Ceftriaxone 2 g Powder for Solution for Injection or Infusion – patient leaflet, side effects, dosage

1. WHAT CEFTRIAXONE INJECTION IS AND WHAT IT IS USED FOR

Ceftriaxone Injection 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 Injection 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 INJECTION

You must not be given Ceftriaxone Injection 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, chest pain 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 Injection 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 Injection 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 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.

• 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 and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).

  • You have liver or kidney problems ( see section 4) If you need a blood or urine test

If you are given Ceftriaxone Injection for a long time, you may need to have regular blood tests. Ceftriaxone Injection 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 Injection.

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 Injection 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

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 Injection against the risk to your baby.

Driving and using machines

Ceftriaxone Injection 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 Injection contains sodium

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

3. HOW CEFTRIAXONE INJECTION IS GIVEN

Ceftriaxone Injection 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 Injection 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 Injection 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 Injection 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 Injection 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.

The following information is intended for healthcare professionals only

Prueba N.º

Version No. 8

Fecha

Date 27.10.2025

REIG JOFRE

Código

Factory Code 229755/2508

Sustituye a

Replace to 229755/2407

Producto / Product Name

PROSP. CEFTRIAXONE 1G/2G IV UK

Tamaño / Size Diseño realizado a escala: 100%

Image prints @ 100% 170 x 520 mm

Plegado / Folded

170 x 30 mm

N.º de Colores / No Colours

Colores / Colours

Negro / Black

Cód. Barras / Barcode

206

Papel / Paper

Offset blanco / Offset white 40 g/m²

Tipografía / Fonts

Helvetica

(condensed, italic y bold)

Tamaño / Type Size : 8 pt.

Interlínea / Line Spacing : 8,2 pt.

Correcciones

Not Approved Aprobado

Approved

Por favor, marque lo que corresponda Please, check the appropiate box

Fecha y Firma / Date and Signed

Anverso / Front

170 mm

Sentido de lectura

206

After addition of the recommended reconstitution solution specified below, shake well (up to 60 seconds) until the contents of the vial have dissolved completely. 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.

When reconstituted for intramuscular or intravenous injection, the white to yellowish crystalline powder gives a pale yellow to amber solution.

Ceftriaxone should not be mixed in the same syringe with any drug other than 1% w/v Lidocaine Injection

BP (for intramuscular injection only).

Intramuscular injection:

1 g ceftriaxone should be dissolved in 3.5 ml of 1 % w/v Lidocaine Injection BP. The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site. Not more than 1 g should be injected on either side of the body. The maximum dose by intramuscular injection should not exceed 2 g.

Solutions in lidocaine should not be administered intravenously. Intravenous injection:

1 g ceftriaxone should be dissolved in 10 ml 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. Intravenous infusion:

2 g ceftriaxone should be dissolved in 40 ml of one of the following calcium-free solutions: Sodium Chloride Intravenous Infusion BP 0.9%, Sodium Chloride and Glucose Intravenous Infusion BP (sodium chloride 0.45% and glucose 2.5%), Glucose Intravenous Infusion BP 5% or 10%, Dextran 6% in Glucose Intravenous Infusion BP 5%. The infusion should be administered over at least 30minutes. Displacement value

Any unused product or waste material should be disposed of in accordance with local requirements.

Incompatibilities

Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides. Solutions containing ceftriaxone should not be mixed with or added to other agents except those mentioned in ‘Instructions for use’. 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 or bottle for intravenous administration because a precipitate can form. Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions including total parenteral nutrition.

Shelf life Unopened:

Powder: 3 years.

Opened and after reconstitution:

For reconstituted solutions, chemical and physical in-use stability has been demonstrated for 6 hours at 25°C and for 24 hours at 2-8°C. Protect from light.

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 or 6 hours at 25°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Special precautions for storage

Unopened: Do not store above 25°C. Keep the container in the outer carton in order to protect from light.

This leaflet was last revised in October 2025. 229755/2508 Pre-operative prophylaxis of surgical site infections 20-50 mg/kg as a single pre-operative dose.

Syphilis

The generally recommended dose is 50 mg/kg once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.

