AMIWOK amikacin (as sulfate) 500mg/2mL solution for injection infusion vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

amikacin sulfate, Quantity: 333.76 mg/mL (Equivalent: amikacin, Qty 250 mg/mL)

Dostupno od:

Wockhardt Bio Pty Ltd

Farmaceutski oblik:

Injection, solution

Sastav:

Excipient Ingredients: sodium citrate; water for injections; sulfuric acid; sodium metabisulfite

Administracija rute:

Intramuscular, Intravenous Infusion

Jedinice u paketu:

2mL

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

AMIWOK is indicated in the short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria, (see Microbiology).,Staphylococcus aureus, including methicillin-resistant strains is the principal Gram-positive organism sensitive to amikacin.,The use of amikacin in the treatment of staphylococcal infections should be restricted to second-line therapy, and should be confined to patients suffering from severe infections caused by susceptible strains of stapylococcus who have failed to respond or are allergic to other available antibiotics.,AMIWOK is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used.,In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci. If concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately because in-vitro mixing of the two drugs causes inactivation of amikacin.,Clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal sepsis and serious infections of the respiratory tract, bones and joints, central nervous system, skin and skin structures (including those resulting from burns), intra-abdominal organs, post- operative infections and complicated and recurrent urinary tract infections, when caused by susceptible organisms.

Proizvod sažetak:

Visual Identification: Colourless to yellowish liquid, practically free of particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autorizacije:

Registered

Datum autorizacije:

2018-02-14

Uputa o lijeku

AMIWOK
TM SOLUTION FOR INJECTION OR
INFUSION
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 medicine is available only with
a doctor’s prescription.
YOU MUST NOT BE GIVEN AMIKACIN
This
leaflet
answers
some
common
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e
D
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IN
a
G
m
.
ikacin
questions about 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
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 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.
BEFORE YOU ARE GIVEN
AMIKACIN INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN 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
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 AMIKACIN
INJECTION IF YOU HAVE MYASTHENIA
GRAVIS, A CON

Svojstava lijeka

Version 2.0(09/10/19)
1
AUSTRALIAN PRODUCT INFORMATION – AMIWOK (AMIKACIN
SULFATE) SOLUTION FOR INJECTION OR INFUSION
1
NAME OF THE MEDICINE
Amikacin sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMIWOK is a sterile clear, colourless solution of amikacin sulfate,
sodium citrate and sodium
metabisulfite in water for injections. Sulfuric acid is added to
adjust pH to 4.5. Each mL contains
amikacin sulfate equivalent to amikacin activity 250 mg (250,000 IU).
AMIWOK is available in 500
mg/2 mL strength.
EXCIPIENT WITH KNOWN EFFECT
• Sodiu
m metabisulfite
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection or infusion
AMIWOK is a sterile clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
AMIWOK injection is indicated in the short‐term treatment of serious
infections caused by
susceptible strains of Gram‐negative bacteria, (see section 5.1
PHARMACODYNAMIC PROPERTIES
Microbiology).
Staphylococcus aureus, including methicillin‐resistant strains is
the principal Gram‐positive organism
sensitive to amikacin.
The use of amikacin in the treatment of staphylococcal infections
should be restricted to second‐line
therapy, and should be confined to patients suffering from severe
infections caused by susceptible
strains of stapylococcus who have failed to respond or are allergic to
other available antibiotics.
AMIWOK injection is indicated in the treatment of neonatal sepsis when
sensitivity testing indicates
that other aminoglycosides cannot be used.
In certain severe infections such as neonatal sepsis, concomitant
therapy with a penicillin type drug
may be indicated because of the possibility of infections due to
Gram‐positive organisms such as
streptococci or pneumococci. If concomitant treatment with a
penicillin type drug is indicated, then
the drugs should be administered separately because in‐vitro mixing
of the two drugs causes
inactivation of amikacin.
Version 2.0(09/10/19)
2
Clinical studies have shown amika