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CIPROFLOXACIN SANDOZ 500MG
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1223974
Name of medicinal product:
CIPROFLOXACIN SANDOZ 500MG
Active substances:
Ciprofloxacin
Estonian
,
English
,
Latin
ATC code:
J01MA02
Dosage form:
film-coated tablet
Route of administration:
oral use
Strengh:
500mg
Amount in package:
50TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
[nationally completed name] 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 available information on resistance to ciprofloxacin before commencing therapy. Adults Lower respiratory tract infections due to Gram-negative bacteria ? exacerbations of chronic obstructive pulmonary disease o In exacerbation of chronic obstructive pulmonary disease, ciprofloxacin 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 Uncomplicated acute cystitis o In uncomplicated acute cystitis, ciprofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. Acute pyelonephritis Complicated urinary tract infections Bacterial prostatitis Genital tract infections - gonococcal uretritis 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 neutropenic patients with fever that is suspected to be due to a bacterial infection. Children and adolescents - Broncho-pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis - Complicated urinary tract infections and acute 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). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated July 20, 2022)
Package information leaflet (PIL):
EST
(last updated July 20, 2022)
Labelling:
(last updated October 17, 2018)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Sandoz Pharmaceuticals d.d.
Marketing authorization number:
514506
Marketing authorization issued on:
May 18, 2006
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Mutual recognition
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Perscription conditions and restrictions
Description
Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada
Entry/Changing date: October 27, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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