Posaconazole JUNO

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Posaconazole 100mg;  

Dostupné s:

Juno Pharmaceuticals NZ Limited

Dávkování:

100 mg

Léková forma:

Modified release tablet

Složení:

Active: Posaconazole 100mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Methacrylic acid - ethyl acrylate copolymer Microcrystalline cellulose Opadry yellow 85F520152 Propyl gallate Sodium stearyl fumarate Triethyl citrate Xylitol

Druh předpisu:

Prescription

Terapeutické indikace:

Posaconazole JUNO 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 JUNO is also indicated for the 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 haematopoietic stem cell transplant (HSCT) recipients.

Přehled produktů:

Package - Contents - Shelf Life: Blister pack, PVC/PCTFE (Aclar)/Al , 12 tablets per strip - 24 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Aluminium/Aluminium or PVC/PE/PVDC/Al , 12 tablets per strip - 24 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PCTFE (Aclar)/Al , 12 tablets per strip - 96 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Aluminium/Aluminium or PVC/PE/PVDC/Al , 12 tablets per strip - 96 tablets - 36 months from date of manufacture stored at or below 25°C - Strip, Aluminium/Aluminium , 12 tablets per strip - 24 tablets - 36 months from date of manufacture stored at or below 25°C - Strip, Aluminium/Aluminium , 12 tablets per strip - 96 tablets - 36 months from date of manufacture stored at or below 25°C

Datum autorizace:

2020-11-06

Informace pro uživatele

Posaconazole JUNO CMI
1
POSACONAZOLE JUNO MODIFIED
RELEASE TABLETS
_Posaconazole _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Posaconazole JUNO. 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
Posaconazole JUNO against the
benefits
this
medicine
is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
POSACONAZOLE
JUNO,
ASK YOUR DOCTOR OR PHARMACIST.
READ
THIS
LEAFLET
CAREFULLY
BEFORE
TAKING
POSACONAZOLE
JUNO.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
POSACONAZOLE
JUNO IS USED FOR
Posaconazole JUNO contains the
active ingredient, posaconazole.
Posaconazole is a medicine that
belongs to the triazole group of
antifungal medicines.
Posaconazole
JUNO
works
by
killing or stopping the growth of
the
fungi
causing
these
infections.
Posaconazole
JUNO
Modified
Release Tablets are used for:
•
The
treatment
of
invasive
aspergillosis,
a
fungal
infection caused by a fungus
called aspergillus
•
The
treatment
of
other
serious
fungal
infections
called
fusariosis,
cryptococcosis,
zygomycosis,
chromoblastomycosis
and
mycetoma.
These types of fungal infections
usually occur in some patients
who
may
have
lowered
resistance
to
infection
due
to
poor immunity.
Treatment of these serious fungal
infections
with
Posaconazole
JUNO
is
usually
reserved
for
patients who do not respond to or
cannot tolerate other medicines
used to treat these types of fungal
infections.
Posaconazole JUNO is also used
to
treat
coccidioidomycosis,
a
rare and serious fungal infection.
Posaconazole JUNO 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.
Your doctor may have prescribed
Posaconazole JUNO for another
reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
POSACONAZOLE JUNO HAS BEEN
PRES

Charakteristika produktu

Posaconazole Juno Datasheet v2.0
Page | 1
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Posaconazole JUNO (posaconazole) modified release 100 mg tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Posaconazole JUNO modified release tablets contain 100 mg of
posaconazole per tablet.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Posaconazole JUNO modified release tablets are yellow, coated,
capsule-shaped tablets,
debossed with “100P” on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Posaconazole JUNO 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 JUNO is also indicated for the 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 haematopoietic
stem cell transplant (HSCT) recipients.
4.2 DOSE AND METHOD OF ADMINISTRATION
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
POSACONAZOLE
JUNO
MODIFIED
RELEASE TABLETS
AND
POSACONAZOLE ORAL SUSPENSION (AVAILABLE FROM OTHER SPONSORS)
The
prescriber
sho