Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
CIPROFLOXACIN
Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland
J01MA02
CIPROFLOXACIN 200 mg
SOLUTION FOR INFUSION
CIPROFLOXACIN 200 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2006-11-03
BP22036_REC30610 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CIPROXIN SOLUTION FOR INFUSION 2MG/ML, 100ML 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 Ciproxin is and what it is used for 2. What you need to know before you are given Ciproxin 3. How to use Ciproxin 4. Possible side effects 5. How to store Ciproxin 6. Contents of the pack and other information 1. WHAT CIPROXIN IS AND WHAT IT IS USED FOR Ciproxin 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 Ciproxin 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 Ciproxin. BP22036_REC30610 2 Children and adolescents Ciproxin is used in children and adolescents, under specialist Lesen Sie das vollständige Dokument
BP22036_REC30610 1 1. NAME OF THE MEDICINAL PRODUCT Ciproxin Solution for Infusion 2 mg/ml, 100 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each glass bottle with 100 mL infusion solution contains 200 mg ciprofloxacin. The sodium chloride content is 900 mg (15.4 mmol). Excipient with known effect: sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. Clear, nearly colourless to slightly yellowish solution. The pH-value of the solution for infusion ranges from 3.9 to 4.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciproxin Solution for Infusion 2 mg/ml 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 - exacerbation of chronic obstructive pulmonary disease. In exacerbation of chronic obstructive pulmonary disease Ciproxin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. - 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 - Acute pyelonephritis - Complicated pyelonephritis - Bacterial prostatitis • 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 BP22036_REC30610 2 • Infection Lesen Sie das vollständige Dokument