SODIUM NITROPRUSSIDE MEDSURGE sodium nitroprusside 50 mg/2 mL concentrated injection vial

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

sodium nitroprusside

Beszerezhető a:

Medsurge Pharma Pty Ltd

Gyógyszerészeti forma:

Injection, concentrated

Összetétel:

Excipient Ingredients: water for injections

Az alkalmazás módja:

Intravenous Infusion

db csomag:

1 x 2 mL

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

- 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. - Producing controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures where surgeon and anaesthetist deem it appropriate. - 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.

Termék összefoglaló:

Visual Identification: Reddish brown colour solution practically free from any visible particles; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Registered

Engedély dátuma:

2020-02-25

Betegtájékoztató

Sodium Nitroprusside Medsurge CMI June 2022
1
SODIUM NITROPRUSSIDE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SODIUM NITROPRUSSIDE MEDSURGE?
Sodium Nitroprusside Medsurge contains the active ingredient sodium
nitroprusside. Sodium Nitroprusside Medsurge is used
to quickly lower very high blood pressure (also known as hypertensive
crisis).
For more information, see Section 1. Why am I using Sodium
Nitroprusside Medsurge?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SODIUM NITROPRUSSIDE MEDSURGE?
Do not use if you have ever had an allergic reaction to Sodium
Nitroprusside Medsurge or any of the ingredients listed at the
end of the CMI
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2 What should I know before I use
Sodium Nitroprusside Medsurge? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sodium Nitroprusside Medsurge and
affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI
4.
HOW DO I USE SODIUM NITROPRUSSIDE MEDSURGE?
Your doctor will decide what dose of Sodium Nitroprusside Medsurge you
will receive. This depends on your condition and
other factors, such as your weight.
More instructions can be found in Section 4. How do I use Sodium
Nitroprusside Medsurge?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SODIUM NITROPRUSSIDE MEDSURGE?
THINGS YOU SHOULD
DO
•
Remind any doctor or pharmacist you visit that you are using
_U_
Sodium Nitroprusside Medsurge.
THINGS YOU SHOULD
NOT DO
•
You must not be given Sodium Nitroprusside Medsurge if you have an
allergy to sodium
nitroprusside or cyanide.
DRIVING OR USING
MACHINES
•
Sodium nitroprusside may cause dizziness and drowsiness in some
people, which could affect t

Termékjellemzők

1
AUSTRALIAN PRODUCT INFORMATION
SODIUM NITROPRUSSIDE MEDSURGE (SODIUM NITROPRUSSIDE)
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Sodium Nitroprusside
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium
Nitroprusside
Medsurge
50
mg/2
ml
(25
mg/mL)
concentrated
Injection
contains
the
equivalent of 50 mg sodium nitroprusside dihydrate in 2 ml solution.
3
PHARMACEUTICAL FORM
Sodium Nitroprusside Medsurge is a Reddish Brown color solution free
of visible particulate matter.
It is presented in a 2 mL amber coloured, rubber stoppered vial.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sodium Nitroprusside 50 mg/2 mL (25 mg/mL) 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.
DOSAGE
DILUTION TO PROPER STRENGTH FOR INFUSION:
Depending on the desired concentration, Sodium Nitroprusside Medsurge
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
2
sleeve, aluminium foil, or other opaque material. It is not necessary
to cover the infusion drip chamber
or the tubing.
VERIFICATION OF THE CHEMICAL INTEGRITY OF THE PRODUCT:
Sodium nitroprusside solution can be inactivated