Ceftriaxone Tzf

Leaflet accompanying the packaging: patient information

Ceftriaxone TZF, 2 g, powder for solution for injection/infusion

Ceftriaxone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ceftriaxone TZF and what is it used for
• 2. Important information before using Ceftriaxone TZF
• 3. How to use Ceftriaxone TZF
• 4. Possible side effects
• 5. How to store Ceftriaxone TZF
• 6. Contents of the packaging and other information

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

Ceftriaxone TZF is an antibiotic used in adults and children (including newborns). Its action is to kill susceptible bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Ceftriaxone TZF 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,
• bones and joints,
• skin and soft tissues,
• blood,
• heart.

This medicine can be used:

• to treat certain sexually transmitted infections (gonorrhea and syphilis),
• to treat patients with a low white blood cell count (neutropenia) who have a fever caused by a bacterial infection,
• to treat chest infections in adults with chronic bronchitis,
• to treat Lyme disease (a disease transmitted by ticks) in adults and children, including newborns from the 15th day of life,
• to prevent infections during surgery.

2. Important information before using Ceftriaxone TZF

When not to use Ceftriaxone TZF:

• if the patient is allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems, monobactams); symptoms of such a reaction 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, and a rapidly spreading severe rash;
• if the patient is allergic to lidocaine and is to receive Ceftriaxone TZF by intramuscular injection.

Ceftriaxone TZF must not be used in newborn babies if:

• the baby is premature,
• the baby is a newborn (up to 28 days old) and has certain blood disorders or jaundice (yellowing of the skin and/or eyes) or is to receive calcium intravenously.

Warnings and precautions

Before starting treatment with Ceftriaxone TZF, the patient should discuss it with their doctor, pharmacist, or nurse if:

• the patient has recently received or is about to receive products containing calcium,
• the patient has recently had diarrhea after antibiotic treatment. The patient has had intestinal problems, in particular, colitis (inflammation of the colon).
• the patient has liver or kidney problems,
• the patient has gallstones or kidney stones,
• the patient has other diseases, such as hemolytic anemia (reduced red blood cell count, which can cause pallor and weakness or shortness of breath),
• the patient is on a low-sodium diet,
• the patient has or has had any of the following symptoms: rash, skin redness, blisters around the mouth, eyes, or genital area, skin peeling, high fever, flu-like symptoms, increased liver enzyme activity in blood tests, and increased white blood cell count (eosinophilia) and swollen lymph nodes (symptoms of severe skin reactions, see also section 4).
• the patient has liver or kidney problems (see section 4).

In case of blood or urine tests

If the patient is taking Ceftriaxone TZF for a long time, regular blood tests may be necessary. Ceftriaxone TZF may affect the results of urine sugar tests and a blood test called the Coombs test. If the patient is having tests, they should inform the person taking the sample that they are taking Ceftriaxone TZF.

If the patient has diabetes or needs to control their blood sugar levels, they should not use tests that may incorrectly measure blood sugar levels while taking ceftriaxone. If the patient is monitoring their blood sugar levels, they should check the instructions and tell their doctor, pharmacist, or nurse. Alternative test methods should be used if necessary.

Children

Before giving Ceftriaxone TZF to a child, the doctor or pharmacist should be consulted if the child has recently received or is about to receive a calcium-containing product intravenously.

Ceftriaxone TZF and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

In particular, the patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• an antibiotic belonging to the aminoglycoside group,
• an antibiotic called chloramphenicol (used to treat infections, especially eye infections).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor for advice before taking this medicine.

Pregnancy

The doctor will assess the benefits of treatment with Ceftriaxone TZF for the mother and the risks for the baby.

Breastfeeding

Ceftriaxone is excreted into human milk in small amounts, and during therapeutic doses, no effect on the breastfed newborn or infant is expected. However, the risk of diarrhea and fungal infection of the mucous membranes cannot be excluded. The possibility of an allergic reaction should be considered.

The doctor will decide whether to stop breastfeeding or stop taking ceftriaxone, considering the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and using machines

Ceftriaxone TZF may cause dizziness. If the patient feels dizzy, they should not drive or use any tools or machines. The patient should tell their doctor if they experience such symptoms.

Ceftriaxone TZF contains sodium

Each gram of the medicine contains about 83 mg of sodium (the main component of common salt). This corresponds to 4.2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ceftriaxone TZF

Ceftriaxone TZF is usually given by a doctor or nurse. It can be given:

• as an intravenous infusion (drip) or as an injection directly into a vein or
• intramuscularly into a muscle. Ceftriaxone TZF is prepared by a doctor, pharmacist, or nurse and will not be mixed or given at the same time as solutions containing calcium.

