Voriconazole

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Voriconazole 200mg

Sẵn có từ:

Arrotex Pharmaceuticals (NZ) Limited

INN (Tên quốc tế):

Voriconazole 200 mg

Liều dùng:

200 mg

Dạng dược phẩm:

Film coated tablet

Thành phần:

Active: Voriconazole 200mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose Magnesium stearate Maize starch Opadry white 33K18618 Povidone Pregelatinised maize starch

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

MSN Laboratories Private Limited

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 2 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/Al - 10 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/Al - 14 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/Al - 20 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/Al - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/Al - 50 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/Al - 56 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP CRC closure - 2 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP CRC closure - 10 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP CRC closure - 14 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP CRC closure - 20 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP CRC closure - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP CRC closure - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP CRC closure - 50 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP CRC closure - 56 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP CRC closure - 100 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Ngày ủy quyền:

2016-09-07

Đặc tính sản phẩm

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Voriconazole (Arrotex Pharmaceuticals) 50mg and 200mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets
Each 50mg film-coated tablet contains 50mg voriconazole.
Each 200mg film-coated tablet contains 200mg voriconazole.
Excipients with known effect: each tablet contains lactose
monohydrate.
For full list of excipients, see
SECTION 6.1
3.
PHARMACEUTICAL FORM
Tablets
50mg Film-coated tablets
white, round, biconvex film coated 7mm tablet with ‘V50’ on one
side and plain on the other side.
200mg Film-coated tablets
white, capsule-shaped, film coated 15.6mm tablet with ‘V200’
debossed on one side and plain on the other
side.
4.
CLINICAL PARTICULARS
4.1
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
_USE IN ADULTS_
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral
Voriconazole to achieve plasma concentrations on Day 1 that are close
to steady state. On the
basis of the
high oral bioavailability (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
oesophageal candidiasis;
dosage
recommendations for oesophageal candidiasis are provided in the
following table.
DETAILED INFORMATION ON DOSAGE RECOMMENDATIONS IS PROVIDED IN THE
FOLLOWING TABLE:
INTRAVENOUS
ORAL
PATIENTS 40 KG OR
ABOVE
PATIENTS LESS THAN 40
KG
SERIOUS INVASIVE _CANDIDA _
INFECTIONS
Loading Dose Regimen
(first 24 hours)
Maintenance Dose (after
first 24