Fidato

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

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

1. What Fidato is and what it is used for

Fidato 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.
Fidato 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 need to know before you are given Fidato

Do not be given Fidato 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 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, chest pain, and a severe rash that develops rapidly.
• you are allergic to lidocaine and Fidato is to be administered by intramuscular injection.

Fidato 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 the whites of the eyes), or requires intravenous administration of a product containing calcium.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Fidato 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, weakness, or shortness of breath).
• you are on a low-sodium diet.
• you are experiencing or have previously experienced any combination of the following symptoms: 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 serious skin reactions; see also section 4 “Possible side effects”).

If you are to undergo blood or urine tests
If you are given Fidato for a prolonged period, you may need to have regular blood tests. Fidato may affect the results of 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 given Fidato.

Children
Talk to your doctor, pharmacist, or nurse before Fidato is given to a child if:

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

Other medicines and Fidato
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, ask your doctor for advice before taking this medicine.
Your doctor will assess the benefits that treatment with Fidato would provide you and the possible risks to the baby.

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

Fidato contains sodium
Fidato 1 g/10 ml powder and solvent for injectable solution for intravenous use 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.

3. How Fidato is administered

Fidato is generally administered by a doctor or nurse through an intravenous infusion (IV infusion) or via an injection directly into a vein. Fidato will be prepared by a doctor, pharmacist, or nurse and must not be mixed with, or administered simultaneously with, injections containing calcium.

Standard dose
Your doctor will determine the appropriate dose of Fidato 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 kidney and liver function. The number of days or weeks during which you will receive Fidato 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.

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

• 50–80 mg of Fidato 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 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 standard adult dose.

Newborns (0–14 days of age):

• 20–50 mg of Fidato 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 standard one. Your doctor will decide how much Fidato you need and will monitor you closely, depending on the severity of your liver or kidney disease.

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

If you miss a dose of Fidato
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 a missed dose.

If you stop Fidato treatment
Do not stop taking Fidato unless instructed by your doctor. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With this medicine, you may experience the following side effects:

Severe allergic reactions (frequency not known, cannot be estimated from the 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
• chest pain occurring in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

Severe skin reactions (frequency not known, 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 possibly blisters 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 Fidato 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).
• Decrease in the number of white blood cells (granulocytopenia).
• Reduction in the number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Fidato 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 retention).
• Chills.
• 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.

Frequency not known (cannot be estimated from the available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Seizures.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain radiating 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 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).
• Fidato 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 .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Fidato

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 stored correctly in its original packaging.
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 Fidato contains
Fidato 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 Fidato and contents of the pack
Fidato 1 g/10 ml powder and solvent for injectable solution for intravenous use:
1 powder vial + 1 solvent vial of 10 ml.
Marketing Authorization Holder and Manufacturer
Fidia Farmaceutici S.p.A. – Via Ponte della Fabbrica, 3/A – 35031 Abano Terme (PD)
Laboratorio Farmaceutico CT – Via Dante Alighieri, 71 – 18038 Sanremo (IM)
Mitim S.r.l. – Via Cacciamali, 34-36-38 – 25125 Brescia
Disposal of expired/unused medicines

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE PATIENT

FIDATO 2 g powder for solution for infusion

Ceftriaxone (as ceftriaxone sodium)
Please read this leaflet carefully before you are given this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Never give it to 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 Fidato is and what it is used for
2. What you need to know before being given Fidato
3. How Fidato is administered
4. Possible side effects
5. How to store Fidato
6. Contents of the pack and other information

2. What Fidato is and what it is used for

Fidato 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.
Fidato 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 surgery.

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

Do not be given Fidato 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, chest pain, and a severe rash that develops rapidly.
• you are allergic to lidocaine and Fidato is to be administered by intramuscular injection.

Fidato 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 the 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 Fidato 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 the skin to appear pale yellow and lead to weakness or breathlessness).
• you are on a low-sodium diet.
• you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering of lips, eyes, or 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”).

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

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

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

Other medicines and Fidato
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, are 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 Fidato would provide you and the possible risks to the baby.

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

Fidato contains sodium
Fidato 2 g powder for solution for infusion contains 165.8 mg of sodium (the main component of table salt) per vial. This corresponds to 8% of the maximum daily recommended dietary intake for an adult.

5. How Fidato is administered

Fidato is generally administered by a doctor or nurse through an intravenous infusion (intravenous drip) or via an injection directly into a vein.
Fidato 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 Fidato 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 Fidato 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 Fidato 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 Fidato 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 Fidato you need and will monitor you closely, depending on the severity of your liver or kidney disease.

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

If you miss a dose of Fidato
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 a forgotten dose.

If you stop treatment with Fidato
Do not stop taking Fidato unless instructed by your doctor. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
With this medicine, you may experience the following adverse reactions:

Severe allergic reactions (not known, frequency 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.
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

Severe skin reactions (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 developing rapidly, with blistering or peeling of the skin and possibly blisters 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 may occur shortly after starting Fidato treatment for spirochete infections such as Lyme disease.

Other possible adverse reactions:
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).
• loose 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).
• reduced 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 Fidato 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 itchy welts (urticaria), which may cover large areas of the body, associated with itching and swelling.
• blood or sugar in the urine.
• oedema (fluid accumulation).
• chills.
• treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation and seizures.

