GENTAMICIN PANPHARMA 80 MG2 ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GENTAMICIN AS SULFATE

Available from:

PHARMALOGIC LTD

ATC code:

J01GB03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

GENTAMICIN AS SULFATE 80 MG / 2 ML

Administration route:

I.M, I.V. INFUSION, I.V INJECTION

Prescription type:

Required

Manufactured by:

PANPHARMA, FRANCE

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:

2019-12-11

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
GENTAMICIN PANPHARMA 80 MG/2 ML
Solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ampoule of 2 ml solution for injection contains:
135.6 mg gentamicin sulfate equivalent to 80 mg gentamicin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
For I.V., I.M. injection and I.V. infusion.
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 are 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.
_Pediatric patients: _
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 first month of life is 4.5-7.5
mg/kg body weight per
day as 1 single dose (preferred) or up to 2 single doses.
The daily dose in neonates is 4-7 mg/kg body weight per day. Due to
the longer half-
life, neonates are giv