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CEFTRIAXONE 250MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFTRIAXONE SODIUM

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Cefotaxime Sodium for Injection 500mg, 1g
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or your pharmacist.








In this leaflet:
1. What Cefotaxime Injection is and what it is used for.
2. Before you are given Cefotaxime Injection.
3. How Cefotaxime Injection is given.
4. Possible side effects.
5. How to store Cefotaxime Injection
6. Further information.

The name of your medicine is “Cefotaxime sodium for injection”
(referred to as Cefotaxime Injection throughout this leaflet).
1. WHAT CEFOTAXIME INJECTION IS AND WHAT IT IS USED FOR
Cefotaxime is an antibiotic. It belongs to a group of antibiotics that
are called cephalosporins. These types of antibiotic are similar to
penicillin.
Cefotaxime kills bacteria and it can be used to treat infections of the:

• Kidneys and bladder

• Blood (septicaemia)

• Skin and flesh immediately under the skin

• Bones

• Heart valves

• Brain (meningitis)

• Abdomen (peritonitis)

• Some sexually transmitted infections (gonorrhoea)
It can also be used to prevent and treat infections following surgical
operations.
2. BEFORE YOU ARE GIVEN CEFOTAXIME INJECTION
You should not be given Cefotaxime injection if:
• you are allergic (hypersensitive) to cefotaxime
• you are allergic to any similar antibiotics (known as “cephalosporins”)
• you have ever had a serious allergic reaction when given penicillin
or similar antibiotics
• you are allergic to lidocaine
Tell your doctor or nurse if any of the above apply to you.
Before you are given Cefotaxime injection
You must tell the doctor or nurse if any of the following apply to you:
• you have a history of allergies or asthma
• you are on a low sodium diet
• you have a heart or kidney disorder
• you are having any blood or urine tests
• you have a history of gastro-intestinal problems e.g. colitis, which
causes diarrhoea containing blood.

Taking other medicines
Tell the doctor or nurse if you are taking any of the following medicines:
• the contraceptive pill (in which case you will need to take extra
contraceptive precautions such as using a condom)
• any diuretic medicine (“water tablets”) e.g. furosemide
• another antibiotic e.g. chloramphenicol or aminoglycoside
antibiotics
• probenecid (for gout)
Please tell your doctor if you are taking, or have recently taken, any
other medicines including any that you may have bought without a
prescription.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant or are breastfeeding, you
must tell your doctor before you are given this medicine.
Driving and using machines
If you are given high doses of cefotaxime, you may feel dizzy/drowsy or
fall asleep or experience convulsions (fits) or unusual body movements.
If this happens, you should not drive or operate machinery.
Important information about some of the ingredients of Cefotaxime
injection
Cefotaxime Injection contains approximately 50mg (2.2 mmol)
of sodium per 1g dose. This should be taken into consideration by
patients on a controlled sodium diet. Tell your doctor or nurse if you
are on a low sodium diet.
3. HOW CEFOTAXIME INJECTION IS GIVEN
Cefotaxime Injection is supplied as a powder so before it can be
given it must be diluted and made into a solution. Your doctor or
nurse normally does this. They will inject this directly into a vein
(intravenous) or muscle (intramuscular). It may also be given by an
intravenous infusion (“drip”).
Your doctor will decide how much you need and how often the
injections should be given.
The usual doses are given below but doctors may prescribe different
doses depending on the severity and type of your infection, your
weight, your age and how well your kidneys are working.

Cefotaxime Sodium for Injection
500mg, 1g

PACKAGE LEAFLET: INFORMATION FOR THE USER

Treatment with Cefotaxime injection is usually continued for
2-3 days after you start to recover from your illness or after your
operation.

Cefotaxime Sodium for Injection
500mg, 1g

Adults and children over 12 years old:
The usual dose is 1 g every twelve hours. In some patients where
infections are severe, the doctor may give a higher dose up to 12g
every day.
For the treatment of gonorrhoea, a single 500mg dose is usually given.
To prevent an infection after surgery, 1 -2 g is given before the
operation. A second dose may be needed after the operation.

