GENTAMICIN 40MG/ML INJECTION

Active substance: GENTAMICIN SULPHATE

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Gentamicin Injection is used to
treat a wide variety of infections
such as chest, wound and blood
infections.

PACKAGE LEAFLET:
INFORMATION FOR
THE USER
Gentamicin 40 mg/ml
Injection
Read all of this leaflet
carefully before you start
using this medicine.
• Keep this leaflet. You may
need to read it again.
• If you have any further
questions, ask your doctor
or pharmacist.
• If any of the side effects
gets serious, or if you
notice any side effects not
listed in this leaflet, please
tell your doctor.
In this leaflet:
1. What Gentamicin Injection is
and what it is used for
2. Before you use Gentamicin
Injection
3. How to use Gentamicin
Injection
4. Possible side effects
5. How to store Gentamicin
Injection
6. Further Information

1. What Gentamicin
Injection is and what it
is used for
Gentamicin Injection is an
aminoglycoside antibiotic
medicine, in the form of a
solution for injection (a solution
which can be given as an
injection).

2. Before you use Gentamicin
Injection
Do not use Gentamicin
Injection
• if you have shown signs
of hypersensitivity (severe
allergy) to gentamicin or
any other ingredients listed
in section 6 on previous
occasions.
Take special care with
Gentamicin Injection
• if treating premature babies
• if you are an elderly patient
• if your kidneys are not working
properly
• if you have diabetes
• if you have an ear, hearing or
balance disorder, a history of
ear infections or if you have
been treated with medicines
that affect hearing in the past

Taking/using other medicines
Special care is needed if you
are taking/using other medicines
such as:
• antibiotics that also affect
your kidneys or hearing such
as other aminoglycosides,
cephalothin and methicillin
• medicines used to thin the
blood, such as warfarin and
phenindione
• amphotericin (medicine used
to treat fungal infections)
• neostigmine and
pyridostigmine (medicines
used in the treatment of
muscle weakness)
• cyclosporin (a medicine that
reduces the activity of the
body’s immune system)
• cisplatin (anti-cancer medicine)

• some diuretics (water tablets),
such as ethacrynic acid and
furosemide
• muscle relaxants used
during general anaesthesia
(such as tubocurarine and
succinylcholine)
Please tell your doctor if you are
taking or have recently taken
any other medicines, including
medicines obtained without a
prescription.

Pregnancy and breast-feeding
Gentamicin Injection will not
normally be used if you are
pregnant or breast-feeding.

Driving and using machines
Do not drive if you experience
any effect which may impair your
ability to drive or use machines.

The following information
is intended for medical or
healthcare professionals only:
Further to the information included in
section 3, practical information on the
preparation/handling of the medicinal
product is provided here.

Instructions for use, handling
and disposal
The prescribed dose may be
dissolved in up to 100 ml of normal
saline or 5% glucose in water, but not
solutions containing bicarbonate, and
the solution infused over a period of
20 to 30 minutes.
Any unused product or waste
material should be disposed of in
accordance with local requirements.

3. How to use Gentamicin
Injection
The dose of medicine given to
you will depend on how serious
the infection is, your age, body
weight and how well your kidneys
are working.
The medicine is usually injected
into a muscle but may also be
injected into a vein in some
patients.
If it is given into a vein, it can
either be given as an injection
or dissolved with, e.g. saline or
5% glucose in water and given
as a slow injection via a drip
(infusion). It will be given daily,
with your dose usually divided
into two or three separate doses.
As this medicine will be given to
you whilst you are in hospital it is
unlikely that you will be given too
little or too much, however tell
your doctor or pharmacist if you
have any concerns.
The amount of gentamicin in your
blood will be measured regularly
to check that the correct blood
levels have been achieved.

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4XXXXX

Treatment with gentamicin
may cause damage to hearing
and also to kidney function. In
some cases, your doctor may
carry out blood tests to check
your kidney function before and
during treatment with gentamicin.
Occasionally you may also be
asked to take a hearing test to
check the drug is not affecting
your hearing.

4. Possible side-effects
Like all medicines Gentamicin
Injection can cause side-effects,
although not everybody gets
them.
If any of the following happen,
please tell your doctor
immediately
• severe allergic reaction - you
may experience a sudden
itchy rash (hives), swelling
of the hands, feet, ankles,
face, lips, mouth or throat
(which may cause difficulty in
swallowing or breathing), and
you may feel you are going to
faint.
This is a very serious side-effect.
You may need urgent medical
attention. This very serious sideeffect is rare.
If you experience any of the
following tell your doctor as soon
as possible:
• hearing problems (if you
have this side-effect your
doctor may need to change
your dose or give you other
treatments)
• feeling or being sick
• skin rash or development
of raised coloured blotches
which may be itchy
• fever
• sore throat
• muscle weakness
Your doctor may also carry out
blood tests to check for changes
in your kidney function.

If any of the side effects gets
serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

5. How to store Gentamicin
Injection
Keep out of the reach and sight
of children.
Do not use Gentamicin Injection
after the expiry date printed on
the vial label and carton. The
expiry date refers to the last day
of that month.
The vials should not be stored
above 25°C.

This medicine is presented in
glass containers called vials. It
is available in packs containing
5 x 80 mg/2 ml vials

Marketing Authorisation
Holder and manufacturer
responsible for batch release
in Europe:
Hospira UK Limited, Queensway,
Royal Leamington Spa,
Warwickshire, CV31 3RW, UK.
The manufacturer is Hospira
Australia Pty Ltd, Lexia Place,
Mulgrave, Victoria 3170,
Australia.
This leaflet was last approved
in 03/2012.

6. Further Information
What Gentamicin Injection
contains
The active substance is
Gentamicin sulphate.
Each millilitre (ml) of
gentamicin injection contains
40 milligrams (mg) of gentamicin
(as sulphate).
The other ingredients are
sodium metabisulphite (E223),
disodium edetate, methyl
hydroxybenzoate (E218), propyl
hydroxybenzoate, sulphuric acid
(for pH-adjustment), sodium
hydroxide (for pH-adjustment)
and Water for Injections.
Contains preservative.

What Gentamicin Injection
looks like and contents of the
pack
This medicinal product is a
solution for injection (a solution
which can be given as an
injection). The solution for
injection is a clear, colourless
solution.

Q72966
4XXXXX

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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