Gentamicin 40 mg/ml solution for injection or infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
29-06-2016
Summary of Product characteristics
(SPC)
18-04-2020
Active ingredient:
Gentamicin
Available from:
Wockhardt UK Limited
ATC code:
J01GB; J01GB03
INN (International Name):
Gentamicin
Dosage:
40 milligram(s)/millilitre
Pharmaceutical form:
Solution for injection/infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other aminoglycosides; gentamicin
Authorization status:
Marketed
Authorization date:
2015-03-13
Patient Information leaflet
CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
GENTAMICIN 10MG/ML SOLUTION FOR INJECTION OR INFUSION
AND
GENTAMICIN 40MG/ML SOLUTION FOR INJECTION OR INFUSION
pg1/2
WHAT IS IN THIS LEAFLET:
1. What gentamicin is and what it is used for
2. What you need to know before you take gentamicin
3. How to take gentamicin
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
The name of this medicine is Gentamicin 10mg/ml Solution for
Injection or Infusion and Gentamicin 40mg/ml Solution for Injection or
Infusion (called “gentamicin” in this leaflet).
It contains a medicine called gentamicin sulfate. This belongs to a
group of antibiotics called aminoglycosides.
Gentamicin is used to treat infections caused by bacteria in adults
and
children including new-borns. This includes infections in:
• Your urinary tract (including your kidneys or bladder)
• Your chest (including your lungs)
• Your blood – this is sometimes called ‘bacteraemia’
• Other serious infections
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
GENTAMICIN
DO NOT TAKE GENTAMICIN IF:
• You have Myasthenia Gravis. This is a disease that causes muscle
weakness
• You are allergic (hypersensitive) to gentamicin or to any of the
other
ingredients of this medicine (listed in section 6). Signs of an
allergic
reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat and tongue.
Do not take this medicine if any of the above applies to you. If you
are
not sure, talk to your doctor or pharmacist before taking gentamicin.
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Gentamicin if:
• You are pregnant, might become pregnant, or think you may be
pregnant
• You are breast-feeding (see ‘Pregnancy and breast-feeding’
section
below)
• You have any muscle weakness
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Summary of Product characteristics
Health Products Regulatory Authority
17 April 2020
CRN00938W
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gentamicin 40mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection or infusion contains gentamicin sulfate
equivalent to 40 mg gentamicin.
Each ampoule (2ml) contains Gentamicin Sulfate Ph Eur equivalent to
80mg Gentamicin.
This medicine contains 0.78 mg of sodium per ampoule; it is
essentially sodium free.
This medicine contains 3.2 mg of sodium metabisulfite
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection or Infusion.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indications : gentamicin is indicated in bacteraemia, urinary tract
infections, chest infections, severe neonatal infections and
other serious systemic infections due to susceptible organisms, in
adults and children including neonates.
Please see section 5.1.
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:
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 d
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