Package leaflet: Information for the patient

Ceftriaxone Aurobindo 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
Ceftriaxone Aurobindo 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
Equivalent medicine
Please read this leaflet carefully before you are given this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. 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 effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Ceftriaxone Aurobindo is and what it is used for

Ceftriaxone Aurobindo contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including newborns). It works by killing the bacteria causing infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone Aurobindo is administered by injection into a muscle in a solution containing lidocaine, which reduces the pain associated with the injection.
Ceftriaxone Aurobindo 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 low white blood cell count 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.

2. What you should know before being given Ceftriaxone Aurobindo

Do not be given Ceftriaxone Aurobindo 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, and a severe rash that develops rapidly.
you are allergic to lidocaine and Ceftriaxone Aurobindo 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 suffer from reduced blood volume (hypovolemia).

Ceftriaxone Aurobindo 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
Tell your doctor, pharmacist or nurse before you are given Ceftriaxone Aurobindo 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 which 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 suffer from seizures (epilepsy).
you have any heart problems, especially if they affect your heart rate.
you have breathing 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, skin redness, blistering on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).

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

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 analytical methods should be used if necessary.

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

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

Other medicines and Ceftriaxone Aurobindo
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, as they may interact with ceftriaxone:

an antibiotic called an aminoglycoside.
an antibiotic called chloramphenicol (used to treat infections, particularly eye infections).
Several medicines may interact with lidocaine, resulting in altered effects. These include:
medicines used to treat infections (clarithromycin, erythromycin).
medicines used to treat stomach ulcers (e.g. cimetidine).
strong painkillers such as codeine and meperidine (narcotic or opioid medicines).
medicines used to treat irregular heart rate (e.g. mexiletine, tocainide).

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

Driving and using machines
Ceftriaxone Aurobindo 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.

Ceftriaxone Aurobindo 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
contains sodium:
This medicine contains 41.5 mg of sodium (main component of table salt) per vial.
This corresponds to 2.1% of the maximum daily dietary intake recommended for an adult.

Ceftriaxone Aurobindo 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
contains sodium:
This medicine contains 83 mg of sodium (main component of table salt) per vial.
This corresponds to 4.2% of the maximum daily dietary intake recommended for an adult.

3. How Ceftriaxone Aurobindo is administered

Ceftriaxone Aurobindo is generally administered by a doctor or nurse via an injection given directly into a muscle. Ceftriaxone Aurobindo 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 Ceftriaxone Aurobindo for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the extent of your kidney and liver function. The number of days or weeks during which you will receive Ceftriaxone Aurobindo 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 as a single daily dose or divided into two separate doses.

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

50–80 mg of Ceftriaxone Aurobindo once daily per kg of the child’s body weight, depending on the severity and type of infection. If the infection is severe, your doctor may prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.
Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Newborns (0–14 days of life):

20–50 mg of Ceftriaxone Aurobindo once daily per kg of the newborn’s body weight, depending on the severity and type of infection.
The maximum daily dose must not exceed 50 mg per kg of the newborn’s body weight.

Patients with liver or kidney problems
You may be given a different dose from the usual. Your doctor will decide the amount of Ceftriaxone Aurobindo you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more Ceftriaxone Aurobindo than you should
If you are accidentally given more Ceftriaxone Aurobindo than prescribed, contact your doctor or the nearest hospital immediately.
If you miss a dose of Ceftriaxone Aurobindo
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 Ceftriaxone Aurobindo
Do not stop taking Ceftriaxone Aurobindo 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 (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 tends to resolve spontaneously. These symptoms occur

shortly after starting treatment with Ceftriaxone Aurobindo for spirochete infections such as Lyme disease.
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.

Other possible side effects:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

Fungal infections (e.g. oral thrush).
Decreased number of white blood cells (granulocytopenia).
Reduced number of red blood cells (anaemia).
Blood clotting problems. Signs include easy bruising, joint pain and swelling.
Headache.
Dizziness.
Nausea or vomiting.
Itching.
Pain or burning sensation along the vein where Ceftriaxone Aurobindo 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 patches (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.

