Flucloxacillin Panpharma 500 mg, powder for solution for injection/infusion

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

FLUCLOXACILLIN

Disponible desde:

Panpharma Z.I. DU CLAIRAY, 35133 LUITRE, France

Código ATC:

J01CF05

Designación común internacional (DCI):

FLUCLOXACILLIN 500 mg

formulario farmacéutico:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composición:

FLUCLOXACILLIN 500 mg

tipo de receta:

POM

Área terapéutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Estado de Autorización:

Authorised

Fecha de autorización:

2018-08-24

Información para el usuario

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCLOXACILLIN PANPHARMA 500 MG, POWDER FOR SOLUTION FOR
INJECTION/INFUSION.
Flucloxacillin sodium monohydrate
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
The
full
name
of
this
product
is
Flucloxacillin
Panpharma
500
mg,
powder
for
solution
for
injection/infusion, but within the leaflet it will be referred to as
Flucloxacillin Panpharma.
WHAT IS IN THIS LEAFLET
1.
What
FLUCLOXACILLIN PANPHARMA
is and what it is used for
2.
What you need to know before you are given
FLUCLOXACILLIN PANPHARMA
3.
How
FLUCLOXACILLIN PANPHARMA
is given
4.
Possible side effects
5.
How to store
FLUCLOXACILLIN PANPHARMA
6.
Contents of the pack and other information
1.
WHAT FLUCLOXACILLIN PANPHARMA IS AND WHAT IT IS USED FOR
Flucloxacillin Panpharma 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.
Fluclocaxillin Panpharma is used for the treatment of infections such
as:
•
Skin and soft tissue infections, like abscesses, cellulitis
(inflammation of tissue below
the skin), infected burns, pustular dermatitis (impetigo)
•
Upper respiratory tract infections, like sore throat (pharyngitis,
tonsillitis), inflammation
of the sinuses (sinusitis)
•
Lower respiratory tract infections, like pneumonia, lung abscess,
bronchopneumonia
•
Bone and joint infections, like bone and bone mar

Ficha técnica

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Flucloxacillin Panpharma 500 mg, powder for solution for
injection/infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
vial
contains
500 mg
of
flucloxacillin (equivalent to 544 mg of flucloxacillin sodium
monohydrate).
Excipient with known effect: sodium 1.10 mmol/vial.
This medicine contains approximately 25.5 mg sodium per vial,
equivalent to 1.275 % of the WHO
recommended maximum daily intake of 2 g sodium for an adult.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
Flucloxacillin sodium monohydrate is supplied as a white or almost
white powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flucloxacillin Panpharma 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.
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In cases of severe infections: Up to 8 g per day administered in four
infusions (over 20 to 30 min).
No single bolus injection or infusion should exceed 2 g.
T