DIFLUCAN FOR ORAL SUSPENSION 50 mg5 ml

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
16-01-2014
Shusha Tabia za bidhaa (SPC)
26-06-2020

Viambatanisho vya kazi:

FLUCONAZOLE

Inapatikana kutoka:

PFIZER PRIVATE LIMITED

ATC kanuni:

J02AC01

Kipimo:

50 mg/5 ml

Dawa fomu:

SUSPENSION

Tungo:

FLUCONAZOLE 50 mg/5 ml

Njia ya uendeshaji:

ORAL

Dawa ya aina:

Prescription Only

Viwandani na:

Fareva Amboise

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

1996-09-04

Taarifa za kipeperushi

                                 
 
 
 
1.  NAME OF THE MEDICINAL PRODUCT 
 
 
DIFLUCAN 
 
 
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
 
DIFLUCAN contains as its active ingredient fluconazole 50 mg, 100 mg, 150 mg and 200 mg as capsules, 
50 mg or 200 mg per 5 ml as powder for oral suspension on reconstitution with water, and as 2 mg/ml in a 
saline solution for intravenous infusion. 
 
 
3.  PHARMACEUTICAL FORM 
 
 
Capsule, powder for oral suspension, solution for intravenous infusion. 
 
 
4.  CLINICAL PARTICULARS 
 
4.1  THERAPEUTIC INDICATIONS 
 
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. 
 
1.   Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g., pulmonary, 
cutaneous). Normal hosts and patients with AIDS, organ transplants or other causes of 
immunosuppression may be treated. Fluconazole can be used as maintenance therapy to prevent 
relapse of cryptococcal disease in patients with AIDS. 
 
2. Systemic candidiasis, including candidemia, disseminated candidiasis and other forms of invasive 
candidal infection. These include infections of the peritoneum, endocardium, eye, and pulmonary and 
urinary tracts. Patients with malignancy, in intensive care units, receiving cytotoxic or 
immunosuppressive therapy, or with other factors predisposing to candidal infection may be treated. 
 
3. Mucosal candidiasis. These include oropharyngeal, esophageal, non-invasive bronchopulmonary 
infections, candiduria, mucocutaneous and chronic oral atrophic candidiasis (denture sore mouth). 
Normal hosts and patients with compromised immune function may be treated. 
 
4.  Genital candidiasis. Vaginal c
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                1.
NAME OF THE MEDICINAL PRODUCT
DIFLUCAN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIFLUCAN contains as its active ingredient fluconazole 50 mg, 100 mg,
150 mg and 200 mg as
capsules, 50 mg/5 ml or 200 mg/5 ml as powder for oral suspension on
reconstitution with water, and
as 2 mg/ml in a saline solution for intravenous infusion.
3.
PHARMACEUTICAL FORM
Capsules, powder for oral suspension, solution for intravenous
infusion.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
1.
Cryptococcosis,
including
cryptococcal
meningitis
and
infections
of
other
sites
(e.g.,
pulmonary, cutaneous). Normal hosts and patients with AIDS, organ
transplants or other
causes of immunosuppression may be treated. Fluconazole can be used as
maintenance
therapy to prevent relapse of cryptococcal disease in patients with
AIDS.
2.
Systemic candidiasis, including candidemia, disseminated candidiasis
and other forms of
invasive candidal infections. These include infections of the
peritoneum, endocardium, eye,
and pulmonary and urinary tracts. Patients with malignancy, in
intensive care units, receiving
cytotoxic or immunosuppressive therapy, or with other factors
predisposing to candidal
infection may be treated.
3.
Mucosal
candidiasis.
These
include
oropharyngeal,
esophageal,
non-invasive
bronchopulmonary
infections,
candiduria,
mucocutaneous
and
chronic
oral
atrophic
candidiasis (denture sore mouth). Normal hosts and patients with
compromised immune
function may be treated.
4.
Genital candidiasis. Vaginal candidiasis, acute or recurrent.
5.
Prevention of fungal infections in patients with malignancy who are
predisposed to such
infections as a result of cytotoxic chemotherapy or radiotherapy.
6.
Dermatomycosis including tinea pedis, tinea corporis, tinea cruris,
and dermal
_Candida_
infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Th
                                
                                Soma hati kamili
                                
                            

Tafuta arifu zinazohusiana na bidhaa hii