Ciproxin Solution for Infusion 2 mg/ml, 100 ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-11-2022
Summary of Product characteristics
(SPC)
14-11-2022
Active ingredient:
Ciprofloxacin
Available from:
Bayer Limited
ATC code:
J01MA; J01MA02
INN (International Name):
Ciprofloxacin
Dosage:
2 mg/ml, 100 millilitre(s)
Pharmaceutical form:
Solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Fluoroquinolones; ciprofloxacin
Authorization status:
Not marketed
Authorization date:
1988-12-20
Patient Information leaflet
BP22036_REC30610
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIPROXIN SOLUTION FOR INFUSION 2MG/ML, 100ML
Ciprofloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ciproxin is and what it is used for
2.
What you need to know before you are given Ciproxin
3.
How to use Ciproxin
4.
Possible side effects
5.
How to store Ciproxin
6.
Contents of the pack and other information
1.
WHAT CIPROXIN IS AND WHAT IT IS USED FOR
Ciproxin contains the active substance ciprofloxacin. Ciprofloxacin is
an antibiotic belonging to the
fluoroquinolone family. Ciprofloxacin works by killing bacteria that
cause infections. It only works with
specific strains of bacteria.
Adults
Ciproxin is used in adults to treat the following bacterial
infections:
•
respiratory tract infections
•
long lasting or recurring ear or sinus infections
•
urinary tract infections
•
genital tract infections in men and women
•
gastro-intestinal tract infections and intra-abdominal infections
•
skin and soft tissue infections
•
bone and joint infections
•
anthrax inhalation exposure
Ciprofloxacin may be used in the management of patients with low white
blood cell counts (neutropenia)
who have a fever that is suspected to be due to a bacterial infection.
If you have a severe infection or one that is caused by more than one
type of bacterium, you may be given
additional antibiotic treatment in addition to Ciproxin.
BP22036_REC30610
2
Children and adolescents
Ciproxin is used in children and adolescents, under specialist
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Summary of Product characteristics
Health Products Regulatory Authority
14 November 2022
CRN00D827
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciproxin Solution for Infusion 2 mg/ml, 100 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each glass bottle with 100 mL infusion solution contains 200 mg
ciprofloxacin. The sodium chloride content is 900 mg
(15.4 mmol).
Excipient with known effect: sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, nearly colourless to slightly yellowish solution.
The pH-value of the solution for infusion ranges from 3.9 to 4.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciproxin Solution for Infusion 2 mg/ml 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.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Adults
Lower respiratory tract infections due to Gram-negative bacteria
exacerbation of chronic obstructive pulmonary disease. In exacerbation
of chronic obstructive pulmonary disease
Ciproxin 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
Acute pyelonephritis
Complicated pyelonephritis
Bacterial prostatitis
Genital tract infections
epididymo-orchitis including cases due to susceptible _Neisseria
gonorrhoeae_
pelvic inflammatory disease including cases due to susceptible
_Neisseria gonorrhoeae_
Infections of the gastro-intestinal tract (e.g. travellers` diarrhoea)
Health Products Regulatory Authority
14 November 2022
CRN00D827
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