Ciproxin 100mg/50ml solution for infusion bottles

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ciprofloxacin lactate

Available from:

Bayer Plc

ATC code:

J01MA02

INN (International Name):

Ciprofloxacin lactate

Dosage:

2mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011200; GTIN: 5010605050046

Patient Information leaflet

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Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
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:
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
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 mana

Summary of Product characteristics

OBJECT 1
CIPROXIN SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 28-Sep-2017 | Bayer plc
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
• Infections of the skin and soft tissue caused by Gram-negative
bacteria
• Malignant external otitis
• Infections of the bones and joints
• Inha