CIPROFLOXACIN 2 Micromol Solution for Infusion

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

CIPROFLOXACIN

זמין מ:

Teva UK Limited

INN (שם בינלאומי):

CIPROFLOXACIN

כמות:

2 Micromol

טופס פרצבטיות:

Solution for Infusion

סוג מרשם:

Product subject to prescription which may not be renewed (A)

מצב אישור:

Withdrawn

תאריך אישור:

2014-07-11

עלון מידע

PRODUCT:
AMENDS:
APPROVAL:
SENIOR ARTWORK CO-ORDINATOR
• SUBJECT TO REG. AGENCY APPROVAL
• APPROVED BY REG. DEPT. FOR PRINT 
DESIGN DEPARTMENT 
Harlow
Signed
Signed
24951
CIPROFL OXACIN 2MG/ML SOLUTION 
PIL ALL (V3) TEI PLIVA
2-10-12
210 x 297mm
3
16-1-14
YS
WA
Leafl et
CUTTER GUIDE
PMS PROCESS BLACK
INDESIGN CS5
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SUPPLIER INSTRUCTIONS Artwork, text and content must NOT be altered.
The only exceptions to this are: bleeds, chokes, 
spreads or other adjustments required for print reproduction purposes
only. If you have any diffi culties please contact the 
Teva Artwork Team. We must receive a copy of the 3rd Party Vendors
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PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPROFL OXACIN 2 MG/ML 
SOLUTION FOR INFUSION
CIPROFL OXACIN
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START 
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU.
•  Keep this leafl et. 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 leafl et. See section 4.
WHAT IS IN THIS LEAFL ET:
1.    WHAT CIPROFL OXACIN INFUSION IS AND WHAT IT IS 
USED FOR
2.    WHAT YOU NEED TO KNOW BEFORE YOU USE 
CIPROFL OXACIN INFUSION
3.   HOW TO USE CIPROFL OXACIN INFUSION
4.   POSSIBLE SIDE EFFECTS
5.   HOW TO STORE CIPROFL OXACIN INFUSION
6.   CONTENTS OF THE PACK AND OTHER INFORMATION 
1
   WHAT CIPROFL OXACIN INFUSION IS 
AND WHAT IT IS USED FOR
Ciprofl oxacin is an antibiotic belonging to the 
fl uoroquinolones family. Ciprofl oxacin works by killing 
bacteria that cause infections. It o

מאפייני מוצר

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 Solution for Infusion in glass vials contains the following:
50ml pack size: 100mg Ciprofloxacin (as lactate).
100ml pack size: 200mg Ciprofloxacin (as lactate).
200ml pack size: 400mg Ciprofloxacin (as lactate).
_Excipients_
Sodium (354mg/100ml equivalent to 154mmol sodium per litre).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion. Clear, yellowish 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
o
exacerbations of chronic obstructive pulmonary disease
o
broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
o
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
o
epididymo-orchitis including cases due to susceptible _Neisseria gonorrhoeae_
o
pelvic inflammatory disease including cases due to susceptible _Neisseria gonorrhoeae_
In the above genital tract infections when thought or known to be due to _Neisseria gonorrhoeae _it is particularly important
to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on
labor