CEFTRIAXONE 2 G POWDER FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

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.

• – 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
• 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

Instructions for use and handling

Single use only, whereby any unused solution should be discarded.

The use of freshly prepared solutions is recommended. These maintain potency for at least 6 hours at or below 25o C, or 24 hours at 2–80C (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).

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.
• 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

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.

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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.

Solutions in Lidocaine should not be administered intravenously.

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.

• 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.
• 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 25°C. 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

Contents of the pack

250mg, 1g: Each pack contains 1, 5 or 20 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 November 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.

The displacement value of 250mg of Ceftriaxone is 0.194ml.

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