Daytrix

Package leaflet: Information for the patient

Daytrix 500 mg/2 ml powder and solvent for injectable solution for intramuscular use

Ceftriaxone (as ceftriaxone sodium)
Please read carefully this leaflet 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. Never give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• 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 Daytrix is and what it is used for
2. What you need to know before you are given Daytrix
3. How Daytrix is administered
4. Possible side effects
5. How to store Daytrix
6. Contents of the pack and other information

1. What Daytrix is and what it is used for

Daytrix contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including newborns). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Daytrix 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 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 should know before being given Daytrix

Tell your doctor, pharmacist, or nurse before Daytrix is administered to you if:

• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering of the 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 cells (eosinophilia), and swollen lymph nodes (signs of severe skin reactions; see also section 4 “Possible side effects”).

Daytrix 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 Daytrix is to be administered by intramuscular injection.

Daytrix 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 is to receive a calcium-containing product intravenously.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Daytrix if:

• you have recently received or are about to receive calcium-containing products.
• 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, such as haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin and lead to weakness or shortness of breath).
• you are on a low-sodium diet.

If you are undergoing blood or urine tests
If you are given Daytrix for a prolonged period, you may need to have regular blood tests. Daytrix may affect urine sugar tests and a blood test known as the Coombs test. If you are about to undergo tests:

• inform the person taking your sample that you have been administered Daytrix.

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

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

Other medicines and Daytrix
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 one 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 might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Your doctor will assess the benefits of treatment with Daytrix for you and the possible risks for the unborn or breastfed child.

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

Sodium content
This medicine contains 41.4 mg of sodium (a main component of table salt) per vial. This is equivalent to 2% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Daytrix is administered

Daytrix is generally administered by a doctor or nurse as an injection directly into a muscle. Daytrix will be prepared by a doctor, pharmacist, or nurse and will not be mixed with, nor administered simultaneously with, calcium-containing injections.
Usual dose
Your doctor will determine the correct dose of Daytrix 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 degree of function of your kidneys and liver. The number of days or weeks during which you will receive Daytrix will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight of 50 kilograms (kg) or more:

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor will 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 Daytrix once daily per kg of the child's body weight, depending on the severity and type of infection. If you have a severe infection, 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 of 50 kg or more should receive the usual adult dose.

Newborns (0–14 days of life)

• 20–50 mg of Daytrix 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 how much Daytrix you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you are given more Daytrix than you should
If you are accidentally given more Daytrix than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of Daytrix
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 Daytrix
Do not stop taking Daytrix unless your doctor tells you to. 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.
The following side effects may occur with this medicine:
Treatment with ceftriaxone may, in rare cases, cause reduced consciousness, abnormal movements, agitation, and seizures, particularly in elderly patients with severe renal impairment or neurological disorders.

Severe allergic reactions (frequency 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, which may make breathing or swallowing difficult.
• sudden swelling of the hands, feet, and ankles.

Severe skin rashes (frequency not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, inform your 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 rash, usually resolving spontaneously. These symptoms may occur shortly after starting treatment with Daytrix 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 indicating 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 Daytrix 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.
• Breathing difficulties (bronchospasm).
• Skin rash with wheals (urticaria), possibly covering large areas of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid accumulation).
• Chills.

Frequency 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 the 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 affecting 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 a reduced volume of urine.
• False positive Coombs test (a test to detect blood-related problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Daytrix 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, please inform your doctor, pharmacist, or nurse. You may 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 Daytrix

Expiry date: see the expiry date stated on the packaging.
Warning: do not use the medicinal product after the expiry date stated on the packaging.
The stated expiry date refers to the product in its original, unopened packaging, correctly stored.
For the reconstituted solution, see "Instructions for use".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

6. Package contents and other information

What Daytrix contains
Daytrix 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
Active substance: ceftriaxone disodium 3.5 H2O 596.5 mg equivalent to ceftriaxone 500 mg;
One solvent vial contains: aqueous solution of 1% lidocaine.
Description of the appearance of Daytrix and package contents
Daytrix 500 mg/2 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent vial of 2 ml.
Marketing Authorization Holder
LABORATORIO FARMACEUTICO CT Srl
Via Dante Alighieri, 71 – Sanremo (IM)
Manufacturer
LABORATORIO FARMACEUTICO CT Srl
Via Dante Alighieri, 71 – Sanremo (IM)

Patient information leaflet

Daytrix 2 g powder for solution for infusion

Ceftriaxone (as ceftriaxone sodium)
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. Never 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, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

2. What Daytrix is and what it is used for

Daytrix 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.
Daytrix 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 a 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.

4. What you need to know before you are given Daytrix

Tell your doctor, pharmacist, or nurse before you are given Daytrix 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 severe skin reactions; see also section 4 “Possible side effects”).

Daytrix 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 Daytrix is to be administered by intramuscular injection.

Daytrix 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 Daytrix 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 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 shortness of breath).
• you are on a low-sodium diet.

