Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN SODIUM
Fresenius Kabi Deutschland GmbH
J01CF05
FLUCLOXACILLIN SODIUM
2000 milligram(s)
Powder for solution for injection/infusion
flucloxacillin
Marketed
2020-11-13
In Review Mock-up In Review Mock-up Lue koko asiakirja
Health Products Regulatory Authority 04 July 2023 CRN00DL0G Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 2000 mg powder for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 50 mL vial contains 2000 mg flucloxacillin (as flucloxacillin sodium). Excipientwithknowneffect: Each 2000 mg vial contains approximately 4.4 mmol sodium. This medicine contains approximately 102 mg sodium per vial, equivalent to 5.1 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion A fine white or almost white, hygroscopic, crystalline sterile powder for solution for injection/infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flucloxacillin is indicated for the treatment of the following infections due to beta-lactamase-producing staphylococci and other sensitive Gram-positive organisms such as streptococci (see section 4.2 and 5.1: Skin and soft tissue infections like abscesses, cellulitis, infected burns, impetigo Upper respiratory tract infections, like pharyngitis, tonsillitis, sinusitis Lower respiratory tract infections, like pneumonia, bronchopneumonia, pulmonary abscess Bone and joint infections like osteomyelitis and arthritis Endocarditis Prophylaxis in cardiovascular surgery (valve prostheses, artery prostheses) and in orthopedic surgery (arthroplasty, osteosynthesis and arthrotomy) Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage depends on age, weight and renal function of the patient, as well as the severity and nature of the infection. _Adults and adolescents at and over 12 years of age_ Total daily dosage of 1 g to 4 g, administered in three to four divided doses, by i.v. or i.m. injection. In cases of severe infections: Up to 8 g per day administered in four infusions ( Lue koko asiakirja