Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
sodium nitrite, Quantity: 300 mg
Hope Pharmaceuticals Pty Ltd
Sodium nitrite
Solution
Excipient Ingredients: water for injections
Intravenous
1 glass vial
(S2) Pharmacy Medicine
Sodium Nitrite injection is indicated as an antidote in the treatment of cyanide poisoning, in conjunction with sodium thiosulfate.
Visual Identification: Clear and colourless, sterile solution practically free from visible particles; Container Type: Vial; Container Material: Glass; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-05-16
Page 1 HOPE PHARMACEUTICALS TM SODIUM NITRITE INJECTION Sodium nitrite CONSUMER MEDICINE INFORMATION _Date of Dispensing_ _Consumer Name _ _Pharmacist Name_ _Consumer Address _ _Pharmacist Address_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Hope Pharmaceuticals TM Sodium Nitrite Injection. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Hope Pharmaceuticals TM Sodium Nitrite Injection against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT HOPE PHARMACEUTICALS TM SODIUM NITRITE INJECTION IS USED FOR Hope Pharmaceuticals TM Sodium Nitrite Injection is used in the emergency treatment of cyanide poisoning. Hope Pharmaceuticals TM Sodium Nitrite Injection works by helping to prevent cyanide from binding to important enzymes in the cells of your body. Your doctor may have prescribed Hope Pharmaceuticals TM Sodium Nitrite Injection for another reason. Ask your doctor if you have any questions about why Hope Pharmaceuticals TM Sodium Nitrite Injection has been prescribed for you. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN HOPE PHARMACEUTICALS TM SODIUM NITRITE INJECTION _WHEN YOU MUST NOT BE _ _GIVEN IT_ HOPE PHARMACEUTICALS TM SODIUM NITRITE INJECTION SHOULD NOT BE GIVEN TO YOU IF: • YOU ARE SUFFERING FROM SMOKE INHALATION AND COMBINED CARBON MONOXIDE AND CYANIDE POISONING • YOU HAVE AN ALLERGY TO SODIUM NITRITE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction to sodium nitrite may include skin rash, itching, difficulty breathing and swelling, especially of the face and throat. • THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING • THE EXPIRY DATE ON THE PACK HAS PASSED. Lestu allt skjalið
Page 1 HOPE PHARMACEUTICALS TM SODIUM NITRITE INJECTION (SODIUM NITRITE) 1. NAME OF THE MEDICINE Sodium nitrite (Sodium Nitrite) 2. QUALITATIVE AND QUANTATIVE COMPOSITION Each 10 mL glass vial contains 300 mg of sodium nitrite in 10 mL water for injections (30 mg/mL). Sodium nitrite injection is a clear solution with a pH between 7.0 and 9.0. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM HOPE PHARMACEUTICALS TM Sodium Nitrite Injection is a clear and colourless sterile solution practically free from visible particles and is intended for intravenous injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HOPE PHARMACEUTICALS TM Sodium Nitrite Injection is indicated as an antidote in the treatment of cyanide poisoning, in conjunction with sodium thiosulfate. 4.2 DOSE AND METHOD OF ADMINISTRATION Therapy should be instituted immediately based upon reasonable suspicion of cyanide toxicity. The characteristic smell of bitter almonds may not be obvious, and is not detectable by all individuals. Sodium nitrite should only be administered in severe cases. HOPE PHARMACEUTICALS TM Sodium Nitrite Injection is administered by intravenous injection. Sodium thiosulfate should be administered immediately Page 2 following the sodium nitrite dosage. Methaemoglobin concentration should be monitored and must not exceed 40%. ADULT DOSE: The usual adult dose is 300 mg (10 mL of a 3% solution) administered intravenously at a rate of 75 to150 mg/min (2.5 to 5 mL/min). PAEDIATRIC DOSE: The usual paediatric dose is 4 mg/kg body weight (0.13 mL of a 3% solution/kg body weight) [range 4.0 to 10 mg/kg body weight, 0.13 to 0.33 mL/kg body weight] or 180 to 240 mg/m 2 (6 to 8 mL of a 3% solution/m 2 ) administered at a rate of 75 to 150 mg/min (2.5 to 5 mL of a 3% solution/min). It is advisable to begin with doses at the lower end of the recommended range and increase to the desired effect. A maximum dose of 300 mg (10 mL of a 3% solution) is recommended. For children under 25 kg, where ana Lestu allt skjalið