Ceftriaxone Mylan Generics

Patient Information Leaflet

Ceftriaxone Mylan Generics 500 mg/2 ml powder and solvent

for injectable solution for intramuscular use
Ceftriaxone (as ceftriaxone disodium)
Lidocaine (as lidocaine hydrochloride)
Generic Medicine
Please read this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Ceftriaxone Mylan Generics is and what it is used for

Ceftriaxone Mylan Generics 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 Mylan Generics is administered by injection into a muscle in a solution containing lidocaine, which reduces the pain associated with the injection.
Ceftriaxone Mylan Generics is used to treat infections:

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

It may be administered:

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

2. What you should know before being given Ceftriaxone Mylan Generics

Do not receive Ceftriaxone Mylan Generics 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 hands, feet and ankles, chest pain, and a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone Mylan Generics is to be administered by intramuscular injection.
• you suffer from a heart conduction disorder causing low blood pressure and slowed heart rate (complete atrioventricular block).
• you have a condition characterized by reduced blood volume (hypovolemia).

Ceftriaxone Mylan Generics 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
Talk to your doctor, pharmacist or nurse before you are given Ceftriaxone Mylan Generics if:

• you have recently received or are about to receive products containing calcium.
• you have recently experienced 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 breathlessness).
• you are on a low-sodium diet.
• you suffer from loss of muscle function and weakness (myasthenia gravis).
• you suffer from seizures (epilepsy).
• you have any heart problems, especially if they affect 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, skin redness, blistering on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).

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

• inform the person taking your sample that you have been given Ceftriaxone Mylan Generics.

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

Children
Talk to your doctor, pharmacist or nurse before administering Ceftriaxone Mylan Generics 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 Mylan Generics
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 drugs 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 drugs).
• 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 taking this medicine.
Your doctor will assess the benefits that treatment with Ceftriaxone Mylan Generics would provide you and the potential risks to the unborn child.

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

Ceftriaxone Mylan Generics contains sodium
This medicine contains 41.5 mg of sodium (the main component of table salt) per 500 mg vial. This is equivalent to 2% of the maximum daily recommended dietary intake for an adult.

3. How Ceftriaxone Mylan Generics is administered

Ceftriaxone Mylan Generics is generally administered by a doctor or nurse via an injection directly into a muscle. Ceftriaxone Mylan Generics will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with injections containing calcium.
For reconstitution of the solution, use of a 21G (0.8 mm) needle is recommended.
Ceftriaxone Mylan Generics must not be mixed with other medicinal products in the same syringe, except with 1% lidocaine hydrochloride solution (for intramuscular injection only). Solutions of ceftriaxone containing lidocaine must never be administered intravenously.

Usual dose
Your doctor will determine the correct dose of Ceftriaxone Mylan Generics for you. The dose will depend on the severity and type of infection, whether you are receiving 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 Ceftriaxone Mylan Generics 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 Ceftriaxone Mylan Generics 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 as two separate doses.
• Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Newborns (0–14 days of life):

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

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

If you miss a dose of Ceftriaxone Mylan Generics
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 Mylan Generics
Do not stop taking Ceftriaxone Mylan Generics 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:

Severe allergic reactions (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, which may make breathing or swallowing difficult;
• sudden swelling of the hands, feet and ankles;
• chest pain occurring in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

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

• severe rash 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, which usually resolves spontaneously. These symptoms may occur shortly after starting treatment with Ceftriaxone Mylan Generics for spirochete infections such as Lyme disease.

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

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

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. oral thrush).
• Decreased number of white blood cells (granulocytopenia).
• Reduced number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Ceftriaxone Mylan Generics 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, 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 with the gallbladder and/or liver, which may cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and pale, 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 Mylan Generics may interfere with certain types of tests measuring blood glucose; please consult your doctor.

Following accidental injection of lidocaine into a blood vessel during intramuscular administration of Ceftriaxone Mylan Generics 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, 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.

