Cefepime PharmSol 1 g Powder for Solution for Injection/Infusion

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Disponible desde:

PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta

Código ATC:

J01DE01

Designación común internacional (DCI):

CEFEPIME 1 g

formulario farmacéutico:

SOLUTION FOR INJECTION/INFUSION

Composición:

CEFEPIME 1 g

tipo de receta:

POM

Área terapéutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Estado de Autorización:

Authorised

Fecha de autorización:

2023-10-05

Información para el usuario

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFEPIME PHARMSOL 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION
cefepime
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.
WHAT IS IN THIS LEAFLET
1. What Cefepime PharmSol is and what it is used for
2. What you need to know before you are given Cefepime PharmSol 3. How
Cefepime PharmSol
is given
4. Possible side effects
5. How to store Cefepime PharmSol
6. Contents of the pack and other information
1. WHAT CEFEPIME PHARMSOL IS AND WHAT IT IS USED FOR
Cefepime PharmSol contains the active substance cefepime, which
belongs to a group of medicines
called beta-lactam antibiotics.
These medicines work by killing bacteria or to prevent their growth.
Cefepime PharmSol can be used alone, as a drug of first choice, after
obtaining the results of the
test that evaluates if a bacteria is sensitive to the action of this
antibiotic (sensitivity test) or, if
necessary, can be used safely in combination with other antibiotics.
Cefepime PharmSol is indicated:
Cefepime PharmSol is indicated for the treatment of the severe
infections listed below caused by
cefepime susceptible pathogens
_In adults and children over 12 years of age and with a body weight of
≥ 40 kg:_
•
Pneumonia
•
Complicated urinary tract infections (including pyelonephritis)
•
Complicated intra-abdominal infections
•
Peritonitis associated with dialysis in patients on CAPD
_ _
_In adults:_
•
Acute biliary tract infections
_In children aged 2 months up to 12 years and with a body weight of
_

Ficha técnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Cefepime PharmSol 1 g Powder for Solution for Injection/Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cefepime dihydrochloride monohydrate, equivalent to
1 g of cefepime.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for Solution for Injection / Infusion
White to pale yellow powder.
Osmolality upon reconstitution: >700 - 1300 mOsm/kg
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefepime PharmSol is indicated for the treatment of the severe
infections listed below caused by
cefepime susceptible pathogens (see sections 4.4 and 5.1).
_In adults and children over 12 years of age and with a body weight of
≥ 40 kg:_
•
Pneumonia
•
Complicated urinary tract infections (including pyelonephritis)
•
Complicated intra-abdominal infections
•
Peritonitis associated with dialysis in patients on CAPD
_ _
_In adults:_
•
Acute biliary tract infections
_In children aged 2 months up to 12 years and with a body weight of
_≤ _40 kg:_
•
Pneumonia
•
Complicated urinary tract infections (including pyelonephritis)
•
Bacterial meningitis (see section 4.4)
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be
associated with, any of the infections listed above.
Cefepime may be used in the empirical treatment of adults, adolescents
and children aged 2 months
to 12 years with febrile neutropenia that is suspected to be due to a
bacterial infection. In patients
at
high
risk
of
severe
infections
(e.g.
patients
with
recent
bone
marrow
transplantation,
hypotension at presentation, underlying haematological malignancy, or
severe or prolonged
neutropenia), antimicrobial monotherapy may be inappropriate. No
sufficient data exist to support
the
efficacy
of
cefepime
monotherapy
in
such
patients.
A
combination
therapy
with
an
aminoglycoside or glycopeptide antibiotic may be advisable, taking
into consideration the patient's
individual risk profile.