LINEZOLID Film-coated tablets (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
Linezolid 600 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 600 mg linezolid. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White, ovaloid tablet debossed with LZD on one side and 600 on the other.
Therapeutic indications
Nosocomial pneumonia Community acquired pneumonia Linezolid is indicated in adults for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible ...
Posology and method of administration
Posology Linezolid solution for infusion, film-coated tablets or oral suspension may be used as initial therapy. Patients who commence treatment on the parenteral formulation may be switched to either ...
Contraindications
Hypersensitivity to linezolid or to any of the excipients listed in section 6.1. Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. phenelzine, ...
Special warnings and precautions for use
Myelosuppression Myelosuppression (including anaemia, leucopenia, pancytopenia and thrombocytopenia) has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid ...
Interaction with other medicinal products and other forms of interaction
Monoamine oxidase inhibitors Linezolid is a reversible, non-selective inhibitor of monoamine oxidase (MAOI). There are very limited data from drug interaction studies and on the safety of linezolid when ...
Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of linezolid in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). A potential risk for humans exists. Linezolid should ...
Effects on ability to drive and use machines
Patients should be warned about the potential for dizziness or symptoms of visual impairment (as described in section 4.4 and 4.8) whilst receiving linezolid and should be advised not to drive or operate ...
Undesirable effects
The table below provides a listing of adverse drug reactions with frequency based on all-causality data from clinical studies that enrolled more than 2,000 adult patients who received the recommended linezolid ...
Overdose
No specific antidote is known. No cases of overdose have been reported. However, the following information may prove useful: Supportive care is advised together with maintenance of glomerular filtration. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antibacterials ATC code: J01XX08 General properties Linezolid is a synthetic, antibacterial agent that belongs to a new class of antimicrobials, the oxazolidinones. It ...
Pharmacokinetic properties
Linezolid primarily contains (s)-linezolid which is biologically active and is metabolised to form inactive derivatives. Absorption Linezolid is rapidly and extensively absorbed following oral dosing. ...
Preclinical safety data
Linezolid decreased fertility and reproductive performance of male rats at exposure levels approximately equal to those in humans. In sexually mature animals these effects were reversible. However, these ...
List of excipients
Tablet core: Maize starch (corn derived) Microcrystalline cellulose (E460) Hydroxypropylcellulose (E463) Sodium starch glycollate type A Magnesium stearate (E572) Film coat: Opadry, white, YS-1-18202-A(e) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
White, HDPE bottle with a polypropylene screw cap containing either 10*, 14*, 20*, 24, 30, 50 or 60 tablets. White, HDPE bottle with a polypropylene screw cap containing 100 tablets (for hospital use only). ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/1419
Date of first authorization / renewal of the authorization
Date of first authorisation: 23/11/2012 Date of last renewal: 22/02/2018
Date of revision of the text
02/2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
