DBL AMIKACIN 500mg/2mL injection

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

amikacin, Quantity: 500 mg

Disponibbli minn:

Pfizer Australia Pty Ltd

Għamla farmaċewtika:

Injection, solution

Kompożizzjoni:

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

Rotta amministrattiva:

Intravenous, Intramuscular

Unitajiet fil-pakkett:

5 x 2mL vials

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

DBL 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).,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 staphylococcus who have failed to respond or are allergic to other available antibiotics.,DBL 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), intraabdominal organs, post-operative infections and complicated and recurrent urinary tract infections, when caused by susceptible organisms.

Sommarju tal-prodott:

Visual Identification: A clear colourless to pale yellow solution free from visible particulate matter; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

1994-09-01

Fuljett ta 'informazzjoni

DBL™ AMIKACIN
INJECTION
_amikacin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL 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 DBL 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
DBL AMIKACIN
INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN DBL
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 DBL
AMIKACIN INJECTION IF YOU HAVE
EXPERIENCED SERIOUS REACTIONS (SUCH
AS HEARING LOSS OR KIDNEY
PROBLEMS) TO AMIKACIN,
STREPTOMYCIN, GENTAMICIN,
TOBRAMYCIN, KANAMYCIN,
POLYMYXIN B, COLISTIN, CEFALORADINE,
VIOMYCIN, OR NEOMYCIN IN THE PAST.
YOU MUST NOT BE GIVEN DBL
AMIKACIN INJECTION IF YOU HAVE
MYASTHENIA GRAVIS, A CONDITION IN
WHICH THE MUSCLES BECOME WEAK
AND TIRE EASILY.
YOU MUST NOT BE GIVEN AMIKACIN IF
YOU ARE PREGNANT OR PLANNING TO
BECOME PREGNANT.
Amikacin may affect your
developing baby

Karatteristiċi tal-prodott

Version pfpamiki10522
Superscedes: pfpamiki11121
Page 1 of 17
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™ AMIKACIN INJECTION (AMIKACIN)
1.
NAME OF THE MEDICINE
Amikacin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Amikacin Injection is available in 500 mg/2 mL strength. Each 2 mL
contains amikacin
sulfate equivalent to amikacin activity 500 mg (500,000 IU).
EXCIPIENT WITH KNOWN EFFECT
•
Sulfites
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL Amikacin Injection is a sterile clear, colourless to pale yellow
solution free from visible
particulate matter.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL 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).
_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.
DBL 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_
Version pfpamiki10522
Superscedes: pfpamiki11121
Page 2 of 17
mixing of the two drugs causes inactivation of amikacin.
Clinical studies have shown amikacin to be effective in treating
bacteraemia, septicaemia
including neonatal se