CEFTRIAXONE 500 mg /2 Ml Proszek I Rozpuszczalnik Do Sporządzania Roztworu Do Wstrzykiwań

Treść ulotki

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

Ceftriaxone Accord 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
Ceftriaxone Accord 1 g/3,5 ml powder and solvent for injectable solution for intramuscular use

Ceftriaxone (as ceftriaxone sodium)

Lidocaine (as lidocaine hydrochloride)

Equivalent medicinal product
Read this leaflet carefully before you are given this medicine as it contains
important information for you.

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

Contents of this leaflet:

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

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

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

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

It can be administered:

• to treat specific sexually transmitted infections (gonorrhea and syphilis).
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have a 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 life.
• to prevent infections during surgery.

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

You must not be given Ceftriaxone Accord if:

• you are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).
• you have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include a sudden swelling of the throat or face, which can make it difficult to breathe or swallow, a sudden swelling of hands, feet and ankles, and a severe skin rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone Accord is to be given to you by injection into a muscle.
• you suffer from an abnormality in the propagation of the impulse in the heart that causes a reduction in blood pressure and a slowing of the heart rate (complete atrioventricular block).
• you suffer from a condition of reduced blood volume (hypovolemia).

Ceftriaxone Accord 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 some blood problems or jaundice (yellowing of the skin or the white of the eye) or must receive through a vein a product containing calcium.

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

• you have recently received or are about to receive products containing calcium.
• you have recently had problems with diarrhoea after taking an antibiotic. You have had problems with your intestines, in particular colitis (inflammation of the intestine).
• you suffer from problems with your liver or kidneys (see section 4).
• you have gallstones or kidney stones.
• you have other illnesses, for example hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause 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 suffer from any heart problem, especially if this affects your heart rate.
• you have breathing problems.
• you suffer from porphyria (a rare inherited disease that affects the skin and nervous system)
• you develop or have developed in the past any combination of the following symptoms: skin 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 and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).

If you are to undergo a blood or urine test
If you are given Ceftriaxone Accord for a prolonged period, you may need to undergo
regular blood tests. Ceftriaxone Accord can affect the results of urine tests
relating to sugar 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 Accord.

If you are diabetic or need monitoring of blood glucose levels, you should not use some blood glucose monitoring systems that may detect blood glucose incorrectly during
treatment with ceftriaxone. If you use such systems, check the instructions for use and inform your doctor,
pharmacist or nurse. If necessary, alternative analytical methods should be used.

Children
Talk to your doctor, pharmacist or nurse before giving Ceftriaxone Accord to
the child if:

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

Other medicines and Ceftriaxone Accord
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as
they can interact with ceftriaxone:

• a type of antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used to treat infections, especially eye infections). Several medicines can interact with lidocaine, resulting in altered effects. These medicines include:
• medicines used to treat infections (clarithromycin, erythromycin).
• medicines used in the treatment of stomach ulcers (e.g. cimetidine).
• potent painkillers such as codeine and pethidine (narcotic or opioid drugs).
• medicines used to treat irregular heart rate (e.g. mexiletine, tocainide).

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

Driving and operating machinery
Ceftriaxone Accord can 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 Accord 500 mg/2 ml powder and solvent for solution for injection for intramuscular use
contains sodium
This medicine contains 41.4 mg of sodium (the main component of table salt) per vial.
This is equivalent to 2% of the recommended maximum daily intake of sodium with the diet of an adult.

Ceftriaxone Accord 1 g/3.5 ml powder and solvent for solution for injection for intramuscular use
contains sodium
This medicine contains 82.9 mg of sodium (the main component of table salt) per vial.
This is equivalent to 4% of the recommended maximum daily intake of sodium with the diet of an adult.

3. How Ceftriaxone Accord is administered

Ceftriaxone Accord is generally administered by a doctor or nurse via an injection
performed directly into a muscle. Ceftriaxone Accord will be prepared by a doctor, pharmacist or a
nurse and will not be mixed, nor will it be administered simultaneously with injections containing calcium.

Usual dose
The doctor will determine the right dose of Ceftriaxone Accord for you. The dose will depend on the severity and the
type of infection, any concomitant treatment with other antibiotics, your weight and age,
the degree of functioning of your kidneys and liver. The number of days or weeks during which
you will receive Ceftriaxone Accord will depend on the type of infection you have.