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

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 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 Mylan Generics

Keep this medicine out of sight and reach of children.
Expiry: see the expiry date stated on the packaging.
Warning: do not use the medicine after the expiry date stated on the packaging.
The stated expiry date refers to the product in its original packaging, stored correctly.
It is recommended to use freshly prepared solutions of Ceftriaxone Mylan Generics, even though the medicine, once dissolved, is chemically stable for 6 hours at room temperature and for 24 hours when refrigerated.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and must not exceed the time limits indicated above for chemical and physical stability during use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone Mylan Generics contains
Ceftriaxone Mylan Generics 500 mg/2 ml powder and solvent for injectable solution for
intramuscular use
One vial of powder contains:
Active substance: ceftriaxone disodium 3.5 H2O 596.5 mg equivalent to ceftriaxone 500 mg;
One solvent ampoule contains: aqueous solution of 1% lidocaine.
Ceftriaxone Mylan Generics must not be mixed with other medicinal products in the same syringe,
except with 1% hydrochloride lidocaine solution (only for intramuscular injection).

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

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano

Manufacturer
Laboratorio Farmaceutico CT, Via Dante Alighieri 71, 18038 Sanremo (IM)
Mitim S.r.l., Via Cacciamali 38, 25125 Brescia

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

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

Disposal of expired/unwanted medicines
Medicines released into the environment should be minimized. Medicinal products must not be disposed of via wastewater or household waste. Use designated collection systems, if available.

Patient information leaflet: information for the patient

Ceftriaxone Mylan Generics 1000 mg/3.5 ml powder and solvent

for injectable solution for intramuscular use
Ceftriaxone (as ceftriaxone disodium)
Lidocaine (as lidocaine hydrochloride)
Generic Medicine
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Ceftriaxone Mylan Generics is and what it is used for

Ceftriaxone Mylan Generics 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 Mylan Generics is given by injection into a muscle using a solution containing lidocaine, which reduces the pain associated with the injection.

Ceftriaxone Mylan Generics is used to treat infections of:

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

It may 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 need to know before you are given Ceftriaxone Mylan Generics

Do not receive Ceftriaxone Mylan Generics if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have previously had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams, and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of hands, feet, and ankles, chest pain, and a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone Mylan Generics 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 characterized by reduced blood volume (hypovolemia).

Ceftriaxone Mylan Generics 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 Ceftriaxone Mylan Generics if:

• you have recently received or are about to receive products containing calcium.
• you have recently experienced 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, 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 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 blood or urine tests
If you are given Ceftriaxone Mylan Generics for a prolonged period, you may need to have regular blood tests. Ceftriaxone Mylan Generics 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 Mylan Generics.

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 Mylan Generics 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 Mylan Generics
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, 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 assess the benefits of treatment with Ceftriaxone Mylan Generics for you and the potential risks to the unborn or breastfed child.

Driving and using machines
Ceftriaxone Mylan Generics 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.

Ceftriaxone Mylan Generics contains sodium
This medicine contains 83 mg of sodium (a main component of table salt) per 1 g vial. This is equivalent to 4% of the maximum daily dietary intake recommended for an adult.

3. How Ceftriaxone Mylan Generics is administered

Ceftriaxone Mylan Generics is generally administered by a doctor or a nurse via an injection directly into a muscle. Ceftriaxone Mylan Generics will be prepared by a doctor, pharmacist, or nurse and must not be mixed with, or administered simultaneously with, calcium-containing injections.
For reconstitution of the solution, use of a 21G (0.8 mm) needle is recommended.
Ceftriaxone Mylan Generics must not be mixed with other medicinal products in the same syringe, except with 1% lidocaine hydrochloride solution (for intramuscular injection only). Solutions of ceftriaxone containing lidocaine must never be administered intravenously.

Usual dose
Your doctor will determine the correct dose of Ceftriaxone Mylan Generics 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 Ceftriaxone Mylan Generics will depend on the type of infection you have.