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INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical
or healthcare professionals only.
Storage precautions:
Unopened vial: Do not store above 25°C. Keep container in the
outer carton.
Following reconstitution: 2°C - 8°C.
Instructions for use and handling
Following reconstitution: Cefotaxime sodium is compatible with the
following diluents:
Water for Injections
Sodium Chloride 0.9%
Dextrose 5 and 10%
Ringer’s Solution
Ringer-Lactate Solution
Lidocaine 1% (only freshly prepared solutions should be used)
Chemical and physical in-use stability has been demonstrated for 24
hours at 2°C-8°C. However, from a microbiological point of view, the
product should be used immediately. If not used immediately, in-use
storage times and conditions prior to use are the responsibility of the
user and should not exceed 24 hours at 2°C-8°C.
After 24 hours any unused solution should be discarded.
Preparation and administration of Cefotaxime Injection
Cefotaxime
(as Cefotaxime sodium)
per vial
500mg
1g

Diluent to be
added

Final
concentration
of solution

2ml
4ml

500mg/ 2.2ml
1g/ 4.4ml

Intravenous Injection
Cefotaxime Sodium for Injection 500mg is dissolved in at least 2 ml
water for injections, Cefotaxime Sodium for Injection 1 g in at least 4 ml
and subsequently injected directly into the vein over 3 to 5 minutes
or after clamping of the infusion tube into the distal end of the tube.
During post-marketing surveillance, potentially life-threatening
arrhythmia has been reported in a very few patients who received
rapid intravenous administration of cefotaxime through a central
venous catheter.
Intravenous Infusion
For brief infusion 2g of Cefotaxime Sodium for Injection is dissolved
in 100 ml of isotonic sodium chloride or glucose solution and
subsequently IV infused over 50 to 60 minutes. Another compatible
infusion solution can also be used for the solution.

Intramuscular Injection
For intramuscular injection. Cefotaxime Sodium for Injection 500mg
is dissolved in 2 ml and Cefotaxime Sodium for Injection 1 g in 4 ml
water for injections respectively. Afterwards the injection should take
place deep into the gluteal muscle. Pain with the IM injection can
be avoided by dissolving Cefotaxime Sodium for Injection 500mg
in 2ml or Cefotaxime Sodium for Injection 1 g in 4 ml 1% lidocaine
solution. An intravascular injection is to be avoided in this case, since
with intravascular administration lidocaine may lead to unrest,
tachycardia, disturbances of cardiac conduction as well as vomiting
and cramp. Cefotaxime reconstituted with lidocaine should not be
administered in children under 30 months.
It is recommended that no more than 4 ml be injected unilaterally. If
the daily dose exceeds 2 g Cefotaxime or if Cefotaxime is injected
more frequently than twice per day, the IV route is recommended.
Combination Therapy
Combination therapy of Cefotaxime with aminoglycosides is
indicated without availability of an antibiogram in the case of severe,
life-threatening infections. Kidney function must be watched in such
combination usage.
Cefotaxime and aminoglycosides should not be mixed in the same
syringe or infusion fluid.
In cases of infections with Pseudomonas aeruginosa combination
with other antibiotics effective against Pseudomonas can also be
indicated.
For infection prophylaxis (peri-operative prophylaxis in surgical
procedures such as colorectal, gastrointestinal, prostatic, urogenital,
obstetric and gynaecological surgery) in patients with weakened
defence mechanisms, combination can also be indicated with other
suitable antibiotics.
Posology
Cefotaxime sodium may be administered intravenously, by bolus
injection or infusion, or intramuscularly. The dosage, route and
frequency of administration should be determined by the severity of
infection, the sensitivity of causative organisms and condition of the
patient. Therapy may be initiated before the results of sensitivity tests
are known.
The clinician should consult published protocols for information
on dosage regimens in specific conditions such as gonorrhoea,
Pseudomonas infections and CNS infections.
Dosage and type of administration depend on the severity of the
infection, the sensitivity of the bacterium and the condition of the
patient.
The duration of the treatment depends on the course of the disease. As
a general rule Cefotaxime is administered for a further 3 to 4 days after
improvement/regression of the symptoms.

