Flucloxacillin 2000 mg powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUCLOXACILLIN SODIUM

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

J01CF05

INN (International Name):

FLUCLOXACILLIN SODIUM

Dosage:

2000 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

flucloxacillin

Authorization status:

Marketed

Authorization date:

2020-11-13

Patient Information leaflet

In Review Mock-up
In Review Mock-up

Summary of Product characteristics

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 (