资料单张
FLUCONAZOLE-CLARIS
Fluconazole, Solution for Intravenous Infusion
WHAT IS IN THIS LEAFLET
This leaflet answers some common queries about Fluconazole-Claris, solution
for intravenous infusion. It does not contain all the available information. If you
have any further queries or concerns about this medicine, talk to your doctor
or pharmacist.
KEEP THIS LEAFLET. YOU MAY NEED TO REFER TO IT AGAIN.
WHAT FLUCONAZOLE-CLARIS IS USED FOR
Fluconazole-Claris is used to treat certain fungal and yeast infections.
It belongs to a group of medicines known as azoles. It works by preventing
the growth of the fungal and yeast organisms causing your infection.
Your doctor may have prescribed Fluconazole-Claris for you for another
reason.
ASK YOU DOCTOR IF YOU HAVE ANY QUERIES ABOUT WHY FLUCONAZOLE-CLARIS
WAS PRESCRIBED FOR YOU.
Fluconazole-Claris is only available with a doctor’s prescription and is given
as an injection by a doctor or nurse.
Fluconazole-Claris should not affect your ability to drive a car or operate
machinery.
BEFORE YOU ARE GIVEN THIS MEDICINE
_WHEN IT SHOULD NOT BE GIVEN _
You should not have this medicine if you are allergic to fluconazole or any
similar related medicines such as miconazole, ketoconazole, itraconazole or
clotrimazole or to any of the other ingredients used in this medicine (listed
under the heading Other Ingredients).
Symptoms of allergic reactions include shortness of breath, wheezing or
difficulty breathing, swelling of the face, lips, tongue or other parts of the body,
rash, itching or hives on the skin.
If you are receiving doses of 400 mg or more per day of Fluconazole-Claris do
not take terfenadine (a medicine used to treat allergies).
Do not take Fluconazole-Claris if you are taki
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产品特点
PRODUCT INFORMATION
FLUCONAZOLE-CLARIS
Claris Lifesciences Australia Pty Ltd.
NAME OF THE MEDICINE
Fluconazole-Claris, Fluconazole Injection for Intravenous (I.V.) Infusion.
Fluconazole is a bis-triazole, 2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-
yl)propan-2-ol. It has the chemical formula C
13
H
12
F
2
N
6
O and a molecular weight of
306.3. The CAS number is 86386-73-4.
DESCRIPTION
Fluconazole is a white to off-white crystalline powder which is sparingly soluble in
water and saline.
Fluconazole-Claris, Injection for Intravenous Infusion is a clear colourless infusion
containing 2 mg/mL of Fluconazole in 0.9% saline (sodium chloride dissolved in
water for injection) solution. Each 100 mL of the solution contains 15.4 mmol of
sodium. The pH of the solution is 4.0 – 8.0.
Each 50 mL vial of solution contains 100 mg of fluconazole, each 100 mL vial of
solution contains 200 mg of fluconazole and each 200 mL vial of solution contains
400 mg of fluconazole. Vials are for single use only.
PHARMACOLOGY
_MICROBIOLOGY _
Fluconazole administered orally or intravenously was active in a variety of animal
models of fungal infections using standard laboratory strains of fungi.
Fluconazole exhibits _in vitro_ activity against _Cryptococcus neoformans _and Candida
species. Activity has been demonstrated _in vivo _in normal and immunocomprised
animals against infections with Candida spp., including systemic candidiasis, and in
normal animals with _Cryptococcus neoformans _including intracranial infections. One
case of cross resistance of Candida to fluconazole in a patient (not infected with
human immunodeficiency virus(HIV)) previously treated with ketoconazole has been
reported. The efficacy of fluconazole _in vivo _is greater than
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