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TOBRAMYCIN 40MG/ML INJECTION

Active substance(s): TOBRAMYCIN

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PACKAGE LEAFLET: INFORMATION FOR
THE USER
Tobramycin
40 mg/ml Injection
Read all of this leaflet carefully before you start taking
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• 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 Tobramycin Injection is and what it is used for
2. Before you use Tobramycin Injection
3. How to use Tobramycin Injection
4. Possible side effects
5. How to store Tobramycin Injection
6. Further information

1. WHAT TOBRAMYCIN INJECTION IS AND WHAT IT IS USED FOR
Tobramycin Injection is an antibiotic medicine (used to fight
infections caused by bacteria).
Tobramycin can be used to treat:
• infections of the brain and spinal cord, e.g. meningitis
• infections of the stomach or intestines
• infections of the bladder or kidney (urinary tract infection)
• infections of the lungs, e.g. pneumonia
• infections of the bone, skin or soft tissue including burns

2. BEFORE YOU USE TOBRAMYCIN INJECTION
Tobramycin Injection must never be injected intrathecally (into
the spine).

Do not use Tobramycin Injection

• if you have shown signs of hypersensitivity (severe allergy) to
tobramycin or similar medicines (called aminoglycosides) on
previous occasions
Tell your doctor if the above applies to you before this medicine is
used.

Take special care with Tobramycin Injection

• if you have muscle disorders, such as myasthenia gravis
(a disease in which the muscles become weak and tire easily) or
parkinsonism (a disease of the brain which affects movement)
• if you have kidney trouble
Tell your doctor or pharmacist if either of the above applies to you
before this medicine is used.
Special care is also needed if this medicine is to be given to babies
or infants less than 6 weeks of age, or patients with extensive
burns.

Taking/using other medicines
Special care is needed if you are taking/using other medicines as
some could interact with Tobramycin Injection, for example:
• some other antibiotics (e.g. cephalothin)
• amphotericin B (a medicine used to treat fungal infection)
• some diuretics (water tablets)
• medicines used as general anaesthetics
• medicines used as muscle relaxants during general anaesthesia
• cisplatin (anti-cancer medicine)
• ciclosporin (a medicine that reduces the activity of the body’s
immune system)
• neostigmine and pyridostigmine (medicines used in the
treatment of muscle weakness)
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or
breast-feeding. Your doctor will decide if you should receive this
medicine.
There may be a risk of birth defects if this medicine is used during
pregnancy. Some children whose mothers took a similar medicine
(streptomycin) have been born deaf. It will only be used if the
potential benefits clearly outweigh the risks.
Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines
Do not drive or use machines if you experience any side effect
(e.g. dizziness or drowsiness) which may lessen your ability to do so.

Important information about some of the ingredients of
Tobramycin Injection
This medicine contains sodium metabisulphite, which can cause an
allergic type reaction (skin rash, swelling of eyelids, face or lips, or
difficulty in breathing). This is rare, but you may be more at risk if
you suffer from allergies or asthma.
This medicine contains less than 1 mmol sodium (23 mg) per
700 mg dose of Tobramycin Injection, i.e. essentially sodium free.

3. HOW TO USE TOBRAMYCIN INJECTION
This medicine is given by injection (using a syringe) into a muscle
or a vein, or infusion (drip) into a vein.
If it is given as an infusion it will be diluted before use. It will then be
infused over a 20 to 60 minute period.

Dose
Your doctor will work out the correct dose of Tobramycin Injection
for you and how often it must be given.
The dose will depend on your medical condition, your size, how
serious the infection is, your age and how well your kidneys are
working. Your doctor will tell how well your kidneys are working
using blood or urine samples.
Treatment normally lasts for 7 to 10 days.
If you take tobramycin for more than 10 days or take more than
the recommended dose, you may experience more severe side
effects. These include dangerous breathing difficulties, which
could also occur if you do not drink enough fluid, if you have poor
kidney function or if you are taking other drugs that can affect your
hearing.
Your doctor may take regular blood samples to ensure you are
receiving the correct dose.

