Ciproxin Solution for Infusion 400mg/200ml

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

CIPROFLOXACIN

から入手可能:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

ATCコード:

J01MA02

INN（国際名）:

CIPROFLOXACIN 400 mg

医薬品形態:

SOLUTION FOR INFUSION

構図:

CIPROFLOXACIN 400 mg

処方タイプ:

POM

治療領域:

ANTIBACTERIALS FOR SYSTEMIC USE

認証ステータス:

Withdrawn

承認日:

2006-11-03

情報リーフレット

PMR 81122083 (93/04/MU-0201206629) Pantone: SCHWARZ, 
REFLEXBLUE
81122083
Package leaflet: Information for the patient
0
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. 
If you have a severe infection or one that is caused by more than
one type of

製品の特徴

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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