Voriconazole 200 mg

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Voriconazole 200mg

Available from:

Max Health Limited

INN (International Name):

Voriconazole 200 mg

Dosage:

200 mg

Pharmaceutical form:

Powder for infusion

Composition:

Active: Voriconazole 200mg Excipient: Hydrochloric acid Hydroxypropyl-beta-cyclodextrin Sodium chloride

Prescription type:

Prescription

Manufactured by:

Dishman Pharmaceuticals & Chemicals Ltd

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.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I (25 mL capacity), with chlorobutyl stopper, aluminium cap and plastic flip-off seal - 1 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2016-05-17

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Voriconazole 200 mg Powder for Infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg of voriconazole.
After reconstitution, each ml contains 10 mg of voriconazole.
Once reconstituted further dilution is required before administration.
Excipient with known effect: each vial contains 88.74 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for infusion.
White to off-white lyophilised powder.
pH: 5.0 – 7.0
Osmolality: 530 mOsm/Kg ± 10%
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
Therapy must be initiated with the specified loading dose regimen 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
Pharmacokinetic
properties)
switching
between
intravenous and oral administration is appropriate when clinically
indicated.
Intravenous administration is not recommended for the treatment of
oesophageal candidiasis.
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DETAILED INFORMATION ON DOSAGE RECOMMENDATIONS:
INTRAVENOUS
ORAL
PATIENTS 40 KG OR
ABOVE
PATIENTS 40 KG OR
ABOVE
SERIOUS INVASIVE _CANDIDA _INFECTIONS
Loading dose regimen
(first 24 hours)
6 mg/kg every 12
hours (for the first
24 hours)
400 mg or 10 mL
every 12 hours (for
the first 24 hours)
200 mg or 5 mL
every 12 hours (for
the first 24 hours)
Maintenance dose (after
first 24 hours)
3 mg/kg every 12
hours
200 mg or 5 mL
twice daily
100 mg or 2.5 mL
twice daily
OESOPHAGEAL CANDIDIASIS