Ciprofloxacin Alkaloid concentrate for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ciprofloxacin

Available from:

Alkaloid AD Skopje

ATC code:

J01MA02

INN (International Name):

ciprofloxacin

Dosage:

10mg/ml

Pharmaceutical form:

concentrate for solution for infusion

Units in package:

(5) ampoules 10ml in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-10-22

Summary of Product characteristics

Ciprofloxacin Alkaloid 100 mg/10 ml concentrate for solution for
infusion
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin Alkaloid 100 mg/10 ml concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule (10 ml) contains 100 mg ciprofloxacin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Ciprofloxacin Alkaloid 100 mg/10 ml concentrate for solution for
infusion is a clear, colorless to
slightly yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ciprofloxacin Alkaloid concentrate for solution for infusion is
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.
Adults
•
Lower respiratory tract infections due to Gram-negative bacteria
-
exacerbations of chronic obstructive pulmonary disease. In
exacerbation of chronic
obstructive pulmonary disease Citeral 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
-
community acquired pneumonia
•
Chronic suppurative otitis media
•
Acute exacerbation of chronic sinusitis especially if these are caused
by Gram-negative
bacteria

Uncomplicated acute cystitis In uncomplicated acute cystitis Citeral
should be used only when
it is considered inappropriate to use other antibacterial agents that
are commonly recommended
for the treatment of these infections.
Ciprofloxacin Alkaloid 100 mg/10 ml concentrate for solution for
infusion
Summary of Product Characteristics
2

Acute pyelonephritis.

Complicated urinary tract infections.

Bacterial prostatitis.
•
Genital tract infections
-
epididymo-orchitis including cases due to susceptible
_Neisseria gonorrhoeae