Duration of therapy

The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should be continued for 48 - 72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved. Older people

The dosages recommended for adults require no modification in older people provided that renal and hepatic function is satisfactory. Patients with hepatic impairment

Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment provided renal function is not impaired.

There are no study data in patients with severe hepatic impairment. Patients with renal impairment

In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided hepatic function is not impaired. Only in cases of preterminal renal failure (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 g daily. In patients undergoing dialysis no additional supplementary dosing is required following the dialysis. Ceftriaxone is not removed by peritoneal- or haemodialysis. Close clinical monitoring for safety and efficacy is advised.

Patients with severe hepatic and renal impairment

In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised. Method of administration

Intramuscular administration

Ceftriaxone Injection can be administered by deep intramuscular injection. Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1 g should be injected at one site.

As the solvent used is lidocaine, the resulting solution should never be administered intravenously. The information in the Summary of Product Characteristics of lidocaine should be considered. Intravenous administration

Ceftriaxone Injection can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes. Intravenous intermittent injection should be given over 5 minutes preferably in larger veins. Intravenous doses of 50 mg/kg or more in infants and children up to 12 years of age should be given by infusion. In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy. Intramuscular administration should be considered when the intravenous route is not possible or less appropriate for the patient. For doses greater than 2 g intravenous administration should be used. Ceftriaxone is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium.

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 intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously.

For pre-operative prophylaxis of surgical site infections, ceftriaxone should be administered 30-90 minutes prior to surgery. Instructions for use

The use of freshly prepared solutions is recommended. These maintain potency for at least 6 hours at or below 25°C or 24 hours at 2-8°C. Protect from light.

This medicinal product must not be mixed with other medicinal products except those mentioned below.

Newborn babies (0-14 days)

• 20 – 50 mg Ceftriaxone Injection 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 Injection you will need and will check you closely depending on the severity of the liver and kidney disease. If you are given more Ceftriaxone Injection than you should

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

If you forget to use Ceftriaxone Injection

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 Injection 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.
• Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome). Severe skin reactions (not known, frequency cannot be estimated from the available data)

If you get 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 Injection 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.

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 Injection 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 (hemolytic anemia).
  • 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 clay-coloured 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 Injection may interfere with some types of blood glucose tests - please check with your doctor.

Treatment with ceftriaxone, particularly in elderly patients with serious kidney or nervous system problems may rarely cause decreased consciousness,abnormal movements, agitation and convulsions.

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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. HOW TO STORE CEFTRIAXONE INJECTION

Keep this medicine out of the sight and reach of children. Do not store above 25˚C. Keep the vial in the outer carton in order to protect from light.

Once reconstituted, this medicine should be used within 24 hours if stored at a temperature of 2-8˚C or within 6 hours if stored at 25˚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 or 6 hours at 25°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

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 1 g Powder for Solution for Injection or Infusion contains:

The active substance is ceftriaxone. Each vial contains 1 g of ceftriaxone as the sodium salt. There are no other ingredients. What Ceftriaxone 2 g Powder for Solution for Injection or Infusion contains:

The active substance is ceftriaxone. Each vial contains 2 g of ceftriaxone as the sodium salt. There are no other ingredients. What Ceftriaxone Injection looks like and contents of the pack

Ceftriaxone Injection is an almost white to yellowish crystalline powder, supplied in a glass vial. Before it is given to the patient the powder is dissolved in sterile liquid. The ready-to-use solutions are pale yellow to amber.

Ceftriaxone 1 g vials are available in packs of 1 vial and 5 vials. Not all pack sizes may be marketed. Ceftriaxone 2 g vials are available in packs of 1 vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

Reig Jofre UK Limited

Follaton House, Plymouth Road, Totnes, Devon, TQ9 5NE, United Kingdom

Manufacturer:

Laboratorio Reig Jofré, SA,

Calle del Rio Jarama, 111

45007, Toledo

Spain

This leaflet was last revised in October 2025.

Tipografía / Fonts

Helvetica

(condensed, italic y bold) Tamaño / Type Size : 8 pt. Interlínea / Line Spacing : 8,2 pt.

Correcciones

Not Approved Aprobado

Approved

Por favor, marque lo que corresponda Please, check the appropiate box

Fecha y Firma / Date and Signed

Reverso / Back

170 mm