Cefepime AptaPharma 2 g powder for solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia

ATC code:

J01DE01

INN (International Name):

CEFEPIME 2 g

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Composition:

CEFEPIME 2 g

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-03-27

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFEPIME APTAPHARMA 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION
CEFEPIME APTAPHARMA 2 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.
-
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.
WHAT IS IN THIS LEAFLET
1.
WhatCefepime AptaPharma is and what it is used for
2.
What you need to know before you are givenCefepime AptaPharma
3.
How to useCefepime AptaPharma
4.
Possible side effects
5.
How to storeCefepime AptaPharma
6.
Contents on the pack and other information
1.
WHAT CEFEPIME APTAPHARMA IS AND WHAT IT IS USED FOR
Cefepime AptaPharma is an antibiotic in the cephalosporin group of
beta-lactam antibiotics.
This medicine is prescribed in the treatment of certain bacterial
infections caused by microbes
susceptible to cefepime.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFEPIME APTAPHARMA
YOU MUST NOT BE GIVEN CEFEPIME APTAPHARMA:
if you are allergic to cefepime, other cephalosporins or other
beta-lactam antibiotics
(eg. penicillins, monobactams and carbapenems) or arginine (referred
to in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Cefepime
AptaPharma.
Special precautions
ENCEPHALOPATHY (DISEASE OF THE BRAIN)
Using this medicine may result in a risk of encephalopathy (confusion,
altered consciousness,
seizures or abnormal movements). If any of these signs occur, inform
your doctor, pharmacist
or nurse immediately. This is more likely in the case of overdose or
improper adjustment of the
dosage in patients with kidney problems (see sections 3 and 4).
ALLERGIC REACTIONS
1
Any symptoms of allergies (rash, itching, etc.) during treatment must
be immediately r

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Cefepime AptaPharma 1 g powder for solution for injection/infusion
Cefepime AptaPharma 2 g powder for solution for injection/infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Cefepime AptaPharma 1 g powder for solution for injection/infusion_
Each vial contains 1.19 g cefepime dihydrochloride monohydrate
corresponding to 1.0 g of cefepime.
_Cefepime AptaPharma 2 g powder for solution for injection/infusion_
Each vial contains 2.38 g cefepime dihydrochloride monohydrate
corresponding to 2.0 g of cefepime.
3. PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to off-white crystalline powder.
After reconstitution the solution has a pH between 4.2 and 5.2 and
osmolality between 383
and 389 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefepime AptaPharma is indicated for the treatment of infections
listed below caused by
cefepime-susceptible pathogens (see sections 4.4 and 5.1).
Adults and adolescents above 12 years of age > 40 kg:
Treatment of patients suffering from bacteraemia in combination or
potentially in combination with
one of the infections listed below:
community-acquired lower respiratory tract infections and severe
pneumonia,
complicated and uncomplicated urinary tract infections,
febrile episodes in neutropaenic patients. In the empirical treatment
of patients with febrile
neutropaenia: Cefepime monotherapy is indicated for the empirical
treatment of patients with
febrile neutropaenia. In patients with a high risk of severe infection
(e.g. patients who have
recently undergone a bone marrow transplantation, patients with
hypotension, haematological
malignancies, or severe or prolonged neutropaenia), antibiotic
monotherapy may not be
appropriate. There are insufficient data to support the efficacy of
cefepime monotherapy in
these patients. (see section 5.1.).
biliary tract infections.
Children aged 2 months up to 12 years ≤ 40 kg:
febrile episodes during neutropaenia when the predicted duration of
t