Ceftriaxone tzf

Package leaflet: Information for the patient

Ceftriaxone TZF, 2 g, powder for solution for injection / infusion
Ceftriaxonum
Please read this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What Ceftriaxone TZF is and what it is 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 pack and other information

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

Ceftriaxone TZF is an antibiotic used in adults and children (including newborns). It works by killing susceptible bacteria causing 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 cavity wall (peritonitis),
• the urinary tract and kidneys,
• bones and joints,
• the skin and soft tissues,
• the blood,
• the heart.

This medicine may also be used:

• to treat certain 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 (a tick-borne illness) in adults and children, including newborns from day 15 of life,
• to prevent infections during surgery.

2. 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 previously experienced 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 hands, feet and ankles (ankle joints), chest pain, and rapidly developing severe rash;
• if the patient is allergic to lidocaine and will receive Ceftriaxone TZF by intramuscular injection.

Ceftriaxone TZF must not be used in young children if:

• the child is a premature infant,
• the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice [yellowing of the skin and/or whites of the eyes], or if the child is to receive a calcium-containing medicine intravenously.

Warnings and precautions
Before starting treatment with Ceftriaxone TZF, discuss with your doctor, pharmacist, or
nurse if:

• the patient has recently received or is about to receive calcium-containing products,
• the patient has recently had diarrhoea after antibiotic treatment. The patient has ever had intestinal problems, especially colitis (inflammation of the large intestine),
• the patient has liver or kidney problems,
• the patient has gallstones or kidney stones,
• the patient has other diseases such as haemolytic anaemia (reduced number of red blood cells causing paleness, weakness or shortness of breath),
• the patient is on a low-sodium diet,
• the patient currently has or has ever had any of the following symptoms: rash, redness of the skin, blisters around the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme activity seen in blood test results, increased number of a certain type of white blood cells (eosinophilia), and enlarged lymph nodes (symptoms of severe skin reactions, see also section 4 “Possible side effects”),
• the patient has liver or kidney problems (see section 4).

If blood or urine tests are required
If the patient is receiving Ceftriaxone TZF for a prolonged period, regular blood tests may be
necessary. Ceftriaxone TZF may affect the results of urine glucose tests and blood tests known as
Coombs test. If the patient is undergoing tests, inform the person collecting the sample that the
patient is receiving Ceftriaxone TZF.
If the patient has diabetes or needs to monitor blood glucose levels, do not use tests that may
falsely measure blood glucose levels during ceftriaxone treatment. If the patient monitors blood
glucose, check the instructions and inform the doctor, pharmacist, or nurse. Alternative testing
methods should be used if necessary.

Children
Before giving Ceftriaxone TZF to a child, discuss with the doctor, pharmacist, or nurse if the child
has recently received or is about to receive intravenous calcium-containing products.

Ceftriaxone TZF and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently
taken, or plans to take.
In particular, tell your doctor or pharmacist if the patient is 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, suspects she might be pregnant, or is planning to have
a child, she should consult her doctor before using this medicine.
Pregnancy
The doctor will assess the benefits of treatment with Ceftriaxone TZF for the mother and the risks
for the unborn child.
Breastfeeding
Ceftriaxone is excreted in human milk in small amounts. During therapeutic doses, no effect of
ceftriaxone on the breastfed newborn or infant is expected. However, the risk of diarrhoea and
fungal mucosal infections cannot be excluded. The possibility of allergic sensitisation should also
be considered.
The doctor will decide whether to discontinue breastfeeding or discontinue ceftriaxone treatment,
taking into account the benefits of breastfeeding for the child and the benefits of treatment for the
mother.
Driving and using machines
Ceftriaxone TZF may cause dizziness. If the patient experiences dizziness, he/she should not drive
or operate tools or machinery. Inform the doctor if such symptoms occur.
Ceftriaxone TZF contains sodium
Each gram of the medicine contains approximately 83 mg of sodium (main component of table salt).
This corresponds to 4.2% of the maximum recommended daily sodium intake in the adult diet.

