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GENTAMICIN 40MG/ML INJECTION

Active substance(s): GENTAMICIN SULPHATE

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Hospira

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
1.
2.
3.
4.
5.
6.

this leaflet:
What Gentamicin Injection is and what it is used for
Before you use Gentamicin Injection
How to use Gentamicin Injection
Possible side effects
How to store Gentamicin Injection
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 such as
chest, wound and blood infections.

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
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

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, 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)
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 antiinflammatory 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)
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 breastfeeding.

Driving and using machines
Do not drive if you experience any effect which may impair your ability to
drive or use machines.
The vial stopper contains dry natural rubber (a derivative of latex),
which may cause allergic reactions.

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.

--~---------------------------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.

2017-0000193/3

Designer/Artworker: XX
Date: XX/XX/XX
Version: X

Date: 08 Dec 2017
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Time:

18:20

885119-5

Smallest Body Text
8 pt

Pockaging Site

Black

PGS Melbourne

Dimensions:
342 x 118 mm

Product Details:

Pharmacode:

2017-0000193/3
Version No: 03
PAR-2017-0000193
United Kingdom
Perigord No: 301697

N/A

Bare ode:
N/A

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 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 regularly 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 you get any side effects , talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE GENTAMICIN INJECTION
Keep out of sight and reach 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.

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.
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 , Horizon , Honey Lane, Hurley, Maidenhead , SL6 6RJ , UK.
The manufacturer is Hospira Australia Ply Ltd , 1-5, 7-23 and 25-39 Lexia Place,
MULGRAVE VIC 3170, Australia.
This leaflet was last revised in August2017
Ref: gxGN 1_0

--~---------------------------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 no longer than 20 minutes.
Any unused product or waste material should be disposed of in accordance with
local requirements.
The vial stopper contains dry natural rubber (a derivative of latex), which may
cause allergic reactions.
2017-0000193/3

Designer/Artworker: XX
Date: XX/XX/XX
Version: X

Date: 08 Dec 2017
--------~

Time:

18:20

885119-5

Smallest Body Text
8 pt

Packaging Site

Black

PGS Melbourne

Dimensions:
342 x 118 mm

Product Details:

Pharmacode:

2017-0000193/ 3
Version No: 03
PAR-2017-0000193
United Kingdom
Perigord No: 301697

N/A

Bare ode:
N/A

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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