FLUCLOXACILLIN Powder for solution for injection / infusion (2021)
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Περιεχόμενα
Name of the medicinal product
Flucloxacillin 250mg Powder for Solution for Injection or Infusion.
Qualitative and quantitative composition
Sodium flucloxacillin monohydrate equivalent to flucloxacillin 250mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection or infusion (Powder for injection or infusion). Flucloxacillin sodium is supplied as a white or almost white crystalline powder.
Therapeutic indications
Flucloxacillin is indicated for the treatment of infections due to penicillinase producing staphylococci and other gram positive organisms susceptible to this anti-infective (see Section 5.1). Indications ...
Posology and method of administration
The dosage depends on the severity and nature of the infection. Method of administration The usual routes of administration are by intramuscular injection, slow intravenous injection and intravenous infusion. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Flucloxacillin should not be given to patients with a history of hypersensitivity to β-lactam antibiotics (e.g. ...
Special warnings and precautions for use
Flucloxacillin should be given with caution to patients with a history of allergy, especially to drugs. Before initiating therapy with flucloxacillin, careful enquiry should be made concerning previous ...
Interaction with other medicinal products and other forms of interaction
<u>Other antibacterials:</u> Since bacteriostatic drugs such as chloramphenicol and tetracycline may interfere with the bactericidal effect of penicillins in the treatment of meningitis or in other situations ...
Pregnancy and lactation
Pregnancy There has been no evidence of a teratogenic effect in animals or untoward effect in humans. However, use in pregnancy should be reserved for essential cases. Breastfeeding Trace quantities of ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
<u>Blood and lymphatic system disorders:</u> Transient leucopenia, thrombocytopenia, haemolytic anaemia, agranulocytosis and neutropenia (which might have some immunological basis); prolongation of bleeding ...
Overdose
Symptoms With high parenteral doses of penicillins, neurotoxicity (e.g. convulsions, encephalopathy), blood disorders (e.g. neutropenia, haemolytic anaemia, prolongation of bleeding time, defective platelet ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta-lactamase resistant penicillins ATC code: J01CF05 There is evidence that the risk of flucloxacillin induced liver injury is increased in subjects carrying the HLA-B*5701 ...
Pharmacokinetic properties
Absorption After the intramuscular administration of a single 250 or 500mg dose of flucloxacillin to volunteers, mean peak concentrations of the drug in serum were approximately 10.5 and 16mg.l<sup>-1 ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to those included in other sections.
List of excipients
None.
Incompatibilities
Flucloxacillin may be administered in combination with other antibiotics including ampicillin to produce a wider spectrum of antibacterial activity. If used concurrently with an aminoglycoside the two ...
Shelf life
3 years. The unreconstituted dry powder is stable for 3 years. For the reconstituted solution, chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C. From a microbiological ...
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Flucloxacillin for Injection is supplied in Type II clear glass vials containing 250mg of flucloxacillin equivalent. The vials are closed with a Type I chlorobutyl rubber stopper, sealed with an aluminium ...
Special precautions for disposal and other handling
None.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Marketing authorization number(s)
PL 29831/0091
Date of first authorization / renewal of the authorization
Date of first authorisation: 30/10/1998 Date of latest renewal: 20/09/2008
Date of revision of the text
28 April 2021
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