VORICONAZOLE-AFT voriconazole 200 mg powder for injection vial

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

voriconazole, Quantity: 200 mg

Tillgänglig från:

AFT Pharmaceuticals Pty Ltd

Läkemedelsform:

Injection, powder for

Sammansättning:

Excipient Ingredients: nitrogen; water for injections; sulfobutyl betadex sodium

Administreringssätt:

Intravenous Infusion

Enheter i paketet:

1

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Voriconazole ? AFT 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.

Produktsammanfattning:

Visual Identification: White or almost white lyophilized cake or powder; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Bemyndigande status:

Registered

Tillstånd datum:

2021-09-21

Bipacksedel

Voriconazole – AFT
1
VORICONAZOLE – AFT
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING VORICONAZOLE – AFT?
Voriconazole – AFT contains the active ingredient voriconazole.
Voriconazole – AFT is an anti-fungal agent which works by
preventing the growth of fungal and yeast organisms causing your
infection.
For more information, see Section 1. Why am I using Voriconazole –
AFT? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VORICONAZOLE – AFT?
Do not use if you have ever had an allergic reaction to any medicine
containing voriconazole or any other similar medicine or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Voriconazole – AFT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Voriconazole - AFT and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE VORICONAZOLE – AFT?
Voriconazole – AFT injections are administered to you by doctors or
nurses in hospital
More instructions can be found in Section 4. How do I use Voriconazole
– AFT? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VORICONAZOLE – AFT?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING
VORICONAZOLE – AFT.
•
Tell your doctor if you develop a rash or blister of if you suffer
from chronic, long-lasting fatigue,
muscle weakness, loss of appetite, weight loss or abdominal pain while
using Voriconazole – AFT.
•
Tell your doctor if you are about to have any blood tests while using
Voriconazole – AFT.
DRIVING OR USING
MACHINES
•
BE CAREFUL DRIVING OR OPERATING MACHINERY UNTIL YOU KNOW

Produktens egenskaper

1
AUSTRALIAN PRODUCT INFORMATION
VORICONAZOLE – AFT
(VORICONAZOLE)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Voriconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg voriconazole.
Excipient(s) with known effects: Each vial contains 215.6 mg

228.0 mg of sodium.
After reconstitution with 19 mL water for injection or 19 mL of 9
mg/mL (0.9%) sodium
chloride for infusion, each mL contains 10 mg of voriconazole.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMCEUTICAL FORM
Voriconazole - AFT is a white or almost white lyophilized cake or
powder which provides
a clear solution upon reconstitution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Voriconazole – AFT 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 powder for oral suspension and tablet are unavailable in
this brand, however _
_are available in other brands. Where correct dosing requires oral
voriconazole, the oral _
_formulations _
_available _
_from _
_other _
_suppliers _
_should _
_be _
_used. _
_Refer _
_to _
_the _
_Product _
_Information for oral voriconazole medicines for specific dosage
recommendations_.
2
DOSAGE
_ADULTS _
Therapy must be initiated with the specified loading dose regimen of
either intravenous
or oral voriconazole to achieve plasma concentrations on Day 1 that
are close to steady
state. On the basis of the high oral bioavailability (96%; see Section
5.2 Pharmacok