POSACONAZOLE SUSPENSION ARX posaconazole 40 mg/mL oral suspension bottle

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

posaconazole, Quantity: 40 mg/mL

Dostupné z:

Arrotex Pharmaceuticals Pty Ltd

Forma lieku:

Oral Liquid, suspension

Zloženie:

Excipient Ingredients: sodium benzoate; sodium citrate dihydrate; citric acid monohydrate; titanium dioxide; glycerol; xanthan gum; liquid glucose; PEG-40 hydrogenated castor oil; purified water; PEG-40 stearate; benzoic acid; glyceryl monostearate; methylcellulose; polysorbate 65; simethicone; sorbic acid; sulfuric acid; Flavour

Spôsob podávania:

Oral

Počet v balení:

1 x 105 mL bottle

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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: ? 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.

Prehľad produktov:

Visual Identification: Posaconazole 40 mg/mL Suspension is a white to off-white free flowing suspension.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizácia:

Registered

Dátum Autorizácia:

2023-01-18

Príbalový leták

Posaconazole SUSPENSION ARX Oral Suspension
1
POSACONAZOLE SUSPENSION ARX ORAL SUSPENSION
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 POSACONAZOLE SUSPENSION ARX?
POSACONAZOLE SUSPENSION ARX contains the active ingredient
posaconazole. POSACONAZOLE SUSPENSION ARX is used to
kill or stop the growth of fungi that can cause infections. For more
information, see Section 1. Why am I using POSACONAZOLE
SUSPENSION ARX? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE POSACONAZOLE SUSPENSION ARX?
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 POSACONAZOLE
SUSPENSION ARX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with POSACONAZOLE SUSPENSION ARX 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 POSACONAZOLE SUSPENSION ARX?
Do not switch between taking Posaconazole modified release tablets and
POSACONAZOLE SUSPENSION ARX 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 POSACONAZOLE SUSPENSION ARX?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING POSACONAZOLE SUSPENSION ARX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
POSACONAZOLE SUSPENSION ARX.
•
If you are about to start any other new medicine, tell your doctor
that you are taking POSACONAZOLE SUSPENSION
ARX.
•
If you need to have any blood tests, tell your doctor you are taking
POSACONAZOLE SUSPENSION ARX.
POSAC

Súhrn charakteristických

1
AUSTRALIAN PRODUCT INFORMATION –
POSACONAZOLE SUSPENSION ARX (POSACONAZOLE)
40 MG/ML ORAL SUSPENSION
1
NAME OF THE MEDICINE
Posaconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Posaconazole Suspension ARX Oral Suspension contains 40 mg
posaconazole per mL of
suspension.
EXCIPIENTS WITH KNOWN EFFECT
List of excipients with known effect: Liquid glucose, sodium benzoate,
benzoic acid and
sorbic acid.
For the full list of excipients see section 6.1 List of Excipients
3
PHARMACEUTICAL FORM
Posaconazole Suspension ARX Oral Suspension is a white, strawberry
flavoured immediate-
release oral suspension containing 40 mg of posaconazole per mL.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Posaconazole Suspension ARX 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 Suspension ARX 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Posaconazole modified release tablets may not be available in this
brand however are available _
_in other brands. Where correct dosing requires posaconazole modified
release tablets, refer to _
_the specific product information for this formulation for its
complete dosage and administration _
_instructions._
Posaconazole Suspension ARX should be administered with a full meal or
with a liquid
nutritional supplement in