Gentamicin 20 mg/mL Solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gentamicin

Available from:

Noridem Enterprises Limited

ATC code:

J01GB03

INN (International Name):

Gentamicin

Dosage:

20 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Therapeutic area:

gentamicin

Authorization status:

Not marketed

Authorization date:

2021-11-12

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
GENTAMICIN_ _20 MG / ML SOLUTION FOR INJECTION / INFUSION
GENTAMICIN_ _40 MG / ML SOLUTION FOR INJECTION / INFUSION
GENTAMICIN_ _80 MG / ML SOLUTION FOR INJECTION / INFUSION
Gentamicin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Gentamicin
_ _
is and what it is used for
2.
What you need to know before you are given Gentamicin
_ _
3.
How Gentamicin
_ _
is given
4.
Possible side effects
5.
How to store Gentamicin
_ _
6.
Contents of the pack and other information
1.
WHAT GENTAMICIN_ _IS AND WHAT IT IS USED FOR
Gentamicin
_ _
contains the active substance gentamicin. It belongs to a group of
antibiotics called
aminoglycosides. This medicine is used to treat severe infections
caused by bacteria. This includes:
•
infections of the urinary tract (including kidneys or bladder)
•
infections in the chest (including lungs), such as hospital-acquired
and ventilator-associated pneumonia
(HAP and VAP)
•
bacterial inflammation of the heart lining (endocarditis)
•
infections of the abdomen
•
infections of the brain and spinal cord (meningitis caused by
bacterial)
•
infections of the bones and joints (osteomyelitis and bacterial
arthritis)
•
management of neutropenic patients with fever that is suspected to be
due to a bacterial infection
•
infections of the whole body due to the presence of
_Listeria monocytogenes_
in the blood
•
severe infection in newborn babies.
•
infections of the blood (bacteraemia that occurs in association with,
or is suspected to be associated with,
any of the infections listed above)
Note:
Combination treatment is mainly indicated together with a beta-la

Summary of Product characteristics

Health Products Regulatory Authority
10 November 2022
CRN00CXP0
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gentamicin 20 mg/mL Solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 20 mg gentamicin (as gentamicin sulfate).
Each ampoule of 2 mL solution contains 40 mg gentamicin.
Excipient with known effect
Each mL of solution contains 1.60 mg sodium metabisulfite.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection / infusion
Clear and colourless solution.
pH 3.00-5.50
Osmolality: 80 – 90 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gentamicin is an aminoglycoside antibiotic with broad-spectrum
bactericidal activity. It is indicated in adults and children
including neonates.
Gentamicin is indicated for the treatment of severe infections caused
by pathogens susceptible to gentamicin.
Under these conditions, gentamicin can be used for:
- urinary tract infections
- bacterial endocarditis
- intra-abdominal infections
- meningitis caused by Gram-negative pathogens
- osteomyelitis and bacterial arthritis
- management of neutropenic patients with fever that is suspected to
be due to a bacterial infection
- Hospital-acquired and Ventilator-associated Pneumonia (HAP and VAP)
- listeriosis
- severe neonatal infections.
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated with, any of the
infections listed above.
_ _
Note:
Combination treatment is mainly indicated together with a beta-lactam
antibiotic or with an antibiotic effective against
anaerobic bacteria for life-threatening infections with an unknown
pathogen, for mixed anaerobic/aerobic infections, for
bacterial endocarditis, for systemic Pseudomonas infections and in
neutropenic patients with fever that is suspected to be due
to a bacterial infection.
_ _
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Health Products Re