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CEFOTAXIME 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CEFOTAXIME SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Cefotaxime 500 mg powder for solution for injection
Cefotaxime 1 g powder for solution for injection or infusion
Cefotaxime

this medicine because it contains important information
for you.
- If you have any further questions, ask your doctor,
pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed

1. What Cefotaxime Injection is and what it is used for
2. What you need to know before you use Cefotaxime
Injection
3. How to use Cefotaxime Injection
4. Possible side effects
5. How to store Cefotaxime Injection
6. Contents of the pack and other information
1. WHAT CEFOTAXIME INJECTION IS AND WHAT IT IS
USED FOR
Cefotaxime Injection is an antibiotic belonging to a group
range of micro-organism. It is used for the treatment of a
range of serious bacterial infections of:
• the lungs (pneumonia)
• the urinary tract
• the membranes covering the brain (meningitis)
• the abdomen
• the skin and soft tissue
• the genitals with gonococci
• preoperative prophylaxis in colorectal surgery
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
CEFOTAXIME INJECTION
Do not use Cefotaxime Injection:
• if you are allergic (hypersensitive) to cefotaxime or any
other cephalosporins
• if you previously had acute and/or severe allergic
reactions to penicillin or any other beta-lactam antibiotic
If given as an injection into the muscle:
Your doctor may consider it necessary to inject this medicine
into a muscle. In this case, the doctor will add lidocaine to
the injection to make it less painful. However, this method of
administering the injection will not be suitable for everyone
and should not be given:
• to infants under 30 months
• if you are allergic (hypersensitive) to lidocaine or other
local anaesthetics of the amide type
• if you have irregular heartbeat
• if you have heart problems which can cause shortness of
breath or ankle swelling
• if you are receiving Cefotaxime Injection intravenously
(directly into your bloodstream)
Please inform your doctor if one of these applies to you so
that your doctor can decide on the form of application.
Warnings and precautions
Tell your doctor or healthcare professional if:
• you have ever had an allergic or hypersensitive reaction
to penicillin or other medicines from the penicillin family
(beta-lactam-antibiotics)
• experience skin reactions. Contact your doctor immediately
• you suffer from severe allergies or asthma
• you develop severe persistent (bloody) diarrhoea. You
caused by the use of cefotaxime. In that case, the use of
Cefotaxime Injection must be stopped immediately. Do
not take medicines that reduce bowel movements
• you have kidney problems
• you are on a low-sodium (low salt) diet

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If any of these apply to you, your doctor may want to change
your treatment or give you special advice.
Cefotaxime Injection may cause you to become infected
with organisms that are unsusceptible to antibiotics, so your
doctor will monitor your condition. If you become infected,
This medicine can alter the results of some blood and
urine tests. If you are having blood tests (such as Coombs’
test) or urinary sugar tests (the Fehling’s type which test
for reducing sugars) tell your doctor you are taking this
medicine as this medicine may cause false positive results.
Your doctor may decide to do tests on your blood if you are
given Cefotaxime Injection for longer than 7 days.
Other medicines and Cefotaxime Injection
Please tell your doctor or healthcare professional if you are
taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Concomitant intake of:
• other antibiotics (such as penicillins, aminoglycosides,
tetracyclines, erythromycin and chloramphenicol)
• diuretics (e.g. furosemide)
• probenecid (for the treatment of gout and arthritis) may
increase or decrease the effect of Cefotaxime Injection.
Inform your doctor if you are in treatment with these
medicines