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Infants and children up to 12 years old:
The usual daily dose is 50 mg to 100 mg Cefotaxime per kilogram of
their bodyweight. This is usually split into 2 doses each day. Severely
ill children may receive up to 200 mg per kg bodyweight daily (to a
maximum of 6 g daily), split into 3 separate doses.
Young babies (newborn):
The daily dose should not normally exceed 50 mg Cefotaxime per kg
of their bodyweight.
Patients with kidney problems:
Lower doses may be given if you have severe kidney problems.
Patients on dialysis machines will be monitored for the correct dose.
If you think you have missed an injection
This is unlikely as you will probably receive this medicine in hospital. If
you think you have missed a dose, speak to your doctor or nurse.

If you have been given more of this medicine than you should
This is unlikely to happen but if it does, the doctor will treat any
symptoms that follow.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Cefotaxime Injection can cause side effects,
although not everybody gets them.
As with other antibiotics, some people find they have an allergy to it. Tell
your doctor immediately if any of the following rare symptoms occur:
• Sudden wheeziness and tightness of chest
• Swelling of eyelids, face, lips or throat
• Skin lumps or “hives” (nettle rash)
• Severe skin rashes with itching
• Serious illness with blistering of the skin, mouth, eyes and genitals
• Loss of consciousness, abnormal movements or convulsions (fits)
Antibiotic treatment can affect the normal bacteria in the
gut, causing new infection (colitis). You should tell your doctor
immediately if you develop diarrhoea.
The following side effects may occur in some patients treated with
Cefotaxime injection. Tell your doctor if any become troublesome:
Very common side effects (probably affecting more than 1 in 10 people)
• pain at the injection site
Uncommon side effects (probably affecting less than 1 in 100 patients)
• reduction in blood platelets which increases risk of bruising or
bleeding
• reduction in number of white blood cells which makes infections
more likely
• increase in number of white blood cells
• fever
• increase in liver enzymes and/or bilirubin
• kidney problems
• skin rash, itching, ‘hives’ (nettle rash)
• difficulty breathing
• convulsions (fits)
• diarrhoea
• redness and swelling at injection site

Side effects occurring with unknown frequency
• secondary infections
• serious allergic reactions which may cause difficulty in breathing or
dizziness
• serious allergic reaction which causes swelling of the face or throat
• difficulty in breathing or wheezing
• headache
• dizziness
• loss of consciousness, abnormal movements
• feeling sick (nausea)
• being sick (vomiting)
• stomach pains
• diarrhoea containing blood
• inflammation of the liver (hepatitis)
• skin and whites of the eyes turn yellow (jaundice)
• painful joints
• irregular heart rhythm
• inflammation of the kidneys which may cause dark discolouration
of urine, cloudy/bloody urine, or any change in your urine output.
Treatment with high doses of Cefotaxime, particularly in patients with
kidney problems, has been known to cause loss of consciousness,
abnormal movements and convulsions (“fits”).
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 in
this leaflet. You can also report side effects directly via the 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.
5. HOW TO STORE CEFOTAXIME INJECTION
Keep out of the reach and sight of children.
Do not use Cefotaxime injection after the expiry date which is
printed on the label and carton.
Do not store above 25°C. Keep the vial in the outer carton.
Your doctor, pharmacist or nurse will know how to store Cefotaxime
injection properly.
6. FURTHER INFORMATION
What Cefotaxime injection contains:
Each vial contains 500mg or 1g Cefotaxime (as Cefotaxime sodium).
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 glass vial.
Each carton contains 1, 10, 25 or 50 vials. Not all pack sizes may be
marketed
Marketing Authorisation Holder:
Villerton Invest SA
40, Avenue Monterey
L-2163 Luxembourg
Manufacturers:
Anfarm Hellas S.A.,
Shimatari Viotias,
320 09 Greece
Facta Farmaceutici S.p.A,
Nucleo Industriale S. Atto,
San Nicolò a Tordino, 64100 Teramo - Italy
This leaflet was last revised in January 2015
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Adults and children over 12 years in general receive 1 g Cefotaxime
every 12 hours. In severe cases, the daily dose can be increased up to
12 g. Daily doses up to 6 g can be divided into at least two individual
administrations at 12 hourly intervals. Higher daily doses must be
divided into at least 3 to 4 individual administrations at 8 or 6 hour
intervals respectively.
The following table may serve as a guide to dosages:
Type of Infection

