ZOLFEND voriconazole 200 mg powder for injection vial

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

voriconazole, Quantity: 200 mg

متاح من:

Juno Pharmaceuticals Pty Ltd

INN (الاسم الدولي):

Voriconazole

الشكل الصيدلاني:

Injection, powder for

تركيب:

Excipient Ingredients: hydroxypropylbetadex; sodium chloride

طريقة التعاطي:

Intracranial, Intravenous

الوحدات في الحزمة:

1

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

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. 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.

ملخص المنتج:

Visual Identification: White to off white lyophilized powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

الوضع إذن:

Licence status A

تاريخ الترخيص:

2016-07-22

خصائص المنتج

Australian Product Information
Zolfend PI
Page | 1
AUSTRALIAN PRODUCT INFORMATION
ZOLFEND_ (VORICONAZOLE) _
_ _
1 NAME OF THE MEDICINE
Voriconazole
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
POWDER FOR INJECTION
The lyophilised powder contents of the ZOLFEND 200 mg vials are
intended for reconstitution
with 19 mL Water for Injections to produce a solution containing 10
mg/mL voriconazole, 120
mg/mL of hydroxypropylbetadex (HP-β-CD) and 11.87 mg/mL of sodium
chloride. The
resulting solution is further diluted prior to administration as an
intravenous infusion (see
SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
ZOLFEND IV is a white to off white lyophilised powder containing
nominally 200 mg
voriconazole in a Type I clear glass vial. ZOLFEND IV is intended for
administration by
intravenous infusion. It is a single dose, unpreserved product.
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.
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.
4.2 DOSE AND METHOD OF ADMINISTRATION
ZOLFEND IV requires reconstitution and dilution prior to
administration as an intravenous
infusion (see ADMINISTRATION AND INCOMPATIBILITIES - INTRAVENOUS).
ZOLFEND IV is NOT recommended for bolus injection.
It is recommended that ZOLFEND IV is administered at a maximum rate of
3 mg/kg per hour
over 1 to 2 hours. Electrolyte disturbances such as hypokalaemia,
hypomagn