Ceftriaxone Tecnigen

Package leaflet: Information for the patient

CEFTRIAXONE TECNIGEN

2 g powder for solution for infusion
Ceftriaxone (as ceftriaxone disodium)
Equivalent medicine
Please read this leaflet carefully before this medicine is administered to you
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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What CEFTRIAXONE TECNIGEN is and what it is used for

CEFTRIAXONE TECNIGEN contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including neonates). It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

CEFTRIAXONE TECNIGEN 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
• the bones and joints
• the skin or soft tissues
• the blood
• the heart

It may also 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 neonates from 15 days of age
• to prevent infections during surgery

2. What you need to know before you are given CEFTRIAXONE TECNIGEN

CEFTRIAXONE TECNIGEN must not be administered to you 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 the hands, feet, and ankles, or a severe rash that develops rapidly.
• you are allergic to lidocaine and CEFTRIAXONE TECNIGEN is to be administered by intramuscular injection.

CEFTRIAXONE TECNIGEN must not be administered 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 the whites of the eyes), or if the child is to receive a product containing calcium through a vein.

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

• you are currently experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering on lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increased levels of a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).
• you have recently received or are about to receive products containing calcium.
• you have recently had diarrhoea after taking an antibiotic, or 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, 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.

If you are due to have blood or urine tests
If you are given CEFTRIAXONE TECNIGEN for a prolonged period, you may need to have regular blood tests. CEFTRIAXONE TECNIGEN 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 TECNIGEN.

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

Children
Talk to your doctor, pharmacist, or nurse before administering CEFTRIAXONE TECNIGEN to a child if:

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

Other medicines and CEFTRIAXONE TECNIGEN
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• an antibiotic called an aminoglycoside
• an antibiotic called chloramphenicol (used to treat infections, particularly eye infections).

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

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

CEFTRIAXONE TECNIGEN contains sodium
This medicine contains 165.87 mg of sodium (the main component of table salt) per 2 g vial. This corresponds to 8.29% of the maximum daily dietary intake recommended for an adult.

3. How CEFTRIAXONE TECNIGEN is administered

CEFTRIAXONE TECNIGEN is generally administered by a doctor or nurse via

• intravenous infusion (intravenous drip) or by direct injection into a vein.

CEFTRIAXONE TECNIGEN will be prepared by a doctor, pharmacist, or nurse and must not be mixed or co-administered with calcium-containing injections.
Usual dose
Your doctor will determine the correct dose of CEFTRIAXONE TECNIGEN 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 CEFTRIAXONE TECNIGEN will depend 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 as 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 TECNIGEN 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 administered either 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)
3/24

• 20–50 mg of CEFTRIAXONE TECNIGEN 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 one. Your doctor will decide the amount of CEFTRIAXONE TECNIGEN you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you are given more CEFTRIAXONE TECNIGEN than you should
If you are accidentally given more CEFTRIAXONE TECNIGEN than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of CEFTRIAXONE TECNIGEN
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 administer a double dose (two injections together) to make up for the missed dose.
If you stop treatment with CEFTRIAXONE TECNIGEN
Do not stop taking CEFTRIAXONE TECNIGEN unless instructed by your doctor.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
With this medicine, you may experience the following side effects:
treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced level of consciousness, abnormal movements, agitation, and seizures.

Severe allergic reactions (frequency not known, cannot be estimated from the available data)
If you have 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.

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

• Severe rash developing 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, elevated 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).