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
If you are pregnant or are planning to become pregnant,
your doctor has to determine if a treatment with Cefotaxime
Injection is suitable for you.
Cefotaxime Injection excretes in breast milk in low
concentrations. Therefore it should not be used during
breast-feeding.
Driving and using machines
The effect of cefotaxime on the ability to drive and use
machines has not been investigated. However, this medicine
may cause impairment of consciousness, abnormal
movements and dizziness in some patients. If this happens,
do not drive or use machines.
Important information about some of the ingredients of
Cefotaxime Injection
This medicinal product contains 48 mg sodium per gram.
To be taken into consideration by patients on a controlled
sodium diet.
3. HOW TO USE CEFOTAXIME INJECTION
Cefotaxime Injection is normally given by a doctor or nurse.
You should check with your doctor or healthcare
professional if you are not sure.
Cefotaxime Injection should always be administered
intravenously (in a vein) or intra muscular (in a muscle). The
injection will always be administered by a doctor.
Dose, method of application and intervals between
injections depend on the sensitivity of the micro-organism,
the severity of your infection and your condition.
How much Cefotaxime Injection will be given?
Adults and adolescents (12 to 16-18 years) will usually
be given 1 g every 12 hours. In severe infections, this may
be increased up to 12 g per day, given in 3-4 doses. For
infections caused by sensitive Pseudomonas species, daily
doses of greater than 6 g will usually be required.

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Intravenous or
intramuscular
injection
Intravenous
infusion

Reconstitution solution

Water for Injections Ph. Eur.
Water for Injections Ph. Eur.
Sodium Chloride Injection BP
5% Dextrose Injection BP
Dextrose and Sodium Chloride
Injection BP
Sodium lactate Injection BP

Diluent required

Displacement volume

500 mg

1g

2 ml

4 ml

500 mg

1g

0.45 ml

0.9 ml

40-100 ml for 1-2 g of
Cefotaxime

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information
on the safety of this medicine.

Use in patients with kidney problems
If the condition of the kidneys is very poor (creatinine
clearance of ≤ 5 ml/min), your doctor will reduce the dosage
by half after you have received an initial normal dose.

5. HOW TO STORE CEFOTAXIME INJECTION

If you think you have been given too much Cefotaxime
Injection
This is not likely, as the injection is given to you by a doctor.
If you feel bad after administration of the injection, please
contact your doctor immediately.
If your doctor stops giving you Cefotaxime Injection
The doctor will continue treatment with Cefotaxime Injection
until the infection treated is relieved.

Client: Cox Pharmaceutical Ltd
Date: 17-12-15
Artwork Code: A326/UK/C
Version No: C
Artwork Ref: COX_Cefotaxime_500mg, 1g_PIL_A326-UK

Your doctor or pharmacist is responsible for storing
Cefotaxime Injection. They are also responsible for
disposing of any unused Cefotaxime Injection correctly.

Pack Type: PIL (Leaflet)
Dimensions: 210*400mm

Keep this medicine out of the sight and reach of
children.
Do not use Cefotaxime Injection after the expiry date which
is stated on the vial and carton after EXP. The expiry date
refers to the last day of that month.

PL No: 42671/0004/0005
Barcode: n/a

Like all medicines, Cefotaxime Injection can cause side
effects, although not everybody gets them.

Store the unopened vial below 25°C. Keep container in the
outer carton.
Once the powder has been dissolved, the solution should be
used immediately or stored at 2-8°C and discarded after 24
hours.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

Very common side effects (affects more than 1 user in 10):
• transient pain at the injection site

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Cutter:

What Cefotaxime Injection contains
The active substance in Cefotaxime Injection is cefotaxime
as the sodium salt. The total sodium (salt) content is
approximately 24 or 48 mg respectively.

Colour References:
PMS 1:

PMS 3:

1 vial Cefotaxime Injection, 0.5 g contains 0.524 g
cefotaxime sodium, corresponding to 500 mg cefotaxime.

PMS 2:

Black:

If you have any further questions on the use of this product,
ask your doctor.

