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CEFTRIAXONE SODIUM 2G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CEFTRIAXONE SODIUM

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Package leaflet: information for the Patient
Ceftriaxone 1 g and 2 g 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. Do not pass it
on to others. It may harm them, even if their symptoms
are the same as yours.
- If you get any of the side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
This medicine will be referred to as Ceftriaxone Injection in
this leaflet.
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
1. WHAT CEFTRIAXONE INJECTION IS AND WHAT IT IS
USED FOR
Ceftriaxone Injection 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 or any of the other
ingredients of this medicine (listed in section 6)
• 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 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 whites of the eyes) or is about 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

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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 Injection for a long time, you
may need to have regular blood tests. Ceftriaxone Injection
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 Injection
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 injection
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 Injection against the risk to your baby.
Driving and using machines
Ceftriaxone Injection 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.
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
calcium-containing injections.
The usual dose
Your doctor will decide the correct dose of Ceftriaxone
Injection 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 Injection 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 Injection 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

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

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Instructions for reconstitution
The medicinal product as such is not intended for immediate use and it has to be reconstituted with diluent before
administration.
Concentrations for the intravenous injection: 100 mg/ml,
Concentrations for the intravenous infusion: 50 mg/ml
Reconstitution: From the calculated dose, determine the appropriate number of vials to be used.
For the intravenous or intramuscular injection, add the recommended volume of reconstitution solution specified in the table
below and shake well until the contents of the vial have dissolved completely.
For the intravenous infusion, add 15 ml of reconstitution solution and shake well until the contents of the vial have dissolved
completely.
Draw up this 15 ml of reconstituted solution and add it to 25 ml of reconstitution fluid in an infusion bag or add 25 ml of
reconstitution fluid to the vial to prepare the patient dose (making a total volume of 40 ml reconstitution fluid as specified in the
table).
The solution should be given by intravenous infusion as detailed in section 4.2.

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 Injection you will
need and will check you closely depending on the severity
of the liver and kidney disease.
If you are given more Ceftriaxone Injection 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 Injection 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 sideeffects 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
Severe skin rashes (not known, frequency cannot be
estimated from the available data)
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

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 Injection may interfere with some types of
blood glucose tests - please check with your doctor
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 CEFTRIAXONE INJECTION
Keep out of reach and sight of children
Do not use Ceftriaxone 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.
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. If the solution is cloudy, it should not be used. Any
unused solution should be discarded.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
protect the environment.

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 Injection has been given. Pain where the
injection was given
• A high temperature (fever)
• Abnormal kidney function test (blood creatinine
increased)

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Manufacturer:
IPG Pharma Ltd, Atrium Court, The Ring, Bracknell, RG12
1BW, UK.

The active substance in Ceftriaxone Injection is Ceftriaxone
Sodium.
What Ceftriaxone Injection looks like and the contents
of the pack
Ceftriaxone is a white to slightly yellow powder. It is supplied
in 1g or 2g vials with 1, 5, 10, 25 or 50 vials in a carton.
POM
PL 39655/0001 Ceftriaxone Sodium 1g Powder for Solution
for Injection or Infusion
PL 39655/0002 Ceftriaxone Sodium 2g Powder for Solution
for Injection or Infusion
Marketing Authorisation Holder:
Stravencon Ltd, Landmark House, 17 Hanover Square,
Mayfair, London, W1S 1HU, UK.

This leaflet was last revised in July 2014
A071/UK/E

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Powder
Intramuscular
injection

1g

Intravenous
injection

1g

Intravenous
infusion

2g

Solution for reconstitution
1% Lignocaine
Hydrochloride Injection BP *
Water for Injections BP
Glucose Injection BP 5%
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%
Hydroxyethyl starch 6-10% infusions**

Quantity of
solution

Displacement
volume

3.5 ml

0.63 ml

10 ml

0.63 ml

40 ml

1.25 ml

* Solutions of ceftriaxone in lignocaine should not be administered intravenously.
** Formulae; 6% infusion: 30 g hydroxyethylstarch, 4.5 g sodium chloride, up to 500 ml Water for Injections.
10% infusion: 50 g hydroxyethylstarch, 4.5 g sodium chloride, up to 500 ml Water for Injections.
If other infusion fluids are used, compatibility with ceftriaxone should be checked. The solution should be clear,
do not use the solution if particles are present

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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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