Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Benzylpenicillin sodium
Genus Pharmaceuticals Limited
J01CE; J01CE01
Benzylpenicillin sodium
600 milligram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Beta-lactamase sensitive penicillins; benzylpenicillin
Marketed
2001-04-20
_Please read the back of this leaflet._ * Trademark CRYSTAPEN 600MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION BENZYLPENICILLIN SODIUM TECHNICAL LEAFLET SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF MEDICINAL PRODUCT Crystapen 600mg Powder for Solution for Injection or Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 600mg Benzylpenicillin sodium For a full list of excipients, see Section 6.1 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion. White, crystalline, water-soluble powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS: Crystapen is indicated for most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear, etc. It is also indicated for the following infections caused by penicillin -sensitive microorganisms: Generalised infections, septicaemia and pyaemia from susceptible bacteria. Acute and chronic osteomyelitis, sub-acute bacterial endocarditis and meningitis caused by susceptible organisms. Suspected meningococcal disease. Gas gangrene, tetanus, actinomycosis, anthrax, leptospirosis, rat-bite fever, listeriosis, severe Lyme disease, and prevention of neonatal group B streptococcal infections. Complications secondary to gonorrhoea and syphilis (e.g. gonococcal arthritis or endocarditis, congenital syphilis and neurosyphilis). Diphtheria, brain abscesses and pasteurellosis. Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of antibacterial agents. Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION: Intramuscular, intravenous. PREPARATION OF SOLUTIONS: Pharmaceutical preparation Only freshly prepared solutions should be used. Reconstituted solutions of benzylpenicillin sodium are intended for immediate administration Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Crystapen 600mg Powder for Solution for Injection or Infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 600mg Benzylpenicillin Sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for Solution for Injection or Infusion. White, crystalline, water-soluble sterile powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Crystapen is indicated for most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear, etc. It is also indicated for the following infections caused by penicillin-sensitive microorganisms: Generalised infections, septicaemia and pyaemia from susceptible bacteria. Acute and chronic osteomyelitis, sub-acute bacterial endocarditis and meningitis caused by susceptible organisms. Suspected meningococcal disease. Gas gangrene, tetanus, actinomycosis, anthrax, leptospirosis, rat-bite fever, listeriosis, severe Lyme disease, and prevention of neonatal group B streptococcal infections. Complications secondary to gonorrhoea and syphilis (e.g. gonococcal arthritis or endocarditis, congenital syphilis and neurosyphilis). Diphtheria, brain abscesses and pasteurellosis. Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of antibacterial agents. Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION: Intramuscular, intravenous. PREPARATION OF SOLUTIONS: Pharmaceutical preparation Only freshly prepared solutions should be used. Reconstituted solutions of benzylpenicillin sodium are intended for immediate administration. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Прочитайте повний документ