CEFALEXIN Capsule, hard (2021)
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Περιεχόμενα
Name of the medicinal product
Cefalexin 500mg Capsules.
Qualitative and quantitative composition
Each capsule contains 500 mg of Cefalexin (as monohydrate). <u>Excipient(s) with known effect:</u> Each capsule contains 53.2 mg lactose. For full list of excipients, see 6.1
Pharmaceutical form
Capsules, hard. Size 0 grey/orange capsule containing white powder printed CHX 500.
Therapeutic indications
Cefalexin is a semi synthetic cephalosporin antibiotic for oral administration. Cefalexin is indicated in the treatment of the following infections due to susceptible micro-organisms: Respiratory tract ...
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Cefalexin is contraindicated in patients with known allergy to the cephalosporins group of antibiotics or to ...
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 ...
Interaction with other medicinal products and other forms of interaction
As with other beta-lactam drugs, renal excretion of cephalexin is inhibited by probenecid. Probenecid causes reduced excretion of cefalexin leading to increased plasma concentrations. Cephalosporins may ...
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. Breastfeeding The excretion of cefalexin ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
<u>Gastro-intestinal:</u> 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 ...
Overdose
Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhoea and haematuria. In the event of severe overdosage, general supportive care is recommended including close clinical ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antibacterials for systemic use, first generation cephalsporins <b>ATC code:</b> J01DB01 Cefalexin is bactericidal and has antimicrobial activity similar to that of cephaloridine ...
Pharmacokinetic properties
Absorption Human pharmacology Cefalexin is acid stable and may be given without regard to meals. It is rapidly absorbed after oral administration from the gastro-intestinal tract and produces peak plasma ...
Preclinical safety data
The daily oral administration of cefalexin to rats in doses of 250 or 500mg/kg prior to and during pregnancy, or to rats and mice during the period of organogenesis only, had no adverse effect on fertility, ...
List of excipients
Lactose Magnesium stearate Capsule shell Black iron oxide (E172) Titanium dioxide (E171) Erythrosin (E127) Quinoline yellow (E104) Gelatin
Incompatibilities
None known.
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C. Keep the container tightly closed (for bottles). Store in the original package (for blisters).
Nature and contents of container
Each container consists of a polypropylene tubular container with an open end equipped to accept a polyethylene closure, with a tamper-evident tear strip, or PVC/aluminium blisters, or PVDC coated PVC/ ...
Special precautions for disposal and other handling
No special instructions.
Marketing authorization holder
Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom
Marketing authorization number(s)
PL 16363/0119
Date of first authorization / renewal of the authorization
04/03/2009
Date of revision of the text
21/09/2021
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