Ciprinol tablets film-coated

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

ciprofloxacin (ciprofloxacin hydrochloride monohydrate)

Tersedia dari:

KRKA d.d.

Kode ATC:

J01MA02

INN (Nama Internasional):

ciprofloxacin (ciprofloxacin hydrochloride monohydrate)

Dosis:

500mg

Bentuk farmasi:

tablets film-coated

Unit dalam paket:

(10/1x10/) in blister

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2022-03-09

Karakteristik produk

1.
NAME OF THE MEDICINAL PRODUCT
Ciprinol
®
250 mg film-coated tablets
Ciprinol
®
500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg or 500 mg ciprofloxacin as
ciprofloxacin hydrochloride,
respectively.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
250 mg: round, white, biconvex, bevel edged, scored on one side. The
tablet can be divided into equal
doses.
500 mg: oval, white, biconvex, scored on one side. The tablet can be
divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ciprinol
®
film-coated tablets are indicated for the treatment of the following
infections (see sections
4.4 and 5.1). Special attention should be paid to available
information on resistance to ciprofloxacin
before commencing therapy.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
_Adults_
-
Lower respiratory tract infections due to Gram-negative bacteria
-
Acute exacerbations of chronic obstructive pulmonary disease
In acute exacerbations of chronic obstructive pulmonary disease
Ciprinol
®
should be used
only when it is considered inappropriate to use other antibacterial
agents that are commonly
recommended for the treatment of these infections.
-
broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
-
pneumonia
-
Chronic suppurative otitis media
-
Acute exacerbation of chronic sinusitis especially if these are caused
by Gram-negative bacteria
-
Urinary tract infections
-
uncomplicated acute cystitis
In uncomplicated acute cystitis ciprofloxacin should be used only when
it is considered
inappropriate to use other antibacterial agents that are commonly
recommended for the
treatment of these infections.
-
acute pyelonephritis
-
complicated urinary tract infections
-
bacterial prostatitis
-
Genital tract infections
-
Gonococcal uretritis and cervicitis due to susceptible _Neisseria
gonorrhoeae_
-
Epididymo-orchitis including cases due to suscepti