BIOTRAKSON 1 g Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Biotrakson, 2 g, powder for solution for injection or infusion
   2. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet
2. What is Biotrakson and what is it used for
3. Important information before using Biotrakson
   1. When not to use Biotrakson:
   2. Biotrakson should not be used in young children if:
   3. Warnings and precautions
   4. In case of blood or urine tests
   5. Children
   6. Biotrakson and other medicines
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Biotrakson contains sodium
4. How to use Biotrakson
   1. Usual dose
   2. Adults, elderly, and children over 12 years old and weighing at least 50 kg:
   4. Newborns, infants, and children from the 15th day to 12 years old and weighing less than 50 kg:
   5. Patients with liver or kidney problems
   6. Using a higher dose of Biotrakson than recommended
   7. Missing a dose of Biotrakson
   8. Stopping Biotrakson treatment
5. Possible side effects
   1. Severe allergic reactions (frequency not known - cannot be estimated from available data)
   2. Severe skin reactions (frequency not known - cannot be estimated from available data)
   3. Other possible side effects
   4. Common (up to 1 in 10 patients)
   5. Uncommon (up to 1 in 100 patients)
   6. Rare (up to 1 in 1,000 patients)
   7. Unknown frequency (frequency cannot be estimated from available data)
   8. Reporting side effects
6. How to store Biotrakson
7. Contents of the packaging and other information
   1. What Biotrakson contains
   2. What Biotrakson looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Information intended exclusively for healthcare professionals
   7. Method of vial puncture
   8. Method of administration
   9. Preparation of solutions for injection and infusion
   10. Intramuscular injection
   11. Intravenous injection (5 minutes)
   12. Intravenous infusion (at least 30 minutes)

Leaflet attached to the packaging: patient information

Biotrakson, 1 g powder for solution for injection or infusion

Biotrakson, 2 g, powder for solution for injection or infusion

Ceftriaxone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask 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 side effects 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 Biotrakson and what is it used for
• 2. Important information before using Biotrakson
• 3. How to use Biotrakson
• 4. Possible side effects
• 5. How to store Biotrakson
• 6. Contents of the packaging and other information

1. What is Biotrakson and what is it used for

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

Biotrakson 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 Biotrakson

When not to use Biotrakson:

• if the patient is allergic to ceftriaxone;
• 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 can 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 Biotrakson by intramuscular injection.

Biotrakson should not be used in young 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 calcium intravenously.

Warnings and precautions

Before starting to use Biotrakson, you should discuss it 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 large intestine),
• the patient has liver or kidney problems (see section 4),
• 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 mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme activity observed in blood test results, and increased white blood cell count (eosinophilia) and swollen lymph nodes (symptoms of severe skin reactions, see also section 4 "Possible side effects").

In case of blood or urine tests

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

Biotrakson 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 Biotrakson.

If the patient has diabetes or needs to control their blood sugar levels, they should not use certain tests that may incorrectly measure blood sugar levels while taking ceftriaxone.

If the patient is monitoring their blood sugar levels, they should check the test instructions and tell their doctor, pharmacist, or nurse.

Alternative testing methods should be used if necessary.

Children

Before giving Biotrakson to a child, you should discuss it with a doctor, pharmacist, or nurse if:

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

Biotrakson and other medicines

You should tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines they plan to take.

In particular, you should 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

The doctor will assess the benefits of treatment with Biotrakson for the mother and the risks for the child.

Driving and using machines

Biotrakson may cause dizziness. If the patient feels dizzy, they should not drive or operate machinery.

The patient should inform their doctor if they experience such symptoms.

Biotrakson contains sodium

The medicine contains 83 mg of sodium (3.6 mmol) (the main component of table salt) per 1 g.

This corresponds to 4.15% of the maximum recommended daily intake of sodium in the diet for adults.

Preparation of the medicine for administration - see the section: "Information intended exclusively for healthcare professionals" at the end of the leaflet.

When calculating the total sodium content in the prepared dilution of the medicine, the sodium from the diluent should be taken into account.

