Posaconazole

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Posaconazole 40 mg/mL ((Form-1))

Dostupné z:

Devatis Limited

Dávkovanie:

40 mg/mL

Forma lieku:

Oral suspension

Zloženie:

Active: Posaconazole 40 mg/mL ((Form-1)) Excipient: Cherry flavour 10787-33 Citric acid monohydrate Glucose liquid Glycerol Polysorbate 80 Simethicone emulsion USP Sodium benzoate Sodium citrate Titanium dioxide Xanthan gum

Typ predpisu:

Prescription

Terapeutické indikácie:

POSACONAZOLE Oral Suspension is indicated for use in the treatment of the following invasive fungal infections in patients 18 years of age or older: - Invasive aspergillosis in patients with disease that is refractory to, or are intolerant of, amphotericin B, itraconazole or voriconazole.

Prehľad produktov:

Package - Contents - Shelf Life: Bottle, glass, Type III amber coloured with CR cap - 105 mL - 24 months from date of manufacture stored at or below 25°C. Do not freeze

Dátum Autorizácia:

2019-09-17

Príbalový leták

POSACONAZOLE 40 MG/ML ORAL SUSPENSION
MODULE 1.3.2 CONSUMER MEDICINE INFORMATION
(CMI)
DEVATIS LIMITED Property-Strictly confidential
Page 1 / 7
Version: NZ-V03/October 2023
POSACONAZOLE 40 MG/ML ORAL SUSPENSION
_Posaconazole _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using POSACONAZOLE
Oral Suspension.
This leaflet answers some common questions about POSACONAZOLE Oral
Suspension. It does not contain
all the available information. It does not take the place of talking
to your doctor, nurse or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking POSACONAZOLE
Oral Suspension against the benefits he/she expects it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING POSACONAZOLE ORAL SUSPENSION,
ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT POSACONAZOLE ORAL SUSPENSION IS USED FOR
POSACONAZOLE Oral Suspension are used for:

The treatment of invasive aspergillosis, a fungal infection caused by
a fungus called aspergillus

The treatment of some other serious fungal infections called
fusariosis, cryptococcosis, zygomycosis,
chromoblastomycosis and mycetoma.
POSACONAZOLE Oral Suspension is also used for:

The treatment of fungal infections in the mouth and throat caused by
Candida, such as oral thrush, and the
more serious systemic infection called candidemia.
Treatment of these serious fungal infections with POSACONAZOLE is
usually reserved for patients who do
not respond to or cannot tolerate other medicines used to treat these
types of fungal infections.
POSACONAZOLE is also used to treat coccidioidomycosis, a rare and
serious fungal infection.
These types of serious fungal infections usually occur in some
patients who may have lowered resistance to
infection due to poor immunity.
POSACONAZOLE is also used to prevent fungal infections, such as yeasts
and moulds, from occurring in
patients who are at high-risk of developin

Súhrn charakteristických

POSACONAZOLE 40 mg/ml Oral Suspension
MODULE 1.3.1 NEW ZEALAND DATA SHEET
DEVATIS LIMITED Property-Strictly confidential
Page 1 / 18
Version: NZ-V03/October 2023
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
POSACONAZOLE 40 mg/ml Oral Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ml of oral suspension contains 40 mg of posaconazole.
EXCIPIENT WITH KNOWN EFFECT:
This medicinal product contains approximately 1.75 g of glucose per 5
ml of suspension.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension
White to off-white suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
POSACONAZOLE Oral Suspension is indicated for use in the treatment of
the following invasive fungal
infections in patients 18 years of age or older:

Invasive aspergillosis in patients with disease that is refractory to,
or are intolerant of, amphotericin B,
itraconazole or voriconazole.

Oesophageal candidiasis or candidemia in patients with disease that is
refractory to, or who are intolerant
of, amphotericin B, fluconazole or itraconazole.

Fusariosis, zygomycosis, cryptococcosis, chromoblastomycosis, and
mycetoma in patients with disease
refractory to other therapy, or patients who are intolerant of other
therapy.

Coccidioidomycosis.
POSACONAZOLE Oral Suspension is also indicated for use as:

Prophylaxis of invasive fungal infections, including both yeasts and
moulds, in patients 13 years of age and
older who are at high risk of developing these infections, such as
patients with prolonged neutropenia or
hematopoietic stem cell transplant (HSCT) recipients.
POSACONAZOLE Oral Suspension is also indicated for the use in the
treatment of the following fungal
infections in patients 18 years of age or older:

Treatment of oropharyngeal candidiasis in immune-compromised adults,
including patients with disease
that is refractory to itraconazole and fluconazole.
4.2 DOSE AND METHOD OF ADMINISTRATION
Co-administration of drugs that can decrease the plasma concentr