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 reduction in white blood cell count (agranulocytosis).
• seizures.
• vertigo.
• inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• inflammation of the oral mucosa (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 urine output may decrease.
• a false positive Coombs test (a blood test to detect blood-related problems).
• a false positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Fidato may interfere with certain types of blood glucose tests; please consult your doctor.

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

5. How to store Fidato

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 stored correctly in its original packaging.
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 Fidato contains
Fidato 2 g powder for solution for infusion
One vial contains:
Active substance: ceftriaxone disodium 3.5 H₂O 2.386 g, equivalent to 2 g of ceftriaxone.
Description of the appearance of Fidato and package contents
Fidato 2 g powder for solution for infusion: 1 vial.
Fidato 2 g powder for solution for infusion: 10 vials.
Marketing Authorization Holder and Manufacturer
Fidia Farmaceutici S.p.A. – Via Ponte della Fabbrica, 3/A – 35031 Abano Terme (PD)
Laboratorio Farmaceutico CT – Via Dante Alighieri, 71 – 18038 Sanremo (IM)
Mitim S.r.l. – Via Cacciamali, 34-36-38 – 25125 Brescia

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE PATIENT

FIDATO 250 mg/2 ml powder and solvent for injectable solution for intramuscular use, 500 mg/2 ml powder and solvent for injectable solution for intramuscular use, 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use

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

3. What Fidato is and what it is used for

Fidato 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.
Fidato is used to treat infections:

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

It may be administered:

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

6. What you should know before being given Fidato

Do not be given Fidato 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 the hands, feet, and ankles, chest pain, and a severe rash that develops rapidly.
• you are allergic to lidocaine and Fidato is to be administered by intramuscular injection.

Fidato 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 the white part of the eye), or needs to receive a product containing calcium through a vein.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before being given Fidato 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 the skin to appear pale yellow and lead to weakness or shortness of breath).
• you are on a low-sodium diet.
• you are experiencing or have previously experienced any combination of the following symptoms: 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 serious skin reactions, see also section 4 “Possible side effects”).

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

Children
Talk to your doctor, pharmacist, or nurse before Fidato is given to a child if:

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

Other medicines and Fidato
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 to treat 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 of treatment with Fidato for you and the possible risks to the unborn child.

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

Fidato contains sodium
Fidato 250 mg/2 ml powder and solvent for injectable solution for intramuscular use contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.
Fidato 500 mg/2 ml powder and solvent for injectable solution for intramuscular use contains 41.4 mg of sodium (the main component of table salt) per vial. This corresponds to 2% of the maximum daily intake recommended in an adult's diet.
Fidato 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use contains 82.9 mg of sodium (the main component of table salt) per vial. This corresponds to 4% of the maximum daily intake recommended in an adult's diet.

7. How Fidato is administered

Fidato is generally administered by a doctor or nurse as an injection given directly into a muscle. Fidato will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with injections containing calcium.
Usual dose
Your doctor will determine the correct dose of Fidato 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 Fidato 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 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 Fidato 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 will prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose 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 Fidato 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 how much Fidato you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you receive more Fidato than you should
If you are accidentally given more Fidato than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of Fidato
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 a missed dose.
If you stop treatment with Fidato
Do not stop taking Fidato unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
With this medicine, you may experience the following adverse reactions:

Severe allergic reactions (not known, frequency cannot be determined 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.
• Chest pain in the context of allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

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

• Severe rash developing rapidly, with blistering or peeling of the skin and possibly blisters 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 Fidato to treat spirochete infections such as Lyme disease.

Other possible adverse reactions:
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).
• Decrease in the number of white blood cells (granulocytopenia).
• Reduction in the number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Fidato 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 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.
• 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.

Not known (frequency cannot be determined 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 oral mucosa (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 your urine output may decrease.
• False positive Coombs test result (a test to detect blood problems).
• False positive result for galactosemia (an abnormal accumulation of the sugar galactose).
• Fidato may interfere with certain types of blood glucose tests; please consult your doctor.

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

5. How to store Fidato

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 expiry date indicated applies to the product stored correctly in its original packaging.
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 Fidato contains
Fidato 250 mg/2 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
Active substance: ceftriaxone disodium 3.5 H₂O 298.2 mg equivalent to ceftriaxone 250 mg;
One ampoule of solvent contains: aqueous solution of 1% lidocaine.

Fidato 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 ampoule of solvent contains: aqueous solution of 1% lidocaine.

Fidato 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 ampoule of solvent contains: aqueous solution of 1% lidocaine.

Description of the appearance of Fidato and contents of the pack
Fidato 250 mg/2 ml powder and solvent for injectable solution for intramuscular use:
1 vial of powder + 1 solvent ampoule of 2 ml.
Fidato 500 mg/2 ml powder and solvent for injectable solution for intramuscular use:
1 vial of powder + 1 solvent ampoule of 2 ml.
Fidato 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
Fidia Farmaceutici S.p.A. – Via Ponte della Fabbrica, 3/A – 35031 Abano Terme (PD)
For all packs:
Laboratorio Farmaceutico CT – Via Dante Alighieri, 71 – 18038 Sanremo (IM)
Mitim S.r.l. – Via Cacciamali, 34-36-38 – 25125 Brescia