देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
CIPROFLOXACIN
Teva Pharma B.V.
J01MA02
CIPROFLOXACIN
2 Mg/Ml
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Fluoroquinolones
Authorised
2010-01-08
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Ciprofloxacin Teva 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. - 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 Teva 2 mg/ml Solution for Infusion is and what it is used for 2. What you need to know before you are given Ciprofloxacin Teva 2 mg/ml Solution for Infusion 3. How Ciprofloxacin Teva 2 mg/ml Solution for Infusion is given 4. Possible side effects 5. How to store Ciprofloxacin Teva 2 mg/ml Solution for Infusion 6. Contents of the pack and other information 1. WHAT CIPROFLOXACIN TEVA 2 MG/ML SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Ciprofloxacin Teva is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin Teva works by killing bacteria that cause infections. It only works with specific strains of bacteria. _Adults _ Ciprofloxacin Teva 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 patien पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciprofloxacin Teva 2 mg/ml Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for infusion contains 2 mg ciprofloxacin (as ciprofloxacin lactate*). 100 ml infusion bag contains 200 mg ciprofloxacin as 254.4 mg ciprofloxacin lactate*. 200 ml infusion bag contains 400 mg ciprofloxacin as 508.8 mg ciprofloxacin lactate*. *Ciprofloxacin lactate is formed from ciprofloxacin and lactic acid _in situ _during the manufacturing process. Excipient with known effect: 100 ml of Solution for Infusion contains 5 g glucose 200 ml of Solution for Infusion contains 10 g glucose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear, colourless or slightly yellow solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciprofloxacin 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 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_ In the above genital tract infections when thought or known to be due to _Neisser पूरा दस्तावेज़ पढ़ें