Ceftriaxone Accord

Patient Information Leaflet

Ceftriaxone Accord 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
Ceftriaxone Accord 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
Ceftriaxone (as ceftriaxone sodium)
Lidocaine (as lidocaine hydrochloride)
Generic medicine
Please read this leaflet carefully before you are given this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Ceftriaxone Accord is and what it is used for
2. What you need to know before you are given Ceftriaxone Accord
3. How Ceftriaxone Accord is administered
4. Possible side effects
5. How to store Ceftriaxone Accord
6. Contents of the pack and other information

1. What Ceftriaxone Accord is and what it is used for

Ceftriaxone Accord contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including newborns). It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins. Ceftriaxone Accord is administered by injection into a muscle in a solution containing lidocaine, which reduces the pain associated with the injection.
Ceftriaxone Accord is used to treat infections:

• of the brain (meningitis).
• of the lungs.
• of the middle ear.
• of the abdomen and abdominal wall (peritonitis).
• of the urinary tract and kidneys.
• of bones and joints.
• of the skin or soft tissues.
• of the blood.
• of the heart.

It may be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis).
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have fever due to bacterial infection.
• to treat chest infections in adults with chronic bronchitis.
• to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age.
• to prevent infections during surgery.

2. What you need to know before you are given Ceftriaxone Accord

Do not receive Ceftriaxone Accord if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have previously experienced a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams, and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of hands, feet, and ankles, or a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone Accord is to be administered by intramuscular injection.
• you have a heart conduction disorder causing low blood pressure and slowed heart rate (complete atrioventricular block).
• you have a reduced blood volume (hypovolemia).

Ceftriaxone Accord must not be given to children in the following cases:

• the child is premature.
• the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or if the child is to receive a calcium-containing product intravenously.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Ceftriaxone Accord if:

• you have recently received or are about to receive products containing calcium.
• you have recently had diarrhoea after taking an antibiotic. You have intestinal problems, particularly colitis (inflammation of the intestine).
• you have liver or kidney problems (see section 4).
• you have gallstones or kidney stones.
• you have other diseases, for example haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin, weakness, or shortness of breath).
• you are on a low-sodium diet.
• you have loss of muscle function and weakness (myasthenia gravis).
• you have seizures (epilepsy).
• you have any heart conditions, especially if they affect your heart rate.
• you have respiratory problems.
• you have porphyria (a rare inherited disorder affecting the skin and nervous system).
• you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering on lips, eyes, and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels detectable in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).

If you need to have blood or urine tests
If you are given Ceftriaxone Accord for a prolonged period, you may need regular blood tests. Ceftriaxone Accord may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are due to have tests:

• inform the person taking your sample that you have been given Ceftriaxone Accord.

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that may inaccurately measure blood glucose during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist, or nurse. Alternative testing methods should be used if necessary.

Children
Talk to your doctor, pharmacist, or nurse before administering Ceftriaxone Accord to a child if:

• the child has recently received or is about to receive a calcium-containing product intravenously.

Other medicines and Ceftriaxone Accord
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines, as they may interact with ceftriaxone:

• an antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used to treat infections, particularly eye infections).
  Several medicines may interact with lidocaine, leading to altered effects. These include:
  • medicines used to treat infections (clarithromycin, erythromycin).
  • medicines used to treat stomach ulcers (e.g., cimetidine).
  • strong painkillers such as codeine and meperidine (narcotic or opioid medicines).
  • medicines used to treat irregular heart rate (e.g., mexiletine, tocainide).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will evaluate the benefits of treatment with Ceftriaxone Accord for you and the potential risks for your baby.

Driving and using machines
Ceftriaxone Accord may cause dizziness. If you feel dizzy, do not drive and avoid using tools or machinery.
Contact your doctor if you experience these symptoms.

Ceftriaxone Accord 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
contains sodium
This medicine contains 41.4 mg of sodium (main component of table salt) per vial.
This corresponds to 2% of the maximum daily dietary intake recommended for an adult.

Ceftriaxone Accord 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
contains sodium
This medicine contains 82.9 mg of sodium (main component of table salt) per vial.
This corresponds to 4% of the maximum daily dietary intake recommended for an adult.

