Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
sodium nitroprusside, Quantity: 50 mg
Pfizer Australia Pty Ltd
Sodium nitroprusside
Injection, solution
Excipient Ingredients: water for injections
Intravenous
Single Pack
(S4) Prescription Only Medicine
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.
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
Registered
2012-06-15
________________________________________________________________________________ DBL™ Sodium Nitroprusside Concentrated Injection 1 DBL™ 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 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 Baca dokumen lengkap
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. Baca dokumen lengkap