VTTACK voriconazole 50mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

voriconazole, Quantity: 50 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Voriconazole

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; croscarmellose sodium; pregelatinised maize starch; povidone; magnesium stearate; titanium dioxide; hypromellose; triacetin

Administration route:

Oral

Units in package:

100, 10, 56, 50, 28, 14, 2, 20, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VTTACK 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. This brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. For dosing requirements for populations who require intravenous or oral suspension treatment see DOSAGE and ADMINISTRATION

Product summary:

Visual Identification: A white to off-white film-coated, oval, biconvex tablet; debossed with V26 on one side of the tablet and blank on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-09-09

Patient Information leaflet

VTTACK
®
V
T
T
A
C
K
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 VTTACK?
VTTACK contains the active ingredient voriconazole. VTTACK is used to
treat fungal and yeast infections.
For more information, see Section 1. Why am I using VTTACK? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VTTACK?
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. VTTACK 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
VTTACK? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VTTACK 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 VTTACK?
•
Your doctor will prescribe the amount required of VTTACK based on your
weight.
More instructions can be found in Section 4. How do I use VTTACK? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VTTACK?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using VTTACK.
•
Avoid going out in the sun for long periods of time while you are
taking VTTACK. VTTACK can cause
sensitivity to sunlight.
•
Make sure you follow your doctor's instructions and keep all
appointments, including blood tests.
•
If you are about to have any blood tests, tell your doctor that you
are taking this medicine.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or lower the dosage without checking
with your doctor.
•
If you do not complete the full course prescribed by your doct

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
VTTACK
®
_Voriconazole Film-coated Tablets _
1
NAME OF THE MEDICINE
Voriconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Voriconazole, a broad-spectrum, triazole antifungal agent, is
available as film-coated tablets for oral
administration.
Each film-coated tablet contains 50 mg or 200 mg of voriconazole as
the active ingredient.
Excipients with known effect: Sugars as lactose.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
VTTACK 50 mg
:
50 mg film-coated tablets are a white to off-white film-coated, oval,
biconvex
tablet debossed with “
V26
” on one side of the tablet and blank on the other
side.
VTTACK 200 mg
:
200 mg film-coated tablets are a white to off-white film-coated,
capsule
shaped, biconvex tablet debossed with “
M164
” on one side of the tablet and
blank on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VTTACK 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.
This brand is only available as tablets and therefore only indicated
for adults and children 12 years or older
who can tolerate tablets. For dosing requirements for populations who
require intravenous or oral suspension
treatment (see
SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION
).
VTTACK
®
– PRODUCT INFORMATION
2
4.2
DOSE AND METHOD OF ADMINISTRATION
This product is only registered in tablet dosage form and therefore
only indicated for adults and children 12
years