VORICONAZOLE KABI voriconazole 200 mg powder for injection vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

voriconazole, Quantity: 200 mg

Saadav alates:

Fresenius Kabi Australia Pty Ltd

Ravimvorm:

Injection, powder for

Koostis:

Excipient Ingredients: arginine; sodium hydroxide; dilute hydrochloric acid; hydroxypropylbetadex

Manustamisviis:

Intravenous Infusion

Ühikuid pakis:

1

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Voriconazole is indicated for treatment of the following fungal infections:,- Invasive aspergillosis.,- Serious Candida infections (including C. krusei), including systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,- Serious fungal infections caused by Scedosporium spp. and Fusarium spp.,- Other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,Prophylaxis in patients who are at high risk of developing invasive fungal infections. The indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

Toote kokkuvõte:

Visual Identification: White to almost-white lyophilized powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

2019-07-12

Infovoldik

CMI for Voriconazole Kabi
July 2019
Page 1 of 4
VORICONAZOLE KABI
[Voriconazole]
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Voriconazole Kabi. It does not
contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
Voriconazole Kabi against the
benefits they expect it will have for
you.
If you have any concerns about
taking this medicine, ask your
doctor.
Keep this leaflet. You may need to
read it again.
WHAT VORICONAZOLE
KABI IS USED FOR
Voriconazole is used to treat
fungal and yeast infections such
as:
•
invasive aspergillosis (as-pur-
jilosis), a fungal infection
caused by a fungus called
Aspergillus (as-pur-jilus), which
usually begins in the respiratory
tract (in the nose, sinuses or
lungs). Aspergillus is harmless
in most healthy people;
however, in people with poor
immune systems (such as
people who have had organ
transplants and people with
cancer or HIV/AIDS) invasive
aspergillosis can be serious
and spread to other tissues and
organs.
•
serious Candida (can-did-da)
infections, including Candida
infections of the oesophagus
(food pipe or gullet) and those
that have spread into the blood
stream or to other parts of the
body.
•
serious fungal infections
caused by Scedosporium (ski-
doe-sporerium) species and
Fusarium (fewsaa-rium)
species.
•
other serious fungal infections
in patients who do not respond
to, or cannot tolerate, other
antifungal medicines.
Voriconazole is also used to
prevent invasive fungal infections
in patients who are at risk of
developing such infections.
This medicine belongs to a group
of medicines called triazole
antifungals.
This medicine works by preventing
the growth of fungal and yeast
organisms causing your infection.
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 addictiv

Toote omadused

1
AUSTRALIAN PRODUCT INFORMATION – VORICONAZOLE KABI
(VORICONAZOLE)
1
NAME OF THE MEDICINE
Voriconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
200 mg voriconazole per vial.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
White to almost-white lyophilized powder for injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Voriconazole is indicated for treatment of the following fungal
infections:
▪
Invasive aspergillosis.
▪
Serious _Candida _infections (including _C. krusei_), including
systemic _Candida _infections
(hepatosplenic candidiasis, disseminated candidiasis, candidaemia).
▪
Serious fungal infections caused by _Scedosporium _spp. and _Fusarium
_spp.
▪
Other serious fungal infections, in patients intolerant of, or
refractory to, other therapy.
Prophylaxis in patients who are at high risk of developing invasive
fungal infections. The
indication is based on studies including patients undergoing
haematopoietic stem cell
transplantation.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Voriconazole tablet and oral suspension are unavailable in this brand
however, are available _
_in other brands. Where correct dosing requires oral formulations,
refer to the specific product _
_information for these formulations for their complete dosage and
administration instructions. _
Voriconazole Kabi requires reconstitution and dilution prior to
administration as an
intravenous infusion (see ADMINISTRATION AND INCOMPATIBILITIES,
below).
Voriconazole Kabi is NOT recommended for bolus injection. For use in
one patient on one
occasion only. Any residue should be discarded.
It is recommended that Voriconazole Kabi is administered at a maximum
rate of 3 mg/kg/h
over 1–2 hours. Electrolyte disturbances such as hypokalaemia,
hypomagnesaemia and
hypocalcaemia should be corrected prior to initiation of voriconazole
therapy (see Section 4.4
Special Warnings and Precautions for Use, Cardiovascular).
USE IN ADULTS
Therapy must be initiated with the specified loading dose regimen of
either intravenou