Single Dose
Cefotaxime

Typical infections, in which
sensitivity is demonstrated and
bacterium is proven or
suspected
Infections, in which various
bacteria with high to medium
sensitivity are demonstrated or
suspected
Unclear bacterial illness which
cannot be localised and where
the patient is critically ill

1g

Dose
Interval
12 h

Daily Dose
Cefotaxime
2g

In case of life-threatening situations it may be necessary to increase
the daily dose.
In those situations the following table is recommended.





Age
0 - 7 days
7 days - 1 month
> 1 month

Daily Dose of Cefotaxime
50 mg/kg every 12 hours IV
50 mg/kg every 8 hours IV
75 mg/kg every 8 hours IV

It is not necessary to differentiate between premature and normalgestational age infants.
Dosage in the Case of Impaired Renal Function

2g

12 h

4g

2- 3 g

8h
up to 6 h
up to 6 h

6g
up to 8 g
up to 12 g

For the treatment of gonorrhoea in adults, 1 vial of Cefotaxime
Sodium for Injection 500mg administered as a single administration.

With patients with a creatinine clearance of 20ml/minute or less,
the maintenance dose is reduced to half the normal dose. With
patients with a creatinine clearance of 5ml/minute or less, a
reduction of the maintenance dose to 1 g Cefotaxime (divided
into two individual administrations at 12 hour intervals), seems to be
appropriate. The stated recommendations are based on experience
with adults.
Since Cefotaxime is to a large extent eliminated by haemodialysis, an
additional dose should be administered to patients who are dialysed,
after the dialysis procedure.

In most cases due to less sensitive infective bacteria, an increase
may be necessary, i.e. 1 g Cefotaxime. Examination for syphilis
needs to be carried out before commencing therapy.

Elderly Patients

Perioperative Infection Prophylaxis

Other Advice

For peri-operative infection prophylaxis the administration of a single
dose of 1 to 2 g Cefotaxime 30 to 60 minutes prior to the operation is
recommended. Another antibiotic to cover anaerobic organisms is
necessary. A repeat dose is required if the duration of the operation
exceeds 90 minutes.
Special Dose Recommendations
Lyme borrelisosis: A daily dose of 6 g Cefotaxime (14 to 21 days
duration). The daily dose was generally administered divided into 3
parts (2 g Cefotaxime 3 times daily).

Electrolyte content of the injection solutions: Since Cefotaxime is
available as the sodium salt, the sodium content per dose should be
taken into account within the framework of the overall therapy and
with special balance checks.

No dosage adjustments are needed in patients with normal function.

Basis for calculation: 1 g Cefotaxime (equivalent to 1.04 g Cefotaxime
sodium) should be calculated as 48 mg sodium equivalent to
2.1 mmol sodium.

