Gentamicin 1 mg/ml solution for infusion

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Gentamicin

Tilgjengelig fra:

B. Braun Melsungen AG

ATC-kode:

J01GB; J01GB03

INN (International Name):

Gentamicin

Dosering :

1 milligram(s)/millilitre

Legemiddelform:

Solution for infusion

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Other aminoglycosides; gentamicin

Autorisasjon status:

Marketed

Autorisasjon dato:

2009-03-06

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
GENTAMICIN 1 MG/ML SOLUTION FOR INFUSION
GENTAMICIN 3 MG/ML SOLUTION FOR INFUSION
Gentamicin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor.
–
If you get any side effects talk to your doctor. This includes any
possible side effects not listed
in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Gentamicin 1 mg/ml or Gentamicin 3 mg/ml
is and what it is used for
2.
What you need to know before you are given Gentamicin 1 mg/ml or
Gentamicin 3 mg/ml
3.
How Gentamicin 1 mg/ml or Gentamicin 3 mg/ml
is given to you
4.
Possible side effects
5
How to store Gentamicin 1 mg/ml and Gentamicin 3 mg/ml
6.
Contents of the pack and other information
1.
WHAT GENTAMICIN 1 MG/ML OR GENTAMICIN 3 MG/ML IS AND WHAT IT IS USED
FOR
Gentamicin 1 mg/ml or Gentamicin 3 mg/ml
belongs to a group of medicines called antibiotics, that is,
they are used to treat severe infections with bacteria that can be
killed by the active substance
gentamicin.
For the treatment of the diseases listed below, except for complicated
infections of kidneys, urinary
ducts and bladder, Gentamicin 1 mg/ml or Gentamicin 3 mg/ml
should only be used in combination
with other antibiotics.
You may receive Gentamicin 1 mg/ml or Gentamicin 3 mg/ml
to treat the following diseases:
–
Complicated and recurrent infections of kidneys, urinary ducts and
bladder
–
Infections of lungs and airways occurring during in-patient treatment
–
Infections within the belly, including inflammation of the peritoneum
–
Infections of skin and soft tissues, including severe burns
–
Sepsis (an infection of the entire body), bacteria in the blood
–
Inflammation of the inner lining of the heart (to treat infections)
–
To treat infections after operations
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GENTAMICIN 1 MG/ML OR
GENTAMICIN 3 MG/ML
THIS MEDICINE MUST NO

Preparatomtale

Health Products Regulatory Authority
15 March 2021
CRN00C17T
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gentamicin 1 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
_ _
Excipient with known effect: 283 mg (12 mmol) of sodium (as chloride)
per 80 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 severe infections due to bacteria susceptible to
gentamicin when less toxic antimicrobial agents are not
effective.
Gentamicin 1 mg/ml solution for infusion 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 1 mg/ml solution for infusion 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 NORMAL RENAL FUNCTION
_Adultsand adolescents_
Treatment of bacterial infections
The daily dose recommended in adolescents and adults with normal renal
function, is 3 – 6 mg/kg body weight per day as 1
(preferred) up to 2 single doses.
A maximum daily dose of 6 mg/kg may be needed for the treatment of
serious infections and when the susce