Floxapen 2000 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 PTC ehf

ATC code:

J01CF; J01CF05

INN (International Name):

Flucloxacillin

Dosage:

2000 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:

2012-08-03

Patient Information leaflet

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1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLOXAPEN 1000 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION
FLOXAPEN 2000 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
include 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 belonging to a class of antibiotics called
beta-lactamase resistant penicillins.
The active substance is flucloxacillin. Flucloxacillin works by
killing bacteria that cause infection. It
only works with specific strains of bacteria.
Floxapen 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
-
Bone and joint infections
-
bone and bone marrow infections (osteomyelitis)
-
arthritis
-
Inflammation of the lining of the heart and its valves (endocarditis).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FLOXAPEN
DO NOT USE FLOXAPEN:
-
if you are allergic to flucloxacillin or other beta-lactam antibiotics
(e.g. penicillins,
cephalosporins), or any of the other ingredients of this medicine
(listed in section 6)
-
if you have previous history of liver problems from taking
flucloxacillin.
WARNINGS AND PRECAUTIONS
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2
Talk to your doctor or pharmacist before taking Floxap

Summary of Product characteristics

Health Products Regulatory Authority
15 April 2021
CRN00C640
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Floxapen 2000 mg powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 2000 mg flucloxacillin (as flucloxacillin sodium).
Each 2000 mg vial contains approximately 4.4 mmol (102 mg) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
White to off-white powder for solution for injection or infusion.
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_
Lower respiratory tract infections: lung abscess, pneumonia.
_Bone and joint infections_
Arthritis, osteomyelitis.
Endocarditis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults and adolescents over 12 years of age:_
Total daily dosage of 1 g – 6 g administered in 3-6 divided doses,
by i.v. or i.m. injection.
In cases of severe infections: Up to 8 g per day administered in three
to four infusions (over 20 to 30 min).
No intramuscular single bolus injection should exceed 2 g.
The maximum dose of 12 g per day should not be exceeded.
Paediatric population
_Children under 12 years of age_
25 to 50 mg/kg/24 hours administered in three to four equally divided
doses by i.m. or i.v. injection.
In cases of severe infections: Up to 100 mg/kg/24 hours in three to
four divided doses.
Health Products Regulatory Authority
15 April 2021
CRN00C640
Page 2 of 8
No single bolus injection or infusion should exceed 33 mg/kg.
Children aged 10 to 14 years usually receive a daily dose of 1.5 g to
2 g and children aged 6 to 10 years 0.75 g to 1.5 g, divided
int