CEFRADINE Capsule, hard (2018)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cefradine 250mg Capsules.

Qualitative and quantitative composition

Each capsule contains 250mg cefradine anhydrous. For the full list of excipients, see section 6.1.

Pharmaceutical form

Capsule, hard.

Therapeutic indications

Cefradine 250mg Capsules are used in the treatment of bacterial infections of the respiratory and urinary tracts and of the skin and soft tissues. These include the following: Upper respiratory tract infections ...

Posology and method of administration

Posology Adults Respiratory tract infections and skin and soft tissue infections: the usual dose is 250mg or 500mg four times daily or 500mg or 1g twice daily depending on the severity and site of infection. ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Following administration of cefradine, a false positive reaction for glucose in the urine may occur with Benedicts or Fehlings solution or with reagent tablets such as Clinitest. This does not occur with ...

Interaction with other medicinal products and other forms of interaction

Loop diuretics may increase nephrotoxicity of cephalosporins. Probenecid has been seen to raise serum concentrations of cefradine, by reducing renal clearance of the cephalosporins. There is evidence of ...

Fertility, pregnancy and lactation

Fertility Although animal studies have shown no teratogenic effects, safety in pregnancy has not been established. Pregnancy As with all medicines, use should be avoided in pregnancy especially in the ...

Effects on ability to drive and use machines

Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Undesirable effects

Undesirable effects are uncommon and mainly mild in nature. They are limited essentially to gastrointestinal disturbances and on occasion to hypersensitivity phenomena. Infections and infestations Rarely: ...

Overdose

The symptoms of cefradine overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large ...

Pharmacodynamic properties

Pharmacotherapeutic group: first generation cephalosporin ATC code: J01DB09 Mechanism of action Cefradine is a broad-spectrum, bactericidal first generation cephalosporin antibiotic active against both ...

Pharmacokinetic properties

Absorption Cefradine has a high degree of stability to many beta-lactamases. It has a low degree of protein binding and a large volume of distribution. Therefore, tissue levels are generally found to be ...

Preclinical safety data

There are no preclinical safety data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

List of excipients

Magnesium stearate Lactose monohydrate The capsule shell contains: Gelatin Titanium dioxide (E171) Indigo carmine (E132)

Incompatibilities

None.

Shelf life

Shelf life: 24 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

PVC/PVDC blister foil, 0.25 +/- 5% mm thick with an aluminium lidding foil 0.025 mm thick containing 10, 20 or 100 capsules.

Special precautions for disposal and other handling

No special instructions.

Marketing authorization holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland

Marketing authorization number(s)

PL 30464/0086

Date of first authorization / renewal of the authorization

8 January 2003 24/02/2010

Date of revision of the text

11<sup>th</sup> December 2018

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