DICLOXACILLIN ORION Capsule (2018)
Βιβλιογραφική αναφορά
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
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Dicloxacillin Orion 250 mg capsules, hard. Dicloxacillin Orion 500 mg capsules, hard.
Qualitative and quantitative composition
Dicloxacillin Orion 250 mg capsules, hard: Each capsule contains dicloxacillin sodium equivalent to 250 mg of dicloxacillin. Dicloxacillin Orion 500 mg capsules, hard: Each capsule contains dicloxacillin ...
Pharmaceutical form
Capsule, hard. <u>Dicloxacillin Orion 250 mg capsules, hard:</u> Off-white/Off-white size 2 hard gelatin capsule filled with white to off-white powder and imprinted with Y on off-white cap & 14 on off-white ...
Therapeutic indications
Infections caused by penicillinase-producing, methicillin-sensitive staphyloccoci, e.g. wound infections, abscesses, osteomyelitis. Consideration should be given to official guidance on the appropriate ...
Posology and method of administration
Posology Adults 500 mg to 1 g 3-4 times daily. In severe and serious infections the daily dose may be increased to a maximum of 6 grams. Paediatric population Children 20-40 kg 250 mg 3-4 times daily. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Additionally, an allergy to penicillin and type I reaction to cephalosporins.
Special warnings and precautions for use
Local requirements on the appropriate use of antibacterial agents should be followed. Initial determination of the causing organisms and their susceptibility should be performed. Serious and occasionally ...
Interaction with other medicinal products and other forms of interaction
Probenecid inhibits the renal tubular excretion resulting in an increase in and prolongation of the plasma concentration of penicillin. Bacteriostatic drugs, such as the tetracyclines, may interfere with ...
Pregnancy and lactation
Pregnancy Long clinical experience indicates low risk of harmful effects during pregnancy or to the foetus or newborn child. Breast-feeding Penicillins are excreted in human milk at low levels. Harmful ...
Effects on ability to drive and use machines
Dicloxacillin has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Approximately 5% of the treated patients can expect side effects. The most common side effects are nausea, vomiting and diarrhoea. As with other penicillins allergic reactions both humoral hypersensitivity ...
Overdose
High doses of penicillin are generally well tolerated. Possible toxic reactions include gastrointestinal symptoms, electrolyte disturbances, convulsions, impaired consciousness. Haemolytic reactions, renal ...
Pharmacodynamic properties
Pharmacotherapeutic group: antibacterial agents for systemic use, beta-lactam resistant penicillins ATC code: J01CF01 Mechanism of action Dicloxacillin is a penicillinase stable, acid-stable semisynthetic ...
Pharmacokinetic properties
Absorption Absorption from the gastrointestinal tract is rapid but incomplete. In fasting healthy adults maximum serum concentration is reached during 30 minutes-2 hours and 35-76% of the oral dose is ...
Preclinical safety data
No data from longterm animal studies with dicloxacillin are available.
List of excipients
<u>Capsule content:</u> Silica colloidal anhydrous Magnesium stearate Capsule shell: Gelatin Water Titanium dioxide (E171) <u>Printing ink:</u> Shellac Dehydrated alcohol Isopropyl alcohol Butyl alcohol ...
Incompatibilities
Aminoglycosides and penicillins can mutually inactivate each other in vitro.
Shelf life
2 years.
Special precautions for storage
Store below 30°C. Store in the original package in order to protect from moisture.
Nature and contents of container
30, 50 or 100 capsules in HDPE plastic jar with PP closure. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
Date of revision of the text
11/06/2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
