TOBRAMYCIN 40MG/ML INJECTION

Active substance: TOBRAMYCIN

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Tobramycin can be used to
treat:

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).

• 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 breastfeeding
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. 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

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.
Q62979
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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.

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.
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
• itching
• feeling or being sick
• headache
• feeling tired or drowsy
• pain at the injection site
• confusion and disorientation
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.
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
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

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
marketed.

may

be

Marketing authorisation
holder and manufacturer
responsible for batch
release in Europe
Hospira
UK
Limited,
Queensway, Royal Leamington
Spa, Warwickshire, CV31 3RW,
UK

Manufacturer
Hospira Australia Pty Ltd, Lexia
Place, Mulgrave, Victoria 3170,
Australia
This leaflet was
approved in 09/2008

last

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

Q62979
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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