Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Gentamicin sulfate 16mg (Gentamicin sulfate 16mg/mL (BP) equivalent to 10mg/mL (10,000IU) Gentamicin)
Pfizer New Zealand Limited
Gentamicin sulfate 16 mg (Gentamicin sulfate 16mg/mL (BP) equivalent to 10mg/mL (10,000IU) Gentamicin)
10 mg/mL
Solution for injection
Active: Gentamicin sulfate 16mg (Gentamicin sulfate 16mg/mL (BP) equivalent to 10mg/mL (10,000IU) Gentamicin) Excipient: Disodium edetate dihydrate Sodium methyl hydroxybenzoate Sodium propyl hydroxybenzoate Water for injection
Vial, glass, 2mL, 5 dose units
Prescription
Prescription
Lek Pharmaceuticals d.d.
DBL™ Gentamicin Injection BP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa Proteus species (indole positive and indole negative) Escherichia coli Klebsiella - Enterobacter - Serratia species Staphylococcus species (coagulase positive and coagulase negative) DBL™ Gentamicin Injection BP should be considered for the treatment of the following conditions when caused by susceptible organisms: Septicaemia Respiratory tract infections Infected wounds, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis Urinary tract infections (recurrent, complicated) DBL™ Gentamicin Injection BP is not routinely indicated in the initial treatment of uncomplicated urinary tract infections unless the organism is resistant to other less toxic antibacterials. DBL™ Gentamicin Injection BP may be considered as initial therapy in suspected or confirmed gram negative infections and therapy may be instituted before obtained results of susceptibility testing. If anaerobic organisms are suspected, additional antimicrobial therapy should be added to the gentamicin regime.
Package - Contents - Shelf Life: Vial, glass, 2mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, 2mL - 50 dose units - 24 months from date of manufacture stored at or below 25°C
1984-11-01
pfdgendi11222 pfdgendi10722 Page 1 of 17 NEW ZEALAND DATA SHEET 1. PRODUCT NAME DBL ™ Gentamicin Injection BP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Gentamicin Injection BP contains Gentamicin sulfate BP equivalent to gentamicin base 10 mg or 40 mg per mL. EXCIPIENT(S) WITH KNOWN EFFECT Each vial of DBL Gentamicin Injection BP contains sodium methyl hydroxybenzoate (2.06 mg/mL) and sodium propyl hydroxybenzoate (0.225 mg/mL) as preservative. Each vial of DBL Gentamicin Injection BP contains less than 1 mmol sodium (23 mg), that is to say essentially 'sodium-free’. Also refer to Section 4.4, Excipients Information. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DBL Gentamicin Injection BP is a sterile solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Gentamicin Injection BP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: _Pseudomonas aeruginosa_ _Proteus_ species (indole positive and indole negative) _Escherichia coli_ _Klebsiella_ -_ Enterobacter - Serratia _species _Staphylococcu_s species (coagulase positive and coagulase negative) DBL Gentamicin Injection BP should be considered for the treatment of the following conditions when caused by susceptible organisms: Septicaemia Respiratory tract infections Infected wounds, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis pfdgendi11222 pfdgendi10722 Page 2 of 17 Urinary tract infections (recurrent, complicated) DBL Gentamicin Injection BP is not routinely indicated in the initial treatment of uncomplicated urinary tract infections unless the organism is resistant to other less toxic antibacterials. DBL Gentamicin Injection BP may be considered as initial therapy in suspected or confirmed gram negative infections and therapy may be instituted before obtained results of susceptibility testing. If anaerobic organisms are suspected, additional antimicrobial therapy should be added to Прочетете целия документ