CLAXON 500 mg /2 Ml Proszek I Rozpuszczalnik Do Roztworu Do Wstrzykiwań

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

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 solution for infusion

Ceftriaxone

Equivalent medicine
Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 CLAXON is given to you
• 3. How CLAXON is given to you
• 4. Possible side effects
• 5. How to store CLAXON
• 6. Contents of the pack and other information

1. What is CLAXON 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 the bones and joints.
• of the skin or soft tissues.
• of the blood.
• of the heart.

It can be administered:

• to treat specific sexually transmitted infections (gonorrhea and syphilis).
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have a 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 life.
• to prevent infections during surgery.

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

You must not be given CLAXON 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 and monobactams). Possible signs include a sudden swelling of the throat or face, which can make it difficult to breathe or swallow, a sudden swelling of hands, feet and ankles, chest pain and a severe skin rash that develops rapidly
• you are allergic to lidocaine and Claxon is to be given to you by injection into a muscle.
• you suffer from an abnormality in the propagation of the impulse in the heart that causes a reduction in blood pressure and a slowing of the heart rate (complete atrioventricular block).
• you suffer from a condition of 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 life) and has some blood problems or jaundice (yellowing of the skin or the white of the eye) or must receive through a vein a product that contains 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 problems with diarrhea after taking an antibiotic. You have had problems with the intestine, in particular colitis (inflammation of the intestine).
• you suffer from problems with the liver or kidneys (see section 4).
• you have gallstones or kidney stones.
• you experience or have experienced a severe and sudden allergic reaction (anaphylactic shock). Before starting therapy with Claxon, the doctor will determine if you have already experienced an allergy to cephalosporins or other antibiotics in the past.
• you have other diseases, for example hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath).
• you are following 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 problem, especially if this affects your heart rate.
• you have breathing problems.
• you suffer from porphyria (a rare hereditary disease that affects the skin and nervous system).
• you experience or have experienced in the past any combination of the following symptoms: skin 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 and increased number of a type of white blood cells (eosinophilia) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).

If you are going to have a blood or urine test
If you are given Claxon for a prolonged period, you may need to have regular
blood tests. Claxon can affect the results of urine tests related to sugar and a blood
test known as the Coombs test. If you are about to have tests:

• inform the person taking your sample that you have been given Claxon. If you are diabetic or need monitoring of blood glucose levels, you should not use some blood glucose monitoring systems that can detect blood glucose incorrectly during treatment with ceftriaxone. If you use such systems, check the instructions for use and inform your doctor, pharmacist or nurse. If necessary, alternative analysis methods should be used.

Children
Talk to your doctor, pharmacist or nurse before giving Claxon to the child if:

• the child has recently received or is about to receive through a vein a product that contains 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, tell your doctor or pharmacist if you are taking any of the following medicines, as
they can interact with ceftriaxone:

• a type of antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used to treat infections, particularly eye infections). Several drugs can interact with lidocaine, resulting in altered effects. These drugs include:
• medicines used to treat infections (clarithromycin, erythromycin).
• medicines used in the treatment of stomach ulcers (e.g. cimetidine).
• potent painkillers such as codeine and pethidine (narcotic or opioid drugs).
• medicines used to treat irregular heartbeat (e.g. mexiletine, tocainide). Pregnancy, breastfeeding and fertilityIf you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The doctor will assess the benefits of treatment with Claxon and the possible risks to the baby.

Driving and operating machinery
CLAXON can cause dizziness. If you feel dizzy, do not drive vehicles and do not use tools or machinery.
Contact your doctor if you experience these symptoms.

Claxon contains sodium
The 500 mg dosage contains 41 mg of sodium (the main component of table salt) per
vial of powder. This is equivalent to 2% of the recommended maximum daily intake with the diet of an
adult.
The 1 g dosage contains 83 mg of sodium (the main component of table salt) per vial of
powder. This is equivalent to 4% of the recommended maximum daily intake with the diet of an adult.
The 2 g dosage contains 166 mg of sodium (the main component of table salt) per vial of
powder. This is equivalent to 8% of the recommended maximum daily intake with the diet of an
adult.

3. How CLAXON is administered

Claxon is generally administered by a doctor or nurse via

• an intravenous drip (intravenous infusion) or via an injection directly into a vein or via an injection directly into a muscle. Claxon will be prepared by a doctor, pharmacist or nurse and will not be mixed or administered with injections containing calcium. Usual doseThe doctor will determine the right dose of Claxon for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your weight and age, the degree of functioning of your kidneys and liver. The number of days or weeks during which you will receive Claxon will depend on the type of infection you have.

Adults, elderly patients and children aged 12 years or older with a body weight of at least
50 kilograms (kg):

• 1 to 2 g once a day depending on the severity and type of infection.

If you have a serious infection, the doctor will administer a higher dose (up to 4 g per day).
If your daily dose is more than 2 g, you may take it as a single dose once a day
or as two separate doses.

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

• 50-80 mg Claxon once a day for each kg of the child's body weight depending on the severity and type of infection. If you have a serious infection, the doctor will 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 is more than 2 g, you may take 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.

Newborns (0-14 days of life)

• 20-50 mg Claxon once a day for each kg of the newborn's body weight depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per kg of the newborn's body weight

People with liver and kidney problems
You may be given a different dose than usual.
The doctor will decide the amount of Claxon you need and will monitor you closely, depending on
the severity of liver and kidney disease.

If you take more CLAXON than you should
If you are accidentally given more Claxon than the prescribed dose, seek immediate medical attention
from your doctor or the nearest hospital.

If you forget to take Claxon
If you miss an injection, you should receive it as soon as possible. However, if it is almost time to receive the next scheduled injection, skip the missed injection.
Do not take a double dose (two injections together) to make up for the missed dose.

If you stop taking CLAXON
Do not stop taking Claxon unless your doctor tells you to.
If you have any doubts about 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.
With this medicine you may experience the following side effects:
Treatment with ceftriaxone, especially in elderly patients with severe kidney failure or pa-
thologies of the nervous system, may in rare cases cause a reduction in the state of co-
sciousness, abnormal movements, agitation and convulsions.

Serious allergic reactions (frequency not known, cannot be defined on the basis of available data)
If you have a serious allergic reaction, seek immediate medical attention
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 a heart attack sca- triggered by an allergy (Kounis syndrome).

Serious skin reactions (frequency not known, cannot be defined on the basis of available data)
If you develop a serious skin reaction, tell your doctor immediately.
The signs may include:

• Severe rash that develops rapidly, with blistering or peeling of the skin and possible blistering in the mouth (StevensJohnson syndrome and toxic epidermal necrolysis, also known by the acronyms SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), enlarged lymph nodes and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known by the acronym DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which can cause fever, chills, headache, muscle pain and rash, which generally tends to resolve spontaneously. These symptoms occur shortly after starting treatment with Claxon for infections caused by spirochetes such as Lyme disease.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• White blood cell abnormalities (such as decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhea.
• Changes in blood test results for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (for example, thrush).
• Decrease in the number of white blood cells (granulocytopenia).
• Reduction in the number of red blood cells (anemia).
• Blood clotting problems. The signs include easy bruising, pain and swelling of the joints.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Claxon was administered. Pain where the injection was given.
• Fever.
• Abnormal values in kidney function tests (increased creatinine in the blood).

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

• Inflammation of the large intestine (colon). The signs include diarrhea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with wheals (urticaria) that can cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid retention).
• Chills.

Frequency not known (cannot be estimated from available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anemia characterized by the destruction of red blood cells (hemolytic anemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Convulsions.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). The signs include severe stomach pain that extends to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). The signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and clay-colored stools.
• A neurological condition that can develop in newborns with severe jaundice (Kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. Pain may occur when urinating, or the amount of urine produced may be reduced.
• A false positive result on the Coombs test (a test to detect blood problems).
• A false positive result for galactosemia (an abnormal accumulation of galactose sugar).
• Claxon may interfere with some types of tests to measure blood glucose; check with your doctor. After accidental injection of lidocaine into a blood vessel during intramuscular administration of Claxon i.m., other side effects may occur, which may include:

Frequency not known (cannot be estimated from available data)

• Changes in heart rate and rhythm.
• Low blood pressure.
• Slowing of heart rate (less than 60 beats/minute).
• Interruption of normal blood circulation due to cardiac arrest and decreased 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, convulsions or seizures, deep state of unconsciousness (coma).
• Blurred vision, double vision or temporary loss of vision.
• Feeling unwell (nausea or vomiting).
• Difficulty breathing.
• Reduced breathing rate or possible cessation of breathing.
• Unusual feeling of drowsiness or fatigue during the day or fainting.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system reported at the address
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 Claxon

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 pack after “Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C. Keep the vials in the outer packaging to
protect them from light.
The chemical and physical stability during use of the reconstituted product has been demonstrated for at least 6 hours at a
temperature equal to or less than 25 °C, or up to 24 hours at a temperature of 2-8 °C.
From a microbiological point of view, the product must be used immediately. If not used im-
mediately, the storage period and conditions before use are the responsibility of the user and must not exceed the times indicated above for the chemical and physical stability during use.
Do not dispose of any medicine in the 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 Claxon contains
Claxon 500 mg/ 2 ml powder and solvent for injectable solution for intramuscular use
The active ingredient is ceftriaxone disodium. One vial of powder contains 3.5 H O 596.5 mg equivalent to
ceftriaxone 500 mg.
One solvent vial contains: aqueous solution of lidocaine 1%.

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

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

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

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

Marketing Authorisation 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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