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Ceftriaxone sodium

Consumer Medicine Information (CMI)

                                         medicine has been prescribed for         tampering or after the expiry date
What is in this leaflet                  you.                                     printed on the pack.

This leaflet answers some common         Your doctor may have prescribed it       If you are not sure whether you
questions about ASPEN                    for another reason.                      should be given ASPEN
CEFTRIAXONE injection. It does                                                    CEFTRIAXONE, talk to your
not contain all the available            This medicine is available only with     doctor.
information. It does not take the        a doctor’s prescription.
place of talking to your doctor or                                                Before you are given it
pharmacist.                              There is no evidence that it is
                                                                                  Tell your doctor if:
All medicines have risks and
benefits. Your doctor has weighed
                                                                                   you have had an allergy or
the risks of you being given ASPEN
CEFTRIAXONE injection against                                                       over-reaction to lignocaine or
                                                                                    other anaesthetic drugs.
the benefits they expect it will have    Before you are given it
for you.
                                                                                     These substances may be used
If you have any concerns about           When you must not be given it               to dissolve ASPEN
being given this medicine, talk to                                                   CEFTRIAXONE prior to
your doctor or pharmacist.               You must not be given ASPEN                 injection.
                                         CEFTRIAXONE if you have had
Keep this leaflet with the               an allergic reaction to:                  you have allergies to any other
medicine.                                                                           medicines, foods,
                                          any medicine containing                  preservatives or dyes.
You may need to read it again.             ceftriaxone
                                          any other cephalosporin                 you are being treated with
                                           antibiotic.                              calcium-containing IV
                                         You must not be given ASPEN
                                         CEFTRIAXONE if you have had a             you have or have had any
What ASPEN                               serious allergic reaction to               medical conditions, including:
CEFTRIAXONE is used                      penicillin.
for                                                                                  - kidney disease
                                         Signs of an allergic reaction may           - stomach or bowel problems
                                         include shortness of breath,                - liver disease
ASPEN CEFTRIAXONE contains               wheezing or difficulty in breathing;        - bleeding problems
ceftriaxone (as ceftriaxone sodium)      swelling of the face, lips, tongue or
as the active ingredient.                other parts of the body; rash, itching    you are pregnant, intend to
                                         or hives on the skin.                      become pregnant, are breast-
ASPEN CEFTRIAXONE is an                                                             feeding or plan to breast feed.
antibiotic used to treat infections in   ASPEN CEFTRIAXONE and
different parts of the body caused       calcium-containing IV solutions             Your doctor will discuss the
by bacteria. It is also used to          must not be mixed or co-                    benefits and possible risks of
prevent infections before, during        administered to newborns                    being given this medicine during
and after surgery.                                                                   breastfeeding or pregnancy.
                                         because of the risk of forming a
                                         ceftriaxone-sodium salt.
ASPEN CEFTRIAXONE belongs to                                                      If you have not told your doctor
a group of antibiotics called                                                     about any of the above, tell them
cephalosporins. These antibiotics        ASPEN CEFTRIAXONE must not
                                         be given to preterm newborns or          before you start being given
work by killing the bacteria that are
                                         newborns with certain liver              ASPEN CEFTRIAXONE.
causing your infection or by
stopping bacteria from growing.          disorders.
                                                                                  Taking other medicines
Ask your doctor if you have any          You must not be given ASPEN
questions about why this                 CEFTRIAXONE if the packaging             Tell your doctor or pharmacist if
                                         is torn or shows signs of                you are taking any other

ASPEN CEFTRIAXONE (ceftriaxone sodium) – CMI                                                             Page 1 of 3
medicines, including any that you                                                   Tell your doctor if you get vaginal
buy without a prescription from          direct injection into a vein,             itching or discharge.
your pharmacy, supermarket or            slow infusion into a vein or
health food shop.                        deep injection into a large               This may mean you have a fungal
                                          muscle.                                   infection called thrush. Sometimes
Some medicines may be affected by                                                   the use of ASPEN CEFTRIAXONE
ASPEN CEFTRIAXONE or may                ASPEN CEFTRIAXONE must only                 allows fungi to grow and the above
affect how well it works.               be prepared and given by a doctor           symptoms to occur. ASPEN
                                        or nurse.                                   CEFTRIAXONE does not work
These include chloramphenicol, a                                                    against fungi.
medicine used to treat infections.      If you are given too much
You may need to be given different      (overdose)                                  Tell any other doctors, dentists
amounts of your medicine, or you                                                    and pharmacists who are treating
may need to be given different          As ASPEN CEFTRIAXONE is given               you that you are being given
medicines. Your doctor will advise      to you under the supervision of your        ASPEN CEFTRIAXONE,
you.                                    doctor, it is very unlikely that you will   especially if you are about to be
                                        receive too much.                           started on any new medicines.
Talk to your doctor about the
need for an additional method of        However, if you experience any              Tell your doctor immediately if
contraception while using ASPEN         side effects after being given              you become pregnant while you
CEFTRIAXONE.                            ASPEN CEFTRIAXONE, tell your                are being given ASPEN
                                        doctor immediately or call the              CEFTRIAXONE.
Some antibiotics may decrease the       Poisons Information Centre on 13
effectiveness of some birth control     11 26 (Australia) or 0800 POISON            If you have to test your urine for
pills.                                  or 0800 764 766 (New Zealand).              sugar while you are being given
                                                                                    ASPEN CEFTRIAXONE, make
Your doctor or pharmacist has more                                                  sure your doctor knows which
information on medicines to be                                                      type of test you use.
careful with or to avoid while being
given ASPEN CEFTRIAXONE.                                                            ASPEN CEFTRIAXONE may affect
                                        While you are being
                                                                                    the results of these tests.
                                        given it
                                                                                    Tell your doctor you are being
                                                                                    given ASPEN CEFTRIAXONE if
                                        Things you must do
How it is given                                                                     you have to have any blood tests.
                                        Tell your doctor if the symptoms
                                                                                    ASPEN CEFTRIAXONE may affect
How much is given                       of your infection do not improve
                                                                                    the results of some blood tests.
                                        within a few days or if they
Your doctor will decide what dose       become worse.
and how long you will receive                                                       Things to be careful of
ASPEN CEFTRIAXONE. This                 Tell your doctor, pharmacist or
depends on the infection being          nurse immediately if you get                Be careful driving or operating
treated and your response to the        severe diarrhoea. Do this even if           machinery until you know how
treatment.                              it occurs several weeks after               ASPEN CEFTRIAXONE affects
                                        ASPEN CEFTRIAXONE has been                  you.
For most infections, it is usually      stopped.
given once or twice a day.                                                          ASPEN CEFTRIAXONE may cause
                                        Diarrhoea may mean that you have            dizziness in some people. Make
Sometimes, only a single dose of        a serious condition affecting your          sure you know how you react to it
ASPEN CEFTRIAXONE is required           bowel. You may need urgent                  before you drive a car, operate
for the treatment and prevention of     medical care.                               machinery or do anything else that
certain infections. Otherwise, the                                                  may be dangerous.
length of treatment is usually          Do not take any diarrhoea
between 4 days and 2 weeks.             medicine without first checking             Side effects
                                        with your doctor.
How it is given
                                        Tell your doctor if you get a sore          Tell your doctor or nurse as soon
ASPEN CEFTRIAXONE is a sterile                                                      as possible if you do not feel well
                                        white mouth or tongue while
powder which is dissolved and                                                       while you are being treated with
diluted with suitable sterile fluids.   using or soon after stopping
                                        ASPEN CEFTRIAXONE.                          ASPEN CEFTRIAXONE.
It is given by:

