GENTAMICIN TEVA 80 MG2 ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GENTAMICIN AS SULFATE

Available from:

TEVA ISRAEL LTD

ATC code:

J01GB03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

GENTAMICIN AS SULFATE 40 MG / 1 ML

Administration route:

I.V, I.M

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic area:

GENTAMICIN

Therapeutic indications:

Gentamicin is indicated in bacteremia, urinary tract infections, endocarditis, chest infections and other serious systemic infections due to confirmed or expected bacteria that are susceptible to gentamicin, in adults and children, including neonates.

Authorization date:

2019-07-14

Summary of Product characteristics

Gentamicin Teva 80mg/2ml FW 08-2022 Minor updates
Summary of Product Characteristics
Gentamicin Teva 80mg/2ml
Solution for I.M. or I.V. Injection
1. Name of the medicinal product
Gentamicin Teva 80mg/2ml
2. Qualitative and quantitative composition
Each ampoule of 2 ml solution contains:
Gentamicin sulfate equivalent to 80 mg gentamicin.
Excipient with known effect:
Each ampoule of 2 ml contains 1.16 mg of sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection.
Clear, colorless to slightly yellowish solution.
4. Clinical particulars
4.1 Therapeutic indications
Gentamicin is indicated in bacteremia, urinary tract infections,
endocarditis, chest
infections and other serious systemic infections due to confirmed or
expected bacteria
that are susceptible to gentamicin, in adults and children, including
neonates.
Bacteriological studies to determine the causative organism(s) and
antimicrobial
susceptibility are recommended when feasible. Monitoring of peak and
trough serum
concentrations of gentamicin is usually recommended.
Consideration should be given to official local guidance on the
appropriate use of
antibacterial agents.
4.2 Posology and method of administration
Adults:
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.
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.
Urinary tract infections: as 'systemic infections'. Or, if renal
function is not impaired,
160mg once daily may be used.
Paediatric Patients:
Gentamicin Teva 80mg/2ml FW 08-2022 Minor updates
The daily dose recommended in children (aged 1 year and above) and
adolescents with
normal renal function, is 3-6 mg/kg body weight per day as 1 single
dose (preferred) or
up to 2 single doses.
The daily dose in infants after the f