Ciprofloxacin Mylan 2mg/1ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ciprofloxacin

Available from:

Generics (UK) Limited

ATC code:

J01MA; J01MA02

INN (International Name):

Ciprofloxacin

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

Fluoroquinolones; ciprofloxacin

Authorization status:

Not marketed

Authorization date:

2010-07-02

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPROFLOXACIN MYLAN 2 MG/ML SOLUTION FOR INFUSION
Ciprofloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1. What Ciprofloxacin Mylan is and what it is used for
2. What you need to know before you are given Ciprofloxacin Mylan
3. How to use Ciprofloxacin Mylan
4. Possible side effects
5. How to store Ciprofloxacin Mylan
6. Contents of the pack and other information
1.
WHAT CIPROFLOXACIN MYLAN IS AND WHAT IT IS USED FOR
Ciprofloxacin Mylan 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 Mylan 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

to treat infections in patients with a very low white blood cell count
(neutropenia)

to prevent infections in patients with a very low white blood cell
count (neutropenia)

anthrax inhalation exposure
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
Mylan.
_ _
_Childre

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin Mylan 2mg/1ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for infusion contains 2 mg ciprofloxacin.
Each bag with 100 ml contains 200 mg ciprofloxacin.
Each bag with 200 ml contains 400 mg ciprofloxacin.
Excipient with known effect:
100 ml bag Contains 5 g of glucose (see section 4.4).
200 ml bag Contains 10 g of glucose (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless to slightly yellow solution.
pH of the solution: 3.5 to 4.6.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciprofloxacin Mylan 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
Inhalation anthrax (post-exposure prophylaxis and curative treatment)
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