Tobramycin
40 mg/ml Injection
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.

Incompatibilities
Incompatibility or loss of activity has been reported between
tobramycin sulphate and some cephalosporins and penicillins and
also heparin sodium. Solutions with clindamycin phosphate in glucose
injection are reported to be unstable.
Tobramycin Injection should not be physically premixed with other
drugs but should be administered separately according to the
recommended dose and route.

Instructions for use and handling
Single use only
2017-0000291/3

Designer/Artworker: xx
Date: xx/xx/xx
Version: x

If you are given too much or too little Tobramycin Injection
This medicine will be given to you in a hospital, under the
supervision of a doctor. It is unlikely that you will be given too
much or too little, however, tell your doctor or nurse if you have any
concerns.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Tobramycin Injection can cause side effects,
although not everybody gets them.

If any of the following happen, 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
• loss of hearing
• ringing, buzzing or roaring noise in your ears
• dizziness
• vertigo (a feeling that you or your surroundings are spinning)
• numbness or pins and needles
• muscle twitching
• convulsions
These are serious side effects. You may need urgent medical
attention.

If any of the following happen, tell your doctor as soon as
possible:

• fever (high temperature)
• rash or development of raised coloured blotches
• scaly skin
• itching
• feeling or being sick
• headache
• feeling tired or drowsy
• pain at the injection site
• confusion and disorientation
• diarrhoea
Tobramycin Injection may lead to changes in your blood cells and
liver and kidney function. Your doctor may take blood samples
to monitor for these. Your doctor may also check for hearing
problems.
Some patients who have received an injection of tobramycin into
the eye have experienced serious vision problems. This is not a
recommended use of this medicine.

Reporting of side effects
If you get any of the 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:
United Kingdom
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 TOBRAMYCIN INJECTION
Keep out of the reach and sight of children

Expiry
This medicine must not be used after the expiry date which is
stated on the vial label and carton after ‘EXP’. Where only a month
and year is stated, the expiry date refers to the last day of that
month.

Storage
The vials should be kept in the outer carton to protect from light and
stored at or below 25°C.
Unused portions of opened vials must not be stored for later use.
Prepared infusions should be used immediately, however, if this is
not possible they can be stored for up to 24 hours provided they
have been prepared in a way to exclude microbial contamination.

6. FURTHER INFORMATION
What Tobramycin Injection contains
The active substance is tobramycin. Each millilitre (ml) of solution
contains 40 milligrams (mg) of tobramycin.
The other ingredients are sodium metabisulphite (E223), disodium
edetate, sulphuric acid and Water for Injections.

What Tobramycin Injection looks like and contents of the pack
Tobramycin Injection is a clear colourless solution for injection
presented in glass containers called vials.
It may be supplied in packs containing:
• 5 x 40 mg/1 ml vials
• 5 x 80 mg/2 ml vials
• 1 or 5 x 240 mg/6 ml vials
Not all packs may be marketed.

Marketing authorisation holder and manufacturer
Hospira UK Limited
Horizon
Honey Lane
Hurley
Maidenhead
SL6 6RJ, UK
This leaflet was last revised in 08/2017
Ref: gxTO 1_1

Discard any unused contents
When given by infusion, Tobramycin Injection may be diluted (with
0.9% Sodium Chloride Intravenous Infusion BP or 5% Dextrose
Intravenous Infusion BP) to volumes of 50-100 ml for adult doses. For
children, the volume of diluent should be proportionately less than for
adults.
After dilution, chemical and physical in-use stability has been
demonstrated in dextrose 5% and sodium chloride 0.9% infusion
solutions for 24 hours at 24°C in the presence of light.
From a microbiological point of view the product should be used
immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user and would
normally not be longer than 24 hours at 2-8°C, unless dilution has
taken place in controlled and validated aseptic conditions.
Ref: gxTO 1_1

2017-0000291/3

Designer/Artworker: xx
Date: xx/xx/xx
Version: x

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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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