HOSPIRA AMIKACIN INJECTION amikacin (as sulfate) 500mg/2mL solution for injection vial

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

amikacin

Verfügbar ab:

Hospira Australia Pty Ltd

INN (Internationale Bezeichnung):

Amikacin

Berechtigungsstatus:

Registered

Gebrauchsinformation

HOSPIRA™ AMIKACIN INJECTION _ _
_ _
Amikacin _(am-I-KAY-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 Hospira™
Amikacin Injection.
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
Hospira™ Amikacin Injection
against the benefits they expect it
will have for you.
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 HOSPIRA™
AMIKACIN INJECTION IS
USED FOR
Amikacin 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.
Amikacin works by killing bacteria
or preventing their growth.
Your doctor may have prescribed
amikacin for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY AMIKACIN
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
HOSPIRA™ AMIKACIN
INJECTION
_ _
_WHEN YOU MUST NOT BE _
_GIVEN IT _
You must not be given Hospira™
Amikacin Injection if you have an
allergy to amikacin or any of the
ingredients listed at the end of this
leaflet.
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing
or difficulty breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin.
YOU MUST NOT BE GIVEN HOSPIRA™
AMIKACIN INJECTION IF YOU HAVE
EXPERIENCED SERIOUS REACTIONS
(SUCH AS HEARING LOSS OR KIDNEY
PROBLEMS) TO AMIKACIN,
GENTAMICIN, TOBRAMYCIN, OR
NEOMYCIN IN THE PAST.
YOU MUST NOT BE GIVEN HOSPIRA™
AMIKACIN INJECTION IF YOU HAVE
MYASTHENIA GRAVIS, A CONDITION IN
WHICH THE MUSCLES BECOME WEAK
AND TIRE EASILY.
YOU MUST

Fachinformation

Product Information - Australia
Version 1.0
Page 1
HOSPIRA™ AMIKACIN INJECTION
NAME OF THE MEDICINE
Amikacin sulfate
The structural formula is shown below.
Molecular formula: C
22
H
43
N
5
O
13.
2H
2
SO
4
Molecular weight: 781.8
CAS Registry No: 39831-55-5
DESCRIPTION
Amikacin is a semisynthetic aminoglycoside antibiotic derived from
kanamycin. It is
described chemically as 6-
_O_
-(3-Amino-3-deoxy-α-D-glucopyranosyl)-4-
_O_
-(6-amino-6-
deoxy-α-D-glucopyranosyl)-1-
_N_
-[(2
_S_
)-4-amino-2-hydroxybutanoyl]-2-deoxy-D-streptamine
sulfate.
Amikacin sulfate is a white crystalline powder. It is freely soluble
in water and practically
insoluble in alcohol and acetone. 1.3 g of amikacin sulfate is
approximately equivalent to 1 g
of amikacin.
Hospira™ Amikacin Injection is a sterile clear, colourless solution
of amikacin sulfate,
sodium citrate and sodium metabisulfite in water for injections. Each
mL contains amikacin
sulfate equivalent to amikacin activity 250 mg (250,000 IU).
Hospira™ Amikacin Injection
is available in 500 mg/2 mL strength.
No antimicrobial preservative is added to the formulation. This
product is for single use in
one patient only. Discard any residue.
Product Information - Australia
Version 1.0
Page 2
PHARMACOLOGY
MICROBIOLOGY
Amikacin is active,
_in vitro_
, against the following organisms:
Gram-negative
MIC microgram/mL
_Pseudomonas species_
1.6 - 12.5
_Proteus species (indole-positive and indole negative)_
1.6 - 3.1
_Klebsiella pneumoniae_
1.6 - 3.1
_Enterobacter cloacae_
1.6 - 3.1
_Serratia species_
0.8 - 3.1
_Acinetobacter_
no information available
_Providencia stuartii_
3.1
_Citrobacter freundii_
1 - 8
_Escherichia coli_
1.6 - 3.1
Gram-positive
_Staphylococcus species_
0.4 - 5.0
(penicillinase and nonpenicillinase producing,
including methicillin resistant strains)
Amikacin’s structure has been altered to reduce the possible route
of enzymatic deactivation,
thus reducing bacterial resistance. Many strains of Gram-negative
organisms resistant to
gentamicin and tobramycin have shown t