Uroflox

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Unduh Karakteristik produk (SPC)
25-02-2015

Bahan aktif:

rufloxacin (rufloxacin hydrochloride)

Tersedia dari:

Mediolanum Farmaceutici S.P.A.

INN (Nama Internasional):

rufloxacin (rufloxacin hydrochloride)

Dosis:

200mg

Bentuk farmasi:

tablets film-coated

Jenis Resep:

Prescription

Karakteristik produk

                                UROFLOX SUMMARY OF PRODUCT CHARACTERISTICS
(RUFLOXACIN HYDROCHLORIDE 200 MG TABLET)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Uroflox 200 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Active ingredient: rufloxacin hydrochloride 200 mg.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Uroflox is indicated in the treatment of all Urinary Tract Infections,
such as acute
cystitis, complicated cystitis, upper urinary tract infections,
pyelonephritis, and chronic
prostatitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Uroflox’s long half-life of approximately 35 hours permits a
once-a-day administration.
The recommended dosage is two tablets in a single administration on
the first day and
one tablet a day thereafter.
The duration of treatment should be adjusted to the severity of the
infection and the
clinical and bacteriological course; five days of therapy are
generally sufficient. In view
of the long half-life, the antibacterial effect persists for 2-3 days
after discontinuing the
treatment. There is therefore no need to continue treatment after the
patient has become
afebrile or symptoms have subsided. For the treatment of uncomplicated
cystitis a single
dose of 400mg of Uroflox (2 tablets taken in a single administration
once) is sufficient.
Chronic prostatitis: initial (loading) dose of two tablets, then 1
tablet daily for 4 weeks.
Other Urinary Tract Infections: initial (loading) dose of two tablets
on the first day,
followed by 1 tablet daily for the next 4 days. In persistent cases,
the course may be
prolonged up to 20 days according to medical prescription.
Elderly patients: the dosage need not be modified if renal function is
normal for the
patient’s age.
Impaired renal function: the frequency of administration should be
reduced according to
the degree of renal impairment (see “Precautions”).
Impaired hepatic function: a possible dosage reduction should be
considered only in
                                
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