Claxon

PACKAGE LEAFLET: INFORMATION FOR THE USER

CLAXON 500 mg / 2 ml powder and solvent for injectable solution for intramuscular use, 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use, 1 g / 10 ml powder and solvent for injectable solution for intravenous use, 2 g powder for infusion solution

Ceftriaxone
Generic medicine
Please read this leaflet carefully before using this medicine because 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. Do not 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 CLAXON is and what it is used for
2. What you need to know before being administered CLAXON
3. How CLAXON is administered
4. Possible side effects
5. How to store CLAXON
6. Contents of the pack and other information

1. What CLAXON is and what it is used for

Claxon 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.
CLAXON 500 mg/ 2 ml powder and solvent for injectable solution for intramuscular use
CLAXON 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
Claxon is administered by injection into a muscle in a solution containing lidocaine, which reduces the pain associated with the injection.
Claxon 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 surgical procedures.

2. What you need to know before you are given CLAXON

Do not be given CLAXON if:

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

CLAXON 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 needs to receive intravenous products containing calcium.

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

• you have recently received or are about to receive products containing calcium;
• you have recently had diarrhoea after taking an antibiotic; you have had intestinal problems, particularly colitis (inflammation of the intestine);
• you suffer from liver or kidney problems (see section 4);
• you have gallstones or kidney stones;
• you have experienced or have previously experienced a severe and sudden allergic reaction (anaphylactic shock). Before starting treatment with Claxon, your doctor will determine whether you have previously had an allergy to cephalosporins or other antibiotics;
• you have other diseases, such as 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 suffer from loss of muscle function and weakness (myasthenia gravis);
• you suffer from seizures (epilepsy);
• you suffer from any heart condition, especially if it affects your heart rate;
• you have respiratory problems;
• you suffer from porphyria (a rare inherited disease 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 levels of liver enzymes detectable in blood tests, increase in 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 undergo blood or urine tests
If you are given Claxon for a prolonged period, you may need to have regular blood tests. Claxon may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to undergo testing:

• inform the person collecting your sample that you have been given Claxon. 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 giving Claxon to a child if:

• the child has recently received or is about to receive intravenous products containing calcium.

Other medicines and CLAXON
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, resulting in 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 pethidine (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, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will assess the benefits of treatment with Claxon for you and the potential risks for the baby.

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

Claxon contains sodium
The 500 mg dose contains 41 mg of sodium (the main component of table salt) per vial of powder. This corresponds to 2% of the maximum daily dietary intake recommended for an adult.
The 1 g dose contains 83 mg of sodium (the main component of table salt) per vial of powder. This corresponds to 4% of the maximum daily dietary intake recommended for an adult.
The 2 g dose contains 166 mg of sodium (the main component of table salt) per vial of powder. This corresponds to 8% of the maximum daily dietary intake recommended for an adult.

3. How CLAXON is administered

Claxon is generally administered by a doctor or nurse via

• intravenous infusion (IV infusion), or by an injection given directly into a vein or by an injection given directly into a muscle. Claxon will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered together with calcium-containing injections.

Usual dose
Your doctor will determine the correct dose of Claxon 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 extent of kidney and liver function. The number of days or weeks during which you will receive Claxon depends on the type of infection you have.

Adults, elderly patients, and children aged 12 years and 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 either as a single daily dose or divided into two separate doses.

Newborns, infants, and children from 15 days up to 12 years of age with a body weight below 50 kg:

• 50–80 mg of Claxon once daily per kg of the child’s body weight, depending on the severity and type of infection.
  If the child has a severe infection, the 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 the daily dose exceeds 2 g, it may be given either as a single daily dose or divided into 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 Claxon 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 from the usual.
Your doctor will decide the amount of Claxon you need and will monitor you closely based on the severity of your liver or kidney disease.

If you are given more CLAXON than you should
If you are accidentally given more Claxon than prescribed, contact your doctor or go to the nearest hospital immediately.

If you miss a dose of Claxon
If you miss an injection, it should be given as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose.
Do not take a double dose (two injections at the same time) to make up for a forgotten dose.

If you stop treatment with CLAXON
Do not stop taking Claxon unless your doctor tells you to do so.
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 everyone will experience them.
With this medicine, you may experience the following side effects:
Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or neurological
conditions, may rarely cause reduced level of consciousness, abnormal movements, agitation, and seizures.

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you experience a severe allergic reaction, seek immediate medical attention.
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.
• Chest pain occurring during allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).

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 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 skin rash, which usually resolves spontaneously. These symptoms may occur shortly after starting Claxon treatment for spirochete infections such as Lyme disease.

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

• Abnormalities in white blood cells (such as reduced leukocytes and increased eosinophils) and platelets (decreased 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., oral thrush).
• Decreased number of white blood cells (granulocytopenia).
• Reduced 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 Claxon was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function test results (increased blood creatinine).

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).
• Skin rash with wheals (urticaria), which may cover a large area 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 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 and/or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and clay-coloured stools.
• 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 a reduced amount of urine produced.
• False positive Coombs test (a blood test to detect blood-related problems).
• False positive galactosaemia test (an abnormal accumulation of the sugar galactose).
• Claxon may interfere with certain types of blood glucose tests; please check with your doctor. Following accidental intravascular injection of lidocaine during intramuscular administration of Claxon i.m., the following additional side effects may occur:

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 per 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 fatigue during the day or fainting.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Claxon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30 °C. Keep the vials in the outer packaging to protect them from light.
Chemical and physical in-use stability has been demonstrated for at least 6 hours at a temperature not exceeding 25 °C, or up to 24 hours at 2-8 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the period and conditions of storage prior to use are the responsibility of the user and must not exceed the times indicated above for chemical and physical in-use stability.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Claxon contains
Claxon 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
The active substance is ceftriaxone disodium. One vial of powder contains 3.5 H₂O 596.5 mg equivalent to
ceftriaxone 500 mg.
One solvent ampoule contains: 1% aqueous solution of lidocaine.

Claxon 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
The active substance is ceftriaxone disodium. One vial of powder contains 3.5 H₂O 1.193 g equivalent to
ceftriaxone 1 g.
One solvent ampoule contains: 1% aqueous solution of lidocaine.

Claxon 1 g / 10 ml powder and solvent for injectable solution for intravenous use
The active substance is ceftriaxone disodium. One vial of powder contains 3.5 H₂O 1.193 g equivalent to
ceftriaxone 1 g.
One solvent ampoule contains: water for injection.

Claxon 2 g powder for infusion solution
The active substance is ceftriaxone disodium. One vial of powder contains 3.5 H₂O 2.386 g equivalent to
ceftriaxone 2 g.

Description of the appearance of Claxon and contents of the package
Claxon 500 mg/2 ml powder and solvent for injectable solution for intramuscular use:
1 powder vial + 1 solvent ampoule of 2 ml.
Claxon 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use:
1 powder vial + 1 solvent ampoule of 3.5 ml.
Claxon 1 g / 10 ml powder and solvent for injectable solution for intravenous use:
1 powder vial + 1 solvent ampoule of 10 ml.
Claxon 2 g powder for infusion solution: 1 powder vial.

Marketing Authorization Holder
GENETIC S.p.A. – Via Della Monica, n. 26 – Castel San Giorgio (SA)

Manufacturer
ESSETI FARMACEUTICI S.r.L., Via Campobello 15, Pomezia 00040 Roma

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