POSACONAZOLE DR. REDDY'S (Posaconazole 100 mg Modified Release tablets)

מדינה: מלזיה

שפה: אנגלית

מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

מרכיב פעיל:

Posaconazole

זמין מ:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (שם בינלאומי):

Posaconazole

יחידות באריזה:

3 x 8 Tablets

תוצרת:

DR. REDDY'S LABORATORIES LIMITED

עלון מידע

1
Consumer Medication Information Leaflet (RiMUP)
POSACONAZOLE DR. REDDY’S (POSACONAZOLE
100MG MODIFIED RELEASE TABLETS)
Posaconazole (100mg)
WHAT IS IN THIS LEAFLET
1.
What POSACONAZOLE DR.
REDDY’S is used for
2.
How POSACONAZOLE DR.
REDDY’S works
3.
Before you take POSACONAZOLE
DR. REDDY’S
4.
How to take POSACONAZOLE DR.
REDDY’S
5.
While you are taking
POSACONAZOLE DR. REDDY’S
6.
Side effects
7.
Storage and Disposal of
POSACONAZOLE DR. REDDY’S
8.
Product description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT POSACONAZOLE DR.
REDDY’S IS USED FOR
POSACONAZOLE DR. REDDY’S is
used for:
•
The treatment of invasive aspergillosis,
a fungal infection caused by a fungus
called aspergillus
•
The treatment of other serious fungal
infections called fusariosis, zygomycosis,
chromoblastomycosis and mycetoma.
These types of fungal infections usually
occur in some patients who may have
lowered resistance to infection due to poor
immunity.
Treatment of these serious fungal
infections with POSACONAZOLE DR.
REDDY’S is usually reserved for patients
who do not respond to or cannot tolerate
other medicines used to treat these types
of fungal infections.
POSACONAZOLE DR. REDDY’S is
also used to treat coccidioidomycosis, a
rare and serious fungal infection.
POSACONAZOLE DR. REDDY’S is
also used to prevent fungal infections,
such as yeasts and moulds, from occurring
in patients who are at high-risk of
developing these infections.
Your doctor may have prescribed
POSACONAZOLE DR. REDDY’S for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
POSACONAZOLE DR. REDDY’S
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a
doctor's prescription.
HOW POSACONAZOLE DR.
REDDY’S WORKS
POSACONAZOLE DR. REDDY’S
contains the active ingredient,
posaconazole. Posaconazole is a
medicine that belongs to the triazole
group of antifungal medicines.
POSACONAZOLE DR. REDDY’S
works by killing or stopping the growth
of the fungi causing these infections.
BEFORE

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PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
POSACONAZOLE DR. REDDY’S (Posaconazole 100mg Modified Release
Tablets)
2.
COMPOSITION
_Each modified release tablet contains: _
Posaconazole 100 mg
3.
PHARMACEUTICAL FORM
Modified Release tablet
Brown, capsule shaped, bevelled edge, film coated tablet, debossed
with 470 on one side and plain
on other side.
4.
CLINICAL INFORMATION
4.1 THERAPEUTIC INDICATION
POSACONAZOLE DR. REDDY’S Modified Release Tablets is indicated for
use in the treatment
of the following fungal infections in adults:
• Invasive aspergillosis in patients with disease that is refractory
to amphotericin B or itraconazole
or in patients who are intolerant of these medicinal products;
• Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis,
and mycetoma in patients
with disease that is refractory to other therapy or patients who are
intolerant of other therapy.
Refractoriness is defined as progression of infection or failure to
improve after a minimum of 7
days of prior therapeutic doses of effective antifungal therapy.
POSACONAZOLE DR. REDDY’S Modified Release Tablets is also indicated
for prophylaxis of
invasive fungal infections in the following adult patients:
 Patients receiving remission-induction chemotherapy for acute
myelogenous leukaemia (AML)
or myelodysplastic syndromes (MDS) expected to result in prolonged
neutropenia and who are at
high-risk of developing invasive fungal infections.
 Haematopoietic stem cell transplant (HSCT) recipients who are
undergoing high- dose
immunosuppressive therapy for graft versus host disease and who are at
high risk of developing
invasive fungal infections.
POSACONAZOLE DR. REDDY’S Modified Release Tablets are not indicated
for the treatment
of oropharyngeal candidiasis. Please refer to the package insert of
Posaconazole oral suspension
for use in oropharyngeal candidiasis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Non-Interchangeability between POSACONAZOLE DR. REDDY’S Modified
Release Tablets
and Posaco