DIFLUCAN fluconazole 200 mg/100 mL injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

fluconazole, Quantity: 2 mg/mL

Prieinama:

Pfizer Australia Pty Ltd

Vaisto forma:

Injection, solution

Sudėtis:

Excipient Ingredients: sodium chloride; water for injections

Vartojimo būdas:

Intravenous

Vienetai pakuotėje:

200mg/100mL x1

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

INDICATIONS AS AT 21 MAY 2004 : DIFLUCAN, given orally, is indicated for: 1. Treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B. NOTE : Data suggest that the clinical efficacy of DIFLUCAN is lower than that of amphotericin B in the treatment of the acute phase of cryptococcal meningitis. 2. Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with AIDS. 3. Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients. 4. Secondary prophylaxis of oropharyngeal candidiasis in patients with HIV infection. 5. Serious and life-threatening candida infections in patients who are unable to tolerate amphotericin B. NOTE : It remains to be shown that DIFLUCAN is as effective as amphotericin B in the treatment of serious and life-threatening Candida infections. Until such data are available, amphotericin B remains the drug of choice. 6. Vaginal candidiasis when topical therapy has failed. 7. Treatment of extens

Produkto santrauka:

Visual Identification: Clear colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Autorizacija statusas:

Registered

Leidimo data:

1993-12-16

Pakuotės lapelis

DIFLUCAN
® IV
_Fluconazole (flu-con-a-zole)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Diflucan IV. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given Diflucan
IV against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DIFLUCAN IV IS
USED FOR
Diflucan IV is used to treat certain
fungal and yeast infections.
It belongs to a group of medicines
called azole antibiotics.
It works by preventing the growth of
the fungal and yeast organisms
causing your infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DIFLUCAN IV
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Diflucan IV is available only with a
doctor's prescription.
This medicine is not addictive.
BEFORE STARTING
_WHEN IT MUST NOT BE GIVEN_
DIFLUCAN IV SHOULD NOT BE GIVEN IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
fluconazole
•
medicines related to fluconazole
such as miconazole, ketoconazole
or clotrimazole
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may 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.
YOU MUST NOT BE GIVEN DIFLUCAN IV
IF YOU ARE TAKING ANY OF THE
FOLLOWING MEDICINES:
•
terfenadine or astemizole (a
medicine used to treat allergy)
•
cisapride (a medicine used to treat
stomach problems)
•
erythromycin (a medicine used to
treat infections)
•
pimozide (a medicine used to
treat mental illness)
•
quinidine (a medicine used to
treat irregular heartbeat).
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR

Prekės savybės

Version: pfpdiflb10721
Supersedes: pfpdiflb11020
Page 1 of 25
AUSTRALIAN
PRODUCT
INFORMATION
–
DIFLUCAN
® (FLUCONAZOLE)
1.
NAME OF THE MEDICINE
Fluconazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIFLUCAN is available as:
1.
Gelatin capsules containing 50 mg, 100 mg, 150 mg or 200 mg
fluconazole.
2.
An intravenous infusion containing fluconazole 2 mg/mL in 0.9% saline
solution. The
pH of the solution is 4.0 - 8.0. Each 100 mL contains 15 mmol each of
sodium and
chloride.
3.
A powder for oral suspension containing fluconazole 50 mg/5 mL.
EXCIPIENT(S) WITH KNOWN EFFECT:
_CAPSULES_:
Lactose monohydrate
_POWDER FOR ORAL SUSPENSION_:
Sodium benzoate and sucrose
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
HARD GELATIN CAPSULES
50 mg light turquoise blue opaque cap and white opaque body, marked
with the Pfizer logo
and FLU-50.
100 mg standard blue opaque cap and white opaque body, marked with the
Pfizer logo and
FLU-100.
150 mg light turquoise blue opaque cap and body, marked with the
Pfizer logo and FLU-150.
200 mg purple opaque cap and white opaque body, marked with the Pfizer
logo and FLU-200.
VIAL
Solution for injection.
POWDER FOR ORAL SUSPENSION
35 mL bottle containing 50 mg/5 mL of orange flavoured suspension when
reconstituted.
Not all presentations may be marketed.
Version: pfpdiflb10721
Supersedes: pfpdiflb11020
Page 2 of 25
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DIFLUCAN, given orally, is indicated for:
1.
Treatment
of
cryptococcal
meningitis
in
patients
who
are
unable
to
tolerate
amphotericin B.
NOTE: Data suggest that the clinical efficacy of DIFLUCAN is lower
than that of
amphotericin B in the treatment of the acute phase of cryptococcal
meningitis.
2.
Maintenance therapy to prevent relapse of cryptococcal meningitis in
patients with AIDS.
3.
Treatment
of
oropharyngeal
and
oesophageal
candidiasis
in
AIDS
and
other
immunosuppressed patients.
4.
Secondary prophylaxis of oropharyngeal candidiasis in patients with
HIV infection.
5.
Serious and