País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Sodium thiosulfate
Hope Pharmaceuticals Ltd
V03AB; V03AB06
Sodium thiosulfate
250 milligram(s)/millilitre
Solution for injection
Antidotes; thiosulfate
Not marketed
2019-08-23
1_ _ SODIUM THIOSULFATE READ ALL OF THIS LEAFLET CAREFULLY This leaflet contains information about sodium thiosulfate, which will have already been given to you by injection into one of your veins. • Although you will not be taking this medicine yourself, this leaflet contains important information to help you understand how Sodium Thiosulfate is used. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET 1. What is sodium thiosulfate and what it is used for 2. Before you are given sodium thiosulfate 3. How sodium thiosulfate is given 4. Possible side effects 5. How to store sodium thiosulfate 6. Contents of the pack and other information 1. WHAT SODIUM THIOSULFATE IS AND WHAT IT IS USED FOR Leia o documento completois used as an antidote for cyanide poisoning. Cyanide poisoning is a condition that develops when you inhale, touch, or swallow cyanide. Cyanide is a poisonous chemical that prevents your body from absorbing oxygen. The lack of oxygen can damage your organs and be life-threatening. 2. BEFORE YOU ARE GIVEN SODIUM THIOSULFATE Your doctor will take special care if you: • have had an allergic reaction to sulfites. You will be monitored during use with sodium thiosulfate, and the dose of the medication will be adjusted if necessary. This medicine contains approximately 3.6 g of sodium per vial, equivalent to 180% of the WHO recommended maximum daily intake of 2g sodium for an adult. This medicine contains 115 mg of potassium per 50ml vial. This medicine also contains 140 mg of boric acid per 50ml vial. If you are pregnant, talk to your doctor as it contains boron, which may be harmful to your baby. 2 USING OTHER MEDICINES The following medicines have side effects that are similar to the side effects that may occur with sodium thiosulfate. • Other solutions for injection
Health Products Regulatory Authority 09 June 2023 CRN00D7KT Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Thiosulfate Hope Pharmaceuticals 250 mg/mL Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 50 mL vial contains 12.5 g of sodium thiosulfate (250 mg/mL). Excipients of known effect 3.6 g of sodium in 50 ml of solution for injection. 115 mg of potassium in 50 ml of solution for injection. 140 mg of boric acid in 50 mL of solution for injection. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection The solution for injection is a clear and colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sodium thiosulfate is indicated for sequential use withhydroxocobalamin or sodium nitrite for the treatment of acute cyanide poisoning that is judged to be life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with sodium thiosulfate should be carefully weighed against the potential benefits, especially if the patient is not in extremis. Sodium thiosulfate is to be administered together with appropriate decontamination and supportive measures (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For intravenous use. For single use only. _Adults_ Initial dose: 10 mL (300 mg) of sodium nitrite (rate of 2.5 to 5 mL/minute) should be administered intravenously, immediately followed by 50 mL (12.5 g) of sodium thiosulfate (rate of 5 mL/minute). Alternatively, an initial dose of 5 g hydroxocobalamin administered as an intravenous infusion over 15 minutes followed by 50 mL (12.5 g) of sodium thiosulfate (rate of 5 mL/minute). _Special populations _ _Older people_ No specific dose adjustment is required in elderly patients (aged > 65 years). _Paediatric population_ In infants to adolescents (0 to 18 years old), 0.2 mL/kg (6 mg/kg or 6-8 mL/m2 BSA) of sodium nitrite (rate of 2.5 to 5 mL/minute) not to exceed 10 mL should be admini Leia o documento completo