Tobramycin Injection

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

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Last ned Preparatomtale (SPC)
07-06-2024

Aktiv ingrediens:

Tobramycin

Informasjon til brukeren

                                TOBRAMYCIN
INJECTION
 
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tobramycin
Injection. It does not contain all the
available information. It does not
take the place of talking to your
doctor or nurse.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Tobramycin
Injection against the benefits this
medicine is expected to have for you.
This medicine is likely to be used
while you are at the clinic or in
hospital. If possible, please read this
leaflet carefully before this medicine
is given to you. In some cases this
leaflet may be given to you after the
medicine has been used.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR NURSE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT TOBRAMYCIN
INJECTION IS USED FOR
Tobramycin Injection belongs to a
group of medicines known as
aminoglycoside antibiotics.
Aminoglycoside antibiotics work by
preventing bacteria from growing,
thereby killing them.
Tobramycin Injection is used to treat
serious bacterial infections in many
different parts of the body such as:
•
meningitis (infection of the brain)
•
septicaemia (infection of the
blood)
•
respiratory tract infections (such
as pneumonia, bronchitis)
•
gastrointestinal tract infections
•
skin and bone infections,
including burns
•
urinary tract infections
Tobramycin Injection may be
prescribed for other reasons that are
not mentioned above. Your doctor
will be able to tell you about the
specific condition for which you
have been prescribed it.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
TOBRAMYCIN INJECTION
DO NOT USE TOBRAMYCIN INJECTION
IF:
•
you have an allergy to tobramycin
or any of the ingredients listed at
the end of this leaflet
•
you have an allergy to other
aminoglycoside antibiotics such
as gentamicin, streptomycin,
amikacin or neomycin
Symptoms of an allergic reaction
may include: shortness of breath,
wheezing or difficulty 
                                
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Preparatomtale

                                Version:  pfptobri10211 
Supersedes: pfptobrt10704 
 
Page 1 of 14 
PRODUCT INFORMATION 
TOBRAMYCIN INJECTION 
NAME OF THE DRUG
 
Tobramycin BP 
DESCRIPTION 
Tobramycin 
is 
_O_-3-amino-3-deoxy- -D-glucopyranosyl-(1→6)-_O_-[2,6-diamino-2,3,6-
trideoxy- -D-_ribo_-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine, 
an 
antimicrobial 
substance produced by _Streptomyces tenebrarius_.  It is a white or almost white powder that 
is  freely  soluble  in  water;  very  slightly  soluble  in  ethanol  (96%);  practically  insoluble  in 
chloroform and in ether. 
The structural formula is represented below: 
 
 
Molecular formula: 
C
18
H
37
N
5
O
9
 
Molecular weight: 
467.5 
CAS No: 
 
32986-56-4 
Tobramycin  Injection  is  a  sterile  solution  containing  80 mg/2 mL  Tobramycin  BP  (as 
tobramycin sulfate), Disodium Edetate BP, Phenol BP, 40% v/v Sulfuric Acid and Sodium 
Metabisulfite BP in Water for Injections BP. 
PHARMACOLOGY 
CLASS:  Aminoglycoside antibiotic. 
Version:  pfptobri10211 
Supersedes: pfptobrt10704 
 
Page 2 of 14 
PHARMACOKINETICS 
_ABSORPTION _
In  adults  with  normal  renal  function,  a  single  intramuscular  injection  of  1 mg/kg  body 
weight  will  produce  peak  plasma  levels  of  about  4  g/mL  within  30-90 minutes.    Serum 
concentrations can be measured for as long as eight hours.  Following intravenous infusion 
over  one  hour,  the  serum  concentrations  achieved  are  similar  to  those  obtained  after 
intramuscular administration.  Tobramycin is poorly absorbed from
the gastrointestinal tract. 
_DISTRIBUTION _
Tobramycin has been detected in body fluids such as sputum, peritoneal fluid, synovial fluid 
and  abscess  fluids  following  intravenous  administration  but  only  low  concentrations  are 
found  i
                                
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