Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC, UK: Klaricid 250mg Tablets (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Abbott Healthcare Products Limited
Διεύθυνση :
Mansbridge Road, West End, Southampton, SO18 3JD
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Name of the medicinal product

Klaricid or Clarithromycin 250 mg Tablets.

Qualitative and quantitative composition

250 mg/tablet Active: Clarithromycin.

Pharmaceutical form

A yellow, ovaloid film-coated tablet containing 250 mg of clarithromycin.

Therapeutic indications

Consideration should be given to official guidance on the appropriate use of antibacterial agents. Klaricid 250mg Tablets are indicated in adults and children 12 years and older. Clarithromycin is indicated ...

Posology and method of administration

Patients with respiratory tract/skin and soft tissue infections Adults: The usual dose is 250 mg twice daily although this may be increased to 500mg twice daily in severe infections. The usual duration ...

Contraindications

Klaricid 250mg Tablets are contra-indicated in patients with known hypersensitivity to macrolide antibiotic drugs or to any of its excipients Concomitant administration of clarithromycin and ergotamine ...

Special warnings and precautions for use

The physician should not prescribe clarithromycin to pregnant women without carefully weighing the benefits against risk, particularly during the first three months of pregnancy (see section 4.6). Caution ...

Interaction with other medicinal products and other forms of interaction

The use of the following drugs is strictly contraindicated due to the potential for severe drug interaction effects Cisapride, pimozide, astemizole and terfenadine Elevated cisapride levels have been reported ...

Pregnancy and lactation

The safety of clarithromycin during pregnancy and breast feeding of infants has not been established. Based on variable results obtained from studies in mice, rats, rabbits and monkeys, the possibility ...

Effects on ability to drive and use machines

There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should ...

Undesirable effects

a. Summary of the safety profile The most frequent and common adverse reactions related to clarithromycin therapy for both adult and peadiatric populations are abdominal pain, diarrhoea, nausea, vomiting ...

Overdose

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin ...

Pharmacodynamic properties

ATC classification Pharmacotherapeutic group: Anti-infectious ATC code: J01FA09 Mode of Action Clarithromycin is a semi-synthetic derivative of erythromycin A. It exerts its antibacterial action by binding ...

Pharmacokinetic properties

H. pylori is associated with acid peptic disease including duodenal ulcer and gastric ulcer in which about 95% and 80% of patients respectively are infected with the agent. H. pylori is also implicated ...

Preclinical safety data

In acute mouse and rat studies, the median lethal dose was greater than the highest feasible dose for administration (5g/kg). In repeated dose studies, toxicity was related to dose, duration of treatment ...

List of excipients

Croscarmellose sodium Starch pregelatinised Cellulose microcrystalline Silica gel Povidone Stearic acid Magnesium stearate Talc Hypromellose Hydroxypropylcellulose Propylene glycol Sorbitan monooleate ...

Incompatibilities

None known.

Shelf life

The recommended shelf life is 24 months.

Special precautions for storage

Protect from light. Store in a dry place.

Nature and contents of container

2/14/56 tablets in a blister original pack. The blisters are packaged in a carton with a pack insert.

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Abbott Laboratories Limited Abbott House Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE UK

Marketing authorization number(s)

PL 0037/0211

Date of first authorization / renewal of the authorization

09/04/91

Date of revision of the text

03 November 2011