POSACONAZOLE DR.REDDY'S posaconazole 100 mg modified release tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

posaconazole, Quantity: 100 mg

זמין מ:

Dr Reddys Laboratories Australia Pty Ltd

טופס פרצבטיות:

Tablet, modified release

הרכב:

Excipient Ingredients: croscarmellose sodium; macrogol 400; hypromellose acetate succinate; silicon dioxide; triacetin; purified talc; hyprolose; iron oxide red; magnesium stearate; titanium dioxide; microcrystalline cellulose; hypromellose

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

96, 24

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

POSACONAZOLE DR.REDDY'S (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: ,? Invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ,? Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. ,POSACONAZOLE DR.REDDY'S is also indicated for the: ,? Prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.

leaflet_short:

Visual Identification: Brown, capsule-shaped, bevelled edge, film-coated tablet, debossed with '470' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Registered

תאריך אישור:

2020-07-24

עלון מידע

POSACONAZOLE
DR.REDDY’S
1
POSACONAZOLE DR.REDDY’S
MODIFIED RELEASE TABLETS
_Posaconazole_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about POSACONAZOLE
DR.REDDY’S. 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
POSACONAZOLE DR.REDDY’S
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING POSACONAZOLE
DR.REDDY’S, ASK YOUR DOCTOR OR
PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
TAKING POSACONAZOLE
DR.REDDY
’
S.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
POSACONAZOLE
DR.REDDY’S IS USED
FOR
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.
POSACONAZOLE DR.REDDY’S
Modified Release Tablets are 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

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION – POSACONAZOLE DR.REDDY’S
(POSACONAZOLE) MODIFIED RELEASE TABLETS
1
NAME OF THE MEDICINE
Posaconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains 100 mg of posaconzole.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
POSACONAZOLE DR.REDDY’S MODIFIED RELEASE TABLET is a
brown, capsule shaped,
bevelled edge, film coated tablet, debossed with ‘470’ on one side
and plain on other side
.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
POSACONAZOLE DR.REDDY’S (posaconazole) is indicated for use in the
treatment of the
following invasive fungal infections in patients 13 years of age or
older:
•
Invasive aspergillosis in patients intolerant of, or with disease that
is refractory to,
alternative therapy.
•
Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and
mycetoma in
patients intolerant of, or with disease that is refractory to,
alternative therapy.
POSACONAZOLE DR.REDDY’S is also indicated for the
prophylaxis of invasive fungal infections among patients 13 years of
age and older, who are at
high risk of developing these infections, such as patients with
prolonged neutropenia or
haematopoietic stem cell transplant (HSCT) recipients.
4.2
D
OSE AND METHOD OF ADMINISTRATION
POSACONAZOLE DR.REDDY’S Modified Release Tablets should be swallowed
whole, and not be
divided, crushed, or chewed. POSACONAZOLE DR.REDDY’S Modified
Release Tablets may be
taken without regard to food intake.
Coadministration of drugs that can decrease the plasma concentrations
of posaconazole should
generally be avoided unless the benefit outweighs the risk. If such
drugs are necessary, patients
should be monitored closely for breakthrough fungal infections (see
4.5 INTERACTIONS WITH
OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS).
1
ADMINISTRATION INSTRUCTIONS FOR POSACONAZOLE DR.REDDY’S MODIFIED
RELEASE TABLETS
REFRACTORY INVASIVE FUNGAL INFECTIONS (IFI) / INTOLERANT PATIENTS WITH
IFI: Loading d