CLAVOMID 250 mg/125 mg Film-coated tablet (2016)
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Περιεχόμενα
1. Name of the medicinal product
Clavomid 250 mg/125 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains amoxicillin trihydrate equivalent to 250 mg amoxicillin and diluted potassium clavulanate equivalent to 125 mg clavulanic acid. For the full list of excipients, see section ...
3. Pharmaceutical form
Film-coated tablet. White, oval, film-coated tablets.
4.1. Therapeutic indications
Clavomid is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): acute bacterial sinusitis (adequately diagnosed). cystitis. pyelonephritis. ...
4.2. Posology and method of administration
Posology Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component. The dose of Clavomid that is selected to treat ...
4.3. Contraindications
Hypersensitivity to the active substances, 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
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactam agents. Serious ...
4.5. Interaction with other medicinal products and other forms of interaction
Oral anticoagulants Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are cases of increased international ...
4.6. Pregnancy and lactation
Pregnancy Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Limited data ...
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 vomiting. The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin/clavulanic, sorted by ...
4.9. Overdose
Symptoms and signs of overdose Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Antibacterials for systemic use; Beta-lactam antibacterials, penicillins <b>ATC Code:</b> J01CR02 Mechanism of action Amoxicillin is a semisynthetic penicillin (beta-lactam ...
5.2. Pharmacokinetic properties
Absorption Amoxicillin and clavulanic acid, are fully dissociated in aqueous solution at physiological pH. Both components are rapidly and well absorbed by the oral route of administration. Absorption ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, genotoxicity and toxicity to reproduction. Repeat dose toxicity studies performed in dogs with amoxicillin/clavulanic ...
6.1. List of excipients
<u>Core:</u> Microcrystalline cellulose Sodium lauryl sulfate Sodium starch glycolate Colloidal silicon dioxide Magnesium stearate <u>Coating:</u> Hypromellose Propylene glycol Titanium dioxide E171 Talc ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Store below 25°C. Protected from light and moisture.
6.5. Nature and contents of container
Aluminium/Aluminium blisters. Pack-size of 20 film-coated tablets.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, P. O. Box 51706, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
19666
9. Date of first authorization / renewal of the authorization
Date of first authorization: 16 May 2005 Date of latest renewal: 29 July 2013
10. Date of revision of the text
19/09/2016
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