Flucloxacillin Panpharma 250 mg, powder for solution for injection/infusion

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

FLUCLOXACILLIN

Disponible depuis:

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

Code ATC:

J01CF05

DCI (Dénomination commune internationale):

FLUCLOXACILLIN 250 mg

forme pharmaceutique:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

FLUCLOXACILLIN 250 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

ANTIBACTERIALS FOR SYSTEMIC USE

Statut de autorisation:

Authorised

Date de l'autorisation:

2018-08-24

Notice patient

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCLOXACILLIN PANPHARMA 250 MG, POWDER FOR SOLUTION FOR
INJECTION/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, 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 250 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 marrow infect

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flucloxacillin Panpharma 250 mg, powder for solution for
injection/infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg of flucloxacillin (equivalent to 272 mg of
flucloxacillin sodium).
Excipient with known effect: sodium: 0.55 mmol / vial.
Each 250 mg vial contains approximately 0.55 mmol sodium.
This medicine contains approximately 12.75 mg sodium per vial,
equivalent to 0.6375% of the
WHO recommended maximum daily intake of 2 g sodium for adult.
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 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.
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.