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

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

amikacin sulfate, Quantity: 667.5 mg (Equivalent: amikacin, Qty 500 mg)

Tilgjengelig fra:

Emcure Pharmaceuticals Pty Ltd

Legemiddelform:

Injection

Sammensetning:

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

Administreringsrute:

Intramuscular, Intravenous

Enheter i pakken:

5 x 2 mL

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Amikacin Injection is indicated in the short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria.,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 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.,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.

Produkt oppsummering:

Visual Identification: Clear colourless to light straw coloured solution packed in a glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

2019-08-13

Informasjon til brukeren

AMIKACIN EMC Page | 1
AMIKACIN EMC
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
AMIKACIN EMC.
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 EMC 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 EMC
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 EMC HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
AMIKACIN EMC
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN
AMIKACIN EMC 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 EMC 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 EMC IF YOU HAVE
MYASTHENIA GRAVIS, A CONDITION
IN WHICH THE MUSCLES BECOME
WEAK AND TIRE EASILY.
YOU MUST NOT BE GIVEN
AMIKACIN EMC IF YOU ARE
PREGNANT OR PLANNING TO
BECOME PREGNANT.
Amikacin may affect your
developing baby if

Preparatomtale

1
AUSTRALIAN PRODUCT INFORMATION – AMIKACIN EMC (AMIKACIN
SULFATE) INJECTION
1
NAME OF THE MEDICINE
Amikacin sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Amikacin Injection is a sterile clear colorless to light straw-colored
solution of amikacin sulfate, packed
as 2 mL clear Type-1 glass vial stoppered with 13 mm rubber stopper
and sealed with 13 mm purple
MT flip off seal.
No antimicrobial preservative is added to the formulation. This
product is for single use in one patient
only. Discard any residue.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Amikacin 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 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 amika