Adults, elderly patients, and children aged 12 years or older with a body weight equal to or greater than 50 kilograms (kg):

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor will administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given 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 Mylan Generics 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 administered 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 Mylan Generics 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 Ceftriaxone Mylan Generics you need and will monitor you closely, depending on the severity of your liver or kidney disease.

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

If you miss a dose of Ceftriaxone Mylan Generics
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 Mylan Generics
Do not stop taking Ceftriaxone Mylan Generics 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 advice immediately.
Signs may include:

• sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
• sudden swelling of the hands, feet and ankles.
• chest pain occurring in the context of allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

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

• a severe rash that develops rapidly, with blistering or peeling of the skin and possible development of blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs 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 Ceftriaxone Mylan Generics 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 Ceftriaxone Mylan Generics was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (increased creatinine in blood).

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

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

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

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Seizures.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver, which may cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and 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 result for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone Mylan Generics may interfere with certain types of tests to measure glucose in the blood; please check with your doctor.

Following accidental injection of lidocaine into a blood vessel during intramuscular administration of Ceftriaxone Mylan Generics 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, deep state of 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 feeling of drowsiness or tiredness during the day or fainting.

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

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 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 Mylan Generics

Keep this medicine out of the sight and reach of children.
Expiry date: see the expiry date stated on the packaging.
Warning: do not use this medicine after the expiry date stated on the packaging.
The stated expiry date refers to the product in its original, unopened packaging and stored under
recommended conditions.
It is recommended to use freshly prepared solutions of Ceftriaxone Mylan Generics, even though the drug, once dissolved, is stable for 6 hours at room temperature and for 24 hours under refrigeration (2–8°C).
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and must not exceed the time limits indicated above for chemical and physical stability during use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone Mylan Generics contains
Ceftriaxone Mylan Generics 1000 mg/3.5 ml powder and solvent for injectable solution for
intramuscular use
One vial of powder contains:
Active substance: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g.
One solvent vial contains: aqueous solution of 1% lidocaine.
Ceftriaxone Mylan Generics must not be mixed with other medicinal products in the same syringe,
except with 1% lidocaine hydrochloride solution (for intramuscular injection only).

Description of the appearance of Ceftriaxone Mylan Generics and contents of the pack
Ceftriaxone Mylan Generics 1000 mg/3.5 ml powder and solvent for injectable solution for
intramuscular use: 1 vial of powder + 1 solvent vial of 3.5 ml.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano

Manufacturer
Laboratorio Farmaceutico CT, Via Dante Alighieri 71, 18038 Sanremo (IM)
Mitim S.r.l., Via Cacciamali 38, 25125 Brescia

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

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

Disposal of expired/unwanted medicines
Release of medicines into the environment must be minimized. Medicines must not be
flushed down drains or thrown into household waste. Use dedicated collection systems, if available.

Patient Information Leaflet

Ceftriaxone Mylan Generics 1000 mg powder for injectable solution

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Ceftriaxone Mylan Generics is and what it is used for

Ceftriaxone Mylan Generics 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 Mylan Generics 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 Mylan Generics

Do not receive Ceftriaxone Mylan Generics if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have previously had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of the hands, feet and ankles, chest pain, or a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone Mylan Generics is to be administered by intramuscular injection.

Ceftriaxone Mylan Generics 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 if the child is to receive a calcium-containing product intravenously.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Ceftriaxone Mylan Generics if:

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

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

• inform the person taking your sample that you have been given Ceftriaxone Mylan Generics.

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that may incorrectly measure blood glucose 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 giving Ceftriaxone Mylan Generics to a child if:

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

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

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Your doctor will assess the benefits of treatment with Ceftriaxone Mylan Generics for you and the possible risks to the unborn or breastfed child.

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

Ceftriaxone Mylan Generics contains sodium
This medicine contains 83 mg of sodium (a key component of table salt) per 1 g vial. This is equivalent to 4% of the maximum daily recommended dietary intake for an adult.

