Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Benzylpenicillin sodium
Genus Pharmaceuticals Ltd
J01CE01
Benzylpenicillin sodium
600mg
Powder for solution for injection
Intravenous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010101; GTIN: 5011309237016 5011309236217
PRODUCT SUMMARY QUALITATIVE AND QUANTITATIVE COMPOSITION Benzylpenicillin sodium available as 600 mg and 1200 mg vials. PHARMACEUTICAL FORM White crystalline, water-soluble sterile powder for injection. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS: Benzylpenicillin 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. 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. 600 mg vial _Intramuscular injection:_ 600 mg (1 mega unit) is usually dissolved in 1.6 to 2.0 ml of Water for Injections BP. 600 mg and 1200 mg vials _Intravenous Injection:_ A suitable concentration is 600 mg (1 mega unit) dissolved in 4 to 10 ml of Water for Injections BP or Sodium Chloride Injection BP and 1200 mg (2 mega units) disso Leggi il documento completo
OBJECT 1 BENZYLPENICILLIN SODIUM 600MG POWDER FOR INJECTION Summary of Product Characteristics Updated 16-Sep-2016 | Genus Pharmaceuticals 1. Name of the medicinal product Benzylpenicillin sodium 600mg Powder for Injection 2. Qualitative and quantitative composition Each vial contains Benzylpenicillin sodium 600 mg 3. Pharmaceutical form Powder for injection White crystalline, water-soluble sterile powder. 4. Clinical particulars 4.1 Therapeutic indications Benzylpenicillin 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. 600 mg vial _Intramuscular injection_: 600 mg (1 mega unit) is usually dissolved in 1.6 to 2.0 ml of Water for Injections BP Leggi il documento completo