TARTRIAKSON 1 g Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Tartriakson, 1 g, powder for solution for injection and infusion
3. Tartriakson, 2 g, powder for solution for injection and infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Tartriakson and what is it used for
5. Important information before using Tartriakson
   1. When not to use Tartriakson:
   2. Do not use Tartriakson in small children if:
   3. Warnings and precautions
   4. In case of blood or urine tests
   5. Children
   6. Tartriakson and other medicines
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Tartriakson contains sodium
6. How to use Tartriakson
   1. Usual dose
   2. Adults, elderly, and children over 12 years old and weighing at least 50 kg
   3. Newborns, infants, and children from the 15th day to 12 years old and weighing less than 50 kg
   4. Patients with liver or kidney problems
   5. Using more Tartriakson than prescribed
   6. Missing a dose of Tartriakson
   7. Stopping Tartriakson treatment
7. Possible side effects
   1. Severe side effects – frequency not known, cannot be estimated from available data
   2. Other possible side effects
   3. Common (up to 1 in 10 patients)
   4. Uncommon (up to 1 in 100 patients)
   5. Rare (up to 1 in 1000 patients)
   6. Frequency not known (cannot be estimated from available data)
   7. Reporting side effects
8. How to store Tartriakson
9. Contents of the packaging and other information
   1. What Tartriakson contains
   2. What Tartriakson looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:
   5. Information intended for healthcare professionals only

Leaflet attached to the packaging: patient information

Tartriakson, 1 g, powder for solution for injection and infusion

Tartriakson, 2 g, powder for solution for injection and infusion

Ceftriaxone

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 Tartriakson and what is it used for
• 2. Important information before using Tartriakson
• 3. How to use Tartriakson
• 4. Possible side effects
• 5. How to store Tartriakson
• 6. Contents of the packaging and other information

1. What is Tartriakson and what is it used for

Tartriakson is an antibiotic used in adults and children (including newborns born at term). Its action is based on killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Tartriakson 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 Tartriakson

When not to use Tartriakson:

• 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 Tartriakson by intramuscular injection.

Do not use Tartriakson in small children if:

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

Warnings and precautions

Before starting Tartriakson, discuss with your 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, particularly 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 or has had liver or kidney problems (see section 4).

In case of blood or urine tests

If the patient is taking Tartriakson for a long time, regular blood tests may be necessary. Tartriakson 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 Tartriakson.

Children

Before giving Tartriakson to a child, discuss with the doctor, pharmacist, or nurse if the child has recently received or is about to receive a calcium-containing product intravenously.

Tartriakson and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take. In particular, tell your doctor or pharmacist if the patient is taking:

• an antibiotic belonging to the aminoglycoside group,
• an antibiotic called chloramphenicol, used to treat 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. The doctor will assess the benefits of Tartriakson treatment for the mother and the risks for the baby.

Driving and using machines

Tartriakson may cause dizziness. If the patient feels dizzy, they should not drive or use any tools or machines. They should inform their doctor if they experience such symptoms.

Tartriakson contains sodium

Each gram of the medicine contains 74.4 mg (3.2 mmol) of sodium. This should be taken into account in patients with reduced kidney function and in patients on a controlled sodium diet.

3. How to use Tartriakson

Tartriakson 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 into a muscle. Tartriakson 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 Tartriakson 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 Tartriakson depends on the type of infection.

Adults, elderly, and children over 12 years old and weighing at least 50 kg

• 1 to 2 g once a day, depending on the severity and type of infection. For severe infections, the doctor may 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 to 12 years old and weighing less than 50 kg

• 50 to 80 mg of Tartriakson per kilogram of the child's weight once a day, depending on the severity and type of infection. For severe infections, the doctor may use a higher dose, up to 100 mg per kilogram of the child's weight, up to a maximum of 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 Tartriakson per kilogram of the child's weight once a day, depending on the severity and type of infection.
• The maximum daily dose should not exceed 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 Tartriakson is suitable for the patient and will closely monitor their condition, depending on the severity of liver and kidney disease.

Using more Tartriakson than prescribed

If the patient accidentally receives a higher dose than prescribed by the doctor, they should contact their doctor or the nearest hospital immediately.

Missing a dose of Tartriakson

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

Stopping Tartriakson treatment

Do not stop taking Tartriakson unless the doctor tells you to. If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Tartriakson can cause side effects, although not everybody gets them. The following side effects may occur during treatment with this medicine.

Severe side effects – frequency not known, cannot be estimated from available data

• Severe allergic reactionsSymptoms to look out for:
• 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 associated with an allergic reaction, which can be a sign of an allergic heart attack (Kounis syndrome).
• Severe skin reactions (frequency not known - cannot be estimated from available data)If a severe skin reaction occurs, tell your doctor immediately. Symptoms may include:
• rapidly spreading severe rash, with blisters or peeling skin and possible blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN);
• any of the following symptoms: spreading rash, high body temperature, increased liver enzyme activity, blood test abnormalities (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 causing fever, chills, headache, muscle pain, and skin rash, usually self-limiting; this reaction occurs shortly after starting treatment with Tartriakson for infections caused by spirochetes, such as Lyme disease.