Infants and children up to 12 years receive 50 to 100 mg Cefotaxime
according to the severity of the infection (up to 150 mg) per Kilogram
of body weight per day, divided into equal doses, administered
at 12 (up to 6) hour intervals. In individual cases - particularly in life
threatening situations - it may be necessary to increase the daily dose
to 200 mg Cefotaxime per kilogram of body weight.
In neonates and infants doses of 50 mg Cefotaxime per kilogram of
body weight per day should not be exceeded in view of not fully
matured kidney clearance.
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Package leaflet: Information for the Patient
Ceftriaxone 250 mg, 1g, 2g Powder for Solution for
Injection or Infusion
Ceftriaxone (as Ceftriaxone Sodium)
Read all of this leaflet carefully before you are given 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.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet
1. What Ceftriaxone injection is and what it is used for
2. What you need to know before you are given
Ceftriaxone injection
3. How Ceftriaxone injection is given
4. Possible side effects
5. How to store Ceftriaxone injection
6. Contents of the pack and other information
The name of your medicine is “Ceftriaxone Powder for Solution
for Injection or Infusion” (referred to as Ceftriaxone injection
throughout this leaflet).
1. What Ceftriaxone injection is and what it is used for
Ceftriaxone is an antibiotic given to adults and children
(including newborn babies). It works by killing bacteria that
cause infections. It belongs to a group of medicines called
cephalosporins.
Ceftriaxone injection is used to treat infections of:
• the brain (meningitis).
• the lungs.
• the middle ear.
• the abdomen and abdominal wall (peritonitis).
• the urinary tract and kidneys.
• bones and joints.
• the skin or soft tissues.
• the blood.
• the heart.
It can be given:
• to treat specific sexually transmitted infections (gonorrhoea
and syphilis).
• to treat patients with low white blood cell counts
(neutropenia) who have fever due to bacterial infection.
• to treat infections of the chest in adults with chronic
bronchitis.
• to treat Lyme disease (caused by tick bites) in adults and
children including newborn babies from 15 days of age.
• to prevent infections during surgery.
2. What you need to know before you are given Ceftriaxone
injection
You must not be given Ceftriaxone injection if:
• You are allergic to ceftriaxone
• You have had a sudden or severe allergic reaction to
penicillin or similar antibiotics (such as cephalosporins,
carbapenems or monobactams). The signs include sudden
swelling of the throat or face which might make it difficult to
breath or swallow, sudden swelling of the hands, feet and
ankles, and a severe rash that develops quickly.
• You are allergic to lidocaine and you are to be given
Ceftriaxone injection as an injection into a muscle.
Ceftriaxone injection must not be given to babies if:
• The baby is premature.
• The baby is newborn (up to 28 days of age) and has certain
blood problems or jaundice (yellowing of the skin or the
whites of the eyes) or is to be given a product that contains
calcium into their vein.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before you are
given Ceftriaxone injection if:
• You have recently received or are about to receive
products that contain calcium.
• You have recently had diarrhoea after having an antibiotic
medicine.
• You have ever had problems with your gut, in particular
colitis (inflammation of the bowel).
• You have liver or kidney problems.
• You have gall stones or kidney stones
• You have other illnesses, such as haemolytic anaemia (a
reduction in your red blood cells that may make your skin
pale yellow and cause weakness or breathlessness).
• You are on a low sodium diet.
If you need a blood or urine test
If you are given Ceftriaxone for a long time, you may need to
have regular blood tests. Ceftriaxone can affect the results of
urine tests for sugar and a blood test known as the Coombs
test. If you are having tests:
• Tell the person taking the sample that you have been given
Ceftriaxone.
Children
Talk to your doctor or pharmacist or nurse before your child is
administered Ceftriaxone if:
• He/she has recently been given or is to be given a product

