PHARMACOR POSACONAZOLE posaconazole 100 mg modified release tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

posaconazole, Quantity: 100 mg

Disponible desde:

Pharmacor Pty Ltd

formulario farmacéutico:

Tablet, enteric coated

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

96, 24

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

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

Estado de Autorización:

Registered

Fecha de autorización:

2020-11-12

Información para el usuario

_PHARMACOR POSACONAZOLE Ver: 02 _
1
PHARMACOR POSACONAZOLE 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 PHARMACOR POSACONAZOLE?
PHARMACOR POSACONAZOLE 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 PHARMACOR
POSACONAZOLE? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PHARMACOR POSACONAZOLE?
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 PHARMACOR POSACONAZOLE? in the full CMI
.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PHARMACOR POSACONAZOLE 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 PHARMACOR POSACONAZOLE?
Do not switch between taking PHARMACOR POSACONAZOLE 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 PHARMACOR
POSACONAZOLE
? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PHARMACOR POSACONAZOLE?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
PHARMACOR
POSACONAZOLE.
•
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
PHARMACOR
POSACONAZOLE. PHARMACOR POSACONAZOLE may affect the results of some
laboratory tests.
THINGS YOU SHOULD
NOT DO
•
Do not gi

Ficha técnica

PHARMACOR POSACONAZOLE Ver: 02 1
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR POSACONAZOLE
(POSACONAZOLE)
MODIFIED RELEASE TABLETS
1.
NAME OF THE MEDICINE
Posaconazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR POSACONAZOLE 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
PHARMACOR POSACONAZOLE modified release tablets is yellow, coated,
capsule-shaped
tablet containing 100 mg of posaconazole.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PHARMACOR POSACONAZOLE (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.
PHARMACOR 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
PHARMACOR POSACONAZOLE modified release tablets should be swallowed
whole, and not
be divided, crushed, or chewed. PHARMACOR POSACONAZOLE modified
release tablets may
be taken without regard to food intake.
PHARMACOR POSACONAZOLE 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-INTERCH