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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.

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.
Q78665
434522

Component Specification

Requester

Item number:

Q78665

Request number:

AS4991

Country:

United Kingdom

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.

OI template:
Amalia version:
Mulgrave version:

88S119
6
5

Dimensions:
Container(s):
Supplier:
Stock:

118 x 513 mm (18 panels)
vial
Howden Printing
Primapharm 40gsm /
Teropaque Thin Medical 40gsm
Folded dimensions: 28.5 x 118 mm
Printed both sides: Yes
Perforated:
No
Pharma code:
Pharma code length:
Mulgrave 4 series no.:

Colours
Black:

115 (221211)
11 mm
434522

Previous Item Number: Q62989 / 431470
Signed:
Date:

Version 1
Technician:
Date:

LB
18/Feb/15

Version 2
Technician:
Date:

JH
10/Mar/15

Version 3
Technician:
Date:

NR
18/Sep/15

Version 4
Technician:
Date:

NR
18/Sep/15

Version 5
Technician:
Date:

JW
15/Oct/15

Version 6
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

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.

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 responsible
for batch release in Europe
Hospira UK Limited
Horizon
Honey Lane
Hurley
Maidenhead
SL6 6RJ, UK

Manufacturer
Hospira Australia Pty Ltd
1-5, 7-23 and 25-39 Lexia Place
MULGRAVE VIC 3170
Australia
This leaflet was last revised in 09/2015

Instructions for use and handling
Single use only
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.
Q78665
434522

Component Specification

Requester

Item number:

Q78665

Request number:

AS4991

Country:

United Kingdom

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.

OI template:
Amalia version:
Mulgrave version:

88S119
6
5

Dimensions:
Container(s):
Supplier:
Stock:

118 x 513 mm (18 panels)
vial
Howden Printing
Primapharm 40gsm /
Teropaque Thin Medical 40gsm
Folded dimensions: 28.5 x 118 mm
Printed both sides: Yes
Perforated:
No
Pharma code:
Pharma code length:
Mulgrave 4 series no.:

Colours
Black:

115 (221211)
11 mm
434522

Previous Item Number: Q62989 / 431470
Signed:
Date:

Version 1
Technician:
Date:

LB
18/Feb/15

Version 2
Technician:
Date:

JH
10/Mar/15

Version 3
Technician:
Date:

NR
18/Sep/15

Version 4
Technician:
Date:

NR
18/Sep/15

Version 5
Technician:
Date:

JW
15/Oct/15

Version 6
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

Component Specification

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.

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
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.
Q78666
434523

Item number:

Q78666

Request number:

AS4992

Country:

United Kingdom

OI template:
Amalia version:
Mulgrave version:

88S078
5
4

285 x 200 mm (5 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:
6636 (211222212212)
Pharma code length: 25 mm
Mulgrave 4 series no.: 434523

Colours
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: Q62979 / 431428
Signed:
Date:

Version 1
Technician: LB
Date: 18/Feb/15

Version 2
Technician: JH
Date: 10/Mar/15

Version 3
Technician: NR
Date: 18/Sep/15

Version 4
Technician: NR
Date: 18/Sep/15

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

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.

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.

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
responsible for batch
release in Europe
Hospira UK Limited
Horizon
Honey Lane
Hurley
Maidenhead
SL6 6RJ, UK

Item number:

Q78666

Request number:

AS4992

Country:

United Kingdom

OI template:
Amalia version:
Mulgrave version:

88S078
5
4

285 x 200 mm (5 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:
6636 (211222212212)
Pharma code length: 25 mm
Mulgrave 4 series no.: 434523

Colours
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: Q62979 / 431428
Signed:
Date:

Manufacturer
Hospira Australia Pty Ltd
1-5, 7-23 and 25-39 Lexia Place
MULGRAVE VIC 3170
Australia
This leaflet was last revised
in 09/2015
Q78666
434523

Version 1
Technician: LB
Date: 18/Feb/15

Version 2
Technician: JH
Date: 10/Mar/15

Version 3
Technician: NR
Date: 18/Sep/15

Version 4
Technician: NR
Date: 18/Sep/15

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

Expand view ⇕

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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