Not known (frequency cannot be estimated from the available data)

Secondary infections that may not respond to the prescribed antibiotic.
A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
Severe decrease in the number of white blood cells (agranulocytosis).
Seizures.
Dizziness.
Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
Inflammation of the mouth lining (stomatitis).
Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
Problems with the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and pale stools.
A neurological condition that may develop in newborns with severe jaundice (kernicterus).
Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease.
False positive Coombs test (a test to detect blood problems).
False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
Ceftriaxone Aurobindo may interfere with certain types of blood glucose tests; please consult your doctor.

Following accidental injection of lidocaine into a blood vessel during intramuscular administration of Ceftriaxone 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 (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, profound 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 effects, including those not listed in this leaflet, please contact your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceftriaxone Aurobindo

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 after EXP. The expiry date refers to the last day of that month.
The 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 below 25°C.
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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone Aurobindo contains
Ceftriaxone Aurobindo 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
The active substance is ceftriaxone disodium.
One vial of powder contains 500 mg of ceftriaxone as ceftriaxone disodium; one solvent ampoule contains: aqueous solution of lidocaine 1%.
Ceftriaxone Aurobindo 1 g/3.5 ml powder and solvent for injectable solution
The active substance is ceftriaxone disodium.
One vial of powder contains 1 g of ceftriaxone as ceftriaxone disodium; one solvent ampoule contains: aqueous solution of lidocaine 1%.

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2,
Valletta Waterfront,
Floriana FRN 1914, Malta

Manufacturer
Mitim S.r.l. – Via Cacciamali 34-36-38 – 25125 Brescia

Package leaflet: Information for the patient

Ceftriaxone Aurobindo 500 mg/5 ml powder and solvent for injectable solution for intravenous use
Ceftriaxone Aurobindo 1 g/10 ml powder and solvent for injectable solution for intravenous use
Generic medicine
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 they have the same symptoms 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:

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

1. What Ceftriaxone Aurobindo is and what it is used for

Ceftriaxone Aurobindo 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.
Ceftriaxone Aurobindo 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.

2. What you need to know before you are given Ceftriaxone Aurobindo

Do not be given Ceftriaxone Aurobindo 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 Ceftriaxone Aurobindo is to be administered by intramuscular injection.

Ceftriaxone Aurobindo must not be given to children in the following cases:

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

Warnings and precautions
Tell your doctor, pharmacist, or nurse before you are given Ceftriaxone Aurobindo if:

you have recently received or are about to receive products containing calcium;
you have recently had diarrhoea after taking an antibiotic; you have intestinal problems, particularly colitis (inflammation of the intestine);
you have liver or kidney problems (see section 4);
you have gallstones or kidney stones;
you have other diseases, for example haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin and lead to weakness or 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 need to have blood or urine tests
If you are given Ceftriaxone Aurobindo for a prolonged period, you may need to have regular blood tests. Ceftriaxone Aurobindo may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to have tests:

inform the person taking your sample that you have been given Ceftriaxone Aurobindo.

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that may give inaccurate glucose readings 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 Ceftriaxone Aurobindo is given to a child if:

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

Other medicines and Ceftriaxone Aurobindo
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 Ceftriaxone Aurobindo would provide you and the possible risks to the baby.

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

Ceftriaxone Aurobindo 500 mg/5 ml powder and solvent for solution for intravenous injection contains sodium:
This medicine contains 41.5 mg of sodium (a main component of table salt) per vial.
This corresponds to 2.1% of the maximum daily recommended dietary intake for an adult.

Ceftriaxone Aurobindo 1 g/10 ml powder and solvent for solution for intravenous injection contains sodium:
This medicine contains 83 mg of sodium (a main component of table salt) per vial.
This corresponds to 4.2% of the maximum daily recommended dietary intake for an adult.

3. How Ceftriaxone Aurobindo is administered

Ceftriaxone Aurobindo is generally administered by a doctor or nurse through a drip
(intravenous infusion) or via an injection directly into a vein. Ceftriaxone Aurobindo
will be prepared by a doctor, pharmacist, or nurse and will not be mixed with, nor administered simultaneously with, injections containing calcium.
Usual dose
Your doctor will determine the correct dose of Ceftriaxone Aurobindo for you. The dose will depend on the severity and
type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the functioning of your kidneys and liver. The number of days or weeks during which you will receive Ceftriaxone Aurobindo 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 as a single dose once daily or as two separate doses.