3. How Ceftriaxone Mylan Generics is administered

Ceftriaxone Mylan Generics is usually administered by a doctor or nurse
via intravenous infusion (IV infusion) or by direct injection into a vein.
Ceftriaxone Mylan Generics will be prepared by a doctor, pharmacist, or nurse and must not be
mixed with, nor administered simultaneously with, calcium-containing injections.
A 21G (0.8 mm) needle is recommended for reconstitution of the solution.
Ceftriaxone Mylan Generics must not be mixed with other medicinal products in the same syringe or
in the same infusion solution.

Usual dose
Your doctor will determine the correct dose of Ceftriaxone Mylan Generics for you. The dose will depend
on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight
and age, and the function of your kidneys and liver. The number of days or weeks during which you will
receive Ceftriaxone Mylan Generics 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 Ceftriaxone Mylan Generics 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 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 Ceftriaxone Mylan Generics once daily per kg of the newborn's body weight, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the newborn's body weight.

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

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

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

If you stop treatment with Ceftriaxone Mylan Generics
Do not stop taking Ceftriaxone Mylan Generics 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 everyone gets them.
You may experience the following side effects with this medicine:

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

• sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
• sudden swelling of the hands, feet and ankles.
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

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

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

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

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

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g., 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 Mylan Generics was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (increased creatinine in blood).

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

• Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• 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 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 cell count (agranulocytosis).
• Seizures.
• Dizziness.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Gallbladder and/or liver problems that may cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
• False positive Coombs test (a blood test to detect blood-related problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone Mylan Generics may interfere with certain types of blood glucose tests; please consult your doctor.

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

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 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 Mylan Generics

Keep the medicine out of the sight and reach of children.
Expiry date: see the date indicated on the packaging.
Warning: do not use the medicine after the expiry date stated on the packaging.
The stated expiry date refers to the product stored in its original intact packaging and properly
stored.
It is recommended to use freshly prepared solutions of Ceftriaxone Mylan Generics, even though the drug, once dissolved, is stable for 6 hours at room temperature and for 24 hours under refrigeration.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and must not exceed the times indicated above for chemical and physical stability during use.
Ceftriaxone Mylan Generics must not be mixed with other medicines in the same syringe or in the same infusion solution.
The infusion line must be flushed after each administration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone Mylan Generics contains
Ceftriaxone Mylan Generics 1000 mg powder for injectable solution
One vial of powder contains:
Active substance: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g.

Description of the appearance of Ceftriaxone Mylan Generics and contents of the pack
Ceftriaxone Mylan Generics 1000 mg powder for injectable solution: 1 or 10 vials of powder.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano

Manufacturer
Laboratorio Farmaceutico CT, Via Dante Alighieri 71, 18038 Sanremo (IM)
Mitim S.r.l., Via Cacciamali 38, 25125 Brescia
Wessling Hungary Kft., Anonymus u. 6., Budapest, 1045, Hungary

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

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

Disposal of expired/unwanted medicines
Release of medicines into the environment should be minimized as much as possible. Medicines must not be disposed of via wastewater or household waste. Use designated collection systems, if available.

Patient information leaflet

Ceftriaxone Mylan Generics 2000 mg powder for solution for infusion

Ceftriaxone (as ceftriaxone disodium)
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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Ceftriaxone Mylan Generics is and what it is used for

Ceftriaxone Mylan Generics 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 Mylan Generics 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 low white blood cell counts (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 surgical procedures.

2. What you need to know before you are given Ceftriaxone Mylan Generics

Do not receive Ceftriaxone Mylan Generics if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have previously experienced a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of hands, feet and ankles, chest pain, and a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone Mylan Generics is to be administered by intramuscular injection.

Ceftriaxone Mylan Generics 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 Ceftriaxone Mylan Generics 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 the skin to appear pale yellow and lead to weakness or shortness of breath).
• you are on a low-sodium diet.
• you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).

