CIPROFLOXACIN I.V ALTAN 2 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CIPROFLOXACIN

Available from:

PROPHARM LTD

ATC code:

J01MA02

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

CIPROFLOXACIN 2 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

ALTAN PHARMACEUTICALS S.A., SPAIN

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 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.

Authorization date:

2019-05-15

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin IV Altan 2 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bag with 100 ml of solution for infusion contains 200 mg of
ciprofloxacin
Each bag with 200 ml of solution for infusion contains 400 mg of
ciprofloxacin
_ _
Excipients
with known effect:
Each bag with 100 ml of solution for infusion contains 5 g of glucose
monohydrate
Each bag with 200 ml of solution for infusion contains 10 g of glucose
monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear 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. I.V. 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
recommende