3. How Ceftriaxone Accord is administered

Ceftriaxone Accord is generally administered by a doctor or nurse via an injection given directly into a muscle. Ceftriaxone Accord will be prepared by a doctor, pharmacist, or nurse and will not be mixed with, nor administered simultaneously to, injections containing calcium.
Usual dose
Your doctor will determine the correct dose of Ceftriaxone Accord for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the functioning of your kidneys and liver. The number of days or weeks during which you will receive Ceftriaxone Accord will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight equal to or greater than 50 kilograms (kg):

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.
  Newborns, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:
• 50–80 mg of Ceftriaxone Accord once daily per kg of the child's body weight, depending on the severity and type of infection. If the infection is severe, your doctor may prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be administered as a single daily dose or as two separate doses.
• Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Newborns (0–14 days of life)

• 20–50 mg of Ceftriaxone Accord once daily per kg of the newborn's body weight, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the newborn's body weight.

Patients with liver or kidney problems
You may be given a different dose than the usual one. Your doctor will decide how much Ceftriaxone Accord you will need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given too much Ceftriaxone Accord
If you are accidentally given more Ceftriaxone Accord than prescribed, contact your doctor or the nearest hospital immediately.
If you miss a dose of Ceftriaxone Accord
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not administer a double dose (two injections together) to make up for a missed dose.
If you stop treatment with Ceftriaxone Accord
Do not stop taking Ceftriaxone Accord unless instructed by your doctor. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

With this medicine, you may experience the following side effects:

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, seek medical attention immediately.
Signs may include:

• Sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
• Sudden swelling of the hands, feet and ankles.

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, inform a doctor immediately.
Signs may include:

• Severe rash that develops rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, which usually resolves spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone Accord for spirochete infections such as Lyme disease. Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause a reduced level of consciousness, abnormal movements, agitation and seizures.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Abnormalities in white blood cells (such as reduced white blood cell count and increased eosinophils) and platelets (reduced thrombocytes).
• Soft stools or diarrhoea.
• Changes in blood test results for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• Decrease in the number of white blood cells (granulocytopenia).
• Reduction in the number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Ceftriaxone Accord was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (increased creatinine in blood).

Rare (may affect up to 1 in 1,000 people)

• Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with raised itchy areas (urticaria) that may cover large areas of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid accumulation).
• Chills.

Not known (frequency cannot be estimated from the available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Seizures.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Gallbladder problems that may cause pain, nausea and vomiting.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease.
• False positive Coombs test (a blood test to detect blood-related problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone Accord may interfere with certain types of tests to measure blood glucose; please check with your doctor.

Following accidental injection of lidocaine into a blood vessel during intramuscular administration of Ceftriaxone Accord, additional side effects may occur, which may include:
Not known (frequency cannot be estimated from the available data)

• Changes in heart rhythm and rate.
• Low blood pressure.
• Slowed heart rate (less than 60 beats/minute).
• Interruption of normal blood circulation due to cardiac arrest and reduced blood flow.
• Loss of balance, tingling around the mouth, numbness of the tongue, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or lightheadedness, confusion, nervousness, involuntary rhythmic muscle contractions, seizures or epileptic fits, deep unconsciousness (coma).
• Blurred vision, double vision or temporary loss of vision.
• Feeling unwell (nausea or vomiting).
• Breathing difficulties.
• Reduced respiratory rate or possible cessation of breathing.
• Unusual drowsiness or tiredness during the day or fainting.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceftriaxone Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
From a microbiological standpoint, the product should be used immediately after reconstitution. If not used immediately, the period and conditions of storage prior to use are the responsibility of the user. The chemical and physical stability of the medicine after reconstitution has been demonstrated for 24 hours between +2°C and +8°C and for 6 hours when stored below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ceftriaxone Accord contains
Ceftriaxone Accord 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains: ceftriaxone sodium 596.5 mg equivalent to 500 mg of ceftriaxone.
One solvent ampoule contains: 1% aqueous lidocaine solution.
Ceftriaxone Accord 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains: ceftriaxone sodium 1.193 g equivalent to 1 g of ceftriaxone.
One solvent ampoule contains: 1% aqueous lidocaine solution.
Ceftriaxone Accord must not be mixed with other medicinal products in the same syringe.

Description of the appearance of Ceftriaxone Accord and contents of the pack
Ceftriaxone Accord 500 mg/2 ml powder and solvent for injectable solution for intramuscular use:
1 powder vial + 1 solvent ampoule of 2 ml.
Ceftriaxone Accord 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use:
1 powder vial + 1 solvent ampoule of 3.5 ml.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain.

Manufacturer
Laboratorio Farmaceutico CT Srl
Via Dante Alighieri, 71
18038 Sanremo (IM)