Sirtap: detailed information

Package leaflet: Information for the patient

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

Ceftriaxone (as ceftriaxone sodium)
Lidocaine (as lidocaine hydrochloride)
Generic medicine
Please read this leaflet carefully before this medicine is administered to you because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
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:

What SIRTAP is and what it is used for
What you need to know before SIRTAP is administered to you
How SIRTAP is administered
Possible side effects
How to store SIRTAP
Contents of the pack and other information

1. What SIRTAP is and what it is used for

SIRTAP 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. SIRTAP is given by intramuscular injection in a solution containing lidocaine, which reduces the pain associated with the injection.
SIRTAP 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.

2. What you should know before being given SIRTAP

SIRTAP 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 similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of hands, feet and ankles, or a severe rash that develops rapidly.
you are allergic to lidocaine and SIRTAP is to be administered by intramuscular injection.
you have a heart conduction disorder causing low blood pressure and slowed heart rate (complete atrioventricular block).
you have a condition of reduced blood volume (hypovolemia).

SIRTAP 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 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 SIRTAP if:

you have recently received or are about to receive products containing calcium.
you have recently had diarrhoea after taking an antibiotic, or 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 have muscle weakness and loss of muscle function (myasthenia gravis).
you have seizures (epilepsy).
you have any heart condition, especially if it affects your heart rate.
you have respiratory problems.
you have porphyria (a rare inherited disease affecting the skin and nervous system).
you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels detectable in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes (signs of serious skin reactions; see also section 4 "Possible side effects").

If you are undergoing blood or urine tests
If you are given SIRTAP for a prolonged period, you may need regular blood tests. SIRTAP 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 SIRTAP.

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

the child has recently received or is about to receive intravenously a product containing calcium. If the child is diabetic or requires monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that may inaccurately measure blood glucose during ceftriaxone treatment. If such systems are used, check the instructions for use and inform your doctor, pharmacist, or nurse. Alternative analytical methods should be used if necessary.

Other medicines and SIRTAP
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).

Several medicines may interact with lidocaine, leading to altered effects. These include:

medicines used to treat infections (clarithromycin, erythromycin).
medicines used to treat stomach ulcers (e.g. cimetidine).
strong painkillers such as codeine and meperidine (narcotic or opioid medicines).
medicines used to treat irregular heart rate (e.g. mexiletine, tocainide).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before using this medicine.
Your doctor will assess the benefits of treatment with SIRTAP for you and the possible risks to the baby.

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

SIRTAP contains sodium
This medicine contains 45.84 mg of sodium (a main component of table salt) per 500 mg vial. This is equivalent to 2.3% of the maximum daily dietary intake recommended for an adult.

3. How SIRTAP is administered

SIRTAP is generally administered by a doctor or nurse as an injection given directly into a muscle. SIRTAP will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with injections containing calcium.
Usual dose
Your doctor will determine the correct dose of SIRTAP 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 SIRTAP 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 will 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 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 SIRTAP 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 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 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 SIRTAP 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 SIRTAP you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you are given more SIRTAP than you should
If you are accidentally given more SIRTAP than prescribed, contact your doctor or go immediately to the nearest hospital.
If you miss a dose of SIRTAP
If you miss an injection, it should be given as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for the missed dose.
If you stop treatment with SIRTAP
Do not stop taking SIRTAP 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.
The following side effects may occur with this medicine:
Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced level of consciousness, abnormal movements, agitation, and seizures.

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

Sudden swelling of the face, throat, lips, or mouth. This may make breathing or swallowing difficult.
Sudden swelling of the hands, feet, and ankles.

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

Severe rash developing rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
Any combination of the following symptoms: widespread rash, high body temperature, elevated liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain, and rash, usually resolving spontaneously. These symptoms may occur shortly after starting SIRTAP treatment for spirochete infections such as Lyme disease.

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

Abnormalities in white blood cells (such as reduced leukocytes and increased eosinophils) and platelets (reduced thrombocytes).
Soft stools or diarrhoea.
Changes in blood test results indicating liver function abnormalities.
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 SIRTAP 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).
Rash with raised red itchy welts (urticaria), possibly affecting large areas 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 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.
Gallbladder and/or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and clay-coloured stools.
A neurological condition that may develop in newborns with severe jaundice (kernicterus).
Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
False positive Coombs test (a blood test to detect blood-related problems).
False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
SIRTAP may interfere with certain types of blood glucose tests; please consult your doctor.

Following accidental injection of lidocaine into a blood vessel during intramuscular administration of SIRTAP i.m., additional side effects may occur, which may include:
Frequency not known (cannot be estimated from available data)

Changes in heart rhythm and rate.
Low blood pressure.
Slowed heart rate (less than 60 beats per minute).
Interruption of normal blood circulation due to cardiac arrest and reduced blood flow.
Loss of balance, tingling around the mouth, numbness of the tongue, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or lightheadedness, confusion, nervousness, involuntary rhythmic muscle contractions, seizures or epileptic fits, deep unconsciousness (coma).
Blurred vision, double vision, or temporary loss of vision.
Feeling unwell (nausea or vomiting).
Breathing difficulties.
Reduced respiratory rate or possible cessation of breathing.
Unusual drowsiness or tiredness during the day or fainting.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, 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 SIRTAP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial,
after "Exp.". The expiry date refers to the last day of that month.
From a microbiological standpoint, the product should be used immediately after reconstitution.
If not used immediately, the conditions and duration of storage prior to use are the responsibility
of the user. Chemical and physical stability of the medicine after reconstitution has been demonstrated for 24 hours between
+2°C and +8°C and for 6 hours when stored at a temperature below 25°C.
The solution may vary in colour from pale yellow to amber depending on concentration and storage duration;
this characteristic does not affect the drug's efficacy or tolerability.
Store in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Package contents and other information

What SIRTAP contains

The active substances are ceftriaxone and lidocaine. Each vial contains 500 mg of ceftriaxone as ceftriaxone sodium. Each ampoule contains 20 mg of lidocaine hydrochloride in 2 ml. The other excipient is: water for injections, contained in the solvent ampoule.

Description of the appearance of SIRTAP and contents of the pack
1 vial of powder + 1 solvent ampoule of 2 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
So.Se.PHARM S.r.l., Via Dei Castelli Romani, 22 - 00071 Pomezia (RM), Italy
Manufacturer
ESSETI Farmaceutici S.r.l. - Via Campobello, 15 - 00071 Pomezia (RM), Italy

Package leaflet: information for the patient

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

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 adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What SIRTAP is and what it is used for
What you need to know before SIRTAP is administered to you
How SIRTAP is administered
Possible side effects
How to store SIRTAP
Contents of the pack and other information

2. What SIRTAP is and what it is used for

SIRTAP 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. SIRTAP is administered by injection into a muscle in a solution containing lidocaine, which reduces the pain associated with the injection.

SIRTAP is used to treat the following 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.

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

Do not be given SIRTAP 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 rash that develops rapidly.
You are allergic to lidocaine and SIRTAP is to be administered by intramuscular injection.
You have a heart conduction disorder causing low blood pressure and slowed heart rate (complete atrioventricular block).
You have a reduced blood volume (hypovolemia).

SIRTAP 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 whites of the eyes), or needs to receive a calcium-containing product intravenously.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given SIRTAP 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 suffer from loss of muscle function and weakness (myasthenia gravis).
You have seizures (epilepsy).
You have any heart condition, especially if it affects your heart rate.
You have respiratory problems.
You suffer from porphyria (a rare inherited disease affecting the skin and nervous system).
You are experiencing or have previously experienced any combination of the following symptoms: rash, redness of the skin, blistering on 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 cell (eosinophilia), and swollen lymph nodes (signs of serious skin reactions; see also section 4 “Possible side effects”).

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

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

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

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

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

Several medicines may interact with lidocaine, leading to altered effects. These include:

Medicines used to treat infections (clarithromycin, erythromycin).
Medicines used to treat stomach ulcers (e.g., cimetidine).
Strong painkillers such as codeine and meperidine (narcotic or opioid medicines).
Medicines used to treat irregular heart rate (e.g., mexiletine, tocainide).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will weigh the benefits of treatment with SIRTAP for you against the possible risks to your baby.

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

SIRTAP contains sodium
This medicine contains 91.69 mg of sodium (a main component of table salt) per 1 g vial. This is equivalent to 4.6% of the maximum daily dietary intake recommended for an adult.

5. How SIRTAP is administered

SIRTAP is generally administered by a doctor or nurse via an injection given directly into a muscle. SIRTAP will be prepared by a doctor, pharmacist, or nurse and must not be mixed or co-administered at the same time with injections containing calcium.

Usual dose
Your doctor will determine the correct dose of SIRTAP 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 SIRTAP 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 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 SIRTAP 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 of 50 kg or more should receive the usual adult dose.

Newborns (0–14 days of life):

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

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

If you miss a dose of SIRTAP
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 administer a double dose (two injections together) to make up for the missed dose.

If you stop treatment with SIRTAP
Do not stop taking SIRTAP 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 everyone will experience them.
The following side effects may occur with this medicine:
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 the available data)
If you experience a severe allergic reaction, seek immediate medical attention.
Signs may include:

Sudden swelling of the face, throat, lips, or mouth. This may make breathing or swallowing difficult.
Sudden swelling of the hands, feet, and ankles.

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

Severe rash developing rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known by the abbreviations SJS and TEN).
Any combination of the following symptoms: widespread rash, high body temperature, elevated liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes, and involvement of other organs in the body (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 SIRTAP 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 SIRTAP 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).
Rash with wheals (urticaria), possibly affecting 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 form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
Severe reduction 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.
Gallbladder and/or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and clay-coloured stools.
A neurological condition that may develop in newborns with severe jaundice (kernicterus).
Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
False positive Coombs test (a blood test to detect blood-related problems).
False positive galactosaemia test (an abnormal accumulation of the sugar galactose).
SIRTAP may interfere with certain types of tests to measure blood glucose; please consult your doctor.

Following accidental intravascular injection of lidocaine during intramuscular administration of SIRTAP i.m., additional side effects may occur, which may include:
Not known (frequency cannot be estimated from the available data)

Changes in heart rhythm and rate.
Low blood pressure.
Slowed heart rate (below 60 beats per minute).
Interruption of normal blood circulation due to cardiac arrest and reduced blood flow.
Loss of balance, tingling around the mouth, tongue numbness, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or lightheadedness, confusion, nervousness, involuntary rhythmic muscle contractions, seizures or epileptic fits, deep unconsciousness (coma).
Blurred vision, double vision, or temporary loss of vision.
Feeling unwell (nausea or vomiting).
Breathing difficulties.
Reduced respiratory rate or possible cessation of breathing.
Unusual drowsiness or fatigue during the day or fainting.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell 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 SIRTAP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial,
following "Exp.". The expiry date refers to the last day of that month.
From a microbiological standpoint, the product should be used immediately after reconstitution.
If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user.
Chemical and physical stability of the medicine after reconstitution has been demonstrated for 24 hours between +2°C and +8°C, and for 6 hours when the product is stored at a temperature below 25°C.
The solution may vary in colour from pale yellow to amber depending on concentration and storage duration; this characteristic does not affect the drug's efficacy or tolerability.
Keep in the original packaging.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SIRTAP contains

The active substances are ceftriaxone and lidocaine. Each vial contains 1 g of ceftriaxone as ceftriaxone sodium. Each ampoule contains 35 mg of lidocaine hydrochloride in 3.5 ml.
The other excipient is: water for injections, contained in the solvent ampoule.

Description of the appearance of SIRTAP and contents of the pack
1 vial of powder + 1 solvent ampoule of 3.5 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
So.Se.PHARM S.r.l., Via Dei Castelli Romani, 22 - 00071 Pomezia (RM), Italy
Manufacturer
ESSETI Farmaceutici S.r.l. - Via Campobello, 15 - 00071 Pomezia (RM), Italy

Patient information leaflet

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

Ceftriaxone (as ceftriaxone sodium)
Generic medicine
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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What SIRTAP is and what it is used for
What you need to know before being given SIRTAP
How SIRTAP is administered
Possible side effects
How to store SIRTAP
Package contents and other information

3. What SIRTAP is and what it is used for

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.

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

Do not be given SIRTAP 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, or a severe rash that develops rapidly.
You are allergic to lidocaine and SIRTAP is to be administered by intramuscular injection.

