Ciprofloxacin 2mg/ml, Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ciprofloxacin lactate

Available from:

Claris Lifesciences (UK) Limited

ATC code:

J01MA; J01MA02

INN (International Name):

Ciprofloxacin lactate

Dosage:

2 milligram(s)/millilitre

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:

2008-06-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPROFLOXACIN 2 MG/ML SOLUTION FOR INFUSION
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.
IN THIS LEAFLET:
1. What Ciprofloxacin Infusion is and what it is used for
2. What you need to know before you are given Ciprofloxacin Infusion
3. How to take Ciprofloxacin Infusion
4. Possible side effects
5. How to store Ciprofloxacin Infusion
6. Contents of the pack and other information
1. WHAT CIPROFLOXACIN INFUSION IS AND WHAT IT IS USED FOR
Ciprofloxacin Infusion 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
Ciprofloxacin Infusion 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
Ciprofloxacin infusion.
Children and Adolescent

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin 2mg/ml, Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each presentation of Ciprofloxacin 2mg/ml infusion contains the
following:
CIPROFLOXACIN 100 MG/50 ML, SOLUTION FOR INFUSION
1 ml of Solution for Infusion contains 2mg Ciprofloxacin as 2.544mg
Ciprofloxacin lactate.
Each 50 ml vial or Non-PVC bag contains 100 mg Ciprofloxacin (as
Ciprofloxacin Lactate).
Excipient: Each 50ml contains 7.7 mmol
(177 mg) Sodium.
CIPROFLOXACIN 200 MG/100 ML, SOLUTION FOR INFUSION
1 ml of Solution for Infusion contains 2mg Ciprofloxacin as 2.544mg
Ciprofloxacin lactate
Each 100 ml vial or Non-PVC bag contains 200 mg Ciprofloxacin. (as
Ciprofloxacin Lactate).
Excipient: Each 100ml contains 15.4 mmol (354 mg) Sodium.
CIPROFLOXACIN 400 MG/200 ML, SOLUTION FOR INFUSION
1 ml of Solution for Infusion contains 2mg Ciprofloxacin as 2.544mg
Ciprofloxacin lactate.
Each 200 ml
bottle or Non-PVC bag contains 400 mg Ciprofloxacin. (as Ciprofloxacin
Lactate).
Excipient: Each 200 ml contains 30.8 mmol (708 mg) Sodium.
For a 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
Ciprofloxacin 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.
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
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
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___