Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
SODIUM NITRITE
Hope Pharmaceuticals Ltd
V03AB08
SODIUM NITRITE
30 milligram(s)/millilitre
Solution for injection
sodium nitrite
Not marketed
2019-02-22
1_ _ SODIUM NITRITE READ ALL OF THIS LEAFLET CAREFULLY This leaflet contains information about sodium nitrite, 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 nitrite 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, talke 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 nitrite and what it is used for 2. Before you are given sodium nitrite 3. How sodium nitrite is given 4. Possible side effects 5. How to store sodium nitrite 6. Contents of the pack and other information 1. WHAT SODIUM NITRITE IS AND WHAT IT IS USED FOR Citiți documentul completis 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 NITRITE Your doctor will take special care if you: • are pregnant or breast-feeding (See Pregnancy and breast-feeding); • have low blood pressure; • have a condition called anaemia (This is a reduction in number of red blood cells in the bloodstream. Anaemia can make the skin appear pale and can cause weakness or breathlessness); • suffer from Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency (This may result in anaemia.); • have a history of elevated levels of methemoglobin (This is a modified form of hemoglobin that reduces the amount of oxygen in the bloodstream and can cause weakness or breathlessness.); 2 • have inhaled smoke from a fire; • have had an allergic reaction to sodium nitrite. You will be monitored during use with sodium nitrite, and the dose of the medicatio
Health Products Regulatory Authority 18 September 2023 CRN00DTTF Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Nitrite Hope Pharmaceuticals 30 mg/mL Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mL vial contains 300 mg of sodium nitrite (30 mg/mL). 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 nitrite is indicated for sequential use with sodium thiosulfate 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 sodiumnitrite should be carefully weighed against the potential benefits, especially if the patient is not in extremis. Sodium nitrite is to be administered together with appropriate decontamination and supportive measures (see section 4.4). Consideration should be given to official guidelines for the treatment of cyanide intoxication. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For intravenous use. For single use only. _Adults_ 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). _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 administered intravenously, immediately followed by 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m2 of BSA) (rate of 2.5 to 5 mL/minute) not to exceed 50 mL total dose of sodium thiosulfate. NOTE: If no treatment response is observed within 30 to 60 minutes or if signs of poisoning reappear, repeat treatment after 3 Citiți documentul complet