Ceftriaxone Zentiva

Package leaflet: Information for the patient

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

Ceftriaxone Zentiva 1 g / 10 ml powder and solvent for injectable solution for
intravenous use
Generic medicine
Please read this leaflet carefully before this medicine is administered to you because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Ceftriaxone Zentiva 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 Zentiva 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 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 Zentiva

Do not receive Ceftriaxone Zentiva if:

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

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

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

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

• You have recently received or are about to receive products containing calcium.
• You have recently had diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine).
• You have liver or kidney problems (see section 4).
• You have gallstones or kidney stones.
• You have other diseases, for example haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin and lead to weakness or breathlessness). You are experiencing or have previously experienced 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, 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”).
• You are on a low-sodium diet.

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

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

• An antibiotic called an aminoglycoside.
• An antibiotic called chloramphenicol (used in the treatment of infections, particularly eye infections).

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

Driving and using machines
Ceftriaxone Zentiva 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 Zentiva contains sodium
Each gram of Ceftriaxone Zentiva contains 3.6 mmol of sodium. This should be taken into account in patients on a controlled sodium diet.
Ceftriaxone Zentiva 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
This medicine contains 82.8 mg of sodium per vial, equivalent to 4.14% of the maximum daily recommended dietary intake for an adult.
Ceftriaxone Zentiva 1 g / 10 ml powder and solvent for injectable solution for intravenous use
This medicine contains 82.8 mg of sodium per vial, equivalent to 4.14% of the maximum daily recommended dietary intake for an adult.

3. How Ceftriaxone Zentiva is administered

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

Usual dose
Your doctor will determine the correct dose of Ceftriaxone Zentiva for you. The dose depends on the severity and type of infection, whether you are receiving 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 Zentiva depends on the type of infection you have.

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

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.

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

• 50–80 mg of Ceftriaxone Zentiva per kg of body weight once daily, 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 daily dose or divided into 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 Zentiva per kg of body weight once daily, 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 recommended dose. Your doctor will decide the appropriate amount of Ceftriaxone Zentiva you require and will monitor you closely, depending on the severity of your liver or kidney disease.

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

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

If you stop treatment with Ceftriaxone Zentiva
Do not stop taking Ceftriaxone Zentiva unless your doctor tells you to. If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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. This may make breathing or swallowing difficult.
• Sudden swelling of the hands, feet, and ankles.

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

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

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

• Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain, and fever.
• Difficulty breathing (bronchospasm).
• Skin rash with 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.
  • Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation, and seizures.

Frequency 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 clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease.
• False positive Coombs test result (a test to detect blood problems).
• False positive result for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone Zentiva may interfere with certain types of blood glucose tests; 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
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 Zentiva

From a microbiological standpoint, the product should be used immediately after reconstitution.
If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user.
Chemical and physical stability of the medicinal product after reconstitution has been demonstrated for 24 hours between +2°C and +8°C, and for 6 hours when stored at temperatures below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines 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 Zentiva contains

• The active substance is:

Ceftriaxone Zentiva 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g
Ceftriaxone Zentiva 1 g / 10 ml powder and solvent for injectable solution for intravenous use
One vial of powder contains:
ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g

• Other components:
  Powder and solvent for injectable solution for intramuscular use: the solvent vial contains lidocaine hydrochloride

Powder and solvent for injectable solution for intravenous use:
the solvent vial contains water for injections

Description of the appearance of Ceftriaxone Zentiva and package contents
Glass vial (and possibly additional glass vial for reconstitution liquids) with a puncturable rubber stopper secured with a metal crimp cap and a plastic cap. The vial is contained in a cardboard box together with the package leaflet.
Ceftriaxone Zentiva 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use:
1 vial of powder + 1 solvent vial of 3.5 ml.
Ceftriaxone Zentiva 1 g / 10 ml powder and solvent for injectable solution for intravenous use:
1 vial of powder + 1 solvent vial of 10 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
ZENTIVA ITALIA S.r.l. - Viale Bodio, 37/b - 20158 Milan, Italy

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via D. Alighieri, 71 - Sanremo (IM)