MOXILEN Capsule, Powder for oral suspension, Powder for solution for injection (2017)
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Περιεχόμενα
1. Name of the medicinal product
Moxilen 250 mg hard capsules. Moxilen 500 mg hard capsules. Moxilen 125mg/5ml powder for oral suspension. Moxilen Forte 250mg/5ml powder for oral suspension. Moxilen 500 mg powder for solution for injection ...
2. Qualitative and quantitative composition
Moxilen hard capsules contain the equivalent of either 250mg or 500mg amoxicillin as amoxicillin trihydrate. Following reconstitution, Moxilen powder for oral suspension contains the equivalent of either ...
3. Pharmaceutical form
Capsule, hard. Powder for oral suspension. Powder for solution for injection or infusion. Moxilen hard capsules, Moxilen powder for oral suspension and Moxilen Forte powder for oral suspension are for ...
4.1. Therapeutic indications
Moxilen is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): Oral indications Acute bacterial sinusitis Acute otitis media Acute streptococcal ...
4.2. Posology and method of administration
Posology The dose of Moxilen that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) ...
4.3. Contraindications
Hypersensitivity to the active substance, to any of the penicillins or to any of the excipients listed in section 6.1. History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another ...
4.4. Special warnings and precautions for use
Hypersensitivity reactions Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam ...
4.5. Interaction with other medicinal products and other forms of interaction
Probenecid Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels ...
4.6. Fertility, pregnancy and lactation
Pregnancy Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ...
4.8. Undesirable effects
The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin rash. The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin, presented by MedDRA ...
4.9. Overdose
Symptoms and signs of overdose Gastrointestinal symptoms (such as nausea, vomiting and diarrhoea) and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> penicillins with extended spectrum <b>ATC code:</b> J01CA04 Mechanism of action Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or ...
5.2. Pharmacokinetic properties
Oral Absorption Amoxicillin fully dissociates in aqueous solution at physiological pH. It is rapidly and well absorbed by the oral route of administration. Following oral administration, amoxicillin is ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. Carcinogenicity ...
6.1. List of excipients
Moxilen powder for solution for injection or infusion contain no excipients. Moxilen capsules 250 mg contain magnesium stearate. The capsule shell contains: Gelatine Erythrosine (E127) Red iron oxide (E172) ...
6.2. Incompatibilities
<u>Oral formulations:</u> Not applicable. <u>Parenteral formulations:</u> 500 mg, 1 g powder for solution for injection or infusion. This medicinal product must not be mixed with other medicinal products ...
6.3. Shelf life
<u>Moxilen hard capsules:</u> 36 months. <u>Moxilen and Moxilen Forte powder for oral suspension:</u> 36 months. Following reconstitution, they have a shelf life of 15 days if kept in a refrigerator (2°C-8°C) ...
6.4. Special precautions for storage
Moxilen hard capsules should be stored below 25°C in the original package, in order to protect from moisture. Moxilen and Moxilen Forte powder for oral suspension should be stored below 25°C. Moxilen powder ...
6.5. Nature and contents of container
Moxilen hard capsules 250 mg and 500 mg are packed in polyvinylchloride film-aluminium foil blisters with a leaflet, in cartons. Cartons containing 16, 20, 100, 250, 500 or 1000 capsules are available. ...
6.6. Special precautions for disposal and other handling
Capsules Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Powder for oral suspension (bottles) Check cap seal is intact before use. Invert and ...
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Moxilen capsules 250 mg: 7236 Moxilen capsules 500 mg: 7237 Moxilen Powder for Oral Suspension 125 mg/5ml: 7278 Moxilen Forte Powder for Oral Suspension 250 mg/5ml: 7277 Moxilen powder for solution for ...
9. Date of first authorization / renewal of the authorization
Moxilen capsules 250 mg: Date of first authorisation: 14.12.1979 / 14.01.2015 Moxilen capsules 500 mg: Date of first authorisation: 14.12.1979 / 14.01.2015 Moxilen Powder for Oral Suspension 125 mg/5ml: ...
10. Date of revision of the text
22/09/2017
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