Vfend

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Voriconazole 200mg;  ;  

Предлага се от:

Pfizer New Zealand Limited

INN (Международно Name):

Voriconazole 200 mg

дозиране:

200 mg

Лекарствена форма:

Powder for injection

Композиция:

Active: Voriconazole 200mg     Excipient: Sulfobutyl betadex sodium Water for injection

Броя в опаковка:

Vial, glass, multi-dose, 30 mL

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Pfizer Limited

Терапевтични показания:

VFEND is indicated for treatment of the following fungal infections: · Invasive aspergillosis. · Serious Candida sp. infections (including C. krusei), including oesophageal and systemic Candida sp. 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.

Каталог на резюме:

Package - Contents - Shelf Life: Vial, glass, multi-dose, - 30 mL - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Дата Оторизация:

2001-01-25

Листовка

Vfend®
1
VFEND®
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 tablets, oral
suspension or powder for injection. 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
•
Advise any doctor or dentist you visit that you are using VFEND and
remind them of this if they ask you
to have a blood test.
•
Avoid going out in the sun for long periods while you are taking
VFEND. VFEND can cause sensitivity to
sunlight.
•
Advise your doctor immediately if you notice any changes to your skin
including a rash or blisters, or
suffer from long-lasting fatigue, muscle weakness, loss of appetite,
weight loss or abdominal pain.
•
Use an effective method of contraception if you are a woman of
childbearing potential.
•
Inform your doctor

Данни за продукта

Version: pfdvfend11123
Supersedes: pfdvfend10223
Page 1 of 40
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
VFEND
®
50 mg,
200 mg film-coated Tablets.
VFEND
®
40 mg/mL Powder for Oral Suspension.
VFEND
®
200 mg Powder for Infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FILM-COATED TABLETS
Each tablets contain 50 mg or 200 mg of voriconazole.
_EXCIPIENT(S) WITH KNOWN EFFECT _
Each tablet contains 63.42 mg or 253.675 mg lactose monohydrate. For
the full list of
excipients, see Section 6.1 List of excipients.
POWDER FOR ORAL SUSPENSION
Each bottle contains 45 g of Powder for Oral Suspension. Following
reconstitution, the volume
of suspension is 75 mL, providing a usable volume of 70 mL of
suspension at a voriconazole
concentration of 40 mg/mL.
_EXCIPIENT(S) WITH KNOWN EFFECT _
Each mL of suspension contains 0.54 g sucrose. For the full list of
excipients, see Section 6.1
List of excipients.
POWDER FOR INFUSION
Each vial contains 200 mg voriconazole. The lyophilised powder
contents of the vials are
intended for reconstitution with 19 mL Water for Injections to produce
a solution containing
10 mg/mL voriconazole and 160 mg/mL of sulfobutyl betadex sodium
(SBECD). The
resulting solution is further diluted prior to administration as an
intravenous infusion (see
Section 4.2 Dose and method of administration).
_EXCIPIENT(S) WITH KNOWN EFFECT _
Each vial contains 217.6 mg sodium. For the full list of excipients,
see Section 6.1 List of
excipients.
3.
PHARMACEUTICAL FORM
Vfend 50 mg film-coated Tablets are white, round tablets, debossed
“Pfizer” on one side and
“VOR50” on the reverse.
Vfend 200 mg film-coated Tablets are white, capsule-shaped tablets,
debossed “Pfizer” on one
side and “VOR200” on the reverse.
Version: pfdvfend11123
Supersedes: pfdvfend10223
Page 2 of 40
Vfend Powder for Oral Suspension is a white to off-white powder
providing a white to off-
white, orange flavoured suspension when reconstituted.
Vfend Powder for Infusion is a white to off white powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUT