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CEFTRIAXONE 250 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFTRIAXONE SODIUM

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Patient Information Leaflet
Ceftriaxone 250 mg Powder for Solution for
Injection
Ceftriaxone 1 g Powder for Solution for
Injection
Ceftriaxone 2 g Powder for Solution for
Infusion

Ceftriaxone
Please read all of this leaflet carefully. It includes important
information on how you should take this medicine correctly and
safely.
Keep this leaflet. You may need to read it again.
If you are the parent of a child who is to be given this medicine,
read the leaflet replacing ‘you’ with ‘your child’ throughout.
This medicine is prescribed for you, and you should 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 you notice any side effects
not listed in the leaflet please tell your doctor, nurse or
pharmacist.
If you have any further questions, please ask your doctor, nurse
or pharmacist.
The name of your medicine is one of the following:
- Ceftriaxone 250 mg Powder for Solution for Injection
- Ceftriaxone 1 g Powder for Solution for Injection
- Ceftriaxone 2 g Powder for Solution for Infusion
In the rest of this leaflet your medicine is called Ceftriaxone.
________________________________________________
In this leaflet there is information about:
1. What Ceftriaxone is and what it used for
2. Before you take Ceftriaxone
3. How to take Ceftriaxone
4. Possible side effects
5. How to store Ceftriaxone
6. Further Information
________________________________________________

1. What is Ceftriaxone and what it is used for
Ceftriaxone is a type of medicine called an antibiotic. Antibiotics
work by killing the bacteria (germs) that can cause an infection. If the
infection is not treated by your medicine, the bacteria (germs) can
continue to grow in your body. This will make you feel very unwell,
and could even be life threatening. Ceftriaxone works by killing some
types of bacteria. Your doctor will decide if Ceftriaxone is the right
antibiotic to treat your infection. Ceftriaxone is used to treat
infections caused by bacteria (germs). These include:
Infection around the brain or spinal cord (meningitis)
Severe blood infections (your doctor or nurse may call this
septicaemia or blood poisoning)
Infection of the lungs and breathing airways (pneumonia)
Infection of the bones, skin or soft tissue (such as wound
infections)
Infections in patients with low numbers of white blood cells in their
circulation
Infection of the genital (sex) organs (gonorrhoea)
Ceftriaxone may also be given around the time of surgical operations
to help prevent infection happening afterwards.

2. Before you take Ceftriaxone
The nurse or doctor giving you this medicine will ask some questions
about you. They need the following information before you have this
medicine for the first time.
Do not take Ceftriaxone
If you are allergic to this medicine or any other cephalosporin
antibiotics
If you are allergic to penicillin antibiotics
Ceftriaxone should not be given to babies:
If they are a premature baby
If they are a premature baby or a small baby with jaundice
(yellowing of the skin or eyes) or with blood problems
If they require treatment with calcium given via an infusion drip.
Do not take Ceftriaxone if any of the above statements are true

