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CEFTRIAXONE 1G POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFTRIAXONE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Ceftriaxone 1 g Powder for Solution for Injection/Infusion
Ceftriaxone 2 g Powder for Solution for Injection/Infusion
Ceftriaxone

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 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 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 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 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.

The following information is intended for medical or healthcare professionals only:
Method and route of administration of Ceftriaxone powder for
solution for injection/infusion
Ceftriaxone may be administered by intravenous bolus injection, by
intravenous infusion or by intramuscular injection after
reconstitution of the solution according to the directions below.
Ceftriaxone should not be mixed in the same syringe with any drug
other than 1 % lidocaine hydrochloride solution (for intramuscular
injection only).
Do not use diluents containing calcium, such as Ringer’s solution
or Hartmann’s solution, to reconstitute Ceftriaxone. Particulate
formation can result.

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.

3.

How Ceftriaxone is given

Ceftriaxone 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 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 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.

Intramuscular injection: Ceftriaxone 1 g Powder for Solution for
Injection/Infusion should be dissolved in 3.5 ml and Ceftriaxone 2 g
Powder for Solution for Injection/Infusion in 7.0 ml of 1 % lidocaine
hydrochloride solution.
The solution should be administered by deep intramuscular
injection. Dosages greater than 1 g should be divided and injected
at more than one site. Solutions of lidocaine should not be
administered intravenously.
(Please note the manufacturer's information on the risks of
lidocaine hydrochloride in the relevant information documents on
the respective lidocaine preparations used).
Intravenous injection: Ceftriaxone 1 g Powder for Solution for
Injection/Infusion is dissolved in 10 ml of water for injections. The
injection should be administered over at least 2 – 4 minutes,
directly into the vein or via the tubing of an intravenous infusion.
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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.

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.
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.

5.

How to store Ceftriaxone

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the label after EXP. The expiry date refers to the last day of that
month.
This medicine does not require any special temperature storage
conditions.
Keep container in the outer carton in order to protect from light.
Reconstituted solution:
Once the powder has been dissolved, the solution should be used
immediately or stored in a refrigerator 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.

6.

Contents of the pack and other information

What Ceftriaxone contains
The active substance is ceftriaxone disodium 3.5 hydrate.
Each 1 g vial contains 1 g ceftriaxone (as disodium 3.5 hydrate).
Each 2 g vial contains 2 g ceftriaxone (as disodium 3.5 hydrate).
There are no other ingredients.
What Ceftriaxone looks like and contents of the pack
Ceftriaxone is a white to yellowish crystalline powder. The
ready-to-use solutions are pale yellow to amber.
Do not use Ceftriaxone if you notice the following: The solution is
not clear.
Ceftriaxone Powder for Solution for Injection/Infusion is supplied in
(hospital) packs of 1, 5x1, 10x1, 10, 25, 50 and 100 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Limited
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Manufacturer:
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

This leaflet was last revised in 04/2015.

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.
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
(www.mhra.gov.uk/yellowcard). By reporting side effects, you can
help provide more information on the safety of this medicine.
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Intravenous infusion: 1 to 2 g of Ceftriaxone should be dissolved in
20 to 40 ml of one of the following calcium-free infusion solutions:
• sodium chloride 0.9%
• sodium chloride 0.45% and glucose 2.5%
• glucose 5 % or 10%
• dextran 6% in glucose 5%
• hydroxyethyl starch 6-10% infusions
See also the section on Miscibility below. The infusion should be
administered over at least 30 minutes.
When reconstituted for intramuscular or intravenous injection, the
white to yellowish-orange crystalline powder gives a pale yellow to
amber solution.
Reconstituted solutions should be inspected visually. Only clear
solutions free of visible particles should be used.

The reconstituted product is for single use only and any unused
solution must be discarded.
Miscibility
Solutions containing ceftriaxone should not be mixed with or added
to other agents. In particular diluents containing calcium (e.g.
Ringer’s solution or Hartmann’s solution), 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 not compatible with
amsacrine, vancomycin, fluconazol and aminoglycosides.

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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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