ZYVOXID I.V. 2 MGML

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

LINEZOLID

Saadav alates:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC kood:

J01XX08

Ravimvorm:

SOLUTION FOR INFUSION

Koostis:

LINEZOLID 2 MG/ML

Manustamisviis:

I.V

Retsepti tüüp:

Required

Valmistatud:

PFIZER INC, USA

Terapeutiline rühm:

LINEZOLID

Terapeutiline ala:

LINEZOLID

Näidustused:

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.

Loa andmise kuupäev:

2022-06-30

Infovoldik

Zyvoxid
600mg PIL WC
050720
2016-0014742 2017-0026916
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
ZYVOXID
®
600 MG
TABLETS
ACTIVE INGREDIENT
EACH TABLET CONTAINS: LINEZOLID 600 MG
For a list of inactive ingredients and allergens in this medicine, see
section 6 "Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information about
this medicine. If you have any further questions, consult your doctor
or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems to
you that their medical condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
To treat infections in adults and children that are caused by
micro-organisms that are resistant to all
other antibiotics and susceptible to linezolid; this includes
infections that cause recurrent bacteremia
such as
•
pneumonia (cases contracted in the community and in hospital)
•
skin and soft tissue infections including diabetic foot infections
•
infections caused by enterococcal bacteria
THERAPEUTIC GROUP:
an antibiotic of the oxazolidinones group.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients in
this medicine (see section 6).
•
You are breastfeeding. This is because this medicine passes into
breast milk and could
affect the baby.
•
You are taking or have taken within the last 14 days any medicines
known as monoamine
oxidase inhibitors (MAOIs) (for example phenelzine, isocarboxazid,
selegiline,
moclobemide). These are sometime used to treat depression or
Parkinson’s disease.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH ZYVOXID
®
, TELL YOUR DOCTOR IF:
•
You have high blood pressure, whether or not you are taking medicines
for this condition.
•
You have been diagnosed with an overactive th

Toote omadused

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