Flucloxacillin 250 mg Powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUCLOXACILLIN SODIUM

Available from:

Ibigen Srl

ATC code:

J01CF; J01CF05

INN (International Name):

FLUCLOXACILLIN SODIUM

Dosage:

250 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Beta-lactamase resistant penicillins; flucloxacillin

Authorization status:

Marketed

Authorization date:

2016-08-26

Patient Information leaflet

PIL_Flucloxacillin Inj_Inf_IE_Ver
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCLOXACILLIN 250 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
FLUCLOXACILLIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
FLUCLOXACILLIN 1000 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
FLUCLOXACILLIN 2000 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
Flucloxacillin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Flucloxacillin is and what it is used for
2.
What you need to know before you use Flucloxacillin
3.
How to use Flucloxacillin
4.
Possible side effects
5.
How to store Flucloxacillin
6.
Contents of the pack and other information
1.
WHAT FLUCLOXACILLIN IS AND WHAT IT IS USED FOR
Flucloxacillin powder for solution for injection/infusion contains the
active substance flucloxacillin.
Flucloxacillin is an antibiotic belonging to a class of antibiotics
called beta-lactamase resistant
penicillins. Flucloxacillin works by killing bacteria that cause
infections. It only works on specific
types of bacteria.
Flucloxacillin is used to treat infections such as:
•
Skin and soft tissue infections: abscesses, cellulites (inflammation
of tissue below the skin)
•
Respiratory tract infections: pneumonia, lung abscess,
bronchopneumonia
•
Bone and joint infections: bone and bone marrow infections
(osteomyelitis), arthritis
•
Inflammation of the lining of the heart and its valves (endocarditis)
Flucloxacillin is also indicated for prophylaxis in cardiovascular
surgery (valve prostheses, artery
prostheses) and in or

Summary of Product characteristics

Health Products Regulatory Authority
28 July 2023
CRN00DNY4
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 250 mg Powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg flucloxacillin (as flucloxacillin sodium
monohydrate).
Excipient with known effect
Each 250 mg vial contains 0.55 mmol (13 mg) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion
White to off-white powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flucloxacillin is indicated for the treatment of the following
infections when caused by susceptible organisms, in particular
Staphylococcus aureus (see sections 4.2 and 5.1):
● Skin and soft tissue infections: abscesses, cellulitis
●Respiratory tract infections: lung abscess, pneumonia,
bronchopneumonia
●Bone and joint infections: arthritis, osteomyelitis
●Endocarditis
Flucloxacillin is also indicated for prophylaxis in cardiovascular
surgery (valve prostheses, artery prostheses) and in orthopedic
surgery (arthroplasty, osteosynthesis and arthrotomy) because of the
dominant pathogenic potential of staphylococci during
such surgical procedures.
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 the patient's age, weight and kidney function as
well as the severity and type of infection.
_ _
_Adults and adolescents 12 years and older _
Standard dose: total daily dosage of 1g – 4 g administered in three
to four divided doses, by intravenous or intramuscular
injection.
In cases of severe infections: up to 8 g daily in the form of four
infusions (over 20 to 30 min).
The maximum dose of 12 g per day should not be exceeded.
Methicillin-susceptible _Staphylococcus aureus. _
Endocarditis: 2 g of flucloxacillin every 6 h, increasing to 2 g every
4 h in patients
weighing >85 kg.
Health Products Regulato