Uncommon side effects (affects 1 to 10 users in 1,000):
• reduced amount of white blood cells or of blood platelets
• reactions called “Jarisch-Herxhemier” which includes
fever, shivering, headache and joint pain
• convulsions
• diarrhoea
• changes in liver values
• rash, itching and special skin rash named urticaria
• impaired kidney function
• fever

(thrombophlebitis)
Not known (frequency cannot be estimated from the
available data):
• infections with unsusceptible organisms
(“Superinfections”)
• decrease in the number of a type of white blood cells
(neutropenia)
• serious condition in which white blood cells decrease in
number or disappear altogether (Agranulocytosis)
• low levels of red blood cells (anaemia)
• anaphylactoid reactions (that may range from mild to
severe, including a sudden, generalised allergic reaction
that may lead to a life-threatening “anaphylactic” shock
pulse])
• severe allergic reactions as swelling of the face, throat,
and lips (angiooedema)
• bronchial spasms
• headache and dizziness
• brain disorders (e.g. impairment of consciousness,
abnormal movements)
• irregular heartbeat
• feeling sick, vomiting
• pain in the abdomen
• a serious bacterial infection of your gut known as
pseudomembranous colitis (including severe, persistent
or bloody diarrhoea associated with abdominal pain or fever)
• hepatitis, sometimes with jaundice
• serious skin conditions such as Steven-Johnsons
syndrome, erythema multiforme and toxic epidermal
necrolysis

• reactions to lidocaine if Cefotaxime Injection is given as a
injection into a muscle

Fonts: Arial
Min Font Point: Min point 9pt

Technical NON-Printed items:
Braille: n/a

1 vial Cefotaxime Injection, 1 g contains 1.048 g cefotaxime
sodium, corresponding to 1 g cefotaxime.
There are no other ingredients.
What Cefotaxime Injection looks like and contents of the pack
Cefotaxime Injection is a white to slightly yellow powder in a
colourless glass vial. It is supplied in 500 mg or 1 g vials with
1, 5, 10, 25 or 50 vials in a carton.
Not all pack sizes may be marketed
PL 42671/0004 - Cefotaxime 500 mg powder for solution for
injection
PL 42671/0005 - Cefotaxime 1 g powder for solution for
injection or infusion

bilton by design
Please check that the text, pantone colours and general layout are to your
satisfaction as Bilton By Design can accept no liability for any errors
overlooked once this artwork proof has been approved, signed and
returned. It is very important that all text and factual information is correct
at this stage. Client amendments not marked on this proof can be
expensice to impliment at the printers wet proof/chromalin stage.

Marketing Authorisation Holder:
Cox Pharmaceutical Ltd
788-790 Finchley Road
London NW11 7TJ, UK
Manufacturer:
IPG Pharma Ltd
Atrium Court
The Ring
Bracknell
RG12 1BW, UK
This lea et was last revised in December 2015

A326/UK/C

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Reconstitute with:
Water for Injections Ph. Eur.
Sodium Chloride Injection BP
5% Dextrose Injection BP
Dextrose and Sodium Chloride Injection BP
Sodium lactate Injection BP
Metronidazole Infusion (500 mg/100 ml)
1% lidocaine/lignocaine (freshly prepared)
The reconstituted solution should be clear, do not use the solution if particles are present.

Approval / Sign off by appointed representative
Verified by:

Product: Cefotaxime 500mg, 1g

Prepared injections should be used immediately.
Prepared infusion to be administered over 20-60 minutes.
Cefotaxime is for single patient use only, discard any unused solution.

Reconstitution:
From the calculated dose, determine the appropriate number of vials to be used. Add the recommended volume of
reconstitution solution and shake well until the contents of the vial have dissolved completely.
Route of administration

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed

Babies (0-27 days): The recommended dosage is 50 mg/
kg/day in 2-4 divided doses. In severe infections, doses of
up to 150-200 mg/kg/day may be required.

4. POSSIBLE SIDE EFFECTS

concomitant use of cefotaxime. Therefore during treatment
with Cefotaxime Injection additional contraceptive methods
should be used.

INFORMATION FOR THE DOCTOR
Cefotaxime 500 mg Injection and 1 g Injection or Infusion
INFORMATION FOR THE HEALTH CARE PROFESSIONAL

Children: The dose will depend on the size of your body;
the usual dose is 50-100 mg/kg/day in 2-4 divided doses. In
very severe infections, doses of up to 200 mg/kg/day may
be required.

Regulatory
approved by:

Commercial
approved by:

HA Approval Received by:
QA Approved by:

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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