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

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

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

Fáanlegur frá:

Wockhardt Bio Pty Ltd

Lyfjaform:

Injection, solution

Samsetning:

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

Stjórnsýsluleið:

Intramuscular, Intravenous Infusion

Einingar í pakka:

2mL

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

AMIKACIN WOCKHARDT 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.,AMIKACIN WOCKHARDT 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.

Vörulýsing:

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

Leyfisstaða:

Registered

Leyfisdagur:

2018-02-14

Upplýsingar fylgiseðill

AMIKACIN WOCKHARDT
TM
Page 1
CMI – AMIKACIN WOCKHARDT
v 1.0
AMIKACIN WOCKHARDT
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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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

Vara einkenni

Version 2.0(09/10/19)
1
AUSTRALIAN PRODUCT INFORMATION – AMIKACIN WOCKHARDT
(AMIKACIN SULFATE) SOLUTION FOR INJECTION OR INFUSION
1
NAME OF THE MEDICINE
Amikacin sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMIKACIN WOCKHARDT 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). AMIKACIN
WOCKHARDT is available in 500 mg/2 mL strength.
EXCIPIENT WITH KNOWN EFFECT
• Sodium metabisulfite
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection or infusion
AMIKACIN WOCKHARDT is a sterile clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
AMIKACIN WOCKHARDT 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.
AMIKACIN WOCKHARDT 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