SIRTAP 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 through a vein.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given SIRTAP 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.
You develop or have previously developed 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 serious skin reactions, see also section 4 “Possible side effects”).

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

Inform the person taking your sample that you have been given SIRTAP.

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

Children
Talk to your doctor, pharmacist, or nurse before SIRTAP 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 SIRTAP
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

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, ask your doctor for advice before taking this medicine.
Your doctor will weigh the benefits of treatment with SIRTAP for you against the possible risks to your baby.

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

SIRTAP contains sodium
This medicine contains 91.69 mg of sodium (a component of common table salt) per 1 g vial. This is equivalent to 4.6% of the maximum recommended daily dietary intake of sodium for an adult.

7. How SIRTAP is administered

SIRTAP is generally administered by a doctor or nurse via intravenous infusion (drip) or by direct injection into a vein. SIRTAP will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with calcium-containing injections.

Standard dose
Your doctor will determine the correct dose of SIRTAP for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the function of your kidneys and liver. The number of days or weeks during which you will receive SIRTAP depends 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 either as a single daily dose or divided into 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 SIRTAP 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 as a single daily dose or divided into two separate doses.
Children with a body weight of 50 kg or more should receive the standard adult dose.

Neonates (0–14 days of life):

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

If you are given too much SIRTAP
If you are accidentally given more SIRTAP than prescribed, contact your doctor or the nearest hospital immediately.

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

If you stop SIRTAP treatment
Do not stop taking SIRTAP unless instructed by your doctor. If you have any questions 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 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 reactions (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, inform a doctor immediately.
Signs may include:

Severe rash developing rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
Any combination of the following symptoms: widespread rash, high body temperature, 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 as DRESS or drug hypersensitivity syndrome).
Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, which generally resolves spontaneously. These symptoms occur shortly after starting treatment with SIRTAP to treat spirochete infections such as Lyme disease.

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

Abnormalities in white blood cells (such as reduced leukocytes and increased eosinophils) and platelets (reduced thrombocytes).
Soft stools or diarrhoea.
Changes in blood test results for liver function.
Rash.

Uncommon (may affect up to 1 in 100 people)

Fungal infections (e.g., oral thrush).
Decreased number of white blood cells (granulocytopenia).
Reduced number of red blood cells (anaemia).
Blood clotting problems. Signs include easy bruising, joint pain and swelling.
Headache.
Dizziness.
Nausea or vomiting.
Itching.
Pain or burning sensation along the vein where SIRTAP 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 areas (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 form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
Severe reduction in the number of white blood cells (agranulocytosis).
Seizures.
Dizziness.
Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
Inflammation of the mouth lining (stomatitis).
Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
Gallbladder and/or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and 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 a reduced amount of urine produced.
False positive Coombs test (a test to detect blood problems).
False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
SIRTAP 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, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SIRTAP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial,
after "Exp.". The expiry date refers to the last day of that month.
From a microbiological point of view, the product should be used immediately after reconstitution.
If not used immediately, the conditions and duration of storage prior to use are the responsibility
of the user.
Chemical and physical stability of the medicine after reconstitution has been demonstrated for 24 hours between +2°C and +8°C and for
6 hours when the product is stored at a temperature below 25°C.
The solution may vary in colour from pale yellow to amber depending on concentration and storage period; this characteristic does not affect the efficacy or tolerability of the medicine.
Store in the original packaging. Do not dispose of any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Package contents and other information

What SIRTAP contains
SIRTAP 1 g/10 ml powder and solvent for injectable solution for intravenous use
The active substance is ceftriaxone.
Each vial contains 1 g (gram) of ceftriaxone as ceftriaxone sodium.
Each ampoule contains water for injections.
SIRTAP 1 g powder for injectable solution for intravenous use
The active substance is ceftriaxone.
Each vial contains 1 g (gram) of ceftriaxone as ceftriaxone sodium.