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

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems, as they may not correctly detect glucose in the blood 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 giving Ceftriaxone Mylan Generics 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 Mylan Generics
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 of treatment with Ceftriaxone Mylan Generics for you and the possible risks to the unborn or breastfed child.

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

Ceftriaxone Mylan Generics contains sodium
This medicine contains 166 mg of sodium (a key component of table salt) per 2 g vial. This is equivalent to 8% of the maximum daily recommended dietary intake for an adult.

3. How Ceftriaxone Mylan Generics is administered

Ceftriaxone Mylan Generics is generally administered by a doctor or nurse
via intravenous infusion (IV infusion) or by direct injection into a vein.
Ceftriaxone Mylan Generics will be prepared by a doctor, pharmacist, or nurse and must not be
mixed with, nor administered simultaneously with, calcium-containing injections.
A 21G (0.8 mm) needle is recommended for reconstitution of the solution.
Ceftriaxone Mylan Generics must not be mixed with other medicines in the same syringe or
in the same infusion solution.

Usual dose
Your doctor will determine the correct dose of Ceftriaxone Mylan Generics for you. The dose will depend
on the severity and type of infection, whether you are receiving concomitant treatment with other antibiotics, your body weight and age, and the function of your kidneys and liver. The number of
days or weeks during which you will receive Ceftriaxone Mylan Generics 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 Ceftriaxone Mylan Generics 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 as two separate doses.
• Children with a body weight equal to or greater than 50 kg should receive the adult usual dose.

Newborns (0–14 days of life):

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

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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;
• chest pain occurring in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

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

• a severe rash developing rapidly, with blistering or peeling of the skin and possible formation of blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, which usually resolves spontaneously. These symptoms may occur shortly after starting treatment with Ceftriaxone Mylan Generics 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 leucocytes 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 Mylan Generics was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (increased creatinine in blood).

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

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

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

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in white blood 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 and vomiting, yellowing of the skin, itching, unusually dark urine and clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
• False positive Coombs test (a test to detect blood problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone Mylan Generics may interfere with certain types of tests to measure blood glucose; please check with your doctor.

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.

Reporting of side effects
If you get any side effects, including ones 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 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 Mylan Generics

Keep this medicine out of the sight and reach of children.
Expiry date: see the expiry date stated on the packaging.
Warning: do not use the medicine after the expiry date stated on the packaging.
The stated expiry date refers to the product in its original, unopened packaging, correctly stored.
It is recommended to use freshly prepared solutions of Ceftriaxone Mylan Generics, even though the medicinal product, once dissolved, is stable for 6 hours at room temperature and for 24 hours under refrigeration.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and must not exceed the times indicated above for chemical and physical stability during use.
Ceftriaxone Mylan Generics must not be mixed with other medicines in the same syringe or in the same infusion solution.
The infusion line must be flushed after each administration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone Mylan Generics contains
Ceftriaxone Mylan Generics 2000 mg powder for solution for infusion
One vial contains:
Active substance: ceftriaxone disodium 3.5 H2O 2.386 g equivalent to ceftriaxone 2 g.
Description of the appearance of Ceftriaxone Mylan Generics and contents of the pack
Ceftriaxone Mylan Generics 2000 mg powder for solution for infusion: 1 or 10 vials of powder.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Laboratorio Farmaceutico CT, Via Dante Alighieri 71, 18038 Sanremo (IM)
Mitim S.r.l., Via Cacciamali 38, 25125 Brescia
Wessling Hungary Kft., Anonymus u. 6., Budapest, 1045, Hungary
Disposal of syringes/sharp objects
The following list of points must be strictly observed regarding the use and disposal of syringes and other sharp medical devices:

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

Disposal of expired/unwanted medicines
Release of medicines into the environment should be minimized. Medicines must not be disposed of via wastewater or household waste. Use designated collection systems, if available.