CEFUROXIME SXP cefuroxime (as sodium) 1500 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefuroxime sodium, Quantity: 1577.7 mg (Equivalent: cefuroxime, Qty 1500 mg)

Available from:

Southern XP IP Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intramuscular, Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CEFUROXIME SXP is indicated in adults and children of 40 kg or greater in weight for the prevention of infections associated with certain surgical procedures of the gastrointestinal (including oesophageal), orthopaedic, cardiovascular and gynaecological systems (including caesarean section) (see SECTION 4.4: SPECIAL WARNINGS AND PRECAUTIONS FOR USE and SECTION 5.2: PHARMACOKINETIC PROPERTIES).,In the prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents such as metronidazole.,Consideration should be given to official guidance on the appropriate use of antibacterial agents, as antibiotic prophylaxis is not required in all gastrointestinal, orthopaedic, cardiovascular and gynaecological procedures or surgeries.,For patients with specific cardiac conditions which predispose them to endocarditis who are undergoing abdominal surgery for which surgical antibiotic prophylaxis is indicated, the prophylaxis regimen should additionally include an antibiotic active against enterococci.,For patients undergoing orthopedic or cardiovascular surgery known to be, or at risk of being, colonised or infected with methicillin-resistant S. aureus (MRSA), add an antibiotic with activity against MRSA, such as vancomycin.,CEFUROXIME SXP is not indicated in children less than 40 kg in weight.

Product summary:

Visual Identification: White or almost white to yellowish powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-11-14

Patient Information leaflet

CEFUROXIME SXP
1
CEFUROXIME SXP
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN CEFUROXIME SXP?
CEFUROXIME SXP contains the active ingredient cefuroxime sodium.
CEFUROXIME SXP is used to prevent infections during surgery.
For more information, see Section 1. Why am I being given CEFUROXIME
SXP? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN CEFUROXIME SXP?
You should not be given CEFUROXIME SXP if you have ever had an
allergic reaction to cefuroxime sodium, penicillins, other
beta-lactams or any other cephalosporin antibiotics.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given CEFUROXIME SXP? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CEFUROXIME SXP and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW AM I GIVEN CEFUROXIME SXP?
•
CEFUROXIME SXP_ _can be given in two ways: as an injection into a vein
or as a drip (intravenous infusion).
•
CEFUROXIME SXP must only be given by a doctor or a nurse.
•
Your doctor will decide on the dose and length of time that you will
receive CEFUROXIME SXP.
More instructions can be found in Section 4. How am I given CEFUROXIME
SXP? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN CEFUROXIME SXP?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are being
given CEFUROXIME SXP.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are being given CEFUROXIME SXP.
•
If you become pregnant while being given this medicine, tell your
doctor immediately.
•
If you are about to have any blood tests, tell your doctor that you
are being given this medicine.
•
Tel

Summary of Product characteristics

Australian PI, version 22062021
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
CEFUROXIME SXP (CEFUROXIME SODIUM) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Cefuroxime sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 750 mg or 1.5 g cefuroxime as cefuroxime sodium.
STRENGTH
AMOUNT OF SODIUM PER VIAL
750 mg
40.65 mg (1.77 mmol)
1.5 g
81.45 mg (3.54 mmol)
For the full list of excipients, see S
ECTION
6.1
L
IST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Powder for injection.
White or almost white to yellowish powder.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC
I
NDICATIONS
_CEFUROXIME SXP_ is indicated in adults and children of 40 kg or
greater in weight for the
prevention of infections associated with certain surgical procedures
of the gastrointestinal
(including oesophageal), orthopaedic, cardiovascular and
gynaecological systems (including
caesarean section) (see SECTION 4.4: SPECIAL WARNINGS AND PRECAUTIONS
FOR
USE and SECTION 5.2: PHARMACOKINETIC PROPERTIES).
In the prevention of infections in which it is very likely that
anaerobic organisms will be
encountered, cefuroxime should be administered with additional
appropriate antibacterial
agents such as metronidazole.
Australian PI, version 22062021
Page 2 of 20
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents,
as
antibiotic
prophylaxis
is
not
required
in
all
gastrointestinal,
orthopaedic,
cardiovascular and gynaecological procedures or surgeries.
For patients with specific cardiac conditions which predispose them to
endocarditis who are
undergoing abdominal surgery for which surgical antibiotic prophylaxis
is indicated, the
prophylaxis regimen should additionally include an antibiotic active
against enterococci.
For patients undergoing orthopaedic or cardiovascular surgery known to
be, or at risk of being,
colonised or infected with methicillin-resistant _ S. aureus_ (MRSA),
add an antibiotic with
activity against MRSA, such as vancomycin.
Cefuroxime SXP is not indicated in children < 40 kg in weight.
4.2