GYRABLOCK Film-coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Gyrablock 400 mg, film-coated tablets.
2. Qualitative and quantitative composition
Each tablet contains 400 mg of norfloxacin. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. Yellow, capsule shaped, convex, scored on one side, film-coated tablet.
4.1. Therapeutic indications
Gyrablock is a broad spectrum quinolone bactericidal agent indicated for the treatment of acute and chronic, urinary tract infections caused by bacteria susceptible to norfloxacin. Such infections include: ...
4.2. Posology and method of administration
Posology The causative agent of the infection should be tested for susceptibility to norfloxacin, but therapy may be started before the test results are available. Adults Urinary tract infections, uncomplicated: ...
4.3. Contraindications
Hypersensitivity to the active substance, chemically related quinolone antibacterials or to any of the excipients listed in section 6.1 Use in pre-pubertal children or growing adolescents (see also section ...
4.4. Special warnings and precautions for use
The use of norfloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment ...
4.5. Interaction with other medicinal products and other forms of interaction
<u>Antacids:</u> Should not be administered concomitantly or within two hours before or two hours after norfloxacin as they interfere with absorption resulting in lower serum/urine levels of norfloxacin. ...
4.6. Pregnancy and lactation
There is inadequate evidence for safety in pregnancy, use is not recommended (see also section5.3). No data is available on the excretion of norfloxacin in breast milk, use in breast- feeding is not recommended. ...
4.7. Effects on ability to drive and use machines
There are no reports of a specific effect. Some patients may experience dizziness or similar side effect. Patients should be cautioned not to drive or operate machinery until they are sure they are not ...
4.8. Undesirable effects
The adverse reactions are presented taking into consideration MedDRA frequency and system organ class database convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), ...
4.9. Overdose
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. If overdose is recent, the stomach should ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Fluoroquinolones <b>ATC code:</b> J01MA06 Norfloxacin is bactericidal and acts by inhibition of bacterial deoxyribonucleic acid (DNA) synthesis. Studies in <em>E. coli ...
5.2. Pharmacokinetic properties
Absorption of norfloxacin is rapid following oral administration, with peak serum levels being reached after about one hour. Between 30% - 40% of the dose is absorbed, the serum half life is about four ...
5.3. Preclinical safety data
Dogs, three to five months old, administered norfloxacin at levels four or more times greater than the usual human dose suffered from blister formation and the eventual erosion of the articular cartilage ...
6.1. List of excipients
Tablets also contain croscarmellose sodium, povidone, microcrystalline cellulose, magnesium stearate, Opadry Yellow 02B220005 and polyethylene glycol 6000.
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store below 25°C in the original package in order to protect from light and moisture.
6.5. Nature and contents of container
Polypropelene securitainer packs, with a leaflet, in a carton. Securitainers of 14, 500 and 1000 tablets, blisters of 14, 20, 30, 50, 100 are available. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
11772
9. Date of first authorization / renewal of the authorization
30/6/1988
10. Date of revision of the text
10/2020 27/10/2020
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