LINEZAN

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

LINEZOLID

Disponible desde:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

Código ATC:

J01XX08

formulario farmacéutico:

SOLUTION FOR INFUSION

Composición:

LINEZOLID 2 MG / 1 ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricado por:

ANFARM HELLAS S.A., GREECE

Área terapéutica:

LINEZOLID

indicaciones terapéuticas:

Therapy is indicated only when an organism resistant to all other antibiotics is suspected.Linezolid is indicated in adult and pediatric patients for the treatment of infections when known or suspected to be caused by susceptible organisms including those associated with concurrent bacteraemia such as:1) Pneumonia - community acquired and nosocomial pneumonia including multi drug resistant streptococcus pneumonia (MDRSP). 2) Skin and soft tissue infections including diabetic foot infections. 3) Enterococcal infections. Combination therapy may be indicated if a concomitant Gram negative pathogen is documented or suspected.

Fecha de autorización:

2020-02-10

Ficha técnica

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LINEZAN
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linezan 2 mg/ml Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg linezolid.
Excipients with known effect: each 1 ml also contains 50.25 mg glucose
(dextrose) monohydrate and 0.38 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion:
Clear, colorless to sub yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Therapy is indicated only when an organism resistant to all other
antibiotics
is suspected. Linezan is indicated in adult and pediatric patients for
the
treatment
of infections
when
known
or
suspected
to
be
caused
by
susceptible
organisms
including
those
associated
with
concurrent
bacteraemia such as:
1)
Pneumonia - community acquired and nosocomial pneumonia including
multi drug resistant streptococcus pneumonia (MDRSP).
2)
Skin and soft tissue infections including diabetic foot infections.
3)
Enterococcal infections.
Combination therapy may be indicated if a concomitant Gram negative
pathogen is documented or suspected.
Linezolid is active against Gram–positive bacteria only. Linezolid
has no
clinical activity against Gram–negative pathogens. Specific
Gram-negative
therapy
is
required
if
a
concomitant
Gram-negative
pathogen
is
documented or suspected (See section 4.4 and 5.1).
Linezolid should only be initiated after consultation with a relevant
specialist
such as a microbiologist or infectious diseases specialist.
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CONSIDERATION
SHOULD
BE
GIVEN
TO
OFFICIAL
GUIDANCE
ON
THE
APPROPRIATE USE OF ANTIBACTERIAL AGENTS.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Linezan solution for infusion may be used as initial therapy. Patients
who
commence treatment on the parenteral formulation may be switched to
either oral presentation when clinically indicated. In such
circumstances, no
dose adjustment is required as linezolid has an oral biovailability of
approximately 100%.
The solution for infusion should