ZYVOXID 600 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

LINEZOLID

Tilgjengelig fra:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC-kode:

J01XX08

Legemiddelform:

TABLETS

Sammensetning:

LINEZOLID 600 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

PFIZER INC, USA

Terapeutisk område:

LINEZOLID

Indikasjoner:

Therapy is indicated only when an organism resistant to all other antibiotics is suspected. Zyvoxid 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.

Autorisasjon dato:

2021-06-30

Informasjon til brukeren

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Preparatomtale

Zyvoxid LPD CC 131222
Page 1 of 21
2020-0065057
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zyvoxid® I.V. 2 mg/ml Solution for Infusion
Zyvoxid® 600 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution for infusion:
1 ml contains 2 mg linezolid.
Excipients with known effect: each 1 ml also contains 45.7 mg
glucose and 0.38 mg sodium.
600 mg tablet:
Each tablet contains 600 mg linezolid.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion:
Isotonic, clear, colourless to yellow solution with pH range of
4.4-5.2.
600mg tablet:
A white to off-white coated tablet with “ZYV” debossed on one side
and “600” debossed on the
other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Therapy is indicated only when an organism resistant to all other
antibiotics is suspected.
Zyvoxid 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.
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.
CONSIDERATION SHOULD BE GIVEN TO OFFICIAL GUIDANCE ON THE APPROPRIATE
USE OF
ANTIBACTERIAL AGENTS.
Zyvoxid LPD CC 131222
Page 2 of 21
2020-0065057
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Zyvoxid
®
solution for infusion and tablets may be used as initial therapy.
Patients who
commence treatment on the parenteral formulation may