Biotrakson

Leaflet accompanying 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

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.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform 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 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 Biotrakson by intramuscular injection.

Biotrakson 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 Biotrakson, the patient should discuss with their doctor, pharmacist, or nurse if:

• they have recently received or are about to receive products containing calcium,
• they have recently had diarrhea after antibiotic treatment,
• they have ever had intestinal problems, particularly colitis (inflammation of the colon),
• they have liver or kidney problems (see section 4),
• they have gallstones or kidney stones,
• they have other diseases, such as hemolytic anemia (reduced red blood cell count, causing pallor, weakness, or shortness of breath),
• they are on a low-sodium diet,
• they have or have 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 "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.

Children

Before giving Biotrakson to a child, the doctor, pharmacist, or nurse should be consulted if:

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

Biotrakson 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 eye infections.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, 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 treating the mother with Biotrakson and the risks to the baby.

Driving and using machines

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

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

Biotrakson contains sodium

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

This is equivalent to 4.15% of the maximum recommended daily intake of sodium for adults.

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

3. How to use Biotrakson

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

In case of doubts, the patient should consult their doctor.

Biotrakson is usually administered by a doctor or nurse.

It can be given 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 at the same time as solutions containing calcium.

Normally used 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 of life to 12 years old and weighing less than 50 kg:

• 50 to 80 mg of Biotrakson per kg of body weight per day, depending on the severity and type of infection.

Newborns up to 14 days old

• 20 to 50 mg of Biotrakson per kg of body weight per day, depending on the severity and type of infection.

Patients with liver or kidney problems

The patient may receive a different dose than usual.

The doctor will determine the suitable dose of Biotrakson 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 Biotrakson

In case of accidental administration of a higher dose than prescribed by the doctor, the patient should immediately contact their 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 soon due, the missed injection should not be given.

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

Stopping Biotrakson treatment

The patient should not stop using Biotrakson unless their doctor tells them to.

In case of further doubts about using this medicine, the patient should consult their 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)

In case of a severe allergic reaction, the patient should immediately inform their doctor.

Symptoms 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;
• chest pain associated with an allergic reaction, which may 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)

In case of a severe skin reaction, the patient should immediately inform their doctor.

Symptoms may include:

• rapidly spreading severe rash, with blisters or skin peeling, 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 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 Biotrakson for infections caused by spirochetes, such as Lyme disease.

Other possible side effects

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• fungal infections (such as thrush),
• reduced white blood cell count (granulocytopenia),
• reduced 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 where Biotrakson was administered; pain at the injection site,
• high body temperature (fever),
• abnormal kidney function test results (increased creatinine levels in the blood).

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

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

Unknown frequency (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 reduction 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 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 small amounts 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),
• Biotrakson 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 those not listed in this leaflet, they should inform their 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, more information can be collected on the safety of this medicine.

5. How to store Biotrakson

Keep the medicine out of the sight and reach of children.

Store in a temperature not exceeding 25°C.

Protect from light.

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

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

Solutions for intravenous infusion prepared with sodium chloride or glucose 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 expiry date stated on the packaging is the date of expiry of the last day of the month.

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

The patient should ask their pharmacist how to dispose of medicines they no longer use.

This will help protect the environment.

6. Contents of the packaging and other information

What Biotrakson contains

• The active substance is ceftriaxone.
• The medicine does not contain any excipients.

What Biotrakson looks like and contents of the pack

The medicine is a white or yellowish crystalline powder.

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

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

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Oddział Produkcyjny w Duchnicach

ul. 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 intravenous intermittent 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 administered to an appropriate depth in a relatively large muscle; no more than 1 g should be injected into one site.

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

Doses greater than 2 g should be administered intravenously.

For reconstitution of Biotrakson or further dilution of the prepared solution for intravenous administration, calcium-containing diluents (e.g., 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.

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

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

To avoid precipitation, ceftriaxone and calcium-containing solutions can be administered sequentially, one after the other, if the infusion lines are inserted at different sites or are replaced, or if the lines are thoroughly flushed with physiological saline between infusions.

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

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

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

Preparation of solutions for injection and infusion

Before administration, the solution should be checked for clarity and the absence of insoluble particles.

Intramuscular injection

The medicine should be administered deep into the muscle after dissolution 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.

The solution with lidocaine should not be administered intravenously.

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

Doses greater than 2 g should be administered intravenously.

Intravenous injection (5 minutes)

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

The solution with lidocaine should not be administered 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 is 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.

The solution with lidocaine should not be administered 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.