3. How to use Ceftriaxone TZF

Ceftriaxone TZF is usually administered by a doctor or nurse. It may be given

• as an intravenous infusion (drip) or by direct injection into a vein, or
• by intramuscular injection into the muscle.
  Ceftriaxone TZF is prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with solutions containing calcium.

Usual dosage
Your doctor will decide the appropriate dose of Ceftriaxone TZF for you. The dose depends on:
the severity and type of infection; whether you are taking other antibiotics; your age and body weight;
your liver and kidney function. The number of days or weeks for which you will receive Ceftriaxone TZF depends on the type of infection.

Adults, elderly patients, and adolescents aged 12 years and older with body weight of at least 50 kg

• 1 to 2 g once daily, depending on the severity and type of infection. In severe infections, your doctor may use a higher dose (up to 4 g once daily). If the daily dose exceeds 2 g, the medicine may be given as a single dose or in two separate doses.

Newborns, infants, and children aged from day 15 to 12 years with body weight below 50 kg

• 50 to 80 mg of Ceftriaxone TZF per kg of body weight once daily, depending on the severity and type of infection. In severe infections, your doctor may use a higher dose, up to 100 mg per kg of body weight, with a maximum of 4 g once daily. If the daily dose exceeds 2 g, the medicine may be given as a single daily dose or in two separate doses.
• Children with body weight of 50 kg or more should receive the usual adult dose.

Newborns aged 0–14 days

• 20 to 50 mg of Ceftriaxone TZF 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 impaired liver or kidney function
You may receive a different dose than usual. Your doctor will determine the appropriate dose of Ceftriaxone TZF for you and will closely monitor your condition depending on the severity of liver or kidney disease.

Accidental overdose of Ceftriaxone TZF
If you accidentally receive more than the prescribed dose, contact your doctor or nearest hospital immediately.

Missed dose of Ceftriaxone TZF
If you miss an injection, it should be given as soon as possible. However, if it is almost time for the next injection, do not take the missed dose. Do not use a double dose (two injections at the same time) to make up for a missed dose.

Stopping Ceftriaxone TZF treatment
Do not stop using Ceftriaxone TZF unless instructed by your doctor. If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects described below may occur during treatment with this medicine.

Severe allergic reactions (frequency unknown, cannot be estimated from available data)
If a severe allergic reaction occurs, you must immediately inform your doctor.
Symptoms to watch for:

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

Severe skin reactions (frequency unknown, cannot be estimated from available data)
If a severe skin reaction occurs, you must immediately inform your doctor.
Symptoms to watch for:

• rapidly developing severe rash, with blisters or peeling 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, abnormal blood test results (eosinophilia), swollen lymph nodes, and involvement of other organs [drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome];
• 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 symptom of an allergic-induced heart attack (Kounis syndrome).

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

Other possible adverse effects

Common (affects not more than 1 in 10 patients)

• abnormalities in white blood cells (such as decreased leukocyte count and increased eosinophilia) and platelets (decreased platelet count),
• loose stools or diarrhoea,
• changes in blood test results assessing liver function,
• rash.

Uncommon (affects not more than 1 in 100 patients)

• fungal infections (e.g. candidiasis),
• decreased number of white blood cells (granulocytopenia),
• decreased number of red blood cells (anaemia),
• problems with blood clotting; symptoms may include easy bruising, and joint pain and swelling,
• headache,
• dizziness,
• nausea and/or vomiting,
• itching (pruritus),
• pain or burning along the vein where Ceftriaxone TZF was administered; pain at the injection site,
• high body temperature (fever),
• abnormal kidney function test results (increased blood creatinine concentration).

Rare (affects not more than 1 in 1,000 patients)

• inflammation of the large intestine (colitis); symptoms include diarrhoea, usually with blood and mucus, abdominal pain, and fever,
• difficulty breathing (bronchospasm),
• raised rash (urticaria), which may affect large areas of the body, itching, and swelling,
• blood or sugar in urine,
• oedema (fluid retention),
• chills.

