTION
_WHEN _
_YOU _
_MUST _
_NOT _
_BE _
_GIVEN IT _
YOU
MUST
NOT
BE
GIVEN
NITROPRUSSIDE-EMC
SODIUM
NITROPRUSSIDE
CONCENTRATED
INJECTION
IF
YOU
HAVE
AN
Nitroprusside-EMC Sod

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – NITROPRUSSIDE-EMC
(SODIUM NITROPRUSSIDE) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Sodium nitroprusside
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitroprusside-EMC Sodium Nitroprusside concentrated injection is a
sterile solution containing the
equivalent of 50 milligram of sodium nitroprusside dihydrate [sodium
nitrosylpentacyanoferrate (III)]
per 2 mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Nitroprusside-EMC Sodium Nitroprusside concentrated injection is a
clear, reddish-brown colored
solution available in amber glass vials containing the equivalent of
50 mg sodium nitroprusside
dihydrate in 2 mL solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Nitroprusside-EMC 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
D
OSE 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.
DILUTION TO PROPER STRENGTH FOR INFUSION:
Depending on the desired concentration, Nitroprusside-EMC 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. It is not
necessary to cover the infusion drip
c