Ciprofloxacin spc

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    Ciprofloxacin spc


    č.: 2014/05920-Z1B Súhrn charakteristických vlastností lieku Ciprofloxacin-Teva 250 mg filmom obalené tablety Ciprofloxacin-Teva 500 mg filmom obalené tablety Ciprofloxacin-Teva 750 mg filmom obalené tablety 250 mg: Každá tableta obsahuje 250 mg ciprofloxacínu vo forme ciprofloxacíniumchloridu. 500 mg: Každá tableta obsahuje 500 mg ciprofloxacínu vo forme ciprofloxacíniumchloridu. 250 mg: Biele, bikonvexné, okrúhle filmom obalené tablety s označením “CIP 250” a deliacou ryhou na jednej strane a bez označenia na druhej strane. 500 mg: Biele, oválne filmom obalené tablety s označením “CIP 500” a deliacou ryhou na jednej strane a bez označenia na druhej strane. 750 mg: Biele, oválne filmom obalené tablety s označením “CIP 750” na jednej strane a bez označenia na druhej strane. 750 mg: Každá tableta obsahuje 750 mg ciprofloxacínu vo forme ciprofloxacíniumchloridu. Ciprofloxacin-Teva filmom obalené tablety sú indikované na liečbu nasledujúcich infekcií (pozri časti 4.4 a 5.1). Pred začatím liečby sa má venovať zvláštna pozornosť dostupným informáciám o rezistencii voči ciprofloxacínu. Majú byť zohľadnené oficiálne odporúčania vzhľadom na primerané použitie antibiotík. - Infekcie dolných dýchacích ciest vyvolané gramnegatívnymi baktériami. - Exacerbácie chronického obštrukčného pulmonálneho ochorenia - Broncho-pulmonálne infekcie pri cystickej fibróze alebo pri bronchiektázii - Pneumónia - Chronický supuratívny zápal otitis media - Akútna exacerbácia chronickej sínusitídy, najmä vyvolanej gramnegatívnymi baktériami - Infekcie močových ciest - Gonokoková uretritída a cervicitída - Epididymálna orchitída zahŕňajúca prípady vyvolané druhom alebo je patogén potvrdený, je obzvlášť dôležité získať miestne informácie o prevalencii rezistencie voči ciprofloxacínu a potvrdiť citlivosť na základe laboratórnych testov. cestovateľská hnačka) - Intraabdominálne infekcie - Infekcie kože a mäkkých tkanív vyvolané gramnegatívnymi baktériami - Malígny zápal vonkajšieho ucha - Infekcie kostí a kĺbov - Liečba infekcií u neutropenických pacientov - Profylaxia infekcií u neutropenických pacientov - Profylaxia invazívnych infekcií vyvolaných druhom sa - Komplikované infekcie močových ciest a pyelonefritída - Inhalácia antraxu (profylaxia a liečba stavov po expozícii). Ciprofloxacin Bayer and associated names is an antibiotic, indicated for the treatment of uncomplicated and complicated infections, including severe infections, caused by ciprofloxacin susceptible pathogens. It is available as immediate release film coated tablets, modified release film coated tablets, granules and solutions for oral suspension, solutions for infusion in bags, solutions for infusion in bottles and sachets. On 22 June 2007, France presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Ciprofloxacin Bayer and associated names. The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Ciprofloxacin Bayer and associated names approved across EU Member States, with respect to the indications, the posology, the contra-indications and the special warnings and precautions for use. This medicinal product belongs to the list of products identified in 2007 for SPC harmonisation. The Marketing Authorisation Holder provided supplementary information on 23 November 2007 and 22 April 2008. During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended. The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Ciprofloxacin Bayer and associated names.

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    Aug 14, 2009. presentations, see Summary of Product Characteristics SPC. In pneumococcal pneumonia ciprofloxacin is not the drug of first choice. Jul 23, 2015. Ciprofloxacin drops for infection This leaflet is about the use of ciprofloxacin drops to treat infections of the outer ear that are caused by bacteria. Ciprofloxacin 250 mg film-coated tablets are indicated for the treatment of the following infections see sections 4.4 and 5.1. Special attention should be paid to.

    1 ml solution for infusion contains: 2 mg ciprofloxacin (as ciprofloxacin lactate). Excipients with known effect: 1 ml solution contains: 50 mg glucose monohydrate: equivalent to 45 mg glucose. Ciprofloxacin 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. • 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 gastrointestinal 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 • Inhalation anthrax (post-exposure prophylaxis and curative treatment) Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. • 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 this is considered to be necessary. Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1). Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal product’s properties and the conditions attached to its use. This information is arranged in an A-Z list by active substance. You can also use the search box on the left to find a medicine by generic name or brand name. This is the most up-to-date information for a medicine according to its licence history. PILS can be updated several times through the product’s lifecycle, so the PIL found with products when purchased or dispensed could be different. MHRA holds data for medicines that are licensed at national level.

    Ciprofloxacin spc

    Label PDF - FDA, Ciprofloxacin drops for infection Medicines for Children

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  6. Oct 7, 2008. The basis for referral was that there were divergences in the Summaries of Product Characteristics SPC of Ciprofloxacin Bayer and.

    • Ciprofloxacin Bayer European Medicines Agency.
    • Ciprofloxacin 500mg Film-coated Tablets - Summary of Product..
    • PrCIPRO® XL - Bayer. Ca.

    Dose oral ciprofloxacin treatment of uncomplicated cystitis. the following statement was recommended in Section 4.2 of the SPCciprofloxacin should. Ofloxacin Ornidazole Tablets Spc antibiotics such as gentamicin, neomycin or streptomycin should be aware of possible interaction with ciprofloxacin. Indications, dose, contra-indications, side-effects, interactions, cautions, warnings and other safety information for CIPROFLOXACIN.

     
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