Ciprofloxacin 400mg/200ml infusion bags

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ciprofloxacin lactate

Available from:

Pfizer Ltd

ATC code:

J01MA02

INN (International Name):

Ciprofloxacin lactate

Dosage:

2mg/1ml

Pharmaceutical form:

Infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011200; GTIN: 5015997809609

Patient Information leaflet

Page 1 of 12
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.
WHAT IS IN THIS LEAFLET
1.
What Ciprofloxacin is and what it is used for
2.
What you need to know before you are given ciprofloxacin
3.
How to use Ciprofloxacin
4.
Possible side effects
5.
How to store ciprofloxacin
6.
Contents of the pack and other information
1.
WHAT CIPROFLOXACIN IS AND WHAT IT IS USED FOR
Ciprofloxacin 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 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.
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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
Ciprofloxacin.
CHILDREN AND ADOLESCENTS
Ciprofloxacin is used in children and adolesce

Summary of Product characteristics

OBJECT 1
CIPROFLOXACIN 2 MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 30-May-2018 | Hospira UK
Ltd
1. Name of the medicinal product
Ciprofloxacin 2 mg/ml solution for infusion
2. Qualitative and quantitative composition
1 ml solution for infusion contains: 2 mg ciprofloxacin (as
ciprofloxacin lactate).
Excipients with known effect: 1 ml solution contains: 50 mg glucose
monohydrate: equivalent to 45 mg
glucose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
Clear, colourless or slightly yellow solution.
The pH-value of the solution for infusion ranges from 3.9 to 4.5.
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
- 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 gastrointestinal 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
• Inhalation anthrax (post-exposure prophylaxis and curative
treatment)
Ciprofloxacin may be used in the management of neutropenic patients
with fever that is suspected to be
d