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

50–80 mg of Ceftriaxone Aurobindo once daily per kg of 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 as a single dose once daily or as two separate doses.
Children with a body weight of 50 kg or more should receive the usual adult dose.
Neonates (0–14 days of life)
20–50 mg of Ceftriaxone Aurobindo once daily per kg of body weight, depending on the severity and type of infection.
The maximum daily dose must not exceed 50 mg per kg of 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 Ceftriaxone Aurobindo you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more Ceftriaxone Aurobindo than you should
If you are accidentally given more Ceftriaxone Aurobindo than prescribed, contact your doctor or the nearest hospital immediately.
If you miss a dose of Ceftriaxone Aurobindo
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 Ceftriaxone Aurobindo
Do not stop taking Ceftriaxone Aurobindo 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 get them.
With this medicine, you may experience the following side effects:

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

Severe rash that develops rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs 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 may occur shortly after starting treatment with Ceftriaxone Aurobindo for spirochete infections such as Lyme disease. 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.

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

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

Uncommon (may affect up to 1 in 100 people)

Fungal infections (e.g. thrush).
Decrease in the number of white blood cells (granulocytopenia).
Reduction in the number of red blood cells (anaemia).
Blood clotting problems. Signs include easy bruising, joint pain and swelling.
Headache.
Dizziness.
Nausea or vomiting.
Itching.
Pain or burning sensation along the vein where Ceftriaxone Aurobindo was administered. Pain at the injection site.
Fever.
Abnormal kidney function test results (increased blood creatinine).

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

Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever.
Difficulty breathing (bronchospasm).
Rash with hives (urticaria), which may cover a large area of the body, associated with itching and swelling.
Blood or sugar in the urine.
Oedema (fluid accumulation).
Chills.

Not known (frequency cannot be estimated from the available data)

Secondary infections that may not respond to the prescribed antibiotic.
A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
Severe decrease in the number of white blood cells (agranulocytosis).
Seizures.
Dizziness.
Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
Inflammation of the mouth lining (stomatitis).
Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
Problems with 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 the amount of urine produced may decrease.
False positive Coombs test (a test to detect blood problems).
False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
Ceftriaxone Aurobindo may interfere with certain types of tests used to measure glucose in the blood; please check with 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 http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceftriaxone Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the
last day of that month.
Chemical and physical in-use stability has been demonstrated for at least 6 hours at a temperature below 25 °C,
or 24 hours at 2-8 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the
period and conditions of storage prior to use are the responsibility of the user and must not exceed the times
indicated above for in-use chemical and physical stability.
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. Pack contents and other information

What Ceftriaxone Aurobindo contains
Ceftriaxone Aurobindo 500 mg/5 ml powder and solvent for injectable solution for intravenous use
Each powder vial contains 500 mg of ceftriaxone as ceftriaxone disodium; one solvent vial contains: water for injection.
Ceftriaxone Aurobindo 1 g/10 ml powder and solvent for injectable solution for intravenous use
Each powder vial contains 1 g of ceftriaxone as ceftriaxone disodium; one solvent vial contains: water for injection.

Description of the appearance of Ceftriaxone Aurobindo and pack contents
Ceftriaxone Aurobindo 500 mg/5 ml powder and solvent for injectable solution for intravenous use: 1 powder vial + 1 solvent vial of 5 ml.
Ceftriaxone Aurobindo 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
Eugia Pharma (Malta) Limited
Vault 14, Level 2,
Valletta Waterfront,
Floriana FRN 1914, Malta

Manufacturer
Mitim S.r.l. – Via Cacciamali 34-36-38 – 25125 Brescia

Patient information leaflet

Ceftriaxone Aurobindo 2 g powder for solution for infusion

Equivalent 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, as it could be harmful.
If any side effect occurs, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Ceftriaxone Aurobindo is and what it is used for

Ceftriaxone Aurobindo contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including newborns). It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone Aurobindo 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 also be administered:

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

2. What you need to know before being given Ceftriaxone Aurobindo

Do not be given Ceftriaxone Aurobindo 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 it difficult to breathe or swallow, sudden swelling of the hands, feet and ankles, and a severe rash that develops rapidly.
you are allergic to lidocaine and Ceftriaxone Aurobindo is to be administered by intramuscular injection.

