CLAVOMID 500 mg/125 mg Film-coated tablet (2017)
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Περιεχόμενα
1. Name of the medicinal product
Clavomid 500 mg/125 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin and diluted potassium clavulanate equivalent to 125 mg clavulanic acid.
For full list of excipients, see sec...
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 (adequantly diagnosed).
acute otitis media.
acu...
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 tr...
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...
4.4. Special warnings and precautions for use
Before initiating therapy with amoxicillin and clavulanate potassium, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other beta-lac...
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 internat...
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 ...
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...
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 acid,...
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 ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic Group:
Antibacterials for systemic use; Beta-lactam antibacterials, penicillins
ATC Code:
J01CR02
Mechanism of action
Amoxicillin is a semisynthetic penicillin (beta-lactam a...
5.2. Pharmacokinetic properties
Absorption
Amoxicillin and clavulanic acid, are fully dissociated in aqueous solution at physicological pH. Both components are rapidly and well absorbed by the oral route of administration. Absorp...
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 amoxici...
6.1. List of excipients
Core:
Microcrystalline cellulose
Sodium lauryl sulfate
Sodium starch glycolate
Colloidal silicon dioxide
Magnesium stearate
Coating:
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-sizes of 15 and 20 film-coated tablets.
Not all pack-sizes may be marketed.
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)
19667
9. Date of first authorization / renewal of the authorization
Date of first authorization: 16 May 2005
Date of latest renewal: 18 November 2011
10. Date of revision of the text
12/07/2017
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