Zyvox

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Linezolid 2 mg/mL

Доступна с:

Pfizer New Zealand Limited

ИНН (Международная Имя):

Linezolid 2 mg/mL

дозировка:

2 mg/mL

Фармацевтическая форма:

Solution for infusion

состав:

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

Штук в упаковке:

Bag, plastic, with overwrap, 10 x 300ml, 3 L

класс:

Prescription

Тип рецепта:

Prescription

Производитель:

Pfizer Asia Pacific Pte Ltd

Терапевтические показания :

Zyvox 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.

Обзор продуктов:

Package - Contents - Shelf Life: Bag, plastic, with overwrap, 10 x 300ml - 3 L - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, with overwrap - 100 mL - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, with overwrap - 200 mL - 36 months from date of manufacture stored at or below 25°C

Дата Авторизация:

2000-01-06

тонкая брошюра

ZYVOX
®
1
ZYVOX
®
_linezolid_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zyvox. It does not
contain all the available information.
It does not take the place of talking to
your or your child's doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
Zyvox against the expected benefits
it will have.
IF YOU HAVE ANY CONCERNS ABOUT YOU
OR YOUR CHILD TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ZYVOX IS USED
FOR
Zyvox 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZYVOX HAS
BEEN PRESCRIBED FOR YOU OR YOUR
CHILD.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
BEFORE TREATMENT WITH
ZYVOX
_WHEN ZYVOX MUST NOT BE _
_USED_
ZYVOX 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 disease)

are taking any medicine that is an
SSRI or serotonin re-uptake
inh

Характеристики продукта

Version: pfdzyvoa10923
Supersedes: pfdzyvoa10422
Page 1 of 26
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Zyvox
®
600 mg Film coated tablets (Tablets)
Zyvox
®
20 mg/mL Granules for oral suspension (Granules)
Zyvox
®
2 mg/mL Solution for infusion (Injection)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
TABLETS
Each Zyvox 600 mg tablet contains 600 mg linezolid.
GRANULES
Following reconstitution with 123 mL of water, each mL contains 20 mg
of linezolid.
INJECTION
Each 1 mL of Zyvox injection contains 2 mg of linezolid. The 300 mL
infusion bag contains
600 mg of linezolid.
The 200 mL infusion bag contains 400 mg linezolid.
The 100 mL
infusion bag contains 200 mg of linezolid.
EXCIPIENTS WITH KNOWN EFFECT
_Granules_
Each mL also contains 7 mg aspartame, 100 mg mannitol, 210.6 mg
sucrose, 1.7 mg sodium
as well as 2.4 mg fructose, 7.2 mg sorbitol (E420), ethanol (alcohol),
less than 20 mg
available in sweeteners and flavouring.
_Injection_
Each mL injection contains 45.6 mg glucose and less than 0.5 mg
sodium.
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
TABLETS
Off-white coated tablet with “ZYV” debossed on one side and
“600” debossed on the other.
GRANULES
White to yellow-orange granules and may contain white to
yellow-orange-brown lumps.
The
constituted suspension is white to yellow-orange and orange flavoured.
INJECTION
Isotonic, clear, colourless to yellow solution with pH range of
4.4-5.2.
Version: pfdzyvoa10923
Supersedes: pfdzyvoa10422
Page 2 of 26
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zyvox 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 G