KLERIMED Film coated tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Klerimed 250mg film-coated tablet. Klerimed 500mg film-coated tablet.
2. Qualitative and quantitative composition
Each tablet contains 250mg or 500 of clarithromycin. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablets. <u>250mg:</u> yellow, oval shaped, convex tablets, scored on one side, film-coated, with dimensions 14 8 mm. <u>500mg:</u> yellow, oval shaped convex tablets film-coated tablets with ...
4.1. Therapeutic indications
For the treatment of infections due to susceptible organisms. The indications include: upper respiratory tract infection, including pharyngitis and sinusitis lower respiratory tract infection, including ...
4.2. Posology and method of administration
Posology Adults The usual recommended dosage of clarithromycin in adults is one 250mg tablet twice daily. In more severe infections, the dosage can be increased to 500mg twice daily. The usual duration ...
4.3. Contraindications
Clarithromycin is contraindicated in patients with known hypersensitivity to the active substance, to macrolide antibiotic drugs or any of the excipients listed in section 6.1. Concomitant administration ...
4.4. Special warnings and precautions for use
The physician should not prescribe clarithromycin to pregnant women without carefully weighing the benefits against risk, particularly during the first three months of pregnancy (see section 4.6). Caution ...
4.5. Interaction with other medicinal products and other forms of interaction
<u>The use of the following drugs is strictly contraindicated due to the potential for severe drug interaction effects:</u> Cisapride, pimozide, astemizole and terfenadine Elevated cisapride levels have ...
4.6. Pregnancy and lactation
Pregnancy The safety of clarithromycin for use in pregnancy has not been established. Based on variable results obtained from animal studies and experience in humans, the possibility of adverse effects ...
4.7. Effects on ability to drive and use machines
There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should ...
4.8. Undesirable effects
a. Summary of the safety profile The most frequent and common adverse reactions related to clarithromycin therapy for both adult and paediatric populations are abdominal pain, diarrhoea, nausea, vomiting ...
4.9. Overdose
Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastrointestinal symptoms. One patient who had a history of bipolar disorder ingested eight grams of clarithromycin ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antibacterials for systemic use, Macrolides <b>ATC code:</b> J01FA09 Clarithromycin is a semi-synthetic derivative of erythromycin A. It exerts its antibacterial action ...
5.2. Pharmacokinetic properties
<em>H. pylori</em> is associated with acid peptic disease including duodenal ulcer and gastric ulcer in which about 95% and 80% of patients respectively are infected with the agent. <em>H. pylori</em> ...
5.3. Preclinical safety data
In acute mouse and rat studies, the median lethal dose was greater than the highest feasible dose for administration (5g/kg). In repeated dose studies, toxicity was related to dose, duration of treatment ...
6.1. List of excipients
Croscarmellose Cellulose microcrystalline Silicon dioxide Povidone Stearic acid Magnesium stearate Talc Hypromellose Propylene glycol Sorbitan oleate Vanilla Quinolline yellow (E104) Titanium dioxide (E171) ...
6.2. Incompatibilities
None known.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25ºC.
6.5. Nature and contents of container
Tablets are packed into PVC/PVDC-Al blisters. Boxes of 14, 16 and 20 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Klerimed tablets 250 mg: 19927 Klerimed tablets 500 mg: 19195
9. Date of first authorization / renewal of the authorization
Klerimed tablets 250 mg: 20.12.2005 / 22.08.2011 Klerimed tablets 500 mg: 29.3.2001 / 28.03.2014
10. Date of revision of the text
02/2021
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