Flucloxacillin 1000 mg powder for solution for injection or infusion

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

FLUCLOXACILLIN SODIUM

Disponibbli minn:

Esteve Pharmaceuticals GmbH

Kodiċi ATC:

J01CF; J01CF05

INN (Isem Internazzjonali):

FLUCLOXACILLIN SODIUM

Dożaġġ:

1000 milligram(s)

Għamla farmaċewtika:

Powder for solution for injection/infusion

Żona terapewtika:

Beta-lactamase resistant penicillins; flucloxacillin

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2019-08-13

Fuljett ta 'informazzjoni

May 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCLOXACILLIN 500MG AND 1000MG POWDER FOR SOLUTION FOR INJECTION OR
INFUSION
Flucloxacillin sodium
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.
The full name of this product is
FLUCLOXACILLIN 500 MG OR 1000MG , POWDER FOR SOLUTION FOR
INJECTION OR INFUSION
, but within the leaflet it will be referred to as
FLUCLOXACILLIN
.
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 is an antibiotic used to treat infections by killing
the bacteria that cause them. It belongs
to a group of antibiotics called “penicillins”.
Flucloxacillin is available in two strengths. Each vial contains 500mg
or 1000mg flucloxacillin
powder for reconstitution for injection.
Flucloxacillin is used for the treatment of a range of bacterial
infections including bone infections
(osteomyelitis) and infections within the lining of the heart
(endocarditis). Flucloxacillin can also be
used to prevent infections that can occur during major surgical
operations, such as heart
(cardiothoracic surgery) or bone, joint and muscle operations
(orthopaedic surgery).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FLUCLOXACILLIN
YOU SHOULD NOT BE GIVEN FLUCLOXACILLIN:
-
if you are allergic to flucloxacillin
-
if you are allergic to penicillins, cephalo

Karatteristiċi tal-prodott

Health Products Regulatory Authority
13 July 2023
CRN00DLLP
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 1000 mg powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1000 mg flucloxacillin as flucloxacillin sodium and
2 mmol sodium per vial.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion
Flucloxacillin sodium is supplied as a white or almost white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flucloxacillin is an isoxazolyl penicillin of the β-lactam group of
antibiotics which exerts a bactericidal effect upon many
Gram-positive organisms including β-lactamase-producing staphylococci
and streptococci.
Flucloxacillin is indicated for the treatment of the following
infections in adults and children caused by flucloxacillin-sensitive
gram positive organisms (see section 5.1.):
- Osteomyelitis
- Endocarditis
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated with, any of the
infections listed above.
Flucloxacillin may also be used in the peri-operative prophylaxis for
surgical procedures when appropriate, for example
cardiothoracic or orthopaedic surgery.
Consideration shouldbe 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.
The usual adult dosage (including the elderly) is as follows:
BY SLOW INTRAVENOUS INJECTION OR BY INFUSION: 250 mg to 1 g every six
hours. These doses may be doubled in severe
infections. Doses of up to 8 g daily divided in 3 to 4 divided doses
have been suggested for osteomyelitis; in endocarditis a
dose of 8 g daily in four divided doses in patients weighing up to 85
kg, and 12 g daily in 6 divided doses may be used in those
weighing more.
DURING SURGICAL PROPHYLAXIS, 1 to 2 g intravenously at induction of
anae