Noxafil

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Posaconazole 18 mg/mL;  

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Posaconazole 18 mg/mL

Dosage:

300mg/16.7mL

Pharmaceutical form:

Concentrate for injection

Composition:

Active: Posaconazole 18 mg/mL   Excipient: Disodium edetate Hydrochloric acid Sodium hydroxide Sulfobutyl betadex sodium Water for injection

Prescription type:

Prescription

Manufactured by:

Schering-Plough (Avondale) Company

Therapeutic indications:

NOXAFIL (posaconazole) concentrated injection is indicated for use in the treatment of the following invasive fungal infections in adults: - 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: - Prophylaxis of invasive fungal infections among adults, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I flint glass, 20 mL, with coated rubber stopper and Al flip-off seal - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2015-05-25

Patient Information leaflet

NOXAFIL
®
1
NOXAFIL
® MODIFIED
RELEASE TABLETS AND
ORAL SUSPENSION
_Posaconazole _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOXAFIL Modified
Release Tablets and Oral Suspension.
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 NOXAFIL
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING NOXAFIL, ASK YOUR DOCTOR
OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
TAKING NOXAFIL.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NOXAFIL IS
USED FOR
NOXAFIL Modified Release Tablets
and 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.
NOXAFIL 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 NOXAFIL is usually
reserved for patients who do not
respond to or cannot tolerate other
medicines used to treat these types of
fungal infections.
NOXAFIL 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.
NOXAFIL 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.
NOXAFIL is a medicine which
belongs to the triazole group of
antifungal medicines.
NOXAFIL works by killing or
stopping the growth of the fungi
causing these infections.
Your doctor may have prescribed
NOXAFIL for

Summary of Product characteristics

NEW ZEALAND DATA SHEET
S-CCDS-MK5592-IV-032019
Page 1 of 35
1 NOXAFIL (POSACONAZOLE) 300 MG CONCENTRATED INJECTION
NOXAFIL (posaconazole) 300 mg concentrated injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 300 mg of posaconazole.
Each mL contains 18 mg of posaconazole.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrated injection.
Clear, colourless to yellow liquid.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NOXAFIL (posaconazole) concentrated injection is indicated for use in
the treatment of the
following invasive fungal infections in adults:
•
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:
•
Prophylaxis of invasive fungal infections among adults, 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
Treatment should be initiated by a physician experienced in the
management of fungal
infections or in the supportive care in the high risk patients for
which posaconazole is
indicated as prophylaxis.
Dose
Recommended dose is shown in Table 1.
NEW ZEALAND DATA SHEET
S-CCDS-MK5592-IV-032019
Page 2 of 35
TABLE 1. Recommended dose according to indication
INDICATION
DOSE AND DURATION OF THERAPY
Refractory invasive fungal
infections (IFI)/intolerant to
alternative therapy
Loading dose of 300 mg NOXAFIL twice a day on the first
day, then 300 mg once a day thereafter. Duration of
therapy should be based on the severity of the underlying
disease, recovery from immunosuppression, and clinical
response.
Prophylaxis of invasive
fungal infections
Loading dose of 300 mg NOXAFIL twice a day on the first
day, then 300 mg once a day thereafter. Duration of
therapy