GENTAMICIN B. BRAUN 3 MGML

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

GENTAMICIN AS SULFATE

Tersedia dari:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

Kode ATC:

S01AA11

Bentuk farmasi:

SOLUTION FOR INFUSION

Komposisi:

GENTAMICIN AS SULFATE 0.3 G / 100 ML

Rute administrasi :

I.V

Jenis Resep:

Required

Diproduksi oleh:

B.BRAUN MELSUNGEN AG, GERMANY

Kelompok Terapi:

GENTAMICIN

Area terapi:

GENTAMICIN

Indikasi Terapi:

Treatment of serious infections caused by susceptible microorganisms

Tanggal Otorisasi:

2017-11-30

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gentamicin B. Braun 1 mg/ml
Gentamicin B. Braun 3 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Gentamicin B. Braun 1 mg/ml, solution for infusion: _
1 ml of solution for infusion contains gentamicin sulphate equivalent
to 1 mg gentamicin.
1 bottle of 80 ml contains 80 mg of gentamicin.
Excipients with known effect:
283 mg (12 mmol) of sodium (as chloride) per 80 ml bottle
Water for injections
_Gentamicin B. Braun 3 mg/ml, solution for infusion: _
1 ml of solution for infusion contains gentamicin sulphate equivalent
to 3 mg gentamicin.
1 bottle of 80 ml contains 240 mg of gentamicin.
1 bottle of 120 ml contains 360 mg of gentamicin.
Excipients:
283 mg (12 mmol) of sodium (as chloride) per 80 ml bottle.
425 mg (18 mmol) of sodium (as chloride) per 120 ml bottle.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
A clear colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of serious infections caused by susceptible
microorganisms.
Gentamicin B. Braun 1 mg/ml and Gentamicin B. Braun 3 mg/ml should for
all indications, except complicated
urinary tract infections, only be used in combination with other
relevant antibiotics (predominantly together
with a beta-lactam antibiotic or with an antibiotic effective against
anaerobic bacteria).
Under these conditions, Gentamicin B. Braun 1 mg/ml and Gentamicin B.
Braun 3 mg/ml may be used in:
●
Complicated and recurrent urinary tract infections
●
Nosocomial lower respiratory tract infections including severe
pneumonia
●
Intraabdominal infections including peritonitis
●
Skin and soft tissue infections including severe burns
●
Septicaemia including bacteraemia
●
Treatment of bacterial endocarditis
●
Treatment of surgical infections
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
DOSAGE IN PATIENTS WITH