Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
CIPROFLOXACIN AS HYDROCHLORIDE
DEXCEL LTD, ISRAEL
J01MA02
CAPLETS
CIPROFLOXACIN AS HYDROCHLORIDE 500 MG
PER OS
Required
DEXCEL LTD, ISRAEL
CIPROFLOXACIN
CIPROFLOXACIN
* Adults :Broad spectrum antibiotic for infections caused by ciprofloxacin sensitive pathogens. * Children and adolescents:• Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa• Complicated urinary tract infections and pyelonephritis• Inhalation anthrax (post-exposure prophylaxis and curative treatment)Ciprofloxacin may also be used to treat severe infections in children and adolescents when there is no other alternative .Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents
2021-10-31
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine can be sold with a physician’s prescription only CIPRODEX ® 500, CAPLETS EACH CAPLET CONTAINS ciprofloxacin as hydrochloride at a dose of 500 mg. Inactive ingredients and allergens in the medicine – see section 6 "Additional information" and in section 2 "Important information about some of the ingredients of the medicine". READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask your physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if you think that their illness is similar. 1. WHAT IS THE MEDICINE USED FOR? CIPRODEX 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 prevent infections due to the bacterium Neisseria meningitidis anthrax inhalation Treatment for children and adolescents, under specialist medical supervision, to treat the following bacterial infections: lung and bronchial infections in children and adolescents suffering from cystic fibrosis complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis). anthrax inhalation exposure. CIPRODEX may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary. THERAPEUTIC GROUP: antibiotic of the fluoroquinolone group. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are hypersensitive (allergic) to the active ingredient (ciprofloxacin), to other medicines of the quinolone group or to one of the additional ingre Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CIPRODEX 500 caplets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each caplet contains 500mg ciprofloxacin (as hydrochloride). Excipient with known effect: Each caplet of Ciprodex 500 contains approximately 46 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Caplet White to Off-white, biconvex, caplet, scored on both sides. The caplets can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciprodex 500 caplets are 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 Broad spectrum antibiotic for infections caused by ciprofloxacin sensitive pathogens. 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 - Gonococcal urethritis and cervicitis due to susceptible _Neisseria gonorrhoeae_ - 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 Prophylaxis of invasive infections due to _Neisseria meningitidis_ Inhalation anthrax (post-exposure prophylaxis and curative treatment) Ciprofloxacin may be used in the management of neutro Pročitajte cijeli dokument