VFEND voriconazole 200mg powder for injection vial

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

voriconazole, Quantity: 200 mg

זמין מ:

Pfizer Australia Pty Ltd

טופס פרצבטיות:

Injection, powder for

הרכב:

Excipient Ingredients: sulfobutyl betadex sodium

מסלול נתינה (של תרופות):

Intravenous

יחידות באריזה:

1 vial

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

VFEND 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.

leaflet_short:

Visual Identification: WHITE POWDER FREE FROM PARTICULATE MATTER; Container Type: Vial; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

2002-09-03

עלון מידע

VFEND
®
V
F
E
N
D
®
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 VFEND?
VFEND contains the active ingredient voriconazole. VFEND is used to
treat fungal and yeast infections.
For more information, see Section 1. Why am I using VFEND? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VFEND?
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. VFEND 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
VFEND? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VFEND 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 VFEND?
•
Your doctor will prescribe the amount required of VFEND based on your
weight. VFEND is also available as tablets, oral
suspension or powder for injection, and the dose will be based on the
form being prescribed.
•
More instructions can be found in Section 4. How do I use VFEND? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VFEND?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using VFEND.
•
Avoid going out in the sun for long periods of time while you are
taking VFEND. VFEND 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 medici

מאפייני מוצר

Version: pfpvfend10722
Supersedes:
pfpvfend11121
Page 1 of 42
AUSTRALIAN
PRODUCT
INFORMATION
–
VFEND
® (VORICONAZOLE)
1.
NAME OF THE MEDICINE
Voriconazole.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FILM COATED TABLETS
Each film coated tablet contains 50 mg or 200 mg of voriconazole.
POWDER FOR INJECTION
Each vial contains nominally 200 mg voriconazole.
After reconstitution with 19 mL water for injection, each mL contains
10 mg of voriconazole
and 160 mg of sulfobutyl betadex sodium (SBECD).
POWDER FOR ORAL SUSPENSION
Each bottle contains 45 g of powder for oral suspension. Each mL of
oral suspension contains
40 mg of voriconazole when reconstituted with water.
Following reconstitution, the volume of suspension is 75 mL providing
a usable volume of
70 mL of suspension.
EXCIPIENT(S) WITH KNOWN EFFECT
_FILM COATED TABLETS _
Contains sugars as lactose. Each film coated tablet contains 62.5 mg
or 250 mg lactose
monohydrate.
_POWDER FOR ORAL SUSPENSION _
Contains sugars as lactose. Each ml of suspension contains 0.54 g
sucrose and 2.4 mg of sodium
benzoate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
FILM COATED TABLETS
50 mg: White to off-white, round convex, film coated tablets, debossed
“Pfizer” on one side
and “VOR50” on the reverse.
200 mg: White to off-white, capsule-shaped film coated tablets,
debossed “Pfizer” on one side
and “VOR200” on the reverse.
Version: pfpvfend10722
Supersedes:
pfpvfend11121
Page 2 of 42
POWDER FOR INJECTION
White, sterile, lyophilised powder providing a clear concentrate when
reconstituted.
POWDER FOR ORAL SUSPENSION
White to off-white powder for oral suspension providing a white to
off-white, orange flavoured
suspension when reconstituted.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VFEND is indicated for treatment of the following fungal infections:
•
Invasive aspergillosis.
•
Serious
_Candida_
infections (including
_C. krusei_
), including oesophageal and systemic
_Candida_
infections (hepatosplenic cand