GIROFLOX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CIPROFLOXACIN

Available from:

BIOAVENIR LTD, ISRAEL

ATC code:

J01MA02

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

CIPROFLOXACIN 200 MG / 100 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

COOPER PHARMACEUTICALS, GREECE

Therapeutic group:

CIPROFLOXACIN

Therapeutic area:

CIPROFLOXACIN

Therapeutic indications:

* Adults :Broad spectrum antibiotic for infections caused by ciprofloxacin sensitive pathogens.* Children and adolescents:• Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa• Complicated urinary tract infections and pyelonephritis• Inhalation anthrax (post-exposure prophylaxis and curative treatment)Ciprofloxacin may also be used to treat severe infections in children and adolescents when there is no otheralternative .Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents

Authorization date:

2021-07-31

Patient Information leaflet

העדוה
לע
הרמחה
(
עדימ
ןולעב )תוחיטב
אפורל
ךיראת
27/08/2015
םש
רישכתה
תילגנאב
רפסמו
םושירה
GIROFLOX (133 31 30984)
םש
לעב
םושירה
BIOAVENIR LTD
.
!דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
SPECIAL WARNINGS
AND PRECAUTIONS
FOR USE
…
_Severe infections and mixed infections with_
_Gram-positive and anaerobic pathogens_
Ciprofloxacin monotherapy is not suited for
treatment of severe infections and
infections that might be due to Gram-
positive or anaerobic pathogens. In such
infections ciprofloxacin must be co-
administered with other appropriate
antibacterial agents.
_Streptococcal Infections (including _
_Streptococcus pneumoniae)_
Ciprofloxacin is not recommended for the
treatment of streptococcal infections due to
inadequate efficacy.
_Genital tract infections_
Epididymo-orchitis and pelvic inflammatory
diseases may be caused by
fluoroquinolone-resistant _Neisseria _
_gonorrhoeae_. Ciprofloxacin should be co-
administered with another appropriate
antibacterial agent unless ciprofloxacin-
resistant _Neisseria gonorrhoeae _can be
excluded. If clinical improvement is not
achieved after 3 days of treatment, the
therapy should be reconsidered.
_Intra-abdominal infections_
There are limited data on the efficacy of
ciprofloxacin in the treatment of post-
surgical intra-abdominal infections.
_Travellers’ diarrhoea_
The choice of ciprofloxacin should take into
account information on resistance to
ciprofloxacin in relevant pathogens in the
countries visited.
_Infections of the bones and joints_
Ciprofloxacin should be used in
combination with other antimicrobial agents
depending on the results of the
microbiological documentation.
_Inhalational anthrax_
Use in humans is based on _in-vitro_
susceptibility
data
and
on
animal
experimental data together with limited
human data. Treating physicians should
refer to national
and /or international
consen

Summary of Product characteristics

GIROFLOX
PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
Giroflox
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 2 mg ciprofloxacin.
Excipients:
Each vial of 100 ml of solution for infusion contains 15.4 mmol (354
mg) sodium.
Each vial of 200 ml of solution for infusion contains 31 mmol (707.70
mg) sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless to slightly yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults :
•
Broad spectrum antibiotic for infections caused by ciprofloxacin
sensitive
pathogens.
Children and adolescents:
•
Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas
aeruginosa
•
Complicated urinary tract infections and pyelonephritis
•
Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Ciprofloxacin may also be used to treat severe infections in children
and adolescents when
there is no other alternative .
Treatment should be initiated only by physicians who are experienced
in the treatment of
cystic fibrosis and/or severe infections in children and adolescents
4
.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage is determined by the indication, the severity and the site
of the infection, the
susceptibility to ciprofloxacin of the causative organism(s), the
renal function of the patient
and, in children and adolescents the body weight.
The duration of treatment depends on the severity of the illness and
on the clinical and
bacteriological course.
After intravenous initiation of treatment, the treatment can be
switched to oral treatment
with tablet or suspension if clinically indicated at the discretion of
the physician. IV
treatment should be followed by oral route as soon as possible.
In severe cases or if the patient is unable to take tablets (e.g.
patients on enteral nutrition), it
is recommended to commence therapy with intravenous ciprofloxacin
until a switch to oral
administration is possible.
Treatment o