4/24

• 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 TecniGen 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 (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., 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 CEFTRIAXONE TECNIGEN was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (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).
• Rash with hives (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 the number of white blood cells (agranulocytosis).
• Seizures.
• Dizziness.
• 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 test to detect blood problems). 5/24
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• CEFTRIAXONE TECNIGEN may interfere with certain types of blood glucose tests; please consult your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at 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 TECNIGEN

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. The indicated expiry date applies to the product stored correctly in its original packaging.
This medicine does not require any special storage conditions. It is recommended to use freshly prepared solutions, even though the medicinal product, once dissolved, is stable for 6 hours at room temperature (temperature below 25°C) and for 24 hours in a refrigerator.
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. Package contents and other information

What CEFTRIAXONE TECNIGEN contains
CEFTRIAXONE TECNIGEN 2 g powder for solution for infusion
One vial contains:
The active substance is ceftriaxone disodium 3,5 H₂O 2,386 g, equivalent to ceftriaxone 2 g.
Description of the appearance of CEFTRIAXONE TECNIGEN and contents of the pack
CEFTRIAXONE TECNIGEN 2 g powder for solution for infusion:
1 vial
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera 29
20149 – Milan
Italy
Exclusive distributor for sale
TECNIGEN S.r.l.
Via Galileo Galilei 40
20092 Cinisello Balsamo (MI) Italy
Manufacturer
Laboratorio Farmaceutico CT - Via Dante Alighieri 71 - 18038 Sanremo (IM) – Italy
6/24

Patient information leaflet

CEFTRIAXONE TECNIGEN 250 mg/2 ml powder and solvent for injectable solution for

intramuscular use
CEFTRIAXONE TECNIGEN 500 mg/2 ml powder and solvent for injectable solution for
intramuscular use
CEFTRIAXONE TECNIGEN 1 g/3.5 ml powder and solvent for injectable solution for
intramuscular use
Ceftriaxone (as ceftriaxone disodium)
Lidocaine (as lidocaine hydrochloride)
Generic medicine
Please read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, 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, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What CEFTRIAXONE TECNIGEN is and what it is used for
2. What you need to know before you are given CEFTRIAXONE TECNIGEN
3. How CEFTRIAXONE TECNIGEN is administered
4. Possible side effects
5. How to store CEFTRIAXONE TECNIGEN
6. Package contents and other information

1. What CEFTRIAXONE TECNIGEN is and what it is used for

CEFTRIAXONE TECNIGEN contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including neonates). It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
CEFTRIAXONE TECNIGEN is given by injection into a muscle as a solution containing lidocaine, which reduces the pain associated with the injection.
CEFTRIAXONE TECNIGEN 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 also be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis)
• to treat patients with a low white blood cell count (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 neonates from 15 days of age
• to prevent infections during surgical procedures.

2. What you need to know before you are given CEFTRIAXONE TECNIGEN

CEFTRIAXONE TECNIGEN must not be administered to you 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, 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, and a severe rash that develops rapidly.
• you are allergic to lidocaine and CEFTRIAXONE TECNIGEN is to be administered by intramuscular injection.
• you suffer from a heart conduction disorder causing low blood pressure and slowing of the heart rate (complete atrioventricular block).
• you suffer from reduced blood volume (hypovolemia).

CEFTRIAXONE TECNIGEN must not be administered to children in the following cases:

• the child is premature
• the child is a newborn (up to 28 days of life) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or needs to receive a product containing calcium through a vein.

Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before you are given CEFTRIAXONE TECNIGEN if:
• 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 cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”)
• 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 and lead to weakness or breathlessness)
• you are on a low-sodium diet
• you suffer from loss of muscle function and weakness (myasthenia gravis)
• you suffer from seizures (epilepsy)
• you have 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).

8/24
If you need to have a blood or urine test
If you are given CEFTRIAXONE TECNIGEN for a prolonged period, you may need to have regular blood tests. CEFTRIAXONE TECNIGEN may affect the results of urine sugar tests 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 administered CEFTRIAXONE TECNIGEN.

If you are diabetic or need to monitor your blood glucose levels, do not use certain blood glucose monitoring systems, as they may incorrectly 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 TECNIGEN to a child if:

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

Other medicines and CEFTRIAXONE TECNIGEN
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor, pharmacist, or nurse 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 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, planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Your doctor will evaluate the benefits of treatment with CEFTRIAXONE TECNIGEN for you and the possible risks for your baby.
Driving and using machines
CEFTRIAXONE TECNIGEN may cause dizziness. If you feel dizzy, do not drive or operate tools or machinery.
Contact your doctor if you experience these symptoms.
CEFTRIAXONE TECNIGEN contains sodium
CEFTRIAXONE TECNIGEN 250 mg/2 ml contains less than 1 mmol (23 mg) of sodium per 250 mg vial, i.e. essentially ‘sodium-free’.
CEFTRIAXONE TECNIGEN 500 mg/2 ml contains 41.47 mg of sodium (main component of table salt) per 500 mg vial. This corresponds to 2.07% of the maximum daily dietary intake recommended for an adult.
9/24
CEFTRIAXONE TECNIGEN 1 g/3.5 ml contains 82.9 mg of sodium (main component of table salt) per 1 g vial. This corresponds to 4.15% of the maximum daily dietary intake recommended for an adult.

3. How CEFTRIAXONE TECNIGEN is administered

CEFTRIAXONE TECNIGEN is generally administered by a doctor or nurse via an injection given directly into a muscle. CEFTRIAXONE TECNIGEN will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with calcium-containing injections.

Usual dose
Your doctor will determine the correct dose of CEFTRIAXONE TECNIGEN 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 TECNIGEN will depend 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 as 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 CEFTRIAXONE TECNIGEN 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 administered either 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 TECNIGEN 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 the amount of CEFTRIAXONE TECNIGEN you need and will closely monitor you, depending on the severity of your liver or kidney disease.

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

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

If you stop treatment with CEFTRIAXONE TECNIGEN
Do not stop taking CEFTRIAXONE TECNIGEN unless your doctor tells you to.
If you have any questions about using 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.
You may experience the following side effects with this medicine:
Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or neurological disorders, may rarely cause reduced level of consciousness, abnormal movements, agitation, and seizures.

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

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

Severe skin reactions (frequency not known, cannot be estimated from available data)
If you develop a severe skin reaction, seek immediate medical attention.
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, elevated 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 rash, which usually resolves spontaneously. These symptoms may occur shortly after starting treatment with CEFTRIAXONE TECNIGEN for spirochetal 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 (reduced thrombocytes).
• Soft stools or diarrhoea.
• Changes in blood test results related to liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g., 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. 11/24
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where CEFTRIAXONE TECNIGEN was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (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).
• Rash with raised red lumps (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 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.
• Problems with the gallbladder and/or liver, which may cause pain, nausea and 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 test for galactosaemia (an abnormal accumulation of the sugar galactose).
• CEFTRIAXONE TECNIGEN may interfere with certain types of blood glucose tests; please consult your doctor.

Following accidental injection of lidocaine into a blood vessel during intramuscular administration of CEFTRIAXONE TECNIGEN i.m., additional side effects may occur, which may include:
Not known (frequency cannot be estimated from 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. 12/24
• 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 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CEFTRIAXONE TECNIGEN

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. The stated expiry date applies to the product in its original, undamaged packaging, correctly stored.
This medicine does not require any special storage conditions. It is advisable to use freshly prepared solutions, even though the drug, once dissolved, is stable for 6 hours at room temperature (below 25°C) and for 24 hours under refrigeration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CEFTRIAXONE TECNIGEN contains
CEFTRIAXONE TECNIGEN 250 mg/2 ml powder and solvent for injectable solution for
intramuscular use
One vial of powder contains:

• The active substance is ceftriaxone disodium 3.5 H₂O 298.2 mg, equivalent to ceftriaxone 250 mg. One solvent ampoule contains: 1% aqueous solution of lidocaine.

CEFTRIAXONE TECNIGEN 500 mg/2 ml powder and solvent for injectable solution for
intramuscular use
One vial of powder contains:

• The active substance is ceftriaxone disodium 3.5 H₂O 596.5 mg, equivalent to ceftriaxone 500 mg. One solvent ampoule contains: 1% aqueous solution of lidocaine.

CEFTRIAXONE TECNIGEN 1 g/3.5 ml powder and solvent for injectable solution for
intramuscular use
One vial of powder contains:

• The active substance is ceftriaxone disodium 3.5 H₂O 1.193 g, equivalent to ceftriaxone 1 g. One solvent ampoule contains: 1% aqueous solution of lidocaine.

Description of the appearance of CEFTRIAXONE TECNIGEN and contents of the pack
CEFTRIAXONE TECNIGEN 250 mg/2 ml powder and solvent for injectable solution for intramuscular use:
1 vial of powder + 1 solvent ampoule of 2 ml
CEFTRIAXONE TECNIGEN 500 mg/2 ml powder and solvent for injectable solution for intramuscular use:
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1 vial of powder + 1 solvent ampoule of 2 ml
CEFTRIAXONE TECNIGEN 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use:
1 vial of powder + 1 solvent ampoule of 3.5 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 – Milan, Italy
Exclusive distributor for sale
TECNIGEN S.r.l.
Via Galileo Galilei 40
20092 Cinisello Balsamo (MI), Italy
Manufacturer
Laboratorio Farmaceutico CT - Via Dante Alighieri 71 - 18038 Sanremo (IM) – Italy
Additionally, for the 1 g/3.5 ml powder and solvent for intramuscular use:
ESSETI FARMACEUTICI S.r.l. - Via Campobello, 15 - 00040 Pomezia (RM) – Italy

Disposal of syringes/sharp objects
The following list of points must be strictly observed regarding the use and disposal of syringes and other sharp medical devices:

• Needles and syringes must never be reused.
• Place all used needles and syringes into a dedicated sharps container (single-use, puncture-resistant container).
• Keep the container out of reach of children.
• Used sharps containers must not be disposed of in household waste.
• Dispose of the full container in accordance with local requirements or as instructed by your physician.

Disposal of expired/unwanted medicines
Release of medicines into the environment must be minimized. Medicines must not be flushed down drains or disposed of in household waste. Use designated collection systems, if available.
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Patient Information Leaflet

CEFTRIAXONE TECNIGEN

1 g/10 ml powder and solvent for injectable solution for intravenous use
Ceftriaxone (as ceftriaxone disodium)
Equivalent medicine
Please read this leaflet carefully before this medicine is administered to you
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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What CEFTRIAXONE TECNIGEN is and what it is used for

CEFTRIAXONE TECNIGEN 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 TECNIGEN 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
• the bones and joints
• the skin or soft tissues
• the blood
• the heart.

It may also be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis)
• to treat patients with a low white blood cell count (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 TECNIGEN

Do not receive CEFTRIAXONE TECNIGEN 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, 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 TECNIGEN is to be administered by intramuscular injection.

CEFTRIAXONE TECNIGEN 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 certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or must receive a product containing calcium through a vein.

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

• 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, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).
• 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 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 which may cause pale yellow skin and lead to weakness or shortness of breath).
• you are on a low-sodium diet.

If you are to undergo blood or urine tests
If you are given CEFTRIAXONE TECNIGEN for a prolonged period, you may need to have regular blood tests. CEFTRIAXONE TECNIGEN 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 taking your sample that you have been administered CEFTRIAXONE TECNIGEN.

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that may incorrectly 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 analytical methods should be used if necessary.

Children
Talk to your doctor, pharmacist, or nurse before administering CEFTRIAXONE TECNIGEN to a child if:

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

Other medicines and CEFTRIAXONE TECNIGEN
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• an antibiotic called an aminoglycoside
• an antibiotic called chloramphenicol (used in the treatment of infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before this medicine is administered.
Your doctor will assess the benefits that treatment with CEFTRIAXONE TECNIGEN would provide you and the potential risks to the unborn or breastfed child.

Driving and using machines
CEFTRIAXONE TECNIGEN may cause dizziness. If you experience dizziness, do not drive or use tools or machines.
Contact your doctor if you experience these symptoms.

CEFTRIAXONE TECNIGEN contains sodium
This medicine contains 82.9 mg of sodium (a component of common salt) per 1 g vial. This is equivalent to 4.15% of the maximum daily recommended dietary intake of sodium for an adult.

