Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gentamicin sulfate
Advanz Pharma
J01GB03
Gentamicin sulfate
40mg/1ml
Solution for injection
Intramuscular; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010400; GTIN: 5013011006492
_I_ TURN OVER CIDOMYCIN® 80MG/2ML SOLUTION FOR INJECTION Gentamicin TECHNICAL LEAFLET – CIDOMYCIN INJECTION The following information is extracted from the SPC. TECHNICAL INFORMATION FOR THE PREPARATION AND ADMINISTRATION OF CIDOMYCIN. 1. NAME OF THE MEDICINAL PRODUCT Cidomycin® 80mg/2ml Solution for Injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule or vial (2ml) contains Gentamicin Sulphate Ph Eur equivalent to 80mg Gentamicin base. Excipients with known effect: Sodium chloride: 12.84mg/2ml ampoule or vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection. Clear, colourless solution. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: Serious infections: If renal function is not impaired, 5mg/kg/daily in divided doses at six or eight hourly intervals. The total daily dose may be subsequently increased or decreased as clinically indicated. Systemic infections: If renal function is not impaired, 3-5mg/kg/day in divided doses according to severity of infection, adjusting according to clinical response and body weight. Urinary tract infections: As “Systemic infections”. Or, if renal function is not impaired, 160mg once daily may be used. ELDERLY: There is some evidence that elderly patients may be more susceptible to aminoglycoside toxicity whether secondary to previous auditory/vestibular impairment or borderline renal dysfunction. Accordingly, therapy should be closely monitored by frequent determination of gentamicin serum levels, assessment of renal function and signs of ototoxicity. RENAL IMPAIRMENT: In impaired renal function, the recommended daily dose has to be decreased and adjusted to the renal function. Gentamicin is excreted by simple glomerular filtration and therefore reduced dosage is necessary where renal function is impaired. Nomograms are available for the calculation of dose, which depends on the patient’s age, weight and renal function. The following table may be useful when treating adults. _*60mg if body weight <60kg. Freq Preberite celoten dokument
OBJECT 1 CIDOMYCIN 80MG/2ML SOLUTION FOR INJECTION Summary of Product Characteristics Updated 07-Jun-2018 | SANOFI 1. Name of the medicinal product Cidomycin 80 mg/2 ml Solution for Injection 2. Qualitative and quantitative composition Each ampoule or vial (2 ml) contains Gentamicin Sulphate Ph. Eur. equivalent to 80 mg Gentamicin base. Excipients with known effect: Sodium chloride: 12.84 mg/2 ml ampoule or vial. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for Injection. Clear, colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Gentamicin is an aminoglycoside antibiotic with broad-spectrum bactericidal activity. It is indicated to treat severe infections caused by bacteria susceptible to gentamicin such as, but not limited to: • Urinary tract infections • Respiratory tract infections • Intra-abdominal infections • CNS infections • Severe neonatal infections It is usually active against most strains of the following organisms: _Escherichia coli_, _Klebsiella spp._, _Proteus spp. _(indole positive and indole negative), _Pseudomonas aeruginosa_, _Staphylococci,_ _Enterobacter spp._, _Citrobacter spp._ and _Providencia spp._ _Consideration should be given to official local guidance on the appropriate use of antibacterial agents._ 4.2 Posology and method of administration Posology Adults _Serious infections:_ If renal function is not impaired, 5 mg/kg/daily in divided doses at six or eight hourly intervals. The total daily dose may be subsequently increased or decreased as clinically indicated. _Systemic infections:_ If renal function is not impaired, 3 – 5 mg/kg/day in divided doses according to severity of infection, adjusting according to clinical response and body weight. _Urinary tract infections:_ As “Systemic infections”. Or, if renal function is not impaired, 160 mg once daily may be used. Elderly There is some evidence that elderly patients may be more susceptible to aminoglycoside toxicity whether secondary to previous auditory/vesti Preberite celoten dokument