ERAXIS anidulafungin 100 mg powder for injection vial

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

anidulafungin, Quantity: 100 mg

Доступно од:

Pfizer Australia Pty Ltd

INN (Међународно име):

Anidulafungin

Фармацеутски облик:

Injection, powder for

Састав:

Excipient Ingredients: tartaric acid; mannitol; fructose; polysorbate 80

Пут администрације:

Intravenous

Јединице у пакету:

one vial per carton

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Treatment of invasive candidiasis, including candidaemia in adult and in paediatric patients one month and older (see Section 5.1)

Резиме производа:

Visual Identification: White to off-white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус ауторизације:

Licence status A

Датум одобрења:

2009-04-03

Информативни летак

ERAXIS
®
_anidulafungin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ERAXIS.
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 taking ERAXIS
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
WHAT ERAXIS IS USED
FOR
ERAXIS belongs to a group of
medicines called echinocandins
which work by preventing the growth
of fungal organisms causing your
infection.
ERAXIS is used to treat fungal
infections such as invasive
candidiasis and candidemia.
These are serious fungal infections in
your bloodstream or in tissues or
organs such as the food pipe or eyes.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
ERAXIS
_WHEN YOU WILL NOT BE GIVEN_
_ERAXIS_
You will not be given ERAXIS if
you have ever had an allergy to:
•
any medicine containing
anidulafungin
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines such
as Cancidas (not all brands
given).
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; skin rash,
itching or hives.
_BEFORE YOU ARE GIVEN_
_ERAXIS_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY FOODS,
PRESERVATIVES OR DYES OR ANY OTHER
MEDICINES.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
any problems affecting your liver.
Your doctor may need to monitor the
function of your liver using blood
tests. Be sure to follow your doctor's
advice if regular checks on your liver

Карактеристике производа

Version: pfperaxv10221
Supersedes: pfperaxv10720
Page 1 of 16
AUSTRALIAN
PRODUCT
INFORMATION
–
ERAXIS
®
(ANIDULAFUNGIN)
POWDER
FOR
INJECTION
1.
NAME OF THE MEDICINE
Anidulafungin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ERAXIS is a sterile, lyophilised product for injection that contains
100 mg anidulafungin.
3.
PHARMACEUTICAL FORM
Powder for Injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of invasive candidiasis, including candidaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Specimens for fungal culture and other relevant laboratory studies
(including histopathology)
should be obtained prior to therapy to isolate and identify causative
organism(s). Therapy may
be instituted before the results of the cultures and other laboratory
studies are known. However,
once these results become available, antifungal therapy should be
adjusted accordingly.
For patients with hereditary fructose intolerance (HFI) see Section
4.4 Special Warnings and
Precautions for Use.
INVASIVE CANDIDIASIS, INCLUDING CANDIDAEMIA
A single 200 mg loading dose should be administered on Day 1, followed
by 100 mg daily
thereafter. Duration of treatment should be based on the patient’s
clinical response. In general,
antifungal therapy should continue for at least 14 days after the last
positive culture. The
duration of treatment should not exceed one month.
PREPARATION OF ERAXIS FOR ADMINISTRATION
ERAXIS must not be given by bolus injection.
ERAXIS must be reconstituted with water for injections and
subsequently diluted with ONLY
9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose
for infusion. The
compatibility of reconstituted ERAXIS with intravenous substances,
additives, or medications
other than 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL
(5%) glucose for
infusion has not been established. The infusion solution must not be
frozen.
Version: pfperaxv10221
Supersedes: pfperaxv10720
Page 2 of 16
RECONSTITUTION
Aseptically reconstitute each vial with 30 ml water for injections to
provide a c