NOXAFIL posaconazole 100mg modified release tablets blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

posaconazole, Quantity: 100 mg

Διαθέσιμο από:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (Διεθνής Όνομα):

Posaconazole

Φαρμακοτεχνική μορφή:

Tablet, modified release

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

96 tablets, 24 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

NOXAFIL (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. NOXAFIL is also indicated for the: Treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole. 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.

Περίληψη προϊόντος:

Visual Identification: Yellow coated, capsule shaped tablets with "100" debossed on one side of the tablet.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2014-11-27

Φύλλο οδηγιών χρήσης

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SUSPENSION
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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 NOXAFIL?
NOXAFIL 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
NOXAFIL? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NOXAFIL?
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 NOXAFIL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NOXAFIL 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 NOXAFIL?
Do not switch between taking NOXAFIL Modified Release Tablets and
NOXAFIL Oral Suspension 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 NOXAFIL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILST USING NOXAFIL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
NOXAFIL.
•
If you are about to start any other new medicine, tell your doctor
that you are taking NOXAFIL.
•
If you need to have any blood tests, tell your doctor you are taking
NOXAFIL. NOXAFIL may affect the
results of some laboratory tests.
THINGS YOU
SHOULD NOT DO
•
Do not give NOXAFIL to anyone else, even if they have the same
condition as you.
•
Do not use NOXAFIL to treat any other medical compla

Αρχείο Π.Χ.Π.

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CCDS-MK-5592-OS-T-042021
Page 1 of 34
AUSTRALIAN PRODUCT INFORMATION
NOXAFIL
®
(POSACONAZOLE)
MODIFIED RELEASE 100 MG TABLETS
AND 40 MG/ML ORAL SUSPENSION
1
NAME OF THE MEDICINE
Posaconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Posaconazole is a white to off-white crystalline powder.
NOXAFIL Oral Suspension contains 40 mg posaconazole per mL of
suspension.
List of excipients with known effect:
-
sodium benzoate
-
liquid glucose
NOXAFIL Modified Release Tablet contains 100 mg of posaconazole.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
NOXAFIL (posaconazole) Oral Suspension is a white, cherry flavoured
immediate-release oral
suspension containing 40 mg of posaconazole per mL.
NOXAFIL (posaconazole) Modified Release Tablet is a yellow, coated,
capsule-shaped tablet
containing 100 mg of posaconazole.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NOXAFIL (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.
NOXAFIL is also indicated for the:
•
Treatment of oropharyngeal candidiasis in immunocompromised adults,
including
patients with disease that is refractory to itraconazole and
fluconazole.
•
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.
For patients being treated for oropharyngeal candidiasis, only the
oral suspension should be
used.
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CCDS-MK-5592-OS-T-042021
Page 2 of 34
4.2
DOSE AND METHOD OF ADMINISTRATION
NOXAFIL Oral Suspension should be administered with a full meal or
with a liquid nutritional