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Questions?
Our "Frequently Asked Questions" section addresses
many common issues.
For more technical questions or help establishing your
program, please contact Axios, the program
administrator directly.
FAQ
Diflucan®
(fluconazole) |
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The Diflucan® Partnership Program |
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The Application Process |
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Privacy |
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Technical Issues |
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For more information, please
review the Web site.
If you do not find what you need, contact Axios, the program
administrator, and you will receive a personalized answer
within five working days.
Diflucan®
Is Diflucan®
a cure for AIDS?
No,
Diflucan® does not treat HIV/AIDS, but as an antifungal
medicine it treats life-threatening opportunistic
infections. In this program, Diflucan® is being donated to
treat two fungal infections, cryptococcal meningitis and
esophageal candidiasis, that are associated with HIV/AIDS. Diagnosis
is made by a health care professional.
Is
this a clinical trial?
No. Diflucan® was approved in 1994 in the United States and has a proven record of safety and efficacy. The Diflucan® Partnership Program is a donation program.
Can anyone living with HIV/AIDS use Diflucan®?
No. Only people who have been diagnosed with cryptococcal meningitis or
esophageal candidiasis by a health care professional should be treated with Diflucan®.
Will Diflucan® be provided free for vaginal candidiasis (thrush) for HIV-infected people?
No. Diflucan® provided by the Diflucan® Partnership Program
is only for the treatment of cryptococcal meningitis and
esophageal candidiasis.
Are there risks associated with the use of Diflucan®?
There are risks associated with use of any medicine. However, it is important to understand that the Diflucan® Partnership Program is not a clinical trial. Diflucan® has been approved and has been used for over
14 years for the treatment of cryptococcal meningitis and
esophageal candidiasis, and other indications.
For
additional information, please see the package
insert for Diflucan®
for donation programs (91K Adobe Acrobat document) or the
prescribing information for
South Africa
(38K Adobe Acrobat document )
and/or the summary below:
DIFLUCAN® (FLUCONAZOLE)
The product information provided in this site is intended only for non-United States residents. The products discussed herein may have different product labeling in different countries.
Important Product Information
Systemic
In more than 4,000 patients, who received multiple doses of Diflucan®, the most common adverse events were nausea (3.7%), headache (1.9%), skin rash (1.8%), vomiting (1.7%), abdominal pain (1.7%), and diarrhea (1.5%). Diflucan® has been associated with rare cases of serious hepatic toxicity, including fatalities, primarily in patients with serious underlying medical conditions. Patients who develop abnormal liver function tests should be monitored for the development of more severe hepatic injury. Patients have rarely developed exfoliative skin disorders during treatment with Diflucan®. Coadministration of terfenadine is contraindicated in patients receiving Diflucan® at multiple daily doses of 400 mg (equivalent to 12 mg/kg pediatric doses or higher) or higher. Coadministration of cisapride is contraindicated in patients receiving Diflucan® .
Pediatric
In 577 children, ages one day to 17 years, who received Diflucan® , the most common treatment-related side effects were vomiting (5.4%), abdominal pain (2.8%), nausea (2.3%), and diarrhea (2.1%).
For additional information, please see the package
insert for Diflucan®
for donation programs (91K Adobe Acrobat document) and/or
the prescribing information for
South Africa (38K Adobe Acrobat document).
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The Diflucan® Partnership Program
Who
is eligible?
The Diflucan® Partnership Program is open to governments and
nongovernmental organizations in all developing countries.
Countries
with HIV/AIDS prevalence greater than 1 percent will be
given priority. The donated medicine is to be used only
for HIV/AIDS patients suffering from cryptococcal meningitis
and/or esophageal candidiasis.
The Application Process
How
do I apply?
Applicants interested in applying to receive Diflucan® must
complete a simple application. The application and the
subsequent review process are designed to ensure that each
application is assessed in a rapid and consistent manner.
Axios assists with the review of all applications.
If you have any issues that cannot be resolved
through this Web site, please contact Axios
International (See the next question for contact
information).