3. How CEFTRIAXONE TECNIGEN is administered

CEFTRIAXONE TECNIGEN is generally administered by a doctor or nurse through an intravenous infusion (IV infusion) or via an injection directly into a vein.
CEFTRIAXONE TECNIGEN will be prepared by a doctor, pharmacist, or nurse and will not be mixed with, nor administered simultaneously with, injections containing calcium.

Usual dose
Your doctor will determine the correct dose of CEFTRIAXONE TECNIGEN 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 function of your kidneys and liver.
The number of days or weeks during which you will receive CEFTRIAXONE TECNIGEN will depend 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 as 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 TECNIGEN per kg of body weight once daily, 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 given either 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 TECNIGEN per kg of body weight once daily, depending on the severity and type of infection. 17/24
• The maximum daily dose must not exceed 50 mg per kg of body weight of the newborn.

Patients with liver or kidney problems
You may be given a different dose than the usual one. Your doctor will decide the amount of CEFTRIAXONE TECNIGEN you need and will monitor you closely, depending on the severity of your liver or kidney disease.

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

If you miss a dose of CEFTRIAXONE TECNIGEN
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 take a double dose (two injections together) to make up for the missed dose.

If you stop treatment with CEFTRIAXONE TECNIGEN
Do not stop taking CEFTRIAXONE TECNIGEN unless instructed by your doctor.
If you have any doubts about how to use 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:
Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or neurological disorders, 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 have 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.

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, seek immediate medical attention.
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 by the abbreviations SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, elevated 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 rash, which generally resolves spontaneously. These symptoms may occur shortly after starting treatment with Ceftriaxone TecniGen for spirochete infections such as Lyme disease.

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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 (reduced thrombocytes).
• Soft stools or diarrhoea.
• Changes in blood test results related to 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 CEFTRIAXONE TECNIGEN was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (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 cell count (agranulocytosis).
• Seizures.
• Dizziness.
• 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.
• Problems with the 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 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 test to detect blood problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• CEFTRIAXONE TECNIGEN may interfere with certain types of tests used to measure blood glucose; please check with your doctor.

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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 the following website:
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 TECNIGEN

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. The indicated expiry date applies to the product in its original, undamaged packaging, when properly stored.
This medicine does not require any special storage conditions. It is recommended to use freshly prepared solutions, although the medicinal product, once dissolved, is stable for 6 hours at room temperature (below 25°C) and for 24 hours in a refrigerator.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CEFTRIAXONE TECNIGEN contains
CEFTRIAXONE TECNIGEN 1 g/10 ml powder and solvent for injectable solution for intravenous use
One vial of powder contains:

• The active substance is ceftriaxone disodium 3.5 H₂O 1.193 g, equivalent to 1 g of ceftriaxone.
  One solvent vial contains: water for injection.

Description of the appearance of CEFTRIAXONE TECNIGEN and contents of the pack
CEFTRIAXONE TECNIGEN 1 g/10 ml powder and solvent for injectable solution for intravenous use:
1 vial of powder + 1 solvent vial of 10 ml

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera 29
20149 – Milan
Italy

Exclusive Sales Licensee
TECNIGEN S.r.l.
Via Galileo Galilei 40
20092 Cinisello Balsamo (MI) Italy

Manufacturer
Laboratorio Farmaceutico CT - Via Dante Alighieri 71 - 18038 Sanremo (IM) - Italy

Disposal of syringes/sharp objects
The following list of points must be strictly observed regarding the use and disposal of syringes and other sharp medical devices:
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• Needles and syringes must never be reused.
• Place all used needles and syringes into a dedicated sharps container (single-use, puncture-resistant container).
• Keep the container out of reach of children.
• Used sharps containers must not be disposed of in household waste.
• Dispose of the full container according to local requirements or as instructed by your physician.

Disposal of expired/unwanted medicines
Medicines must be disposed of in a way that minimizes their release into the environment. Medicines must not be flushed down drains or disposed of in household waste. Use dedicated collection systems, if available.
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