Ciprofloxacin 2mg/ml, Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ciprofloxacin lactate

Available from:

Baxter Holding B.V.

ATC code:

J01MA; J01MA02

INN (International Name):

Ciprofloxacin lactate

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

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

Uncomplicated acute cystitis
In Urinary tract infection Ciprofloxacin Infusion should be used only
when it is
considered
inappropriate
to
use
other
antibacterial
agents
that
are
commonly
recommended for the treatment of these infections.

Acute pyelonephritis

Complicated urinary tract infections

Bacterial prostatitis

genital tract infections in men and women

gastro-intestinal tract infections and intra-abdominal infections

skin and soft tissue infections

Infections of the bones and joints

anthrax inhalation exposure

Gonoccocal urethritis and cervicitis due to susceptible Neis

Summary of Product characteristics

Health Products Regulatory Authority
16 September 2019
CRN0092VJ
Page 1 of 20
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
- in exacerbations of chronic obstructive pulmonary disease
Ciprofloxacin 2mg/ml solution for infusion should be used only
when it is considered inappropriate to use other antibacterial agents
that are commonly recommended for the treatment of
these infections.
- bro