that contains calcium into their vein.
Other medicines and Ceftriaxone
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
• A type of antibiotic called an aminoglycoside.
• An antibiotic called chloramphenicol (used to treat
infections, particularly of the eyes).
Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine.
The doctor will consider the benefit of treating you with
Ceftriaxone against the risk to your baby.
Driving and using machines
Ceftriaxone can cause dizziness. If you feel dizzy, do not
drive or use any tools or machines. Talk to your doctor if you
experience these symptoms.
Ceftriaxone injection contains sodium
This medicine contains 0.9 mmol (250mg vial), 3.6 mmol (1g
vial) or 7.2 mmol (2g vial) of sodium. This should be taken into
consideration by patients on a controlled sodium diet. Tell
your doctor or nurse if you are on a low sodium diet.
3. How Ceftriaxone injection is given
Ceftriaxone injection is usually given by a doctor or nurse. It
can be given as a drip (intravenous infusion) or as an injection
directly into a vein or into a muscle. Ceftriaxone injection
is made up by the doctor, pharmacist or nurse and will not
be mixed with or given to you at the same time as calciumcontaining injections.
The usual dose
Your doctor will decide the correct dose of Ceftriaxone for you.
The dose will depend on the severity and type of infection;
whether you are on any other antibiotics; your weight and
age; how well your kidneys and liver are working. The number
of days or weeks that you are given Ceftriaxone depends on
what sort of infection you have.
Adults, older people and children aged 12 years and over
with a body weight greater than or equal to 50 kilograms (kg):
1 to 2 g once a day depending on the severity and type of
infection. If you have a severe infection, your doctor will give
you a higher dose (up to 4 g once a day). If your daily dose
is higher than 2 g, you may receive it as a single dose once a
day or as two separate doses.
Newborn babies, infants and children aged 15 days to 12
years with a body weight of less than 50 kg:
50-80 mg Ceftriaxone for each kg of the child’s body weight
once a day depending on the severity and type of infection.
If you have a severe infection, your doctor will give you a
higher dose up to 100 mg for each kg of body weight to a
maximum of 4 g once a day. If your daily dose is higher than
2 g, you may receive it as a single dose once a day or as two
separate doses.
Children with a body weight of 50 kg or more should be given
the usual adult dose.
Newborn babies (0-14 days)
20 – 50 mg Ceftriaxone for each kg of the child’s body weight
once a day depending on the severity and type of infection.
The maximum daily dose is not to be more than 50 mg for
each kg of the baby’s weight.
People with liver and kidney problems
You may be given a different dose to the usual dose. Your
doctor will decide how much Ceftriaxone you will need and
will check you closely depending on the severity of the liver
and kidney disease.
If you are given more Ceftriaxone than you should
If you accidentally receive more than your prescribed dose,
contact your doctor or nearest hospital straight away.
If you forget to use Ceftriaxone injection
If you miss an injection, you should have it as soon as possible.
However, if it is almost time for your next injection, skip the
missed injection. Do not take a double dose (two injections at
the same time) to make up for a missed dose.
If you stop using Ceftriaxone injection
Do not stop taking Ceftriaxone unless your doctor tells you to.
If you have any further questions on the use of this medicine,
ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The following side effects may happen with this medicine:
Severe allergic reactions (not known, frequency cannot be
estimated from the available data)
If you have a severe allergic reaction, tell a doctor straight
away.
The signs may include:
• Sudden swelling of the face, throat, lips or mouth. This can
make it difficult to breathe or swallow.
• Sudden swelling of the hands, feet and ankles.

If you get a severe skin rash, tell a doctor straight away.
The signs may include a severe rash that develops quickly, with
blisters or peeling of the skin and possibly blisters in the mouth.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Abnormalities with your white blood cells (such as a
decrease of leucocytes and an increase of eosinophils)
and platelets (decrease of thrombocytes).
• Loose stools or diarrhoea.
• Changes in the results of blood tests for liver functions.
• Rash.
Uncommon (may affect up to 1 in 100 people)
• Fungal infections (for example, thrush).
• A decrease in the number of white blood cells
(granulocytopenia).
• Reduction in number of red blood cells (anaemia).
• Problems with the way your blood clots. The signs may
include bruising easily and pain and swelling of your joints.
• Headache.
• Dizziness.
• Feeling sick or being sick.
• Pruritis (itching).
• Pain or a burning feeling along the vein where Ceftriaxone
has been given.
• Pain where the injection was given.
• A high temperature (fever).
• Abnormal kidney function test (blood creatinine increased).
Rare (may affect up to 1 in 1,000 people)
• Inflammation of the large bowel (colon). The signs include
diarrhoea, usually with blood and mucus, stomach pain
and fever.
• Difficulty in breathing (bronchospasm).
• A lumpy rash (hives) that may cover a lot of your body,
feeling itchy and swelling.
• Blood or sugar in your urine.
• Oedema (fluid build-up).
• Shivering.
Not known (Frequency cannot be estimated from the available
data)
• A secondary infection that may not respond to the antibiotic
previously prescribed.
• Form of anaemia where red blood cells are destroyed
(haemolytic anaemia).
• Severe decrease in white blood cells (agranulocytosis).
• Convulsions.
• Vertigo (spinning sensation).
• Inflammation of the pancreas (pancreatitis). The signs
include severe pain in the stomach which spreads to your
back.
• Inflammation of the mucus lining of the mouth (stomatitis).
• Inflammation of the tongue (glossitis). The signs include
swelling, redness and soreness of the tongue.
• Problems with your gallbladder, which may cause pain,
feeling sick and being sick.
• A neurological condition that may occur in neonates with
severe jaundice (kernicterus).
• Kidney problems caused by deposits of calcium ceftriaxone.
There may be pain when passing water (urine) or low output
of urine.
• A false positive result in a Coombs’ test (a test for some
blood problems).
• A false positive result for galactosaemia (an abnormal build
up of the sugar galactose).
• Ceftriaxone may interfere with some types of blood glucose
tests - please check with your doctor.

