AMIKACIN - MEDO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AMIKACIN AS SULFATE

Available from:

A.L. MEDI-MARKET LTD.

ATC code:

J01GB06

Pharmaceutical form:

SOLUTION FOR INJECTION / INFUSION

Composition:

AMIKACIN AS SULFATE 250 MG / 1 ML

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

MEDOCHEMIE LTD. AMPOULE INJECTABLE FACILITY, CYPRUS

Therapeutic area:

AMIKACIN

Therapeutic indications:

AMIKACIN - MEDO is indicated in the short-term treatment of Gram-negative organisms, including pseudomonas and some Gram-positive organisms.Sensitive Gram-negative organisms include; Pseudomonas aeruginosa, Escherichia coli., indole-positive and indole-negative Proteus spp., Klebsiella, Enterobacter and Serratia spp., Minea-Herralae, Citrobacter freundii, Salmonella, Shigella, Acinetobacter and Providencia spp.The principal Gram-positive organism sensitive to amikacin is Staphylococcus aureus, including some methicillin-resistant strains. AMIKACIN - MEDO has some activity against other Gram-positive organisms including certain strains of Streptococcus pyogenes, Enterococci and Diplococcus pneumoniae.

Authorization date:

2019-12-11

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
.
Name
of
the
medicinal
product
Amikacin – Medo
2. Qualitative and quantitative composition
1
ml
of
solution
for
injection/infusion contains
250
mg
of
amikacin
(as
sulfate).
1
ampoule
of
2
ml
of
solution for
injection/infusion
contains
500
mg
of
amikacin
(as
sulfate).
Excipient(s) with known effect: sodium metabisulphite and sodium.
For
the full list of excipients,
see
section 6.1.
3. Pharmaceutical form
Solution
for
Injection/ infusion.
Clear,
colourless
to
slightly
yellow
solution
4. Clinical particulars
4.1 Therapeutic indications
Amikacin-Medo
is
indicated
in
the
short-term
treatment
of
Gram-negative
organisms,
including
pseudomonas
and
some
Gram-positive
organisms.
Sensitive
Gram-negative
organisms
include;
Pseudomonas
aeruginosa,
Escherichia
coli.,
indole-
positive
and
indole-negative
Proteus
spp.,
Klebsiella,
Enterobacter
and
Serratia
spp.,
Minea-
Herralae,
Citrobacter
freundii,
Salmonella,
Shigella,
Acinetobacter
and
Providencia
spp.
The
principal
Gram-positive
organism
sensitive
to
amikacin
is
Staphylococcus
aureus,
including
some
methicillin-resistant
strains.
Amikacin-Medo
has
some
activity
against
other
Gram-positive
organisms
including
certain
strains
of
Streptococcus
pyogenes,
Enterococci
and
Diplococcus
pneumoniae.
Many
strains
of
these
Gram-negative
organisms
resistant
to
gentamicin
and
tobramycin
show
sensitivity
to
amikacin
in
vitro.
Although
amikacin
is
not
the
drug
of
choice
for
infections
due
to
staphylococci,
at
times
it
may
be
indicated
for
the
treatment
of
known
or
suspected
staphylococcal
disease.
These
situations
include:
the
initiation
of
therapy
for
severe
infections
when
the
organisms
suspected
are
either
Gram-negative
or
staphylococci,
patients
allergic
to
other
antibiotics,
and
mixed
staphylococcal/Gram-negative
infections.
Therapy
with
amikacin
may
be
instituted
prior
to
obtaining
the
results
of
sensitivity
testing.
Surgical
procedures
should
be
performed
where
indicated.
Consideration
should
be
given
to
official
guidance
on
the
appropriate
us