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

CefTRIAXone

1 g Powder for Solution for Injection or Infusion 2 g Powder for Solution for Injection or Infusion

(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 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 Powder for Solution for Injection or Infusion contains the active substance ceftriaxone sodium.

Ceftriaxone sodium 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 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.
• You have signs of severe skin reactions (see section 4 ‘Possible side effects’)
• 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 experience or have previously experienced a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes seen in blood tests, an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (signs of severe skin reactions).

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.

If you are diabetic or need to have your blood glucose level monitored, you should not use certain blood glucose monitoring systems which may estimate blood glucose incorrectly while you are receiving Ceftriaxone. If you use such systems, check the instructions for use and tell your doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

Children

Talk to your doctor or pharmacist or nurse before your child is administered Ceftriaxone if:

• They have recently been given or are 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 for advice before you are given 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.

Ceftriaxone contains sodium

Ceftriaxone 1 g Powder for Solution for Injection or Infusion

This medicine contains 83 mg of sodium (main component of cooking/ table salt) in each vial. This is equivalent to 4.15% of the recommended maximum daily dietary intake of sodium for an adult.

Ceftriaxone 2 g Powder for Solution for Injection or Infusion

This medicine contains 166 mg of sodium (main component of cooking/ table salt) in each vial. This is equivalent to 8.3% of the recommended maximum daily dietary intake of sodium for an adult.

• 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.

Dosage

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 and 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.

INFORMATION FOR HEALTHCARE PROFESSIONALS ONLY

Ceftriaxone 1 g Powder for Solution for Injection or Infusion as ceftriaxone sodium

Ceftriaxone 2 g Powder for Solution for Injection or Infusion as ceftriaxone sodium

The medicinal product as such is not intended for immediate use and it has to be reconstituted with diluent before administration. Freshly prepared solutions are recommended. Solutions should be clear and colourless, do not use if particles are present.

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 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 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. Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1g should be injected at one site.

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 of the SPC.

To maintain potency of solution store for a maximum of 6 hours at or below 25°C or 24 hours at 2 – 8°C.

Protect from light.

Adults, the elderly and children aged over 12 years with a bodyweight 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.
• 50 – 80 mg Ceftriaxone for each kg of the child’s bodyweight 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 bodyweight 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 bodyweight of 50 kg or more should be given the usual adult dose.
• 20 – 50 mg Ceftriaxone for each kg of the child’s bodyweight 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 bodyweight.

Patients 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 or kidney problem.

If you are given more Ceftriaxone than you should

If you accidentally receive more than your prescribed dose, contact your doctor or nearest hospital straightaway.

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 to make up for a forgotten 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.

If any of the following serious side effects occurs after taking this medicine, you should tell a doctor immediately:

Severe allergic reactions – Frequency not known (frequency cannot be estimated from the available data):

If you have 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 reactions – Frequency not known (frequency cannot be estimated from the available data):

If you have a severe skin reaction, 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 (Stevens Johnson syndrome and toxic epidermal necrolysis) which are also known as SJS and TEN.
• A combination of any of the following symptoms: widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome)
• Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle pain, and skin rash that is usually self-limiting. This occurs shortly after starting Ceftriaxone treatment for infections with spirochete such as Lyme disease.

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.
• Fungal infections (e.g. 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).
• 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.
• 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 gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and claycoloured stools.
• 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.

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 carton and on the vial label after EXP. The expiry date refers to the last day of that month.

Do not store unopened vial above 25°C.

Keep the vial in the outer carton to protect from light..

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. From a microbiological point of view, the product should be used immediately. If not used in the recommended way, in-use storage times and conditions prior to use are the responsibility of the user as chemical and physical in-use stability will be impaired.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 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

Ceftriaxone 1 g Powder for Solution for Injection or Infusion

The active substance is ceftriaxone. Each vial contains 1 g (grams) ceftriaxone as ceftriaxone sodium. There are no excipients.

Ceftriaxone 2 g Powder for Solution for Injection or Infusion The active substance is ceftriaxone. Each vial contains 2 g (grams) ceftriaxone as ceftriaxone sodium. There are no excipients.

What Ceftriaxone looks like and contents of the pack

1g vial: Ceftriaxone 1 g Powder for Solution for Injection or Infusion is an almost white or yellowish crystalline powder which is packaged in a 30 ml glass vial with a rubber stopper and flip- off cap. The reconstituted solution is clear and colourless.

2g vial: Ceftriaxone 2 g Powder for Solution for Injection or Infusion is an almost white or yellowish crystalline powder which is packaged in a 50 ml glass vial with a rubber stopper and flip- off cap. The reconstituted solution is clear and colourless.

Ceftriaxone is available in packs containing 1, 5, 10, 25 or 50 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Advance Pharmaceuticals Limited, Old Police Station, Church Street, Swadlincote, DE11 8LN UK

Manufacturer:

ProLife Pharma B.V. Laan van Vredenoord 33, RIJSWIJK, 2289DA, Netherlands

This leaflet was last revised in January 2022

Powder		Solution for reconstitution	Quantity of solution	Displacement volume
Intramuscular injection (I.M)	1 g	1% Lidocaine Hydrochloride Injection BP*	3.5 ml	0.71 ml
Intravenous injection (I.V)	1 g	Water for Injections BP	10 ml	0.71 ml
Intravenous infusion	2 g	5% Dextrose Injection 10% Dextrose Injection 0.9% Sodium Chloride Injection Water for Injection	40 ml	1.37 ml

* Solutions of ceftriaxone in Lidocaine must not be administered intravenously.

If other solutions are used, compatibility with ceftriaxone must be checked. Ceftriaxone should not be mixed in the same syringe with any other drug. The infusion line should be flushed after each administration.

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