TRIFLUCAN I.V.

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

FLUCONAZOLE

Inapatikana kutoka:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC kanuni:

J02AC01

Dawa fomu:

SOLUTION FOR INFUSION

Tungo:

FLUCONAZOLE 2 MG/ML

Njia ya uendeshaji:

I.V

Dawa ya aina:

Required

Viwandani na:

PFIZER INC, USA

Kundi la matibabu:

FLUCONAZOLE

Eneo la matibabu:

FLUCONAZOLE

Matibabu dalili:

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 candidiasis, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis).• Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene 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 ).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.

Idhini ya tarehe:

2022-06-30

Taarifa za kipeperushi

רזייפ
יא ףא יפ
מ"עב לארשי הקיטבצמרפ
רקנש 'חר
9
.ד.ת ,
12133
לארשי ,חותיפ הילצרה
46725
:לט
972-9-9700500
:סקפ
972-9-9700501
רזייפ
יא ףא יפ
מ"עב לארשי הקיטבצמרפ
מ
ץר
2019
,ה/דבכנ ת/חקור ,ה/אפור
םינוכדע לע ךעידוהל וננוצרב
ולעב
ן
אפורל
לש
רישכתה
TRIFLUCAN IV
:
.הרמחה העמשמ השגדה ,טסקט תקיחמ ועמשמ
הצוח וק ,טסקט תפסות ועמשמ יתחת וק
:ןונימ תרוצ
Solution For Injection
קזוחו בכרה
:
Each ml contains 2 mg of fluconazole.
:היוותה
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 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).
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

Tabia za bidhaa

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