CEFEPIME KABI cefepime (as hydrochloride) 1 g powder for injection vial

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

cefepime hydrochloride monohydrate, Quantity: 1189.2 mg (Equivalent: cefepime, Qty 1 g)

可用日期:

Fresenius Kabi Australia Pty Ltd

INN（国际名称）:

Cefepime hydrochloride monohydrate

药物剂型:

Injection, powder for

组成:

Excipient Ingredients: arginine

给药途径:

Intramuscular, Intravenous

每包单位数:

50, 1, 10

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Adults: Cefepime Kabi is indicated in the treatment of the infections listed below when caused by susceptible bacteria.,- Lower respiratory tract infections, including pneumonia and bronchitis. - Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. - Skin and skin structure infections. - Intra-abdominal infections, including peritonitis and biliary tract infections. - Gynaecological infections. - Septicaemia. - Empiric treatment in febrile neutropenic patients (See PRECAUTIONS).,Cefepime Kabi is also indicated for surgical prophylaxis in patients undergoing intra-abdominal surgery. In this indication it is essential that metronidazole also be administered.,Paediatrics: Cefepime Kabi is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria: - Pneumonia. - Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. - Skin and skin structure infections. - Septicaemia. - Empiric treatment in febrile neutropenic patients (See PRECAUTIONS).,Culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. Empiric therapy with Cefepime Kabi may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.,Because of its broad spectrum of bactericidal activity against gram-positive and gram-negative bacteria, Cefepime Kabi can be used appropriately as monotherapy prior to identification of the causative organisms(s). In the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with Cefepime Kabi. In patients who are at risk of mixed aerobic-anaerobic infection, including infections in which Bacterioides fragilis may be present, concurrent initial therapy with an anti-anaerobic agent is recommended before the causative organism(s) is known.

產品總結:

Visual Identification: White to pale yellow powder; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

授权状态:

Licence status A

授权日期:

2015-09-07

资料单张

Feb, 2016
Filename: CefCMI290216-clean
Page 1 of 3
Change: Address change
CEFEPIME KABI
_Powder for Injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cefepime Kabi. It
does not contain all the available
information.
It does not take the place of talking
to your doctor and pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
Cefepime Kabi against the benefits
this medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT CEFEPIME KABI IS
USED FOR
Cefepime Kabi Powder for Injection
belongs to a group of antibiotics
called cephalosporins.
It is used to treat infections in
different parts of the body caused by
bacteria.
Cefepime Kabi is also used to
prevent infections before, during and
after surgery. It may be given before
surgery or if you have a lack of white
blood cells with fever.
It will not work against infections
caused by viruses such as colds or
the flu.
Cefepime Kabi Powder for Injection
is an injectable antibiotic used for
serious infections in adults caused
by bacteria:

in the lungs (pneumonia and
bronchitis),

in the kidney and bladder
(urinary tract infections),

in the skin,

inside the abdomen (peritonitis
and biliary tract infections),

in the womb or vagina, or

in the blood (septicaemia).
Cefepime Kabi Powder for Injection
is also used for serious infections in
children over 2 months of age
caused by bacteria:

in the lungs (pneumonia)

in the kidney and bladder
(urinary tract infections),

in the skin,

in the blood, or

if the child has a lack of white
blood cells with fever.
Your doctor may have prescribed
Cefepime Kabi for another reason.
Ask your doctor if you have any
questions about why Cefepime Kabi
has been prescribed for you.
BEFORE YOU ARE GIVEN
CEFEPIME KABI
_WHEN YOU MUST NOT BE _
_GIVEN IT _
_ _
YOU MUST NOT

产品特点

Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
CEFEPIME KABI Cefepime (as hydrochloride) 1g and 2g Powder for
Injection
1 NAME OF MEDICINE
Cefepime hydrochloride monohydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefepime Kabi Powder for Injection is a sterile powder for injection
available in 20 mL vials
containing cefepime hydrochloride monohydrate equivalent to 1 g or 2 g
cefepime.
For the list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Powder for Injection.
Cefepime hydrochloride monohydrate is a white to pale yellow powder.
It is highly soluble in
water.
Following reconstitution with Water for Injections, it is a pale
yellow to amber coloured
solution with a pH between 4.0 and 6.0.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Cefepime Kabi is indicated in the treatment of the infections listed
below when caused by
susceptible bacteria.
•
Lower respiratory tract infections, including pneumonia and
bronchitis.
•
Urinary tract infections, both complicated, including pyelonephritis,
and
uncomplicated infections.
•
Skin and skin structure infections.
•
Intra-abdominal infections, including peritonitis and biliary tract
infections.
•
Gynaecological infections.
•
Septicaemia.
Page 2 of 22
•
Empiric treatment in febrile neutropenic patients (See Section 4.4
Special Warnings
and Precautions for Use).
Cefepime Kabi is also indicated for surgical prophylaxis in patients
undergoing intra-
abdominal surgery. In this indication it is essential that
metronidazole also be administered.
Paediatrics
Cefepime Kabi is indicated in paediatric patients over 2 months of age
for the treatment of
the infections listed below when caused by susceptible bacteria:
•
Pneumonia
•
Urinary tract infections, both complicated, including pyelonephritis,
and
uncomplicated infections
•
Skin and skin structure infections
•
Septicaemia
•
Empiric treatment in febrile neutropenic patients (See Section 4.4
Special Warnings
and Precautions for Use)
Culture and susceptibility studies s