PRODUCT NAME:

I - Ceftriaxone Villerton UK MK08
PRODUCT CODE:

L08GBCTRX02

For further information, refer to the Summary of Product
Characteristics.
Instructions for use and handling:
This medicinal product is for single use only. Reconstitute
immediately before use.
Discard any unused contents.
Preparation of solutions:
Powder
Intravenous
injection

250 mg
1g

Intramuscular 250 mg
injection
1g

Intravenous
infusion

2g

Reconstitution Volume
solvent
to be
added
Water for
2.5 ml
Injections BP
Water for
10 ml
Injections BP
1.0%
1.0 ml
Lidocaine
Hydrochloride
BP
1.0%
3.5 ml
Lidocaine
Hydrochloride
BP
40.0 ml
Glucose
Injection BP
5% or 10%,
0.9% Sodium
Chloride
Injection BP,
Sodium
Chloride
and Glucose
Injection BP
(0.45% Sodium
Chloride
and 2.5%
Glucose),
Dextran 6%
in Glucose
Injection BP
5%.

Approx.
displacement
volume
0.2 ml
0.6 ml
0.06 ml

0.66 ml

1.2 ml

Solutions reconstituted with Lidocaine Hydrochloride BP
solution should not be administered intravenously.
Dosages greater than 1 g should be divided and injected at
more than one site.

5. How to store Ceftriaxone injection
Keep out of the sight and reach of children.
Do not use Ceftriaxone injection after the expiry date which is
printed on the label and carton.
Do not store above 25°C. Your doctor, pharmacist or nurse will
know how to store Ceftriaxone Injection properly.
6. Contents of the pack and other information
What Ceftriaxone injection contains
Each vial contains 250mg, 1g, or 2g ceftriaxone (as ceftriaxone
sodium).
The vials contain no other ingredients.
What Ceftriaxone injection looks like and contents of the pack
Ceftriaxone injection is a white or almost white powder in a
glass vial.
Each carton contains 1, 5, 10, 20, 50 or 100 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Villerton Invest SA, 40 Avenue Monterey, L-2163 Luxembourg.
Manufacturer
Anfarm Hellas, Schimatari Viotias, 32009 Schimatari, Greece;
or
Facta Farmaceutici S.p.A., Nucleo Industriale S. Atto, S. Nicolò
a Tordino, 64100 Teramo, Italy
This leaflet was last revised in September 2016.
L08GBCTRX02

ARTWORK
THIS ARTWORK IS PROPERTY OF:

The following information is intended for medical or
healthcare professionals only.

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 in this
leaflet. You can also report side effects directly via the 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.

Severe skin rashes (not known, frequency cannot be estimated
from the available data)

FACTA TERAMO

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

SEPARATIONS:
(black)
PHARMACODE: I X I X I I X X X
MEAS. (mm): 420 x 420 (105 x 52,5)
TECHNICAL SPECIF.: ACSI089F00
g/sq.mt: 40 gr/m2 Thikness: 0,049
FONT TYPE: Century Gothic 9 pt

PDF 1.5

Realized by:

QUALITY SYSTEM - ISO 9001:2008

ISSUE DATE

OPERATOR

DRAFT

14/09/16

RI006M

02

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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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