Ceftriaxone Aurobindo 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 calcium-containing product intravenously.

Warnings and precautions
Tell your doctor, pharmacist or nurse before being given Ceftriaxone Aurobindo if:

you have recently received or are about to receive products containing calcium;
you have recently had diarrhoea after taking an antibiotic; you have intestinal problems, particularly colitis (inflammation of the intestine);
you have liver or kidney problems (see section 4);
you have gallstones or kidney stones;
you have other diseases, for example haemolytic anaemia (a reduction in red blood cells which 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: skin rash, redness of the skin, 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 undergo blood or urine tests
If you are given Ceftriaxone Aurobindo for a prolonged period, you may need to have regular blood tests. Ceftriaxone Aurobindo 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 Ceftriaxone Aurobindo.

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

Children
Talk to your doctor, pharmacist or nurse before administering Ceftriaxone Aurobindo 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).

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 Ceftriaxone Aurobindo for you and the possible risks for your baby.

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

Ceftriaxone Aurobindo 2 g powder for solution for infusion contains sodium:
This medicine contains 166 mg of sodium (a main component of table salt) per vial.
This corresponds to 8.3% of the maximum daily dietary intake recommended for an adult.

3. How Ceftriaxone Aurobindo is administered

Ceftriaxone Aurobindo is generally administered by a doctor or nurse through an intravenous infusion (IV infusion) or by an injection directly into a vein.
Ceftriaxone Aurobindo will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered at the same time as calcium-containing injections.

Standard dose
Your doctor will determine the correct dose of Ceftriaxone Aurobindo for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the functioning of your kidneys and liver. The number of days or weeks during which you will receive Ceftriaxone Aurobindo 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 Ceftriaxone Aurobindo once daily per kg of the child’s body weight, depending on the severity and type of infection. If the infection is severe, your doctor may prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be 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 standard adult dose.

Newborns (0–14 days of life):

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

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

If you miss a dose of Ceftriaxone Aurobindo
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 Ceftriaxone Aurobindo
Do not stop taking Ceftriaxone Aurobindo unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, seek medical help 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 that develops rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes, and involvement of other organs 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 usually resolves spontaneously. These symptoms may occur shortly after starting treatment with Ceftriaxone Aurobindo for spirochete infections such as Lyme disease.

Treatment with ceftriaxone may, particularly in elderly patients with severe renal impairment or neurological disorders, rarely cause reduced consciousness, abnormal movements, agitation, and seizures.

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 Ceftriaxone Aurobindo was administered. Pain at the injection site.
Fever.
Abnormal kidney function test results (increased blood creatinine).

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

Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain, and fever.
Difficulty breathing (bronchospasm).
Rash with raised itchy areas (urticaria), possibly affecting large areas of the body, associated with itching and swelling.
Blood or sugar in the urine.
Oedema (fluid retention).
Chills.

Not known (frequency cannot be estimated from the available data)

Secondary infections that may not respond to the prescribed antibiotic.
A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
Severe decrease in white blood cells (agranulocytosis).
Seizures.
Dizziness.
Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
Inflammation of the mouth lining (stomatitis).
Inflammation of the tongue (glossitis). Signs include swelling, redness, and irritation of the tongue.
Problems affecting the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and clay-coloured stools.
A neurological condition that may develop in newborns with severe jaundice (kernicterus).
Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
False positive Coombs test (a blood test to detect blood-related problems).
False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
Ceftriaxone Aurobindo may interfere with certain types of blood glucose tests; please consult your doctor.

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

5. How to store Ceftriaxone Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
The 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 for the product stored at temperatures below 25°C.
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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone Aurobindo contains
The active substance is ceftriaxone disodium.
Each vial contains 2 g of ceftriaxone as ceftriaxone disodium.
Description of the appearance of Ceftriaxone Aurobindo and the contents of the pack
Ceftriaxone Aurobindo 2 g powder for solution for infusion: 1 vial of powder.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2,
Valletta Waterfront,
Floriana FRN 1914, Malta
Manufacturer
Mitim S.r.l. – Via Cacciamali 34-36-38 – 25125 Brescia