Take special care with Ceftriaxone
Before your treatment starts, tell your nurse or doctor if:
You suffer from asthma or any other allergies
You have stomach problems such as inflammation of the bowel
(also called colitis)
You have problems with both your liver and kidneys
You are on a low sodium diet
If you suffer from any other reaction to this medicine or any other
cephalosporin or penicillin antibiotic.
If you have had recent treatment with Calcium.
During or after treatment, make sure to tell your doctor or nurse
immediately if:
You get diarrhoea especially if it is severe and contains blood.
You get pain in the stomach area or chest (this may be a sign of
inflammation of the gall bladder or pancreas)
You feel tired or look pale ( this may be a sign of anaemia)
You think you have another infection starting.
Ceftriaxone may also cause some laboratory tests to have an
unusual result such as:
The Coombs’ test (a test done before a blood transfusion)
Tests for sugar in your urine (these may be done to test for
diabetes).
Taking other medicines
Please tell your doctor about any medicines you may be taking or
have recently been taking. Remember also any medicines you may
be taking that do not need a prescription.
If you are taking any of the following medicines it is very important to
tell your doctor:
The birth control pill (oral contraceptive). The “pill” may not work
so you will need to take extra precautions such as a condom or
diaphragm during the treatment and for the whole month after
treatment has finished.
Chloramphenicol (as both medicines may not work as well as
normal)
Ceftriaxone may also cause some laboratory tests to have an
unusual result such as:
The Coombs’ test
Tests for sugar in your urine (these tests are often done in
diabetics).
Driving and using machines
You should not drive or operate machinery while taking ceftriaxone
as it can make you dizzy and affect your sight.
Pregnancy and breast-feeding
If you are pregnant, or think you may be pregnant you must tell
your doctor.
If you are breast-feeding you must tell your doctor as small
amounts of the ceftriaxone will be in the breast milk and may
affect your baby.
Your doctor will advise you if you should have this medicine during
pregnancy and breastfeeding.
Important information about some of the ingredients of
Ceftriaxone:
If you are on a low sodium diet, it is important to know how much
sodium is in your medicine.
Each gramme of this medicine contains approximately 3.6mmol
(millimoles) of sodium.

3. How to take Ceftriaxone
A doctor or a nurse will usually give you this medicine.
Your doctor or nurse will give the correct dose for you into your vein.
It will be given to you as a slow injection over 2 to 4 minutes or by a
continuous infusion over a longer time (your doctor or nurse may call
this an “IV” or “intravenous infusion” or “drip”). Sometimes, your
doctor or nurse will give you Ceftriaxone by injecting it into the large
muscles in your leg or bottom. The most you will receive in this way
in any one part of your body is 1 gram. You may also receive a local
anaesthetic in this case. Your doctor will decide the amount (dose)
of your medicine to give you. This will depend on a number of things.
These things include how bad your infection is, the type of infection
and the type of bacteria causing it and how healthy you are. Your
doctor will also decide how long you need to take your medicine for.
This will depend on how bad your infection is and how you respond
to your medicine. The usual time is for at least 2 or 3 days after you
are feeling better such as when your temperature is back to normal.
As this medicine is a powder, liquid must be added to make a
solution before you receive it. Your doctor, nurse or pharmacist will
normally do this for you.
Please read the next page of this leaflet

Instructions for use and handling
Single use only, whereby any unused solution should be discarded.
The use of freshly prepared solutions is recommended. Τhese
maintain potency for at least 6 hours at or below 25o C, or 24 hours
at 2-8οC (see section 6.3). Protect from light.
The reconstituted solution should be clear. Do not use if particles are
present.
Ceftriaxone when reconstituted with Water for Injections is a light to
dark yellow solution. Variations in the intensity of the colour will not
affect the potency of the drug.
Ceftriaxone should not be mixed in the same syringe with any drug
other than 1.06% Lidocaine Hydrochloride BP Solution (for
intramuscular injection only).

Solutions containing ceftriaxone should not be mixed with or added
to solutions containing other agents than listed below (see section
6.6). In particular diluents containing calcium, (e.g. Ringer's
solution, 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
The reconstituted solution should be shaken for approximately 90
seconds to ensure complete dissolution of the ceftriaxone.
The user should then allow the solution to stand in order to ensure
that there are no bubbles in the solution.

