CIPROXIN 2 Mg/Ml Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
02-06-2017
Summary of Product characteristics
(SPC)
02-06-2017
Active ingredient:
CIPROFLOXACIN LACTATE
Available from:
Bayer Limited
ATC code:
J01MA02
INN (International Name):
CIPROFLOXACIN LACTATE
Dosage:
2 Mg/Ml
Pharmaceutical form:
Solution for Infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Fluoroquinolones
Authorization status:
Authorised
Authorization date:
2007-11-02
Patient Information leaflet
17025
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIPROXIN SOLUTION FOR INFUSION 2MG/ML, 50ML
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.
Children and adolescents
17025
2
Ciproxin is used in children and adolescents, under specialist medical
supervision, t
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciproxin Solution for Infusion 2mg/ml, 50ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each glass bottle with 50 mL infusion solution contains 100 mg
ciprofloxacin. The sodium chloride content is 450 mg (7.7 mmol).
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 2mg/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
-
exacerbations of chronic obstructive pulmonary disease
-
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
•
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)
•
Intra-abdominal infections
•
Infections of the skin and soft tissue caused by Gram-negative
bacteria
•
Malignant external otitis
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__
Read the complete document
