Ciprofloxacin 2 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ciprofloxacin lactate

Available from:

Hospira 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:

2007-06-01

Patient Information leaflet

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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.
WHAT IS IN THIS LEAFLET
1.
What Ciprofloxacin is and what it is used for
2.
What you need to know before you are given ciprofloxacin
3.
How to use Ciprofloxacin
4.
Possible side effects
5.
How to store ciprofloxacin
6.
Contents of the pack and other information
1.
WHAT CIPROFLOXACIN IS AND WHAT IT IS USED FOR
Ciprofloxacin 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 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.
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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.
CHILDREN AND ADOLESCENTS
Ciprofloxacin is use

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin 2 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for infusion contains: 2 mg ciprofloxacin (as
ciprofloxacin lactate).
Excipients with known effect: 1 ml solution contains: 50 mg glucose
monohydrate: equivalent to 45 mg glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless or slightly yellow solution.
The pH-value of the solution for infusion ranges from 3.9 to 4.5.
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
• 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 gastrointestinal tract (e.g. travellers`
diarrhoea)
• Intra-abdominal infections
• Infections of the skin and soft tissue caused by Gram-negative
bacteria
• Malignant external otitis
• Infections of the bones and joints
• Inhalation anthrax (post-exposure prophylaxis and curative
treatment)
Ciprofloxacin may be used in the management of neutropenic patients
with fever that is suspected to be due to a
bacterial infection.
Children and adolescents
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