To obtain accurate information about the sodium content in the solution used to dilute the medicine, you should consult the patient information leaflet for the diluent used.

3. How to use Biotrakson

This medicine should always be used exactly as prescribed by your doctor.

If you are unsure, you should ask your doctor.

Biotrakson is usually administered by a doctor or nurse.

It can be administered as an intravenous infusion (drip) or as an injection directly into a vein or muscle.

Biotrakson is prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with solutions containing calcium.

Usual dose

The doctor will decide what dose of Biotrakson 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 Biotrakson 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.

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

• 50 to 80 mg of Biotrakson per kg of the child's body weight once a day, depending on the severity and type of infection.
• In the case of severe infection, the doctor will use a higher dose, up to 100 mg per kg of the child's body weight, up to a maximum of 4 g once a day.

Newborns up to 14 days old

• 20 to 50 mg of Biotrakson per kg of the child's body weight once a day, depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per kg of the child's body weight.

Patients with liver or kidney problems

The patient may receive a different dose than usual.

The doctor will determine what dose of Biotrakson is suitable for the patient and will closely monitor their condition, depending on the severity of liver and kidney disease.

Using a higher dose of Biotrakson than recommended

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

Missing a dose of Biotrakson

If the patient misses an injection, they should receive it as soon as possible.

However, if the next injection is approaching, do not take the missed injection.

Do not take a double dose (two injections at the same time) to make up for the missed dose.

Stopping Biotrakson treatment

Do not stop using Biotrakson unless your doctor tells you to.

If you have any further questions about using this medicine, you should ask your doctor or nurse.

4. Possible side effects

Like all medicines, Biotrakson 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 available data)

If a severe allergic reaction occurs, you should immediately tell your doctor.

Symptoms may include:

• sudden swelling of the face, throat, lips, or mouth; this can 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 a heart attack caused by an allergy (Kounis syndrome).

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

If a severe skin reaction occurs, you should immediately tell your doctor.

Symptoms of such a reaction may include:

• rapidly spreading severe rash, with blisters or peeling of the skin, and possible blisters in the mouth (Stevens-Johnson syndrome (toxic epidermal necrolysis) and Lyell's syndrome), 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 ceftriaxone, especially in patients with infections caused by spirochetes, such as Lyme disease.

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 count (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),
• bleeding 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 into which Biotrakson was administered; 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 1,000 patients)

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

Unknown frequency (frequency cannot be estimated from available data)

• secondary infection that 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 radiating 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 test result for galactosemia (a disorder characterized by the abnormal accumulation of galactose in the body),
• Biotrakson may affect the results of some blood sugar tests - you should check with your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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

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, you can help provide more information on the safety of this medicine.

5. How to store Biotrakson

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

Store at a temperature not exceeding 25°C.

Protect from light.

In accordance with the principles of good practice, it is recommended to prepare solutions just before administration.

The prepared solution can be stored for 24 hours in a refrigerator, i.e., at a temperature between 2°C and 8°C.

Solutions for intravenous infusion prepared using sodium chloride and glucose at the same time should not be stored in the refrigerator (2-8°C) due to physical incompatibility of the components at low temperatures.

Do not use this medicine after the expiry date stated on the packaging.

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.

Medicines should not be disposed of via wastewater or household waste.

You should 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 Biotrakson contains

• The active substance of the medicine is ceftriaxone.
• Each vial contains 1 g or 2 g of ceftriaxone in the form of ceftriaxone sodium.
• The medicine does not contain excipients.

What Biotrakson looks like and what the pack contains

The medicine is a white or yellowish, crystalline powder.

Biotrakson, 1 g: a 26 ml glass vial, closed with a rubber stopper and protected with an aluminum cap or an aluminum cap with a hood, in a cardboard box.

Biotrakson, 2 g: a colorless glass vial with a capacity of 26 ml, closed with a bromobutyl rubber stopper and protected with an aluminum cap or an aluminum cap with a hood, in a cardboard box.

The cardboard box contains 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.

Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Polpharma S.A.

Duchnice Production Plant

Ożarowska 28/30, 05-850 Ożarów Mazowiecki

Date of last revision of the leaflet:May 2024

Information intended exclusively for healthcare professionals

Method of vial puncture

To puncture the stopper, a needle with a diameter not greater than 0.8 mm (21 G) should be used.

The needle should be inserted at a 90° angle in the centrally marked area.

Method of administration

Biotrakson can be administered as an intravenous infusion lasting at least 30 minutes (recommended administration method) or as a slow intravenous injection lasting 5 minutes or as a deep intramuscular injection.

In intermittent intravenous injection, the medicine should be administered over 5 minutes, preferably into a large vein.

In children under 12 years old, intravenous doses of 50 mg/kg or more should be administered as an infusion.

In newborns, intravenous doses should be administered over a period longer than 60 minutes to reduce the risk of bilirubin encephalopathy.

Intramuscular injections should be performed to an appropriate depth in a relatively large muscle; do not administer more than 1 g in one place.

Intramuscular administration should be considered when intravenous administration is not possible or is less suitable for the patient.

Doses greater than 2 g should be administered intravenously.

To reconstitute Biotrakson or further dilute the prepared solution for intravenous administration, do not use diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) due to the risk of precipitate formation.

Ceftriaxone calcium salt may also precipitate when ceftriaxone is mixed with a calcium-containing solution in the same intravenous administration set.

Therefore, ceftriaxone should not be mixed or administered simultaneously with calcium-containing solutions.

The volume of the Biotrakson 1 g solution is 0.68 ml, both in water for injections and in 1% lidocaine solution.

After adding 10 ml of water for injections, the final concentration of the resulting solution is 93.63 mg/ml.

After adding 3.5 ml of 1% lidocaine solution, the final concentration of the resulting solution is 239.23 mg/ml.

The volume of the Biotrakson 2 g solution is 1.36 ml in water for injections.

To avoid precipitate formation in patients over 28 days old, ceftriaxone and calcium-containing solutions can be administered sequentially, one after the other, if the infusion lines are inserted in different locations or are replaced, or if the lines are thoroughly flushed with physiological saline between infusions.

If it is necessary to administer continuous infusions of total parenteral nutrition (TPN) solutions containing calcium to patients, a healthcare professional may consider using alternative antibacterial treatment methods that do not carry this risk of precipitate formation.

If the use of ceftriaxone in patients who require continuous TPN is deemed necessary, ceftriaxone and TPN solutions can be administered simultaneously, but through different infusion lines inserted in different locations.

Another option is to interrupt TPN administration during ceftriaxone infusion and flush the infusion line between solution administrations.

Preparation of solutions for injection and infusion

Before administration, the solution should be checked to ensure it is clear and does not contain insoluble particles.

Intramuscular injection

The medicine should be administered deep into the muscle after dissolving it in an appropriate amount of water for injections or 1% lidocaine solution.

The medicine should not be mixed in the same syringe with any other medicines except 1% lidocaine hydrochloride solution.

Do not administer the solution with lidocaine intravenously.

Doses greater than 1 g should be divided and injected into more than one location.

Doses greater than 2 g should be administered intravenously.

Intravenous injection (5 minutes)

The contents of the vial should be dissolved in water for injections, in a volume depending on the dose, as shown in the table above.

Do not administer the solution with lidocaine intravenously.

Intravenous infusion (at least 30 minutes)

To prepare intravenous infusion solutions with a ceftriaxone concentration of 10 mg/ml to 40 mg/ml, the powder should be dissolved in water for injections.

The resulting solution should then be diluted with one of the following solutions:

0.9% sodium chloride solution;

5% glucose solution;

10% glucose solution;

6% dextran solution in 5% glucose solution;

0.45% sodium chloride solution in 2.5% glucose solution.

Do not administer the solution with lidocaine intravenously.

The Biotrakson solution may be colorless or light yellow, and the intensity of the color depends on the type of solvent and the concentration of ceftriaxone.