Frequency unknown (cannot be estimated from available data)

• secondary infection resistant to previously prescribed antibiotics,
• a type of anaemia involving destruction of red blood cells (haemolytic anaemia),
• marked decrease in white blood cells (agranulocytosis),
• seizures,
• severe dizziness (sensation of spinning),
• pancreatitis; symptoms include severe abdominal pain radiating 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 pale stools,
• a neurological condition that may occur in newborns with severe jaundice (kernicterus),
• kidney problems caused by deposition of calcium-ceftriaxone salts. These may manifest as pain during urination or production of small amounts of urine,
• false positive Coombs test (a test detecting certain blood disorders),
• false positive galactosemia test (abnormal accumulation in the body of a sugar called galactose),
• Ceftriaxone TZF may affect results of certain blood glucose tests – please consult your doctor.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Ceftriaxone TZF

Keep the medicine out of sight and reach of children.
Do not use the medicine after the expiry date (EXP) stated on the cardboard box and label. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep the vial in the original packaging to protect from light.
Any unused solution for injection or infusion must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ceftriaxone TZF contains
The active substance is ceftriaxone.
Each vial contains 2 g of ceftriaxone (as ceftriaxone sodium).
The medicine contains no other ingredients.
What Ceftriaxone TZF looks like and contents of the pack
Almost white or yellowish crystalline powder, slightly hygroscopic.
Pack: one 2 g vial in a cardboard box.
Marketing authorisation holder and importer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Telephone number: 22-811-18-14
For further information on this medicine, please contact the marketing authorisation holder.

Information intended exclusively for healthcare professionals

The Summary of Product Characteristics must be consulted.
Ceftriaxone TZF, 2 g, powder for solution for injection / infusion

• Stability of prepared solutions

The prepared ceftriaxone solution for injection maintains physicochemical stability at 25°C for 24 to 30 hours, and at 5°C for 72 to 240 hours, depending on the solvent used and its volume (Table 1). The diluted ceftriaxone solution maintains physicochemical stability at 25°C for 6 to 48 hours, and at 5°C for 24 to 240 hours, depending on the solvent used and its volume (Table 1).
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration, which must not exceed 24 hours at a temperature of 2°C to 5°C (refrigerator).
Table 1. Stability of ceftriaxone solutions depending on the solvent used and its volume.

Before administering the medication, check the appearance of the solution. The solution should be yellowish or brownish-yellow. The solution may be administered only if it is clear and practically free from particles visible to the naked eye.
Any unused remnants of the product or waste materials should be disposed of in accordance with local regulations.
To prepare the solution for administration by a specified route, only use the solvents listed in the table above – see Table 1.

Method of administration

Intramuscular injection
The solution should be administered deep into the gluteal muscle.
Before administering the medication in a 1% lidocaine solution, ensure that the patient is not allergic to lidocaine.
The drug solution containing lidocaine must not be administered intravenously.
Do not administer more than 1 g at a single injection site.
Doses greater than 2 g should be administered intravenously.

Intravenous injection
The prepared solution should be administered slowly intravenously over approximately 5 minutes.

Intravenous infusion
The infusion should be administered over at least 30 minutes.

Do not use calcium-containing diluents, such as Ringer's solution or Hartmann's solution, for reconstitution of Ceftriaxone TZF or for further dilution of the prepared intravenous solution due to the risk of precipitate formation. Calcium salt of ceftriaxone may also precipitate when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration set. Do not administer ceftriaxone simultaneously through a Y-site with calcium-containing intravenous solutions, including calcium-containing intravenous infusion solutions, e.g., for parenteral nutrition. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered consecutively, provided that the infusion lines are thoroughly flushed between infusions with a compatible, pharmaceutically acceptable solution.

• Pharmaceutical incompatibilities

According to literature reports, ceftriaxone is incompatible with amikacin, vancomycin, fluconazole, and aminoglycoside antibiotics.
Solutions containing ceftriaxone must not be mixed with or combined with other medicinal products except those mentioned above. In particular, due to the risk of precipitate formation, diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) must not be used to dissolve ceftriaxone in the vial or for further dilution of the prepared intravenous solution. Ceftriaxone must not be mixed or co-administered simultaneously with calcium-containing solutions, including those used in total parenteral nutrition.