B. BRAUN GENTAMICIN gentamicin (as sulfate) 80 mg/80 mL injection, intravenous infusion, bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gentamicin sulfate, Quantity: 1.39 mg/mL (Equivalent: gentamicin, Qty 1 mg/mL)

Available from:

B Braun Australia Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intravenous Infusion

Units in package:

20 bottles, 10 bottles

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of infections due to one or more susceptible strains of bacteria, including Pseudomonas aeruginosa, Proteus species (indole positive and indole negative), Escherichia coli, Klebsiella, Enterobacter and Serratia species and Staphylococcus (including strains resistant to other antibiotics). Gentamicin may also be used for the treatment of the following conditions when caused by susceptible organisms: bacteraemia, respiratory tract infections, urinary tract infections, skin and skin structure infections, bone infections, peritonitis, septic abortion and burns complicated by sepsis. Aminoglycosides, including gentamicin are generally not indicated in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to less toxic antibiotics. In suspected or documented Gram-negative sepsis, gentamicin should be considered for initial antimicrobial therapy. Therapy may be instituted before obtaining results of susceptibility tests. The decision to continue therapy is based on results of the susceptibility tests, the severity of the infection and risk toxicity. If anaerobic organisms are suspected, antimicrobial therapy in addition to the gentamicin regimen should be considered.

Product summary:

Visual Identification: A clear colourless aqueous solution, practically free from particles; Container Type: Bottle; Container Material: LDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-05-17

Patient Information leaflet

B. BRAUN GENTAMICIN CMI- Version 2.0
Page 1 of 5
B. BRAUN GENTAMICIN INJECTION,
INTRAVENOUS INFUSION
Gentamicin _(jen-tah-mi-sin)_
CONSUMER MEDICINE INFORMATION
_Date of Dispensing _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about B. BRAUN GENTAMICIN
injection, intravenous
infusion (gentamicin).
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits
.
Your doctor has weighed the risks of you being given B. BRAUN
GENTAMICIN injection, intravenous infusion against the benefits they
expect it will 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 BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again.
WHAT B. BRAUN
GENTAMICIN INJECTION, INTRAVENOUS INFUSION IS USED
FOR
Gentamicin is an antibiotic that belongs to a group of medicines
called aminoglycosides (pronounced
a-my-noe-GLY-koe-sides). It is used to treat serious bacterial
infections.
This medicine works by killing bacteria or preventing their growth. It
is used for the treatment of serious
infections, including:
•
septicaemia (infection of the blood)
•
respiratory tract infections
•
infected wounds
•
bone or tissue infections
•
infected burns
•
urinary tract infections.
Your doctor may have prescribed gentamicin for another reason. Ask
your doctor if you have any
questions about why gentamicin has been prescribed for you.
This medicine is available only with a doctor’s prescription.
B. BRAUN GENTAMICIN CMI- Version 2.0
Page 2 of 5
BEFORE YOU ARE GIVEN B. BRAUN GENTAMICIN INJECTION, INTRAVENOUS
INFUSION
_WHEN YOU MUST NOT BE GIVEN IT _
YOU M

Summary of Product characteristics

B. BRAUN GENTAMICIN PI – Version 2.0
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION – B. BRAUN
GENTAMICIN (GENTAMICIN SULFATE) INJECTION
1.
NAME OF THE MEDICINE
Gentamicin Sulfate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
B. BRAUN GENTAMICIN 1 mg/mL injection, intravenous infusion
Gentamicin (as sulfate) 1 mg/mL
Sodium chloride 9 mg/mL
Water for injections q.s. to 1 mL
B. BRAUN GENTAMICIN 3 mg/mL injection, intravenous infusion
Gentamicin (as sulfate) 3 mg/mL
Disodium edetate 10 µg/mL
Sodium chloride 9 mg/mL
Water for injections q.s. to 1 Ml
3.
PHARMACEUTICAL FORM
Injection, intravenous infusion
4. CLINICAL PARTICULARS_ _
_4.1 _
THERAPEUTIC INDICATIONS_ _
For the treatment of infections due to one or more susceptible strains
of bacteria,
including _Pseudomonas aeruginosa_, Proteus species (indole positive
and indole negative),
_Escherichia _
_coli_,
Klebsiella,
Enterobacter
and
Serratia
species
and
Staphylococcus
(including strains resistant to other antibiotics).
Gentamicin may also be used for the treatment of the following
conditions when caused
by
susceptible
organisms:
bacteraemia,
respiratory
tract
infections,
urinary
tract
infections, skin and skin structure infections, bone infections,
peritonitis, septic abortion
and burns complicated by sepsis. Aminoglycosides, including gentamicin
are generally
not indicated in uncomplicated initial episodes of urinary tract
infection unless the
causative organisms are not susceptible to less toxic antibiotics.
In suspected or documented Gram-negative sepsis, gentamicin should be
considered for
initial antimicrobial therapy. Therapy may be instituted before
obtaining results of
susceptibility
tests.
The
decision
to
continue
therapy
is
based
on
results
of
the
susceptibility tests, the severity of the infection and risk of
toxicity. If anaerobic
organisms are suspected, antimicrobial therapy in addition to the
gentamicin regimen
should be considered.
B. BRAUN GENTAMICIN PI – Version 2.0
Page 2 of 16
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
For single use only.
B