SYNTOCLOR Hard capsule (2013)
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Περιεχόμενα
1. Name of the medicinal product
Syntoclor 250 mg capsules. Syntoclor 500 mg capsules.
2. Qualitative and quantitative composition
Each capsule contains either 250mg or 500mg of cefaclor. <u>Excipient with known effect:</u> azorubine. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Lilac-ivory hard capsule. For oral administration.
4.1. Therapeutic indications
Syntoclor is indicated for the treatment of the following bacterial infections when caused by susceptible micro-organisms: otitis media respiratory tract infections, including bronchitis, exacerbation ...
4.2. Posology and method of administration
Posology Adults The normal adult dosage is 250mg administered every eight hours, but in more severe infections or infections due to less susceptible organisms the dosage may be increased to 500mg administered ...
4.3. Contraindications
Hypersensitivity to the active substance, cephalosporins or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
It is important that efforts are made to determine if the patient has had previous hypersensitivity reactions to cefaclor, cephalosporins or penicillins before starting treatment. Due to the fact that ...
4.5. Interaction with other medicinal products and other forms of interaction
Drugs <u>Probenecid:</u> Inhibits the renal excretion of cefaclor. <u>Warfarin:</u> Concomitant administration has led to rare reports of increased prothrombin time, with and without clinical bleeding. ...
4.6. Fertility, pregnancy and lactation
Pregnancy No evidence of fertility impairment or teratogenicity was found in animal studies, however such studies are not always predicative of behaviour in man. There are no adequate or well controlled ...
4.7. Effects on ability to drive and use machines
No known effects.
4.8. Undesirable effects
Blood and lymphatic system disorders Positive Coombs test. Eosinophilia, rare reports of thrombocytopenia. Transient lymphocytosis and leucopenia. Rare reports of haemolytic anaemia, aplastic anaemia, ...
4.9. Overdose
Symptoms Symptoms of overdose include diarrhoea, epigastric distress, nausea and vomiting. Management If a very large dose, 5 times the normal total daily dose, has been ingested then decontamination of ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Second-generation cephalosporins <b>ATC code:</b> J01DC04 Cefaclor is active against the following organisms in vitro: Alpha- and beta-haemolytic streptococci Staphylococci; ...
5.2. Pharmacokinetic properties
Cefaclor is well absorbed following oral administration to fasting subjects. Total absorption is the same whether the drug is given with or without food; however, when it is taken with food, the peak concentration ...
5.3. Preclinical safety data
No further relevant information.
6.1. List of excipients
The capsules also contain sodium starch glycolate, magnesium stearate, gelatin, titanium dioxide (E171), azorubine (E122) and indigo carmine(E132).
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store below 30°C, in the original package.
6.5. Nature and contents of container
Capsules are in combination blisters of aluminium foil and polyvinylchloride film. Cartons of 16, 100, 500 or 1000 capsules, with a patient information leaflet, are available. Not all pack sizes may be ...
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorization holder
Codal Synto Ltd, 33 Theklas Lysioti Street, 3030 Limassol, Cyprus
8. Marketing authorization number(s)
Syntoclor 250mg capsules: 20005 Syntoclor 500mg capsules: 20018
9. Date of first authorization / renewal of the authorization
Syntoclor 250mg capsules: 29/12/2005 Syntoclor 500mg capsules: 29/12/2005
10. Date of revision of the text
December 2013
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