Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Sodium thiosulfate; SODIUM NITRITE
Hope Pharmaceuticals Ltd
V03AB; V03AB06; V03AB08
Sodium thiosulfate; SODIUM NITRITE
30/250 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Antidotes; thiosulfate; sodium nitrite
Not marketed
2018-07-06
1 NITHIODOTE SOLUTION FOR INJECTION_ _ ACTIVE SUBSTANCES SODIUM NITRITE AND SODIUM THIOSULFATE READ ALL OF THIS LEAFLET CAREFULLY This leaflet contains information about Nithiodote, 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, 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 Nithiodote and what it is used for 2. Before you are given Nithiodote 3. How Nithiodote is given 4. Possible side effects 5. How to store Nithiodote 6. Further information 1. WHAT NITHIODOTE IS AND WHAT IT IS USED FOR Nithiodote is a kit that contains two separate medications: Sodium Nitrite Solution for Injection and Sodium Thiosulfate Solution for Injection. Nithiodote is 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 NITHIODOTE Take special care with Nithiodote 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); 2 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.); have inhaled smoke Lue koko asiakirja
Health Products Regulatory Authority 10 February 2021 CRN00C5DT Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nithiodote Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each kitcontains one vial (300 mg)of sodiumnitrite(30mg/mL)and one vial (12.5 g)of sodiumthiosulfate(250 mg/mL). For thefulllistofexcipients, seesection 6.1. 3 PHARMACEUTICAL FORM Solutions for Injection The solutions for injection are clear, colourless solutions in single dose vials 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nithiodoteisindicatedforthetreatment ofacutecyanidepoisoningthatisjudgedtobe life-threatening.Whenthediagnosisofcyanidepoisoningisuncertain,thepotentiallylife-threateningrisksassociatedwithNithiodote should becarefullyweighedagainstthepotentialbenefits,especiallyifthepatientis notinextremis. 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 populations_ 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 5 mL/minute) not to exceed 50 mL total dose of sodium thiosulfate. NOTE: If signs of poisoning reappear, repeat treatment using one-half the original dose of both sodium nitrite and sodium thiosulfate. In adult and paediatric patients with known anaemia, it is recommended that the dosage of sodium nitrite should be reduced proportionately to the hemoglobin concentration (see section 4.4). Method of administration Comprehensive treatment of acute cyanide intoxication requires support of vital functions. Supportive care a Lue koko asiakirja