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CEFTRIAXONE 0.5 G POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFTRIAXONE SODIUM STERILE

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Package leaflet: Information for the use
Ceftriaxone 0.5 g Powder for Solution for Injection
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.
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 is and what it is used for
2.
What you need to know before you are given Ceftriaxone
3.
How Ceftriaxone is given
4.
Possible side effects
5.
How to store Ceftriaxone
6.
Contents of the pack and other information
1.

What Ceftriaxone 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 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

You must not be given Ceftriaxone if:





You are allergic to ceftriaxone sodium.
You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (of the
beta-lactam group). The signs include sudden swelling of the throat or face which might make it
difficult to breathe 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.
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You must not be given Ceftriaxone if any of the above applies to you. If you are not sure, talk to your
doctor or nurse before having Ceftriaxone.
Ceftriaxone 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 give a product that contains calcium
into their vein
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Ceftriaxone 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 any of the above apply to you, or if you are not sure, talk to your doctor or nurse before you have
Ceftriaxone.
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, 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 or pharmacist for advice before taking this medicine.
The doctor will consider the benefit of treating you with Ceftriaxon 500 milligrams 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 contains sodium
1 vial contains 1.8 mmol (or 41.5 mg) sodium. The sodium content per gram of ceftriaxone is 3.6
mmol (corresponding to 83 mg sodium).
To be taken into consideration by patients on a controlled sodium diet.
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3.

How Ceftriaxone is given

Ceftriaxone is usually given by a doctor or nurse:

As a slow injection into one of your veins (this may take between 2 and 4 minutes) or into a
muscle.
Before it is given to the patient, Ceftriaxone is made into a solution by adding sterile liquid to the vial.
The correct dose is then taken out of the vial.
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 too much Ceftriaxone
Your doctor has information on how to recognise and treat an overdose. If you are concerned about
your treatment please talk to your doctor or nurse.
If you forget to use Ceftriaxone
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
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.

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4.

Possible side effects

Like all medicines, Ceftriaxone 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.
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.
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
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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.

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

Keep this medicine out of the sight and reach of children.
You should not be given Ceftriaxone after the expiry date (EXP) which is stated on the outer carton
and vial label. A doctor or nurse will check this before you are given this medicine. The expiry date
(EXP) refers to the last day of that month.
Do not store above 25 °C.
Keep the vial(s) in the outer carton, in order to protect from light.
Do not use this medicine if you notice visible signs of deterioration.
For reconstituted solution chemical and physical in-use stability has been demonstrated for 24
hours at 25°C and 72 hours at 2-8°C. From a microbiological point of view, once opened, 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 would normally not be longer than 24 hours at 2-8°C, stored protected from light, unless
reconstitution has taken place in controlled and validated aseptic conditions.
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 to protect the environment.

6.

Contents of the pack and other information

What Ceftriaxone contains
The active substance is Ceftriaxone.
Each vial contains 500 mg Ceftriaxone equivalent to 596 mg Ceftriaxone Sodium.
There are no other ingredients in Ceftriaxone 0.5 g.
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What Ceftriaxone looks like and contents of the pack
Ceftriaxone 0.5 g is a white to yellowish powder for solution for injection.
It is supplied in a glass vial.
Ceftriaxone is available in the following pack sizes: 1, 5 or 10 vials.
Not all pack sizes may be marketed.
Ceftriaxone is supplied in three different presentations:
Ceftriaxone 0.5 g powder for solution for injection
Ceftriaxone 1 g powder for solution for injection and
Ceftriaxone 2 g powder for solution for infusion
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer
Agila Specialties Polska Sp z o o
10, Daniszewska Str, PL - 03-230 Warsaw
Poland
This leaflet was last revised in 04/2015

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The following information is intended for medical or healthcare professionals only:
Please refer to the Summary of Product Characteristics for full prescribing information.
Incompatibilities
The following active substances or solution for reconstitution/dilution should not be administered
simultaneously:
Solutions containing ceftriaxone should not be mixed with or added to other agents. In particular
diluents containing calcium, (e.g. Ringer’s solution, Hartmann’s solution, Total Parenteral
Nutrition) should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted
vial for IV administration because a precipitate can form. Ceftriaxone must not be mixed or
administered simultaneously with calcium-containing solutions.
Based on literature reports ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole
and aminoglycosides.
Intravenous injection
Ceftriaxone 0.5 g should be dissolved in 5 ml of Water for Injections. The injection should be
administered over at least 1 - 2 minutes, directly into the vein.
Vial size Diluent to be added
Approx. available volume*
500 mg
5 ml
5.4 ml
*calculated from displacement value
Intramuscular injection
Ceftriaxone 0.5 g should be dissolved in 2 ml of 1% Lidocaine Hydrochloride solution. The
solution should be administered by deep intramuscular injection.
The reconstituted solution should be shaken up to 2 minutes to ensure complete dissolution of
ceftriaxone.
When reconstituted for intravenous injection, the white to yellowish crystalline powder gives a
pale yellow solution.
For single use only. Discard any unused solution.
The reconstitution/dilution is to be made under aseptic conditions.
The reconstituted solution is to be inspected visually for particulate matter and discoloration prior
to administration. The solution should only be used if the solution is clear and free from particles.
Any unused product or waste material should be disposed of in accordance with local
requirements.

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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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