Страна: Нидерландия
Език: нидерландски
Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
NATRIUMNITRIET (E 250) 30 mg/ml
Hope Pharmaceuticals, Ltd. 9 Cherrywood TALLANSTOWN (IERLAND)
V03AB08
NATRIUMNITRIET (E 250) 30 mg/ml
Oplossing voor injectie
STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE
Intraveneus gebruik
Sodium Nitrite
1900-01-01
1 NATRIUMNITRIET HOPE 30 MG/ML, OPLOSSING VOOR INJECTIE natriumnitriet 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, 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 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 Sodium Nitrite 30 mg/mL Solution for Injection 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 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 monitor Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Natriumnitriet Hope 30 mg/ml, oplossing voor injectie 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 sodium nitrite 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/m 2 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/m 2 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 30 minutes of initial administration using one-half the original Прочетете целия документ