Linezolid Kabi

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Linezolid 2 mg/mL

Available from:

Fresenius Kabi New Zealand Limited

Dosage:

2 mg/mL

Pharmaceutical form:

Solution for infusion

Composition:

Active: Linezolid 2 mg/mL Excipient: Citric acid Glucose monohydrate Hydrochloric acid Sodium citrate Sodium hydroxide Water for injection

Prescription type:

Prescription

Therapeutic indications:

Indicated for the treatment of infections when known or suspected to be caused by susceptible organisms including those associated with concurrent bacteraemia such as: - Pneumonia - community acquired and nosocomial pneumonia - Skin and soft tissue infections - 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. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Product summary:

Package - Contents - Shelf Life: Bottle, Kabipac PE with PP cap - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, Kabipac PE with PP cap - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, Kabipac PE with PP cap - 20 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, Kabipac PE with PP cap - 30 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, Kabipac PE with PP cap - 50 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2017-08-09

Patient Information leaflet

CMI for Linezolid Kabi
cmi-clean
Page 1 of 4
LINEZOLID KABI
Linezolid
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Linezolid Kabi. 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 or your child taking
Linezolid Kabi against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT LINEZOLID KABI IS
USED FOR
Linezolid Kabi contains the active
ingredient, linezolid.
Linezolid is an antibiotic (an agent
used to destroy certain types of
bacteria). It is used in the treatment
of bacterial infections such as
pneumonia, skin infections or blood
infections.
Depending on the type of bacteria,
you may be given additional
medicines.
Your doctor, however, may
prescribe Linezolid Kabi for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LINEZOLID
KABI HAS BEEN PRESCRIBED FOR
YOU OR YOUR CHILD.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
LINEZOLID KABI
_WHEN YOU MUST NOT BE GIVEN IT _
LINEZOLID KABI MUST NOT BE GIVEN
IF YOU OR YOUR CHILD:

are allergic to linezolid or any of
the other ingredients listed at
the end of this leaflet.
Some of the 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.

have uncontrolled high blood
pressure

have pheochromocytoma (a
type of tumour of the adrenal
gland)

have thyrotoxicosis (an
overactive thyroid gland)

have flushing or other
symptoms caused by a
carcinoid tumour

are taking or have taken in the
last two weeks any medicine
that is a monoamine oxidase
inhibitor (e.g. moclobemide,
phenelzine or tranylcypromine
to treat depression or selegiline
to treat Parkinson's di

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 25
1
PRODUCT NAME
Linezolid Kabi solution for intravenous infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Linezolid 2 mg/mL
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for intravenous infusion.
Each 300 mL infusion bag or bottle contains 600 mg linezolid (i.e. 2
mg/mL) in an isotonic, clear,
colourless to yellow solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Linezolid is indicated for the treatment of infections when known or
suspected to be caused by
susceptible organisms including those associated with concurrent
bacteraemia such as:

Pneumonia - community acquired and nosocomial pneumonia

Skin and soft tissue infections

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.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Patients who commence treatment on the parenteral formulation may be
switched to an oral
preparation when clinically indicated. In such circumstances, no dose
adjustment is required as
linezolid has an oral bioavailability of approximately 100%.
The infusion should be administered over a period of 30 to 120
minutes. An oral preparation
may be taken with or without food.
The maximum recommended duration of treatment is 28 days.
An oral preparation of Linezolid Kabi is not available; where
clinically indicated, another brand
of an oral linezolid dosage form is to be administered.
Dose
Adults and Children 12 years or older
The recommended dosage should be administered intravenously or orally
twice daily as shown
in Table 1. Duration of treatment is variable. It is dependent on the
pathogen, the site of
infection and its severity, and on the patient’s clinical response.
To date, the maximum
treatment
durat