Usual dose

The doctor will decide what dose of Ceftriaxone TZF is suitable for the patient. The dose depends on the severity and type of infection; whether the patient is taking other antibiotics; the patient's age and weight; the patient's liver and kidney function. The number of days or weeks the patient will receive Ceftriaxone TZF depends on the type of infection.

Adults, elderly, and adolescents over 12 years old and weighing 50 kg or more

• 1 to 2 g once a day, depending on the severity and type of infection. In severe infections, the doctor will use a higher dose (up to 4 g once a day). If the daily dose is more than 2 g, the medicine can be given in one dose or in two separate doses.

Newborns, infants, and children from the 15th day of life to 12 years old and weighing less than 50 kg

• 50 to 80 mg of Ceftriaxone TZF per kilogram of the child's weight once a day, depending on the severity and type of infection. In severe infections, the doctor will use a higher dose, up to 100 mg per kilogram of the child's weight, up to 4 g once a day. If the daily dose is more than 2 g, the medicine can be given in one dose per day or in two separate doses.
• Children weighing 50 kg or more should receive the usual adult dose.

Newborns up to 14 days old

• 20 to 50 mg of Ceftriaxone TZF per kilogram of the child's weight once a day, depending on the severity and type of infection.
• The maximum daily dose should not be more than 50 mg per kilogram of the child's weight.

Patients with liver or kidney problems

The patient may receive a different dose than usual. The doctor will determine what dose of Ceftriaxone TZF is suitable for the patient and will closely monitor their condition, depending on the severity of the liver and kidney disease.

Using more than the recommended dose of Ceftriaxone TZF

In case of accidental administration of a higher dose than prescribed by the doctor, the patient should contact their doctor or the nearest hospital immediately.

Missing a dose of Ceftriaxone TZF

If the patient misses an injection, they should receive it as soon as possible. However, if it is almost time for the next injection, the missed dose should not be given. A double dose (two injections at the same time) should not be given to make up for the missed dose.

Stopping treatment with Ceftriaxone TZF

The patient should not stop taking Ceftriaxone TZF unless their doctor tells them to. If the patient has any further questions about taking this medicine, they should ask their doctor or nurse.

4. Possible side effects

Like all medicines, Ceftriaxone TZF can cause side effects, although not everybody gets them.

The following side effects may occur during treatment with this medicine.

Severe allergic reactions (frequency not known, cannot be estimated from the available data)

If a severe allergic reaction occurs, the patient should tell their doctor immediately.

Symptoms to watch out for:

• sudden swelling of the face, throat, or mouth. This may make breathing or swallowing difficult;
• sudden swelling of the hands, feet, and ankles.

Severe skin reactions (frequency not known, cannot be estimated from the available data)

If a severe skin reactionoccurs, the patient should tell their doctor immediately.

Symptoms to watch out for:

• rapidly spreading severe rash, with blisters or peeling of the skin, and possible blisters in the mouth [Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome)];
• any of the following symptoms: spreading rash [e.g., acute generalized exanthematous pustulosis (AGEP)], high fever, increased liver enzyme activity, blood test abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs [drug reaction with eosinophilia and systemic symptoms (DRESS)];
• Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain, and skin rash, usually self-limiting; this reaction occurs shortly after starting treatment with Ceftriaxone TZF for infections caused by spirochetes, such as Lyme disease;
• chest pain associated with an allergic reaction, which may be a sign of a heart attack caused by an allergy (Kounis syndrome).

Treatment with ceftriaxone, especially in elderly patients with severe kidney or neurological disorders, may rarely cause decreased consciousness, abnormal movements, agitation, and seizures.

Other possible side effects

Common (less than 1 in 10 patients)

• blood abnormalities (such as decreased white blood cell count and increased eosinophil count) and platelet count (decreased platelet count),
• loose stools or diarrhea,
• changes in liver function test results,
• rash.

Uncommon (less than 1 in 100 patients)

• fungal infections (e.g., thrush),
• decreased white blood cell count (granulocytopenia),
• decreased red blood cell count (anemia),
• blood clotting problems; symptoms may include easy bruising and pain or swelling of the joints,
• headache,
• dizziness,
• nausea and/or vomiting,
• itching (pruritus),
• pain or burning along the vein into which Ceftriaxone TZF was given; pain at the injection site,
• high fever (pyrexia),
• abnormal kidney function test results (increased creatinine levels in the blood).

Rare (less than 1 in 1000 patients)

• inflammation of the colon (pseudomembranous colitis); symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever,
• breathing difficulties (bronchospasm),
• hives (urticaria), which may spread across the body, itching, and swelling,
• blood or sugar in the urine,
• swelling (fluid retention),
• chills.