Adults and children 12 years and over
The usual dose is 1 gram (1 g) once per day. In severe infections,
you may need up to 4 g per day given in one dose.
The usual dose for gonorrhoea is a single dose of 250 milligram
(mg) injected into a large muscle.
During operations, the usual dose is a single injection of 1 g. This
will be given to you as an injection into a muscle or as a slow
injection into a vein. In some operations such as colorectal surgery,
you may get a dose of 2 g as an injection into a muscle or as a slow
IV infusion (drip). If you are elderly (over 65 years) then you will be
given the usual adult dose.
Newborn and very young babies
The usual dose is 20 to 50 mg per kg of bodyweight once per day.
The maximum dose is 50mg per kg of bodyweight. The medicine will
be given to you as an IV infusion (drip) which may take up to 60
minutes.
Infants and children up to 12 years
The usual dose is 20 to 50 mg per kg of bodyweight once per day. In
severe infections, up to 80 mg per kg bodyweight may be given.
Higher doses should be given as an IV infusion (drip) over at least
30 minutes.
For children who weigh over 50 kg, the usual adult dose may be
given.
Patients with kidney problems:
The maximum dose for adults with very poor kidney function is 2 g
each day.
If you have severe kidney problems and also liver problems or if you
are getting dialysis (blood treatment when your kidneys do not work
properly), your doctor may also take some blood tests to help
calculate the correct dose for you.
If you take more Ceftriaxone than you should
A doctor or a nurse will usually give you this medicine. If you think
you may have received too much medicine please tell your doctor or
nurse at once.
If you forget to take Ceftriaxone
A doctor or a nurse will usually give you this medicine. If you think
you have missed a dose, please tell your doctor or nurse.
If you stop taking Ceftriaxone
It is very important to finish the course of treatment your doctor has
prescribed, even if you start to feel better. If you do not finish the
course of treatment, your infection may get worse again.
If you have any further questions on the use of your medicine, ask
your doctor, nurse or pharmacist.

4. Possible side-effects
Like all medicines, Ceftriaxone can cause side effects, but not
everyone gets them. The expected benefit of your medicine will
usually be greater than the risk of you suffering any harmful side
effects. The side effects with this medicine are usually mild and
short-term. The chance of you having a side effect is described
using words and numbers in this section.
Important: Side effects or symptoms to look out for, and what
to do if you are affected.
The following is a rare side effect which probably affects up to 1
in 1 000 people:
Serious allergic reaction. The first signs of a serious allergic
reaction may be swelling of the face or throat, sudden breathing
difficulties or a bad skin rash.
The following is a very rare side effect which probably affects
up to 1 in 10 000 people:
Severe and continuing diarrhoea which may contain blood (your
doctor or nurse may call this pseudomembranous colitis).
If you get any of the above symptoms you must seek medical
advice immediately.
Other possible side effects:
The following are common side effects. They probably affect up
to 1 in 10 people:
Pain or discomfort at the injection site (a local anaesthetic can be
given to stop this).
Diarrhoea, nausea (feeling sick), vomiting, sore mouth and
tongue.
The following are uncommon side effects. They probably affect
fewer than 1 in 100 people:
Allergic skin reactions, raised or lumpy rash, itching, blisters,
swelling.
The following are rare side effects. They probably affect fewer
than 1 in 1 000 people:
Headache, dizziness.
If you receive Ceftriaxone as an injection into your vein, you may
feel redness, pain, or swelling in your vein (giving the injection
slowly will help this).
Fungal infection of the genital area or other extra infections in
other parts of your body.
Anaemia, changes in your blood cells, slower time for your blood
to clot (these blood problems may cause pale or yellow skin,
tiredness, weakness, difficulty breathing, bruising).
Allergic reactions that may become severe or life-threatening,
high temperature, shivering, chills.
The passage of very little urine and other problems with your
kidneys.

Intramuscular injection:
250mg Ceftriaxone should be dissolved in 1ml of 1.06% Lidocaine
Hydrochloride BP solution or 1 g in 3.5 ml of 1.06% Lidocaine
Hydrochloride BP. The solution should be administered by deep
intramuscular injection. Dosages greater than 1g should be divided
and injected at more than one site.

