DIFLUCAN 50 MG5 ML

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

FLUCONAZOLE

Dostupné s:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC kód:

J02AC01

Léková forma:

POWDER FOR SUSPENSION

Složení:

FLUCONAZOLE 50 MG / 5 ML

Podání:

PER OS

Druh předpisu:

Required

Výrobce:

PFIZER INC, USA

Terapeutické skupiny:

FLUCONAZOLE

Terapeutické oblasti:

FLUCONAZOLE

Terapeutické indikace:

Fluconazole is indicated in the following fungal infections.Fluconazole is indicated in adults for the treatment of:• Cryptococcal meningitis.• 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.• Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.• Candidal balanitis when local therapy is not appropriate.• Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.• Tinea unguinium (onychomycosis) when other agents are not considered appropriate.Fluconazole is indicated in adults for the prophylaxis of:• Relapse of cryptococcal 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.• To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).• Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Hematopoietic Stem Cell Transplantation).Fluconazole is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old:Fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. Fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti infective therapy should be adjusted accordingly.Consideration should be given to official guidance on the appropriate use of antifungals.

Datum autorizace:

2022-07-31

Informace pro uživatele

Diflucan 50mg/5ml PIL CC 041222
Pfleet 2021-0072854
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
DIFLUCAN
® 50 MG/5 ML
Powder for preparing 35 ml oral suspension
Each 5 ml contains: fluconazole 50 mg
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of this
medicine’s ingredients’ and section 6 “Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the doctor or
pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
ADULTS
Diflucan 50 mg/5 ml is intended for treating the following types of
fungal infections:
-
Cryptococcal meningitis – a fungal infection in the brain
-
Coccidioidomycosis – a disease of the bronchopulmonary system
-
Infections caused by _Candida_ and originating in the blood stream,
body organs (e.g., heart,
lungs) or urinary tract
-
Oral thrush – infection affecting the lining of the oral cavity,
throat and dentures
-
Genital thrush – infection of the vagina or penis
-
Skin fungus, including athlete's foot, fungus in the groin area,
pityriasis versicolor, nail fungus
and skin inflammations caused by _Candida_.
THE MEDICINE IS ALSO INTENDED FOR:
-
Preventing cryptococcal meningitis from coming back
-
Preventing oral thrush from coming back
-
Reducing the recurrence of vaginal thrush
-
Stopping you from getting an infection caused by _Candida_ (if your
immune system is weak and
not working properly).
CHILDREN AND ADOLESCENTS (0 TO 17 YEARS OLD)
Diflucan 50 mg/5 ml is intended for treating the following types
of fungal infections:
-
Oral thrush – infection affecting the lining of the oral cavity and
throat
-
Infections caused by

Charakteristika produktu

Triflucan IV LPD CC 041222
Pfleet 2021-0072854
Page 1 of 23
TRIFLUCAN
® I.V.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TRIFLUCAN
®
I.V.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg of fluconazole.
Excipient(s) with known effect:
Each ml contains 9 mg sodium chloride (equivalent to 0.154 mmol
sodium) (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless solution with no visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluconazole is indicated in the following fungal infections (see
section 5.1).
Fluconazole is indicated in adults for the treatment of:
•
Cryptococcal meningitis (see section 4.4).
•
Coccidioidomycosis (see section 4.4).
•
Invasive candidiasis.
•
Mucosal candidiasis (including oropharyngeal candidiasis, oesophageal
candidiasis,
candiduria and chronic mucocutaneous candidiasis).
•
Chronic oral atrophic candidiasis (denture sore mouth) if dental
hygiene or topical
treatment are insufficient.
Fluconazole is indicated in adults for the prophylaxis of:
•
Relapse of cryptococcal 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
patients with haematological malignancies receiving chemotherapy or
patients
receiving Haematopoetic Stem Cell Transplantation (see section 5.1)).
Fluconazole is indicated in term newborn infants, infants, toddlers,
children and
adolescents aged from 0 to 17 years old
:
Triflucan IV LPD CC 041222
Pfleet 2021-0072854
Page 2 of 23
Fluconazole is used for the treatment of mucosal candidiasis
(oropharyngeal,
oesophageal), invasive candidiasis, cryptococcal meningitis and the
prophylaxis of
candidal infections in immunocompromised patients. Fluconazole can be
used as
maintenance therapy to prevent relapse of cry