Who
is my contact?
Under the direction of the Diflucan®
Partnership Program, Axios is the primary contact in all eligible
countries. You can contact Axios at the address and
links below:
Diflucan® Partnership Program
Axios International
Parklane Courts
Plot 2, Park Lane, Kololo
Behind Shell Lugogo
P.O. Box 6924
Kampala
Tel: +256 31 264 475
or +256 414 340 807
Fax: +256 414 340 642
DiflucanPartnership@accesstotreatment.org
www.diflucanpartnership.org
Why
are applications reviewed?
Applications are reviewed to ensure that the donated
Diflucan® will be used appropriately. It is important that
the Diflucan®
Partnership Program partners and the program receiving
Diflucan® have a common understanding of who will benefit
from Diflucan®, how it will be delivered and how it will be
used.
What
are the review criteria?
Click here to read the review criteria.
How
long does the review process take? Within five
days of receiving your completed application, Axios will
screen it to ensure it is ready for a detailed, technical
review, and inform you if any additional information is
needed.
If your application requires
additional work before its technical review, you may re-edit
the form online and re-submit it. If your application does
not require additional work, it will be carefully reviewed
according to the review criteria.
You will be notified if your application meets these guidelines. If
it does, your Diflucan® donation will commence. If the
reviewers conclude that the application does not meet the
guidelines, Axios will work with you to clarify or amend
your application. Once the proposal meets the requirements
outlined in the review criteria, Axios will recommend
that it be considered for approval.
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How
will I know if I will receive the donation?
Each applying institution will receive an e-mail from
Axios to the applicant organization, and include
feedback on the application and quantity of Diflucan®
that will be shipped. Details concerning the quantity of
drugs, timeline and shipping procedures will be defined
with the responsible institution.
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What
happens when my
application is approved?
The institution must provide the exact shipping address
and other information required for sending the drug to
the country (e.g., invoice, packing list, import license,
pre-shipment inspection, etc.) After complete shipping
instructions have been received by Axios, the
organization will be notified of the shipment schedule.
The freight forwarder or the International Dispensary
Association may contact the person responsible for
shipping to obtain information.
The prescription
and use of Diflucan® requires the donated product to be registered
in the country of use. If these dosage forms and indications
of Diflucan® are not registered, the
applying organization must secure and provide to Axios a
special import
license, waiver or any other documentation required by the
government of the country to receive this donation of
medicine.
The Diflucan® Partnership Program will offer Diflucan® for free and will cover
the shipping costs up to the port of entry into the
recipient country. All other costs will be the
responsibility of the recipient organization including costs
of handling, taxes and duties, and distribution in the
country.
Do I have to complete the entire application if I want to request a
repeat donation?
No. Once an institution has received the first donation of
Diflucan®, the request for resupply is straightforward. The
institution will be asked to complete a Reorder Form that
outlines the quantity of Diflucan® requested and the
justification for the amount. The Diflucan® Partnership
Program retains the right to audit any facility.
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What
happens if my application requires clarifications?
If the information provided in your application is not
sufficient to give Axios a level of comfort to recommend
your program, you will be requested to implement
specific changes and revise it. Axios will be happy to
assist you or put you in contact with the relevant
international institutions that can assist you.
Privacy
May
I look at this site without signing in?
You are welcome to browse this Web site anonymously. We only require you to sign in if you have a question or need help with your application.
Who
sees my information?
Only the application manager has access to your information and will keep it confidential. For more information, please see our privacy policy.
Technical Issues
How
do I read the application and/or documents in Adobe Acrobat®
(PDF) format?
You need the Acrobat Reader program. You can download it now free of charge from
Adobe's Web site.
What
if I have a problem with the forms?
If you have trouble viewing the forms or have a technical problem with
this Web site, please send an e-mail to
DiflucanPartnership@AccessToTreatment.org ,
detailing your problem, the page and the circumstances
under which you encountered it. Axios will respond to your
question in five working days.
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