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

Children
Talk to your doctor, pharmacist, or nurse before giving Daytrix to a child if:

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

Other medicines and Daytrix
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:

• 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 taking this medicine.
Your doctor will assess the benefits that treatment with Daytrix would provide you against the possible risks to the unborn or breastfed child.

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

Sodium content
This medicine contains 165.8 mg of sodium (a main component of table salt) per vial. This is equivalent to 8% of the maximum daily recommended dietary intake for an adult.

5. How Daytrix is administered

Daytrix is generally administered by a doctor or nurse via intravenous infusion (IV infusion) or by direct injection into a vein.
Daytrix will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered at the same time as calcium-containing injections.

Usual dose
Your doctor will determine the correct dose of Daytrix 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 your kidney and liver function. The number of days or weeks during which you will receive Daytrix 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 either as a single daily dose or as two separate doses.

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

• 50–80 mg of Daytrix 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.

Neonates (0–14 days of life):

• 20–50 mg of Daytrix once daily per kg of the neonate’s body weight, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the neonate’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 Daytrix you need and will closely monitor you, depending on the severity of your liver or kidney disease.

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

If you miss a dose of Daytrix
If you miss an injection, it should be given as soon as possible. However, if it is almost time for the next scheduled dose, 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 Daytrix
Do not stop taking Daytrix unless your doctor tells you to. 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 will experience 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 (not known, frequency cannot be estimated from available data)
If you have a severe allergic reaction, seek medical advice 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 rashes (not known, frequency cannot be estimated from available data)
If you develop a severe skin reaction, inform your 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 by the abbreviations 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 in the body (drug reaction with eosinophilia and systemic symptoms, also known by the abbreviation 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 Daytrix 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. thrush).
• Decrease in the number of white blood cells (granulocytopenia).
• Reduction in the number of red blood cells (anaemia).
• Problems with blood clotting. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Daytrix was administered. Pain at the injection site.
• Fever.
• Abnormal values in 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 raised red areas (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.
• 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 affecting the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and pale 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 result for galactosaemia (an abnormal accumulation of the sugar galactose).
• Daytrix may interfere with certain types of blood glucose tests; please consult your doctor.

Reporting of side effects
If you experience any side effect, 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 Daytrix

Expiry date: see the expiry date stated on the packaging.
Warning: do not use the medicinal product after the expiry date stated on the packaging.
The stated expiry date refers to the product in its original packaging, correctly stored.
For the reconstituted solution, see "Instructions for administration".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

6. Package contents and other information

What Daytrix contains
Daytrix 2 g powder for solution for infusion
Each vial contains:
Active substance: ceftriaxone disodium 3.5 H2O 2.386 g equivalent to ceftriaxone 2 g.
Description of the appearance of Daytrix and contents of the pack
Daytrix 2 g powder for solution for infusion: 1 vial.
Marketing Authorization Holder
LABORATORIO FARMACEUTICO CT Srl Via Dante Alighieri, 71 – Sanremo (IM)
Manufacturer
LABORATORIO FARMACEUTICO CT Srl Via Dante Alighieri, 71 – Sanremo (IM)

Patient information leaflet

Daytrix 1 g/10 ml powder and solvent for injectable solution for intravenous use

Ceftriaxone (as ceftriaxone sodium)
Please read this leaflet carefully before this medicine is administered to you, 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 other people, even if they have the same symptoms as yours, as it could be dangerous.
• 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 Daytrix is and what it is used for
2. What you need to know before being administered Daytrix
3. How Daytrix is administered
4. Possible side effects
5. How to store Daytrix
6. Contents of the pack and other information

3. What Daytrix is and what it is used for

Daytrix 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.
Daytrix 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 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 a 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.

6. What you need to know before you are given Daytrix

Tell your doctor, pharmacist, or nurse before you are given Daytrix if:

• you are experiencing or have previously experienced any combination of the following symptoms: skin 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").

Daytrix must not be given 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 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 skin rash that develops rapidly.
• you are allergic to lidocaine and Daytrix is to be administered by intramuscular injection.

Daytrix 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 a product containing calcium intravenously.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Daytrix 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 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 and lead to weakness or shortness of breath).
• you are on a low-sodium diet.

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

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

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

Other medicines and Daytrix
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:

• 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 may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will evaluate the benefits that treatment with Daytrix would provide you against the possible risks to the unborn or breastfed child.

Driving and using machines
Daytrix 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.

Sodium content
This medicine contains 82.9 mg of sodium (the main component of table salt) per vial. This is equivalent to 4% of the recommended maximum daily dietary intake for an adult.

7. How Daytrix is administered

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

Usual dose
Your doctor will determine the correct dose of Daytrix 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 degree of function of your kidneys and liver. The number of days or weeks during which you will receive Daytrix will depend on the type of infection you have.

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

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor will 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 Daytrix 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 of 50 kg or more should receive the usual adult dose.

Newborns (0–14 days of life):

• 20–50 mg of Daytrix 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 Daytrix you need and will monitor you closely, depending on the severity of your liver or kidney disease.

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

If you miss a dose of Daytrix
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 the missed dose.

If you stop treatment with Daytrix
Do not stop taking Daytrix 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:
Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or neurological disorders, may rarely cause reduced 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. This may make breathing or swallowing difficult.
• sudden swelling of the hands, feet, and ankles.