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

• from 1 to 2 g once a day depending on the severity and type of infection. If you have a severe infection, the doctor will administer a higher dose (up to 4 g per day). If your daily dose is greater than 2 g, you may take it as a single dose once a day or as two separate doses. Newborns, infants and children from 15 days to 12 years of age with a body weight less than 50 kg:
• 50-80 mg Ceftriaxone Accord once a day for each kg of the child's body weight depending on the severity and type of infection. If you have a severe infection, the doctor will prescribe a higher dose starting from 100 mg for each kg of body weight up to a maximum of 4 g per day. If your daily dose is greater than 2 g, you may take it as a single dose once a day or as two separate doses.
• children with a body weight of 50 kg or more should be given the usual adult dose.

Newborns (0- 14 days of life)

• 20-50 mg Ceftriaxone Accord once a day for each kg of the newborn's body weight depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg for each kg of the newborn's body weight.

People with liver and kidney problems
You may be given a different dose than usual. The doctor will decide the amount of
Ceftriaxone Accord you need and will monitor you carefully, depending on the severity of
liver and kidney disease.

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

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

If you stop taking Ceftriaxone Accord
Do not stop taking Ceftriaxone Accord unless your doctor tells you to. If you have any
doubts about using this medicine, ask 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:

Serious allergic reactions (frequency not known, the frequency cannot be estimated based on 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 can make it difficult to breathe or swallow.
• sudden swelling of the hands, feet and ankles.

Serious skin reactions (frequency not known, the frequency cannot be estimated based on available data)
If you develop a serious 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 by the abbreviations SJS and TEN).
• Any combination of the following symptoms: widespread rash, high temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known by the abbreviation DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which can cause fever, chills, headache, muscle pain and rash, which generally tends to resolve spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone Accord to treat infections caused by spirochetes such as Lyme disease. Treatment with ceftriaxone, especially in elderly patients with severe kidney failure or nervous system disorders, can rarely cause a decrease in consciousness, abnormal movements, agitation and convulsions.

Other possible side effects:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (for example, thrush).
• Decreased number of white blood cells (granulocytopenia).
• Decreased number of red blood cells (anemia).
• 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 Accord was administered. Pain at the injection site.
• Fever.
• Abnormal values in kidney function tests (increased creatinine in the blood).

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

• Inflammation of the large intestine (colon). Signs include diarrhea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with hives (urticaria) that can cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid retention).
• Chills.

Frequency not known (the frequency cannot be estimated based on available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anemia characterized by the destruction of red blood cells (hemolytic anemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Convulsions.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain that spreads to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder that can cause pain, nausea and vomiting.
• A neurological condition that can develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. Pain when urinating may occur, or the amount of urine produced may be reduced.
• A false positive Coombs test (a test to detect blood problems).
• A false positive test for galactosemia (an abnormal build-up of galactose sugar).
• Ceftriaxone Accord may interfere with some types of tests to measure blood glucose; check with your doctor.

After accidental injection of lidocaine into a blood vessel during intramuscular administration
of Ceftriaxone Accord, other side effects may occur, which may include:

• Frequency not known (the frequency cannot be estimated based on available data)
• Changes in heart rate and rhythm.
• Low blood pressure.
• Slowing of the heart rate (less than 60 beats/minute).
• Interruption of normal blood circulation due to cardiac arrest and decreased 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, convulsions or seizures, profound state of unconsciousness (coma).
• Blurred vision, double vision or temporary loss of vision.
• Feeling unwell (nausea or vomiting).
• Difficulty breathing.
• Decreased respiratory rate or possible cessation of breathing.
• An unusual feeling of sleepiness or fatigue during the day or fainting.

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

5. How to store Ceftriaxone Accord

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 package and on the vial label after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
From a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, the storage period and conditions before use are the responsibility of the user. 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 a temperature below 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ceftriaxone Accord contains
Ceftriaxone Accord 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains: ceftriaxone sodium 596.5 mg equivalent to 500 mg of ceftriaxone.
One vial of solvent contains: 1% lidocaine aqueous solution.

Ceftriaxone Accord 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains: ceftriaxone sodium 1.193 g equivalent to 1g of ceftriaxone.
One vial of solvent contains: 1% lidocaine aqueous solution.
Ceftriaxone Accord must not be mixed with other medicinal products in the same syringe.

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

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain.

Manufacturer
Laboratorio Farmaceutico CT Srl
Via Dante Alighieri, 71
18038 Sanremo (IM)