AXOFIL posaconazole 100 mg modified release tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

posaconazole, Quantity: 100 mg

Dostupné z:

Pharmacor Pty Ltd

Forma lieku:

Tablet, enteric coated

Zloženie:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; hyprolose; colloidal anhydrous silica; hypromellose acetate succinate; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Spôsob podávania:

Oral

Počet v balení:

96, 24

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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 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.

Prehľad produktov:

Visual Identification: Yellow, coated, oblong tablets, debossed with 100 on one side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Registered

Dátum Autorizácia:

2020-11-12

Príbalový leták

_AXOFIL Ver: 02 _
1
AXOFIL MODIFIED RELEASE TABLETS
_ _
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 AXOFIL?
AXOFIL contains the active ingredient Posaconazole. Posaconazole is
used to kill or stop the growth of fungi that
can cause infections. For more information, see Section 1.Why am I
using AXOFIL? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AXOFIL?
Do not use if you have ever had an allergic reaction to Posaconazole
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 AXOFIL? in the full CMI
.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AXOFIL 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 AXOFIL?
Do not switch between taking AXOFIL Modified Release tablets without
talking to your doctor. Follow all
directions given to you by your doctor and pharmacist carefully.
More instructions can be found in Section 4. How do I use AXOFIL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AXOFIL?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
AXOFIL.
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist
that you are taking POSACONAZOLE
•
If you need to have any blood tests, tell your doctor you are taking
AXOFIL. AXOFIL
may affect the results of some laboratory tests.
THINGS YOU SHOULD
NOT DO
•
Do not give this medicine to anyone else, even if their condition
seems similar to yours.
•
Do not use it to treat any other complaints unless your doctor tells
you to.
DRIVING OR USING
MACHINES
•
AXOFIL may cause dizziness, sleepiness, or blurre

Súhrn charakteristických

AXOFIL Ver: 02 1
AUSTRALIAN PRODUCT INFORMATION
AXOFIL
(POSACONAZOLE)
MODIFIED RELEASE TABLETS
1.
NAME OF THE MEDICINE
Posaconazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AXOFIL modified release tablets contains 100 mg of posaconazole.
Posaconazole is a white to off-white crystalline powder. It has a
melting range of 164
o
C 165
o
C
and is insoluble in water.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
AXOFIL modified release tablets is yellow, coated, capsule-shaped
tablet containing 100 mg of
posaconazole.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AXOFIL (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.
AXOFIL 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
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
AXOFIL modified release tablets should be swallowed whole, and not be
divided, crushed, or
chewed. AXOFIL modified release tablets may be taken without regard to
food intake.
AXOFIL Ver: 02 2
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
SECTION 4.5 INTERACTIONS WITH
OTHER MEDICINES AND OTHER FORMS OF INTERACTION).
NON-INTERCHANGEABILITY BETWEEN AXOFIL MODIFIED RELEASE TABLETS AND
POSACONAZOLE ORAL
SUSPENSION (AVAILABLE FROM OTHER SPONSORS).
The prescriber should foll