➢ If any of these severe side effects occur, stop taking Tartriakson and tell your doctor immediately.
Treatment with ceftriaxone - especially in elderly patients with severe kidney or nervous system disorders - may rarely cause decreased consciousness, abnormal movements, agitation, and seizures.

Other possible side effects

Common (up to 1 in 10 patients)

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

Uncommon (up to 1 in 100 patients)

• fungal infections (such as 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 in the joints.
• headache,
• dizziness,
• nausea and/or vomiting,
• itching (pruritus),
• pain or burning along the vein where Tartriakson was given; pain at the injection site,
• high body temperature (fever),
• abnormal kidney function test results (increased creatinine levels in the blood).

Rare (up to 1 in 1000 patients)

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

Frequency not known (cannot be estimated from available data)

• secondary infection that cannot be treated with previously prescribed antibiotics,
• a certain type of anemia where 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 that radiates to the back.
• inflammation of the mucous membrane lining the mouth,
• inflammation of the tongue; symptoms include swelling, redness, and pain in the tongue.
• problems with the gallbladder and/or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, very dark urine, and clay-colored stools,
• a neurological condition that can 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),
• Tartriakson may affect the results of some glucose tests - consult your doctor.

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Tartriakson

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Protect from light.
Unused solution for injection or infusion should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Tartriakson contains

The active substance of the medicine is ceftriaxone.
Tartriakson 1 g:each vial contains 1 g of ceftriaxone (as sodium salt).
Tartriakson 2 g:each vial contains 2 g of ceftriaxone (as sodium salt).
The medicine does not contain any other ingredients.

What Tartriakson looks like and contents of the pack

White to cream-colored crystalline powder.
Packaging:one vial in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Phone number: 22-811-18-14
For more detailed information on this medicine, contact the marketing authorization holder.

Date of last revision of the leaflet:

Information intended for healthcare professionals only

• Shelf life after opening the vial and after preparation of the solution

In accordance with the principles of good manufacturing practice, solutions should be administered immediately after preparation. Ceftriaxone solutions in the following solvents, retain their stability at a temperature of 2°C to 8°C (in the refrigerator) for 24 hours.
From a microbiological point of view, the product should be used immediately. If not, the user is responsible for the storage conditions and the storage period, which should not exceed 24 hours at a temperature of 2°C to 8°C.

• Method of administration

Ceftriaxone can be administered by deep intramuscular injection, intravenous injection, or intravenous infusion.
Intramuscular injection
Inject deeply into a large muscle. Do not inject more than 1 g into one site. A solution containing more than 1 g of ceftriaxone should be divided and injected into two separate sites.
Intravenous injection
Inject slowly over 3 to 5 minutes into a large peripheral vein.
Intravenous infusion
The intravenous infusion should last at least 30 minutes.

• Preparation of solutions

Intramuscular injection
Dissolve the contents of a 1 g vial in approximately 3.5 ml of solvent, and a 2 g vial in 7 to 10 ml of solvent.
Solvents: water for injections, 0.9% sodium chloride solution, 1% lidocaine solution).
Warning! A ceftriaxone solution prepared with 1% lidocaine solution should not be administered intravenously.
If a lidocaine solution is used to prepare a solution for intramuscular injection, the Summary of Product Characteristics of the lidocaine solution used to dissolve ceftriaxone should be consulted before intramuscular injection.
Intravenous injection
Dissolve the contents of a 1 g vial in 10 ml, and a 2 g vial in at least 20 ml of water for injections.
Inject slowly over 3 to 5 minutes.
Solvents: water for injections; 0.9% sodium chloride solution; 0.45% sodium chloride solution + 2.5% glucose solution (1:1); 5% glucose solution; 10% glucose solution; 6% dextran solution in 5% glucose solution.
Intravenous infusion
Dissolve the contents of a 1 g or 2 g vial in one of the following calcium-free solvents. Ceftriaxone is best administered in a solution with a concentration of 10 mg/ml to 40 mg/ml over at least 30 minutes.
Solvents: water for injections; 0.9% sodium chloride solution; 0.45% sodium chloride solution + 2.5% glucose solution (1:1); 5% glucose solution; 10% glucose solution; 6% dextran solution in 5% glucose solution.
Ceftriaxone solutions may have a color ranging from pale yellow to amber, depending on the solvent used, concentration, and storage time. This does not affect the activity or tolerance of the medicine.

• 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 a 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 in total parenteral nutrition.