Description of the appearance of SIRTAP and contents of the pack
SIRTAP 1 g/10 ml powder and solvent for injectable solution for intravenous use: 1 vial of powder + 1 ampoule of 10 ml solvent.
SIRTAP 1 g powder for injectable solution for intravenous use: 10 vials of powder.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
So.Se.PHARM S.r.l., Via Dei Castelli Romani, 22 - 00071 Pomezia (RM), Italy

Manufacturer
ESSETI Farmaceutici S.r.l. - Via Campobello, 15 - 00071 Pomezia (RM), Italy

Patient Information Leaflet

SIRTAP 2 g powder for solution for infusion

Ceftriaxone (as ceftriaxone sodium)
Equivalent medicinal product
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 could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What SIRTAP is and what it is used for
What you need to know before being given SIRTAP
How SIRTAP is administered
Possible side effects
How to store SIRTAP
Contents of the pack and other information

4. What SIRTAP is and what it is used for

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

It may also be administered:

to treat specific sexually transmitted infections (gonorrhoea and syphilis).
to treat patients with a low 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.

8. What you need to know before you are given SIRTAP

SIRTAP 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 SIRTAP is to be administered by intramuscular injection.

SIRTAP 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 needs to receive a product containing calcium through a vein.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given SIRTAP 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 which may cause pale yellow skin 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: skin rash, skin redness, blistering of 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 need to undergo blood or urine tests
If you are given SIRTAP for a prolonged period, you may need to have regular blood tests. SIRTAP may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to undergo testing:

Inform the person taking your sample that you have been given SIRTAP.

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

Children
Talk to your doctor, pharmacist or nurse before SIRTAP is administered to a child if:

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

Other medicines and SIRTAP
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, are 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 SIRTAP for you and the possible risks to the baby.

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

SIRTAP contains sodium
This medicine contains 183.37 mg of sodium (a main component of table salt) per 2 g vial.
This corresponds to 9.2% of the maximum recommended daily dietary intake of sodium for an adult.

9. How SIRTAP is administered

SIRTAP is generally administered by a doctor or nurse via

intravenous infusion (IV infusion) or by direct injection into a vein.
SIRTAP 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 SIRTAP for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the extent of kidney and liver function. The number of days or weeks during which you will receive SIRTAP 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 divided into 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 SIRTAP 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 either as a single daily dose or divided into two separate doses.
Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Neonates (0–14 days of life):

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

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

If you forget to take SIRTAP
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 SIRTAP
Do not stop taking SIRTAP 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 everyone 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 disorders of the nervous system, 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 medical attention 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 reactions (frequency not known, cannot be estimated from available data)
If you develop a severe skin reaction, inform a doctor immediately.
Signs may include:

Severe rash developing rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
Any combination of the following symptoms: widespread rash, high body temperature, 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 typically occur shortly after starting treatment with SIRTAP 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 abnormalities.
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 SIRTAP 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).
Rash with wheals (urticaria), possibly affecting 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 available data)

Secondary infections that may not respond to the prescribed antibiotic.
A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
Severe decrease in white blood cells (agranulocytosis).
Seizures.
Dizziness.
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.
Gallbladder and/or liver problems, 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 a reduced amount of urine produced.
False positive Coombs test result (a test to detect blood problems).
False positive test result for galactosaemia (an abnormal accumulation of the sugar galactose).
SIRTAP may interfere with certain types of blood glucose tests; please consult your doctor.

5. How to store SIRTAP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial,
after "Exp.". The expiry date refers to the last day of that month.
From a microbiological point of view, the product should be used immediately after reconstitution. If not used
immediately, the conditions and duration of storage prior to use are the responsibility of the user.
Chemical and physical stability of the medicine after reconstitution has been demonstrated for 24 hours between +2°C and +8°C and for 6 hours when stored at a temperature below 25°C.
The solution may vary in colour from pale yellow to amber depending on concentration and storage duration; this characteristic does not affect the efficacy or tolerability of the medicine.
Store in the original packaging.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SIRTAP contains

The active substance is ceftriaxone. Each vial contains 2 g of ceftriaxone as ceftriaxone sodium.

Description of the appearance of SIRTAP and contents of the pack
1 vial.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
So.Se.PHARM S.r.l., Via Dei Castelli Romani, 22 - 00071 Pomezia (RM), Italy
Manufacturer
ESSETI Farmaceutici S.r.l. - Via Campobello, 15 - 00071 Pomezia (RM), Italy
dedicated collection systems, if available.