CIPROFLOXACIN AMNEAL 2 Mg/Ml Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CIPROFLOXACIN LACTATE

Available from:

Amneal Pharma Europe Limited

INN (International Name):

CIPROFLOXACIN LACTATE

Dosage:

2 Mg/Ml

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPROFLOXACIN AMNEAL 2 MG/ML SOLUTION FOR INFUSION
CIPROFLOXACIN
READ  ALL  OF  THIS  LEAFLET  CAREFULLY  BEFORE  YOU  START  TAKING  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.

– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed 
in this leaflet.
WHAT IS IN THIS LEAFLET:
1.  What Ciprofloxacin Amneal Solution for infusion is and what it
is used for
2.  What you need to know before you receive Ciprofloxacin Amneal
Solution for infusion
3.  How Ciprofloxacin Amneal Solution for infusion is administered
4.  Possible side effects
5.  How to Store Ciprofloxacin Amneal Solution for infusion
6.  Contents of the pack and other information
1.  WHAT CIPROFLOXACIN AMNEAL SOLUTION FOR INFUSION IS AND WHAT IT
IS USED FOR
Ciprofloxacin Amneal Solution for infusion is an antibiotic belonging to the fluoroquinolone family. The active substance 
is ciprofloxacin. Ciprofloxacin Amneal Solution for infusion works by killing bacteria that cause infections. It only works 
with specific strains of bacteria.
ADULTS
Ciprofloxacin Amneal Solution for 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

– infections of the testicles

– genital organ infections in 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)

–

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin Amneal 2 mg/ml Solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each presentation of Ciprofloxacin Amneal 2 mg/ml infusion contains the following:
CIPROFLOXACIN AMNEAL 100 MG/50 ML SOLUTION FOR INFUSION
1 ml of solution for infusion contains 2 mg ciprofloxacin as 2.544 mg ciprofloxacin lactate.
Each 50 ml vial contains 100 mg ciprofloxacin (as ciprofloxacin lactate).
Excipient: Each 50 ml contains 7.7 mmol (177 mg) sodium.
CIPROFLOXACIN AMNEAL 200 MG/100 ML SOLUTION FOR INFUSION
1 ml of solution for infusion contains 2 mg ciprofloxacin as 2.544 mg ciprofloxacin lactate.
Each 100 ml bottle contains 200 mg ciprofloxacin (as ciprofloxacin lactate).
Excipient: Each 100 ml contains 15.4 mmol (354 mg) sodium.
CIPROFLOXACIN AMNEAL 400 MG/200 ML SOLUTION FOR INFUSION
1 ml of solution for infusion contains 2 mg ciprofloxacin as 2.544 mg ciprofloxacin lactate.
Each 200 ml bottle contains 400 mg ciprofloxacin (as ciprofloxacin lactate).
Excipient: Each 200 ml contains 30.8 mmol (708 mg) sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless to slightly yellow solution.
The pH-value of the solution for infusion ranges from 3.90 to 4.50.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciprofloxacin Amneal 2 mg/ 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