FELEXIN Hard capsule (2021)
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Περιεχόμενα
1. Name of the medicinal product
Felexin 250 mg hard capsules. Felexin 500 mg hard capsules.
2. Qualitative and quantitative composition
<u>Felexin 250 mg hard capsules:</u> Each hard capsule contains cefalexin monohydrate equivalent to 250 mg cefalexin. <u>Felexin 500 mg hard capsules:</u> Each hard capsule contains cefalexin monohydrate ...
3. Pharmaceutical form
Hard capsules. Green/White capsules.
4.1. Therapeutic indications
Cefalexin is a semisynthetic cephalosporin antibiotic for oral administration. Felexin is indicated in the treatment of the following infections due to susceptible micro-organisms: respiratory tract infections. ...
4.2. Posology and method of administration
Posology Adults The adult dosage ranges from 1-4 g daily in divided doses; most infections will respond to a dosage of 500 mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis, ...
4.3. Contraindications
Felexin is contra-indicated in patients known allergy to the cephalosporin group of antibiotics.
4.4. Special warnings and precautions for use
Before instituting therapy with cefalexin, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to the cephalosporins, penicillins or other drugs. Cefalexin ...
4.5. Interaction with other medicinal products and other forms of interaction
As with other beta-lactam drugs, renal excretion of cefalexin is inhibited by probenecid. In healthy subjects given single 500 mg doses of cefalexin and metformin, plasma metformin C<sub>max</sub> and ...
4.6. Pregnancy and lactation
Pregnancy Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for the pregnant patient. Breast-feeding The excretion of cefalexin ...
4.7. Effects on ability to drive and use machines
Felexin has no known influence on the ability to drive and use machines.
4.8. Undesirable effects
Gastro-intestinal Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Nausea and vomiting have been reported rarely. The most frequent side-effect has been diarrhoea. ...
4.9. Overdose
Symptoms of oral overdose may include nausea, vomiting, diarrhoea, epigastric distress and haematuria. In the event of severe overdosage, general supportive care is recommended, including close clinical ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antibacterials for systemic use; Other beta-lactam antibacterials <b>ATC code:</b> J01DB01 <em>In vitro</em> tests demonstrate that cephalosporins are bactericidal because ...
5.2. Pharmacokinetic properties
Cefalexin is acid stable. Cefalexin is almost completely absorbed from the gastro-intestinal tract, and 75-100% is rapidly excreted in active form in the urine. Absorption is slightly reduced if the drug ...
5.3. Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
6.1. List of excipients
<u>Capsule content:</u> Sodium starch glycolate (Type A) Sodium laurilsulfate Silica, colloidal anhydrous Magnesium stearate <u>Capsule shell:</u> Titanium dioxide E171 Gelatin Patent blue V E131 Quinoline ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
<u>Felexin 250 mg hard capsules:</u> PVC/Aluminium Blisters. Pack sizes of 20 and 100 hard capsules. PP containers with PE closures. Pack sizes of 500 and 1000 hard capsules. <u>Felexin 500 mg hard capsules: ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
Felexin 250 mg hard capsules: 19696 Felexin 500 mg hard capsules: 19701
9. Date of first authorization / renewal of the authorization
Date of first authorization: 15 July 2005 Date of latest renewal: 17 June 2011
10. Date of revision of the text
11/01/2021
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