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GENTAMICIN 40MG/ML INJECTION

Active substance: GENTAMICIN SULPHATE

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2. BEFORE YOU USE GENTAMICIN
INJECTION

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).
Gentamicin Injection is used to
treat a wide variety of infections

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
• if you suffer from a disorder
called myasthenia gravis
(severe weakness of selected
muscles of the body)
• if you are pregnant or
breast-feeding
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
• if you experience muscle
weakness
• if you are very overweight

• 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)
• indomethacin (one of a group
of medicines called
non-steroidal anti-inflammatory
agents used to treat pain and
inflammations)
• biphosphonates (group of
medicines used to treat e.g.
osteoporosis)
• Botulinum Toxin (medicine
used for the treatment
of muscle spasticity, an
involuntary flexing of the
muscles)

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.

88S078
5
4

228 x 200 mm (4 panels)
vials (blistered)
Howden Printing
Primapharm 40gsm /
Teropaque Thin Medical 40gsm
Folded dimensions: 57 x 100 mm
Printed both sides: Yes
Perforated:
No
Dimensions:
Container(s):
Supplier:
Stock:

Pharma code:
Decimal (Binary)
Pharma code length: ## mm
Mulgrave 4 series no.: 4XXXXX

Black:

Requester
I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q72966 / 4xxxxx

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.

Latest QP Release Date:

3. HOW TO USE GENTAMICIN
INJECTION

Signed:
Date:

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.

OI template:
Amalia version:
Mulgrave version:

Colours

Pregnancy and breast-feeding

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,
cephalosporins, (notably
cephalothin) and methicillin
• medicines used to thin the
blood, such as warfarin and
phenindione
• amphotericin B (medicine
used to treat fungal infections)
• neostigmine and
pyridostigmine (medicines
used in the treatment of
muscle weakness)

United Kingdom

The following information
is intended for medical or
healthcare professionals only:

Please tell your doctor if you are
taking or have recently taken
any other medicines, including
medicines obtained without a
prescription.

Taking/using other medicines

AS3233

Country:
such as chest, wound and blood
infections.

Q75863

Version 1
Technician: BJ
Date: 18/Jun/13
Version 3
Technician: XX
Date: dd/mmm/yy
Q75863
4XXXXX

Version 2
Technician: BJ
Date: 20/Jun/13
Version 4
Technician: XX
Date: dd/mmm/yy

Version 5
Technician: XX
Date: dd/mmm/yy

Version 6
Technician: XX
Date: dd/mmm/yy

Version 7
Technician: XX
Date: dd/mmm/yy

Version 8
Technician: XX
Date: dd/mmm/yy

Version 9
Technician: XX
Date: dd/mmm/yy

Version 10
Technician: XX
Date: dd/mmm/yy

Component Specification
Item number:
Request number:

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
you 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.
Treatment with gentamicin may
cause damage to hearing and
also to kidney function. Your
doctor will decide, depending
on your condition, how long you
should receive gentamicin. 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
side-effect 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, (nausea
or vomiting)
• skin rash or development
of raised coloured blotches
which may be itchy
• purple discolouration under
the skin
• fever
• sore throat and mouth
• muscle weakness
• kidney disease with symptoms
such as reduced urine output
• low blood cell counts (red
and white blood cells) and
further blood abnormalities
or disorders (known as blood
dyscrasia)
• damage to the brain with signs
such as seizures, confusion,
tiredness, depression and
hallucinations
• liver problems
• low potassium or calcium
levels in the blood
• low magnesium levels in
the blood with prolonged
treatment
Your doctor may also regulatory
carry out blood tests to check
for changes in your blood cells,
electrolytes (such as potassium,
calcium and magnesium) in your
blood, kidney and liver function,
as well as hearing tests.
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

AS3233

Country:
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.

Q75863
United Kingdom

expiry date refers to the last day
of that month.
The vials should not be stored
above 25°C.

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.

OI template:
Amalia version:
Mulgrave version:

88S078
5
4

228 x 200 mm (4 panels)
vials (blistered)
Howden Printing
Primapharm 40gsm /
Teropaque Thin Medical 40gsm
Folded dimensions: 57 x 100 mm
Printed both sides: Yes
Perforated:
No
Dimensions:
Container(s):
Supplier:
Stock:

Pharma code:
Decimal (Binary)
Pharma code length: ## mm
Mulgrave 4 series no.: 4XXXXX

Colours
Black:

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.
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 revised in
February 2013.

Q75863
4XXXXX

Requester
I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q72966 / 4xxxxx
Latest QP Release Date:
Signed:
Date:
Version 1
Technician: BJ
Date: 18/Jun/13

Version 2
Technician: BJ
Date: 20/Jun/13

Version 3
Technician: XX
Date: dd/mmm/yy

Version 4
Technician: XX
Date: dd/mmm/yy

Version 5
Technician: XX
Date: dd/mmm/yy

Version 6
Technician: XX
Date: dd/mmm/yy

Version 7
Technician: XX
Date: dd/mmm/yy

Version 8
Technician: XX
Date: dd/mmm/yy

Version 9
Technician: XX
Date: dd/mmm/yy

Version 10
Technician: XX
Date: dd/mmm/yy

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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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