Severe skin rashes (frequency not known, cannot be estimated from available data)
If you develop a severe skin reaction, inform your 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 rash, which usually resolves spontaneously. These symptoms occur shortly after starting treatment with Daytrix 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. 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 Daytrix 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.
• Breathing difficulties (bronchospasm).
• Skin rash with raised 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.

Frequency not known (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 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 blood test to detect blood-related problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Daytrix 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Daytrix

Expiry date: see the expiry date stated on the packaging.
Warning: do not use the medicine after the expiry date stated on the packaging.
The stated expiry date refers to the product in its original packaging, correctly stored.
For the reconstituted solution, see "Instructions for use".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

6. Package contents and other information

What Daytrix contains
Daytrix 1 g/10 ml powder and solvent for injectable solution for intravenous use
one vial of powder contains:
active substance: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g;
one solvent vial contains: water for injection.
Description of the appearance of Daytrix and pack contents
Daytrix 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
LABORATORIO FARMACEUTICO CT Srl Via Dante Alighieri, 71 – Sanremo (IM)
Manufacturer
LABORATORIO FARMACEUTICO CT Srl Via Dante Alighieri, 71 – Sanremo (IM)
Package leaflet: information for the patient

Daytrix 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use

Ceftriaxone (as ceftriaxone sodium)
Please read this leaflet carefully before this medicine is administered to you, 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 other people, even if their symptoms are the same as yours, as it could 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 Daytrix is and what it is used for
2. What you need to know before you are given Daytrix
3. How Daytrix is administered
4. Possible side effects
5. How to store Daytrix
6. Package contents and other information

4. What Daytrix is and what it is used for

Daytrix 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.

Daytrix 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 a 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.

8. What you should know before being given Daytrix

Tell your doctor, pharmacist, or nurse before you are given Daytrix if:

• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering of the 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 severe skin reactions; see also section 4 “Possible side effects”).

Daytrix must not be given 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 had a sudden or severe allergic reaction to penicillin or 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 skin rash that develops rapidly.
• you are allergic to lidocaine and Daytrix is to be administered by intramuscular injection.

Daytrix 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 a product containing calcium intravenously.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Daytrix 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 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 and lead to weakness or shortness of breath).
• you are on a low-sodium diet.

If you need to have a blood or urine test
If you are given Daytrix for a prolonged period, you may need to have regular blood tests. Daytrix 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 given Daytrix.

Children
Talk to your doctor, pharmacist, or nurse before giving Daytrix to a child if:

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

Other medicines and Daytrix
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:

• 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 taking this medicine.
Your doctor will assess the benefits of treatment with Daytrix for you and the possible risks to the unborn or breastfed child.

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

Sodium content
This medicine contains 82.9 mg of sodium (a main component of table salt) per vial.
This corresponds to 4% of the maximum daily recommended dietary intake for an adult.

9. How Daytrix is administered

Daytrix is generally administered by a doctor or nurse via an injection given directly into a muscle. Daytrix will be prepared by a doctor, pharmacist, or nurse and will not be mixed or co-administered with injections containing calcium.
Usual dose
Your doctor will determine the correct dose of Daytrix for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your weight and age, and the degree of function of your kidneys and liver. The number of days or weeks during which you will receive Daytrix will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years and older with a body weight of 50 kilograms (kg) or more:

• 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 Daytrix 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 given as a single daily dose or divided into two separate doses.
• Children with a body weight of 50 kg or more should receive the usual adult dose.

Newborns (0–14 days of life):

• 20–50 mg of Daytrix 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 Daytrix you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you are given more Daytrix than you should
If you are accidentally given more Daytrix than prescribed, contact your doctor or the nearest hospital immediately.
If you miss a dose of Daytrix
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 a missed dose.
If you stop treatment with Daytrix
Do not stop taking Daytrix 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:

Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or disorders of the nervous system, may rarely cause reduced 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 rashes (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, inform your 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, 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 skin rash, which usually resolves spontaneously. These symptoms may occur shortly after starting treatment with Daytrix 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 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 Daytrix 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).
• Skin rash with wheals (urticaria), which 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 type of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in 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.
• 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 blood test to detect blood-related problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Daytrix may interfere with certain types of tests used to measure glucose in the blood; 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Daytrix

Expiry: see the expiry date stated on the packaging.
Warning: do not use the medicine after the expiry date stated on the packaging.
The stated expiry date refers to the product in its original packaging, stored correctly.
For the reconstituted solution, see "Instructions for administration".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

6. Package contents and other information

What Daytrix contains
Daytrix 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
one vial of powder contains:
active substance: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g;
one solvent vial contains: aqueous solution of 1% lidocaine.
Description of the appearance of Daytrix and package contents
Daytrix 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.
Marketing Authorization Holder
LABORATORIO FARMACEUTICO CT Srl Via Dante Alighieri, 71 – Sanremo (IM)
Manufacturer
LABORATORIO FARMACEUTICO CT Srl Via Dante Alighieri, 71 – Sanremo (IM)