Blood or excess sugar may be detected in your urine.
Blood tests may suggest that your liver is not working properly.
Ceftriaxone may deposit in your gall bladder and this may look
like gallstones on x-ray.
Ceftriaxone may deposit in the lung and kidneys of newborns
when administered with calcium containing products at the same
time.
The following are very rare side effects. They probably affect
fewer than 1 in 10 000 people:
Problems with the clotting of your blood leading to bruising or
difficulty stopping bleeding.
Profound reduction in the numbers of white blood cells in your
circulation that may affect how your body can fight infections.
Severe diarrhoea that may contain blood.
Severe pain in your stomach area or back that may be caused by
inflammation of your pancreas.
Serious illness with severe skin reactions that may cause
blistering or peeling of your skin, mouth, eyes or genitals.
Ceftriaxone may deposit in the kidneys. This is more likely to
occur in children and patients who are immobile (not able to move
about) or dehydrated (very little water in body).
You may also have a positive Coombs’ test (a blood test). If you use
Ceftriaxone for a long time, you can get other infections that
Ceftriaxone cannot work against properly. If any of these side effects
gets serious, or if you notice any troublesome symptoms which you
think may be side effects, please tell your doctor, nurse or
pharmacist.

5. How to Store Ceftriaxone
Your doctor, nurse or pharmacist will usually store your medicine for
you. Keep your medicine out of the reach and sight of children. Do
not use your medicine after the expiry date (EXP) given on the
carton and the label on the glass container (vial). The expiry date is
the last day of the month written on the packaging. Store below
25ºC. Always keep the glass container in the outer carton. Protect
from light. Once the powder has been made into a liquid solution, it
should be used immediately or within 24 hours if it is kept in the
fridge, ie 2-8 oC or 6 hours if it is kept at or below 25oC. Protect from
light. Only use the solution if it is clear and contains no particles or
specks of powder. Give any leftover medicine to your doctor, nurse
or pharmacist. Do not put it down the drain or in the dustbin. If you
do this, it will help protect the environment.

6. Further Information
What Ceftriaxone contains
The active medicine is Ceftriaxone. There are no other ingredients in
your medicine. Each glass container will contain either 250 mg, 1 g
or 2 g of Ceftriaxone powder.
What Ceftriaxone looks like
Ceftriaxone is a white to pale yellow powder for solution for injection
or infusion. This means liquid must be added to make a solution
before it can be given to you as an injection. In some cases, more
liquid may be added to make a weaker solution which can then be
given to you as an infusion (a drip).
Normally your doctor, nurse or pharmacist will prepare your
medicine before it is given to you.
Contents of the pack
250mg, 1g: Each pack contains 1, 5, 10, 20 or 50 vials (glass
containers).
2g: Each pack contains 1, 5, 10, 20 or 50 vials (glass containers).
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd.,
Evagorou & Makariou, Mitsi Building 3, Suite 115, 1065 Nicosia,
Cyprus.
Manufacturer: Demo S.A., 21st km National Road Athens, Lamia,
14568 Athens, Greece.

If this leaflet is difficult to see
or read please contact the
following address for help:
Fannin UK Ltd. 42-46 Booth
Drive Park Farm South
Wellingborough,
Northamptonshire NN8 6GT
U.K. Tel +44 118 930 5333.
This leaflet was prepared in December 2015.

Intravenous infusion:
2g Ceftriaxone should be dissolved in 40ml of one of the following
calcium-free solutions: Dextrose injection BP 5% or 10%, Sodium
Chloride Injection BP, Sodium Chloride and Dextrose Injection BP
(0.45% Sodium Chloride and 2.5% Dextrose), Dextran 6% in
Dextrose Injection BP 5%, hydroxyethyl starch 6-10% infusions. The
infusion should be administered over at least 30 minutes.

Solutions in Lidocaine should not be administered intravenously.
The displacement value of 250mg of Ceftriaxone is 0.194ml.
Intravenous injection:
250mg Ceftriaxone should be dissolved in 5ml or 1 g Ceftriaxone
should be dissolved in 10ml of Water for Injections BP. The injection
should be administered over at least 2-4 minutes, directly into the
vein or via the tubing of an intravenous infusion.

Please refer to the Summary of Product Characteristics for full
information.

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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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