Ciprofloxacin 200mg/100ml infusion bags

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ciprofloxacin lactate

Available from:

Bowmed Ibisqus 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: 5060130130270 5060130131444

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPROFLOXACIN 2MG/ML SOLUTION FOR INFUSION
(Ciprofloxacin 100mg/50ml, 200mg/100ml and 400mg/200ml)
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 nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
IN THIS LEAFLET
:
1.
What Ciprofloxacin Infusion is and what it is used for
2.
What you need to know before you are given
Ciprofloxacin Infusion
3.
How to use Ciprofloxacin Infusion
4.
Possible side effects
5.
How to store Ciprofloxacin Infusion
6.
Contents of the pack and other information
1.
WHAT CIPROFLOXACIN INFUSION IS AND WHAT IT IS USED FOR
Ciprofloxacin Infusion is an antibiotic belonging to the
fluoroquinolone family. The active substance
is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause
infections. It only works with
specific strains of bacteria.
_Adults _
Ciprofloxacin Infusion 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 bacterium, you may be
given additional antibiotic treatment in addition to Ciprofloxacin
Infusion.
_Children and adolescents _
Ciprofloxacin Infusion is used in children and adolescents, under
specialist medical supervision, to
treat the following bacterial i

Summary of Product characteristics

OBJECT 1
CIPROFLOXACIN 2MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 17-May-2018 | Bowmed
Ibisqus Limited
1. Name of the medicinal product
Ciprofloxacin 2mg/ml solution for infusion
2. Qualitative and quantitative composition
Each bag contains 2 mg/ml ciprofloxacin (as lactate).
The 50 ml bag contains 100 mg ciprofloxacin (as lactate)
The 100 ml bag contains 200 mg ciprofloxacin (as lactate)
The 200 ml bag contains 400 mg ciprofloxacin (as lactate)
Excipients:
50 ml bag: The sodium chloride content is 450 mg (7.7 mmol).
100 ml bag: The sodium chloride content is 900 mg (15.4 mmol).
200 ml bag: The sodium chloride content is 1800 mg (30.8 mmol).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
Clear, colourless solution
4. Clinical particulars
4.1 Therapeutic indications
Ciprofloxacin 2mg/ml 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 Neisseria gonorrhoeae
- Pelvic inflammatory disease including cases due to 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
• Inhalation anthrax (post-exposure prophy