Floxapen 500 mg Powder for Solution for Injection or Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flucloxacillin

Available from:

Actavis Group hf

ATC code:

J01CF; J01CF05

INN (International Name):

Flucloxacillin

Dosage:

500 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:

1979-01-18

Patient Information leaflet

Floxapen 250 mg Powder for solution for Injection for Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
FLOXAPEN 250 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION
FLOXAPEN 500 MG POWDER FOR SOLUTION FOR INJECTION OR 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 only. 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 Floxapen is and what it is used for
2. What you need to know before you use Floxapen
3. How to use Floxapen
4. Possible side effects
5. How to store Floxapen
6. Contents of the pack and other information
1.
WHAT FLOXAPEN IS AND WHAT IT IS USED FOR
Floxapen is an antibiotic used to treat infections by killing the
bacteria that cause them. It belongs
to a group of antibiotics called “penicillins”.
Floxapen is used to treat a wide range of infections caused by
bacteria including the following:

chest infections

throat or nose infections

ear infections

skin and soft tissue infections

heart infections

bone and joint infections

meningitis

infections of the blood

digestive system infections

kidney, bladder or urethra (the tube which carries urine from the
bladder) infections
Floxapen can also be used to prevent infections following major
surgical procedures, particularly
in heart or orthopaedic surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FLOXAPEN
DO NOT USE FLOXAPEN
- if you are allergic to flucloxacillin or any of the other
ingredients of this medicine (listed in
section 6)
Floxapen 250 mg Powder for solution for Injection for Infusion
- if you have had an allergi

Summary of Product characteristics

Health Products Regulatory Authority
22 March 2021
CRN00C6JK
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Floxapen 500 mg Powder for Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg flucloxacillin (as flucloxacillin sodium).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion
A fine white homogeneous sterile powder for solution for injection,
infusion or nebuliser solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Floxapen is indicated for the treatment of infections due to
β-lactamase-producing staphylococci and other sensitive
Gram-positive organisms such as streptococci (see section 5.1 for
details on sensitive strains). Typical indications include:
_Skin and soft tissue infections:_
- Boils, abscesses,carbuncles,furunculosis, cellulites, infected
burns, infected wounds, impetigo, protection for skin grafts,
infected skin conditions e.g. ulcer, eczema, and acne
_Respiratory tract infections:_
- Pneumonia, lung abscess, sinusitis, tonsillitis, quinsy,
pharyngitis, empyema, otitis media and externa
_Other infections caused by Floxapen-sensitive organisms:_
- Osteomyelitis, arthritis, urinary tract infection, small intestine
and colon infection, meningitis, endocarditis, septicaemia
Floxapen 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 age, weight and renal function of the patient,
as well asthe severity and nature of the infection.
For instructions on the preparation of solution see section 6.6. For
incompatibilities see section 6.2.
Intramuscular or intravenous
_A