国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Benzylpenicillin
Rowex Ltd
J01CE01
Benzylpenicillin
3000 milligram(s)
Powder for solution for injection/infusion
benzylpenicillin
Not marketed
2021-01-29
PACKAGE LEAFLET: INFORMATION FOR THE USER BENZYLPENICILLIN SODIUM 600 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION BENZYLPENICILLIN SODIUM 3000 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION benzylpenicillin sodium _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist, or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Benzylpenicillin sodium is and what it is used for 2. What you need to know before you use Benzylpenicillin sodium 3. How to use Benzylpenicillin sodium 4. Possible side effects 5. How to store Benzylpenicillin sodium 6. Contents of the pack and other information 1. WHAT BENZYLPENICILLIN SODIUM IS AND WHAT IT IS USED FOR Benzylpenicillin sodium is a medicine used to treat infections caused by benzylpenicillin-sensitive bacteria. It is used to treat adults, adolescents, children, newborn infants and premature infants. Benzylpenicillin sodium is used for the following bacterial infections: • skin and wound infections • diphtheria • lung inflammation • pus accumulation in body cavities • infections of the superficial layer of the skin that shows up as a particularly delimited extensive reddening called St. Anthony’s fire • inflammation of the - inner lining of the heart - membrane which lines the abdomen cavity and covers the abdominal organs - meninges - bone marrow • brain abscesses • certain infections of the genital tract • anthrax • tetanus • gas gangrene • an infection mainly spread by spoiled or perished food called listeriosis • pasteurellosis, an infection that can be caught via 完全なドキュメントを読む
Health Products Regulatory Authority 13 January 2023 CRN00D90Y Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benzylpenicillin sodium 3000 mg Powder for Solution for Injection/Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 3000 mg (equivalent to approximately 5 mega IU) benzylpenicillin as sodium salt. Each vial contains 193 mg of sodium. 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion. White to off-white powder for solution for injection/infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benzylpenicillin sodium is indicated for the treatment of the following infections in adults, adolescents, children, newborn infants and pre-term infants, caused by penicillin-sensitive pathogens (see section 5.1): - skin and wound infections - diphtheria (in addition to antitoxin) - community acquired pneumonia - empyema - erysipelas - bacterial endocarditis - peritonitis - meningitis - brain abscesses - osteomyelitis - infections of the genital tract caused by fusobacteria. Benzylpenicillin sodium is also used for the treatment of the following specific infections: - anthrax - tetanus - gas gangrene - listeriosis - pasteurellosis - rat bite fever - fusospirochaetosis - actinomycosis. Furthermore, Benzylpenicillin sodium is also used for complications in gonorrhoea and syphilis (e.g. gonorrhoeal endocarditis or arthritis, congenital syphilis), provided that the isolate of _Neisseria gonorrhea _ is documented to have sensitivity to penicillin. However, in uncomplicated cases, preference should be given to depot penicillins. Benzylpenicillin sodium is not indicated for the treatment of syphilis during pregnancy. Benzylpenicillin sodium is also used in Lyme borreliosis from the second stage of the disease onwards (meningopolyneuritis Garin-Bujadoux-Bannwarth, acrodermatitis chronica atrophicans, Lyme arthritis, Lyme carditis) if oral penicillin therapy is no longer indicated. During pregnancy, high-dose parenteral Benzylpenicillin sodium administra 完全なドキュメントを読む