Frequency not known (cannot be estimated from the available data)

• superinfection, which cannot be treated with previously prescribed antibiotics,
• a certain type of anemia, in which red blood cells are destroyed (hemolytic anemia),
• significant decrease in white blood cell count (agranulocytosis),
• seizures,
• severe dizziness (vertigo),
• pancreatitis; symptoms include severe abdominal pain, which may radiate to the back,
• inflammation of the mucous membrane lining the mouth,
• inflammation of the tongue; symptoms include swelling, redness, and pain of the tongue,
• gallbladder and/or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin, itching, very dark urine, and clay-colored stools,
• a neurological condition that may occur in newborns with severe jaundice (kernicterus),
• kidney problems caused by the deposition of calcium ceftriaxone salt. Symptoms may include pain when urinating or producing a small amount of urine,
• false-positive Coombs test result (a test that detects certain blood disorders),
• false-positive galactosemia test result (a test that detects abnormal galactose accumulation in the body),
• Ceftriaxone TZF may affect the results of some glucose tests in the blood - the patient should check with their doctor.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Ceftriaxone TZF

The medicine should be stored out of sight and reach of children.

Do not use the medicine after the expiry date (EXP) stated on the carton and label. The expiry date refers to the last day of the month.

Store at a temperature below 25°C. Keep the vial in the original packaging to protect it from light.

Any unused solution for injection or infusion should be discarded.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ceftriaxone TZF contains

The active substance is ceftriaxone.

Each vial contains 2 g of ceftriaxone (as ceftriaxone sodium).

The medicine does not contain any other ingredients.

What Ceftriaxone TZF looks like and contents of the pack

Almost white or yellowish crystalline powder, slightly hygroscopic.

Packaging:one vial of 2 g in a cardboard box.

Marketing authorization holder and importer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A., ul. A. Fleminga 2, 03-176 Warsaw, Phone: 22-811-18-14.

For more information about this medicine, the patient should contact the marketing authorization holder.

Date of last revision of the leaflet

Information intended for healthcare professionals only

See the Summary of Product Characteristics

Ceftriaxone TZF, 2 g, powder for solution for injection/infusion

• Shelf-life of the prepared solution

The prepared ceftriaxone solution for injection is stable for 24 to 30 hours at 25°C and for 72 to 240 hours at 5°C, depending on the solvent used and its volume (Table 1). The diluted ceftriaxone solution is stable for 6 to 48 hours at 25°C and for 24 to 240 hours at 5°C, depending on the solvent used and its volume (Table 1).

From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and the storage time, which should not exceed 24 hours at 2°C to 5°C (refrigerator).

Table 1. Stability of ceftriaxone solutions depending on the solvent used and its volume.

Before administration, the appearance of the solution should be checked. The solution should be yellowish or brownish-yellow. The solution can only be administered if it is clear and practically free from visible particles.

Any unused product or waste material should be disposed of in accordance with local regulations.

To prepare a solution for administration, only the solvents listed in the table above should be used - see Table 1.

Administration

Intramuscular injection

The solution should be administered deep into the gluteal muscle.

Before administering the medicine in a 1% lidocaine solution, it should be ensured that the patient is not allergic to lidocaine.

The solution with lidocaine should not be administered intravenously.

No more than 1 g should be administered at one site.

Doses greater than 2 g should be administered intravenously.

Intravenous injection

The prepared solution should be administered slowly, intravenously over about 5 minutes.

Intravenous infusion

The infusion should be administered over at least 30 minutes.

For reconstitution of Ceftriaxone TZF or further dilution of the prepared solution for intravenous administration, calcium-containing diluents, such as Ringer's solution or Hartmann's solution, should not be used due to the risk of precipitation. Ceftriaxone calcium salt may also precipitate when ceftriaxone is mixed with a calcium-containing solution in the same intravenous administration set. Ceftriaxone should not be administered simultaneously with calcium-containing solutions for intravenous administration, including those used for total parenteral nutrition. However, in patients other than newborns, ceftriaxone and calcium-containing solutions can be administered sequentially, one after the other, if the infusion lines are carefully flushed between infusions with a compatible pharmaceutical solution.

• Incompatibilities

According to literature reports, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, and aminoglycoside antibiotics.

Ceftriaxone solutions should not be mixed with other agents or added to them, except for those listed above. In particular, due to the risk of precipitation, calcium-containing diluents (e.g., Ringer's solution or Hartmann's solution) should not be used to dissolve ceftriaxone in the vial or to further dilute the prepared solution for intravenous administration. Ceftriaxone should not be mixed or administered simultaneously with calcium-containing solutions, including those used for total parenteral nutrition.