Fluconazole 0.2% solution for i/v infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fluconazole

Available from:

PharmaTech CJSC

ATC code:

J02AC01

INN (International Name):

fluconazole

Dosage:

2mg/ml

Pharmaceutical form:

solution for i/v infusion

Units in package:

50ml, 100ml and 200ml plastic pack

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-02-08

Patient Information leaflet

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 0.2%
SOLUTION FOR INTRAVENOUS INFUSION
_NAME OF THE MEDICINAL PRODUCT: _Fluconazole 0.2%
_INTERNATIONAL NON-PROPRIETARY NAME (INN): _Fluconazole
_PHARMACEUTICAL FORM: _solution for infusion
_QUALITATIVE AND QUANTITATIVE COMPOSITION: _
Each ml contains:
_Active substance _
Fluconazole
2 mg
_Excipients _
Sodium Chloride
9 mg
Sodium hydroxide (for pH adjustment)
Water for injections
up to 1 мл_ _
50 ml of infusion contains 100 mg of fluconazole.
100 ml of infusion contains 200 mg of fluconazole.
200 ml of infusion contains 400 mg of fluconazole.
_Each ml contains_ 9 mg sodium chloride (equivalent to 0.154 mmol
sodium)
Each 50 ml of the infusion solution contains 7,7 mmol (177 mg) sodium.
Each 100 ml of the infusion solution contains 15,4 mmol (350 мг)
sodium.
Each 200 ml of the infusion solution contains 30,8 mmol (708 мг)
sodium.
pH …………………………….........……..........4.0 ÷
8.0
Osm theoretical …………………………...……...308 mOsm/l
_Description _
Clear, colourless solution.
_PHARMACOLOGICAL PROPERTIES _
_PHARMACOTHERAPEUTIC GROUP: _Antimycotics for systemic use, triazole
derivatives.
_ATC CODE:_ J02AC01
PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
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_PHARMACODYNAMIC PROPERTIES _
Mechanism of action
Fluconazole is a triazole antifungal agent. Its primary mode of action
is the inhibition of fungal cytochrome
P-450-mediated 14 alpha-lanosterol demethylation, an essential step in
fungal ergosterol biosynthesis. The
accumulation of 14 alpha-methyl sterols correlates with the subsequent
loss of ergosterol in the fungal cell
membrane and may be responsible for the antifungal activity of
fluconazole. Fluconazole has been shown
to be more selective for fungal cytochrome P-450 enzymes than for
various mammalian cytochrome P-450
enzyme systems.
Fluconazole
50
mg
daily

Summary of Product characteristics

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
1
SUMMARY OF PRODUCT CHARACTERISTICS
FLUCONAZOLE 0.2%
SOLUTION FOR INTRAVENOUS INFUSION
_1. NAME _
_1.1 NAME OF THE MEDICINAL PRODUCT _
Fluconazole 0.2%
_1.2 INTERNATIONAL NON-PROPRIETARY NAME (INN): _
Fluconazole
_2. QUALITATIVE AND QUANTITATIVE COMPOSITION: _
Each ml contains:
Active substance
Fluconazole
2 mg
50 ml of infusion contains 100 mg of fluconazole.
100 ml of infusion contains 200 mg of fluconazole.
200 ml of infusion contains 400 mg of fluconazole.
Each ml contains 9 mg sodium chloride (equivalent to 0.154 mmol
sodium)
Each 50 ml of the infusion solution contains 7,7 mmol (177 mg) sodium.
Each 100 ml of the infusion solution contains 15,4 mmol (350 мг)
sodium.
Each 200 ml of the infusion solution contains 30,8 mmol (708 мг)
sodium.
pH …………………………….........……..........4.0 ÷
8.0
Osm theoretical …………………………...……...308 mOsm/l
_3._
_ _
_DESCRIPTION _
Clear, colourless solution.
_4._
_ _
_CLINICAL PARTICULARS _
_ _
_4.1 THERAPEUTIC INDICATIONS _
Fluconazole 0.2% is indicated in the following fungal infections.
Fluconazole 0.2% is indicated in adults for the treatment of:
• Cryptococcal meningitis.
PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
2
• Coccidioidomycosis.
• Invasive candidiasis.
•
Mucosal
candidiasis
including
oropharyngeal,
oesophageal
candidiasis,
candiduria
and
chronic
mucocutaneous candidiasis.
•
Chronic
oral
atrophic
candidiasis
(denture
sore
mouth)
if
dental
hygiene
or
topical
treatment
are
insufficient.
Fluconazole 0.2% is indicated in adults for the prophylaxis of:
• Relapse of crytopcoccal meningitis in patients with high risk of
recurrence.
• Relapse of oropharyngeal or oesophageal candidiasis in patients
infected with HIV who are at high risk of
experiencing relapse.
•
Prophylaxis
of
candidal
infections
in
patients
with
prolonged
neutropenia
(such
as
patient