Country: Малта
Језик: Енглески
Извор: Medicines Authority
CIPROFLOXACIN
Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom
J01MA02
CIPROFLOXACIN 2 mg/ml
SOLUTION FOR INFUSION
CIPROFLOXACIN 2 mg/ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2006-11-03
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CIPROXIN SOLUTION FOR INFUSION 100MG/50ML, 200MG/100ML, OR 400MG/200ML 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. Page 2 of 11 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. Children and adolescents Ciproxin is used in children and adolescents, un Прочитајте комплетан документ
026_0 Page 1 of 23 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ciproxin solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each glass bottle with 50 mL infusion solution contains 100 mg ciprofloxacin. The sodium chloride content is 450 mg (7.7 mmol). Each glass bottle with 100 mL infusion solution contains 200 mg ciprofloxacin. The sodium chloride content is 900 mg (15.4 mmol). Each glass bottle with 200 mL infusion solution contains 400 mg ciprofloxacin. The sodium chloride content is 1800 mg (30.8 mmol). 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 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 026_0 Page 2 of 23 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 prop Прочитајте комплетан документ