ASPEN CEFTRIAXONE (ceftriaxone sodium) – CMI                                                            Page 2 of 3
This medicine helps most people                                               What it looks like
with infections, but it may have        skin rash, itching or hives
unwanted side effects in some           severe peeling or flaking of the     ASPEN CEFTRIAXONE is a white
people. All medicines can have side       skin                                to yellow powder in a glass vial with
effects. Sometimes they are             swelling of the face, lips or        a rubber stopper. The powder is
serious, most of the time they are        tongue which may cause              dissolved and diluted with suitable
not. You may need medical                 difficulty in swallowing or         sterile fluids before it is used.
treatment if you experience some of       breathing
the side effects.                        wheezing or shortness of breath     It is available in packs of 5 vials.
                                         swelling of the hands, feet or
Ask your doctor, nurse or                 ankles                              Ingredient
pharmacist to answer any                 bleeding or bruising more easily
questions you may have.                   than normal                         Each vial contains either 1 g or 2 g
                                         signs of frequent infections such   of ceftriaxone (as ceftriaxone
Tell your doctor or nurse if you          as fever, severe chills, sore       sodium). There are no other
notice any of the following side          throat or mouth ulcers              ingredients.
effects and they worry you:              signs of anaemia such as
                                          tiredness, being short of breath    ASPEN CEFTRIAXONE does not
 oral thrush – white, furry, sore        when exercising, looking pale       contain gluten, lactose, sucrose,
  tongue and mouth                       yellowing of the skin or eyes       tartrazine or any other azo dyes.
 vaginal thrush – sore and itchy        fast or irregular heart beat
  vagina sometimes with a white          passing less urine than is normal
  discharge                              blood in the urine.
 pain or swelling at the injection
  site                                 These are serious side effects. You    Sponsor
 mild diarrhoea                       may need medical attention.
 nausea (feeling sick) or vomiting    Serious side effects are rare.
                                                                              In Australia:
 headache or dizziness
 taste disturbances                   Tell your doctor if you notice
                                                                              Aspen Pharmacare Australia Pty Ltd
 fever, sweating                      anything else that is making you
                                                                              34-36 Chandos St
 stomach pain or discomfort           feel unwell, even if you think the
                                                                              St Leonards NSW 2065
 wind                                 problems are not connected with
 indigestion.                         this medicine and are not referred     In New Zealand:
                                       to in this leaflet.
Tell your doctor immediately if                                               Pharmacy Retailing (NZ) Limited
you notice any of the following,       Other side effects not listed above    Trading as Healthcare Logistics
particularly if they occur several     may also occur in some patients.       58 Richard Pearse Drive
weeks after stopping treatment                                                Airport Oaks Auckland
                                       Do not be alarmed by this list of
                                       possible side effects.                 Australian Registration Numbers:
 severe abdominal cramps or
                                       You may not experience any of          1 g: AUST R 148218
  stomach cramps
                                       them.                                  2 g: AUST R 148223
 watery and severe diarrhoea
  which may also be bloody
                                                                              This leaflet was prepared in August
 fever, in combination with one or    After using it                         2011.
  both of the above.

Do not take any diarrhoea              Storage
medicine without first checking
with your doctor.                      ASPEN CEFTRIAXONE will be
                                       stored in the pharmacy or on the
                                       ward. The powder for injection is
These are rare but serious side
                                       kept in a cool dry place, protected
effects. You may have a serious
                                       from light, where the temperature
condition affecting your bowel,
                                       stays below 25⁰C.
requiring urgent medical attention.

Tell your doctor immediately or
go to Accident and Emergency at
your nearest hospital if you
notice any of the following            Product Description

ASPEN CEFTRIAXONE (ceftriaxone sodium) – CMI                                                         Page 3 of 3

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