VORICONAZOLE INTERPHARMA voriconazole 200 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

voriconazole, Quantity: 200 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Voriconazole

Pharmaceutical form:

Solution, powder for

Composition:

Excipient Ingredients: hydroxypropylbetadex; hydrochloric acid; sodium chloride

Administration route:

Intravenous Infusion

Units in package:

1, 5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Voriconazole is indicated for treatment of the following fungal infections:,- Invasive aspergillosis.,- Serious Candida infections (including C. krusei), including oesophageal and systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,- Serious fungal infections caused by Scedosporium spp. and Fusarium spp.,- Other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,- Prophylaxis in patients who are at high risk of developing invasive fungal infections. The indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

Product summary:

Visual Identification: White to off-white lyophilized powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-09-16

Patient Information leaflet

VORICONAZOLE APOTEX
1
VORICONAZOLE APOTEX POWDER FOR INJECTION
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 VORICONAZOLE APOTEX?
VORICONAZOLE APOTEX contains the active ingredient voriconazole.
VORICONAZOLE APOTEX is used to treat fungal and yeast
infections.
For more information, see Section 1. Why am I using VORICONAZOLE
APOTEX?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VORICONAZOLE APOTEX?
Do not use if you have ever had an allergic reaction to voriconazole,
any similar medicines, 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. VORICONAZOLE APOTEX should NOT be used
during pregnancy or breastfeeding, unless
indicated by your doctor. Effective contraception should be used in
women of childbearing potential.
For more information, see Section 2. What should I know before I use
VORICONAZOLE APOTEX?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VORICONAZOLE APOTEX 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 VORICONAZOLE APOTEX?
•
Your doctor will prescribe the amount required of VORICONAZOLE APOTEX
based on your weight. The dose will be based
on the form being prescribed.
•
More instructions can be found in Section 4. How do I use VORICONAZOLE
APOTEX? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VORICONAZOLE APOTEX?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using VORICONAZOLE
APOTEX.
•
Avoid going out in the sun for long periods of time while you are
taking VORICONAZOLE APOTEX.
VORICONAZOLE APOTEX can cause sensitivity to sunlight.
•
Make sure you follow your doctor's instructions and keep all
appointments, including

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
VORICONAZOLE APOTEX (VORICONAZOLE) POWDER
FOR INJECTION
1
NAME OF THE MEDICINE
Voriconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg voriconazole as the active ingredient, as a
lyophilised powder.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
White to off-white sterile lyophilised powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Voriconazole APOTEX powder for injection is indicated for treatment of
the following fungal
infections:

Invasive aspergillosis.

Serious _Candida_ infections (including _C. krusei_), including
systemic _Candida_ infections
(hepatosplenic candidiasis, disseminated candidiasis, candidaemia).

Serious fungal infections caused by _Scedosporium_ spp. and _Fusarium_
spp.

Other serious fungal infections, in patients intolerant of, or
refractory to, other therapy.
Prophylaxis in patients who are at high risk of developing invasive
fungal infections. The
indication
is
based
on
studies
including
patients
undergoing
haematopoietic
stem
cell
transplantation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Voriconazole APOTEX powder for injection is intended for intravenous
infusion.
Vial contents are intended for reconstitution with 19 mL Water for
Injections to produce a
solution containing 10 mg/mL voriconazole, 120 mg/mL
hydroxypropylbetadex and 11.28
mg/mL sodium chloride. The resulting solution is further diluted,
prior to administration as an
intravenous infusion (see below).
2
DOSAGE
Voriconazole i.v. requires reconstitution and dilution prior to
administration as an intravenous
infusion (see ADMINISTRATION AND INCOMPATIBILITIES, below).
Voriconazole i.v. is NOT recommended for bolus injection.
It is recommended that voriconazole i.v. is administered at a maximum
rate of 3 mg/kg/h over
1–2
hours.
Electrolyte
disturbances
such
as
hypokalaemia,
hypomagnesaemia
and
hypocalcaemia should be corrected prior to initiation of voriconazole
therapy (see section 4.4
SPECIAL WARNINGS AND