Vttack

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Voriconazole 200mg;  ;  

Sẵn có từ:

Viatris Limited

INN (Tên quốc tế):

Voriconazole 200 mg

Liều dùng:

200 mg

Dạng dược phẩm:

Film coated tablet

Thành phần:

Active: Voriconazole 200mg     Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Opadry white Povidone Pregelatinised maize starch

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

Zhejiang Huahai Pharmaceutical Co Ltd

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Blister pack, PVC/Alu - 10 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Alu - 14 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Alu - 20 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Alu - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Alu - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Alu - 50 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Alu - 56 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Alu - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Ngày ủy quyền:

2012-12-06

Tờ rơi thông tin

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
VTTACK
_VORICONAZOLE, TABLET, FILM COATED, 50 MG AND 200 MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VTTACK.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking VTTACK
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT VTTACK IS
USED FOR
VTTACK is used to treat fungal and
yeast infections such as:
•
invasive aspergillosis, a
fungal infection caused by a
fungus called _Aspergillus_,
which usually begins in the
respiratory tract (in the
nose, sinuses or lungs) and
can spread to other tissues
and organs
•
serious _Candida_ (yeast)
infections, including
infection of the food pipe
and those that have spread
into the blood stream or
other parts of the body
•
serious fungal infections
•
other serious fungal
infections in patients who
do not respond to, or
cannot tolerate, other
antifungal medicines
VTTACK is also used to prevent
invasive fungal infections in patients
who are at risk of developing such
infections.
VTTACK contains the active
ingredient voriconazole. It belongs
to a group of medicines called
triazole antifungals.
It works by killing or stopping the
growth of fungal and yeast
organisms that cause the infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 2
years.
BEFORE YOU TAKE
VTTACK
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE VTTACK IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
voriconazole
•
any of the ingredients listed
at th

Đặc tính sản phẩm

Page 1 of 29
NEW ZEALAND DATA SHEET
VTTACK
1. PRODUCT NAME
VTTACK 50 mg and 200 mg film coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 50 mg or 200 mg of voriconazole.
Excipient with known effect: Lactose
Allergen Declaration: Sugars as lactose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
VTTACK 50 mg is 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 is 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.
VTTACK
IS
NOT
AVAILABLE
AS
AN
INTRAVENOUS
INFUSION
NOR
AS
AN
ORAL
SUSPENSION
OF
VORICONAZOLE.
CLINICAL
DATA
RELATING
TO
INTRAVENOUS
INFUSIONS
AND
ORAL
SUSPENSIONS
OF
VORICONAZOLE ARE INCLUDED IN THIS DATA SHEET AS AN AID TO THE
PRESCRIBER AND THIS IS NOT AN
IMPLICATION THAT THE TABLET MAY BE SUBSTITUTED FOR THE INTRAVENOUS
INFUSION OR ORAL SUSPENSION
UNLESS SPECIFICALLY STATED.
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.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_USE IN ADULTS_
Therapy must be initiated with the specified loading dose regimen of
VTTACK to achieve plasma
concentrations on Day 1 that are close to steady state. On the basis
of the high oral bioavailability
Page 2 of 29
(96%; see section 5.2), switching between intravenous and oral
administration is appropriate when
clinically indicated.
Intravenous administration is not recommended for the treatment of
oesophagea