País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
sodium thiosulfate pentahydrate, Quantity: 12.5 g
Hope Pharmaceuticals Pty Ltd
sodium thiosulfate pentahydrate
Solution
Excipient Ingredients: water for injections; potassium chloride; boric acid; sodium hydroxide
Intravenous
1 glass vial
Not scheduled. Not considered by committee
HOPE PHARMACEUTICALS Sodium Thiosulfate Injection is indicated as an antidote in the treatment of cyanide poisoning. It is frequently used in conjunction with sodium nitrite.,Sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning.
Visual Identification: Clear and colourless, sterile solution, practically free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2017-05-22
Page 1 HOPE PHARMACEUTICALS TM SODIUM THIOSULFATE INJECTION Sodium thiosulfate pentahydrate _(SOE-dee-um thye-oh-SUL-fate PEN-tah-hi-drate)_ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about HOPE PHARMACEUTICALS TM Sodium Thiosulfate 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 sodium thiosulfate 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. You may need to read it again. WHAT HOPE PHARMACEUTICALS TM SODIUM THIOSULFATE I N J E C T I O N IS USED FOR This medicine is used: in the emergency treatment of cyanide poisoning to prevent cyanide poisoning when sodium nitroprusside is given. This medicine works by helping the body to convert cyanide to a less dangerous chemical called thiocyanate. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOUR. Your doctor may have prescribed it for another reason. BEFORE YOU ARE GIVEN HOPE PHARMACEUTICALS TM SODIUM THIOSULFATE INJECTION _BEFORE YOU ARE GIVEN IT_ _ _ TELL YOUR DOCTOR IF YOU HAVE AN ALLERGY TO: any medicine containing sodium thiosulfate any of the ingredients listed at the end of this leaflet any other medicines, foods, preservatives or dyes. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS: high blood pressure conditions that cause fluid retention, such as liver disease, heart failure, kidney disease or toxaemia of pregnancy. TELL YOUR DOCTOR IF YOU ARE PREGNANT OR ARE BREAST- FEEDING. Your doctor can discuss with you the risks and benefits involved. IF YOU Leia o documento completo
HOPE PHARMACEUTICALS TM SODIUM THIOSULFATE INJECTION (SODIUM THIOSULFATE PENTAHYDRATE) 1. NAME OF THE MEDICINE Sodium thiosulfate pentahydrate 2. QUALATIVE AND QUANTITATIVE COMPOSITION Each vial contains 12.5 grams of sodium thiosulfate pentahydrate in 50 mL solution (250 mg/mL). For the full list of excipients see Section 6.1 List of Excipients 3. PHARMACEUTICAL FORM HOPE PHARMACEUTICALS TM Sodium Thiosulfate Injection is a sterile aqueous solution and is intended for intravenous injection. HOPE PHARMACEUTICALS TM Sodium Thiosulfate Injection is a clear and colourless solution, practically free from visual particles, with a pH between 7.5 and 9.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION HOPE PHARMACEUTICALS TM Sodium Thiosulfate Injection is indicated as an antidote in the treatment of cyanide poisoning. It is frequently used in conjunction with sodium nitrite. Sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning. 4.2 DOSE AND METHOD OF ADMINISTRATION HOPE PHARMACEUTICALS TM Sodium Thiosulfate Injection is for single use in one patient only. Discard any residue. HOPE PHARMACEUTICALS TM Sodium Thiosulfate Injection is administered by slow intravenous injection. If sodium nitrite is administered in the treatment of cyanide poisoning, sodium thiosulfate should be administered immediately following the sodium nitrite infusion. Therapy should be administered 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. CYANIDE POISONING ADULT DOSE: The usual adult dose is 12.5 g (50 mL of a 25% solution) administered intravenously at a rate of 1.25 g/min (5 mL/min). If signs of cyanide toxicity are still present 30 minutes to 2 hours after administration, both sodium nitrite and sodium thiosulfate may be repeated at half the original dose. PAEDIATRIC DOSE: The usual paediatric dose is 412.5 mg/kg (1.65 mL/kg of a 25% solution) or 7 g/m 2 (28 mL/m 2 ) administ Leia o documento completo