Ciproxin Solution for Infusion 200mg/100ml

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

CIPROFLOXACIN

Dostupné z:

Bayer Public Limited Company

ATC kód:

J01MA02

INN (Medzinárodný Name):

CIPROFLOXACIN

Forma lieku:

SOLUTION FOR INFUSION

Zloženie:

CIPROFLOXACIN 200 milligram(s)

Typ predpisu:

POM

Terapeutické oblasti:

ANTIBACTERIALS FOR SYSTEMIC USE

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2006-11-03

Príbalový leták

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIPROXIN SOLUTION FOR INFUSION
100MG/50ML, 200MG/100ML, OR 400MG/200ML
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.
Page 2 of 11
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
Ciproxin is used in children and adolescents, un

Súhrn charakteristických

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Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ciproxin solution for infusion
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).
Each glass bottle with 100 mL infusion solution contains 200 mg
ciprofloxacin. The sodium chloride
content is 900 mg (15.4 mmol).
Each glass bottle with 200 mL infusion solution contains 400 mg
ciprofloxacin. The sodium chloride
content is 1800 mg (30.8 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 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
026_0
Page 2 of 23

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 prop