Diflucan

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Fluconazole 50mg;  

Beschikbaar vanaf:

Pfizer New Zealand Limited

INN (Algemene Internationale Benaming):

Fluconazole 50 mg

Dosering:

50 mg

farmaceutische vorm:

Capsule

Samenstelling:

Active: Fluconazole 50mg   Excipient: Colloidal silicon dioxide Gelatin Lactose monohydrate Magnesium stearate Maize starch

Eenheden in pakket:

Blister pack, 28 capsules

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Pfizer Pharmaceuticals LLC

Product samenvatting:

Package - Contents - Shelf Life: Blister pack, - 28 capsules - 60 months from date of manufacture stored at or below 30°C

Autorisatie datum:

1989-05-15

Bijsluiter

Diflucan®
1
DIFLUCAN
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or
pharmacist.
1.
WHY AM I BEING TREATED WITH DIFLUCAN?
Diflucan contains the active ingredient fluconazole. Diflucan oral
suspension is used to treat certain fungal and yeast
infections. For more information, see Section 1. Why am I being
treated with Diflucan? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH DIFLUCAN?
Do not start treatment if you are allergic to any medicine containing
fluconazole, any of the ingredients listed at the end of this
CMI, or any other similar medicines such as miconazole, ketoconazole
or clotrimazole.
Tell the doctor if you have had any allergic reaction to any
antifungal, or any foods, preservatives or dyes or any other
medicines, if you are pregnant, plan to become pregnant or are
breastfeeding.
You must not be given Diflucan if you are taking certain medicines.
For more information, see Section 2. What should I know before
treatment with Diflucan? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Diflucan and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS DIFLUCAN GIVEN?
Diflucan is available as oral suspension (taken by mouth after
accurately measuring the dose of the medicine with a medicine
measure). Your doctor will decide how much Diflucan will be given to
you each day and for how long. It will depend on your
condition and other factors.
More instructions can be found in Section 4. How is Diflucan given? in
the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH DIFLUCAN?
THINGS YOU
SHOULD DO
•
Tell the doctor if you have any medical conditions, are on any
medicines, or if you are pregnant, plan
to become pregnant or are breastfeeding
•
For more information on "Things you should do" can be found in Section
6 in the full CMI
THINGS YOU
SHOULD NOT DO
•
Do

Productkenmerken

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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
DIFLUCAN

10 mg/mL, 40 mg/mL powder for oral suspension.
DIFLUCAN

50 mg, 100 mg, 150 mg, 200 mg capsules.
DIFLUCAN

100 mg/50 mL solution for infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
POWDER FOR ORAL SUSPENSION
Each mL of reconstituted suspension contains 10 mg fluconazole.
CAPSULES
Each gelatin capsule contains 50 mg, 100 mg, 150 mg or 200 mg
fluconazole.
SOLUTION FOR INFUSION
Each vial of 50 mL solution for infusion contains 100 mg fluconazole
(2 mg/mL) in 0.9% saline
solution.
EXCIPIENT(S) WITH KNOWN EFFECT
POWDER FOR ORAL SUSPENSION
0.58 g sucrose and 1.13 mg sodium per mL of reconstituted suspension.
CAPSULES
Each 50 mg, 100 mg, 150 mg and 200 mg capsule contains 49.707, 99.413,
149.12 mg and
198.826 lactose monohydrate, respectively.
SOLUTION FOR INFUSION
Each mL contains 9 mg sodium chloride (equivalent to 0.154 mmol
sodium) (see section 4.4
Special warnings and precautions for use). For the full list of
excipients, see section 6.1 List
of excipients.
3. PHARMACEUTICAL FORM
POWDER FOR ORAL SUSPENSION
White to off-white powder for oral suspension providing a white to
off-white, orange-flavoured
suspension after reconstitution.
CAPSULES
Diflucan 50 mg capsule has a light turquoise blue opaque cap and white
opaque body, marked
with the Pfizer logo and FLU-50.
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Diflucan 100 mg capsule has a standard blue opaque cap and white
opaque body, marked with
the Pfizer logo and FLU-100.
Diflucan 150 mg capsule has a light turquoise blue opaque cap and
body, marked with the
Pfizer logo and FLU-150.
Diflucan 200 mg capsule has purple opaque cap and white opaque body,
marked with the Pfizer
logo and FLU-200.
SOLUTION FOR INFUSION
Clear, colourless solution with no visible particles. The pH of the
solution is 4.0 - 8.0.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diflucan is indicated for the treatment of the following conditions:
Crypt