Biotrakson

Patient Information Leaflet

Biotrakson, 1 g powder for solution for injection or infusion
Biotrakson, 2 g powder for solution for injection or infusion
Ceftriaxone
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 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. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Biotrakson is and what it is 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 pack and other information

1. What Biotrakson is and what it is used for

Biotrakson is an antibiotic used in adults and children (including newborns). It works by killing 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,
• 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 count (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. Important information before using Biotrakson

When not to use Biotrakson:

• if the patient is allergic to ceftriaxone;
• 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 the hands, feet and ankles (ankle joints), chest pain, and rapidly developing severe rash;
• if the patient is allergic to lidocaine and is to receive Biotrakson by intramuscular injection.

Do not use Biotrakson 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 is to receive intravenous medication containing calcium.

Warnings and precautions
Before starting treatment with Biotrakson, 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 antibiotic-associated diarrhoea,
• the patient has ever 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 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 previously experienced 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 observed in blood tests, 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").

Regarding blood or urine tests
If the patient is receiving Biotrakson for a prolonged period, regular blood tests may be necessary.
Biotrakson may affect the results of urine glucose tests and blood tests known as the Coombs test. If the patient is undergoing tests:

• inform the person collecting the sample that the patient is receiving Biotrakson.

If the patient has diabetes or needs to monitor blood glucose levels, they should not use certain glucose tests which may give inaccurate results during ceftriaxone treatment. If the patient monitors blood glucose levels, they should check the test instructions and inform their doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

Children
Before administering Biotrakson to a child, discuss with a doctor, pharmacist or nurse if:

• the child has recently received or is about to receive intravenous medication containing calcium.

Biotrakson with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform 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 in the treatment of infections, particularly eye infections.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
The doctor will assess the benefits of treatment with Biotrakson for the mother and the potential risks to the child.

Driving and operating machinery
Biotrakson may cause dizziness. If the patient experiences dizziness, they should not drive or operate machinery. Inform the doctor if such symptoms occur.

Biotrakson contains sodium
This medicine contains 83 mg of sodium (3.6 mmol) (main component of table salt) in 1 g. This corresponds to 4.15% of the maximum recommended daily dietary intake of sodium for adults.
When calculating the total sodium content in the prepared diluted solution, the sodium from the diluent must be taken into account. For accurate information on the sodium content in the solution used to dilute the medicine, refer to the patient leaflet of the diluent used.

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

3. How to use Biotrakson

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult the doctor.
Biotrakson is usually administered by a doctor or nurse. It may be given as an intravenous infusion (drip) or as an injection directly into a vein or into a muscle. Biotrakson is prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with solutions containing calcium.

Typically used dose
The doctor will decide the appropriate dose of Biotrakson for the individual patient. The dose depends on the severity and type of infection; whether the patient is taking other antibiotics; the patient's age and body weight; and liver and kidney function. The number of days or weeks during which the patient will receive Biotrakson depends on the type of infection.

Adults, elderly patients, and children aged 12 years and older with body weight of at least 50 kilograms (kg):

• 1 to 2 g once daily depending on the severity and type of infection. In case of severe infection, the 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 Biotrakson per kg of the child's body weight once daily, depending on the severity and type of infection. In case of severe infection, the doctor may use a higher dose, up to 100 mg per kg of the child's 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 standard adult dose.

Newborns aged 0–14 days:

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

Patients with impaired liver or kidney function
The patient may receive a dose different from the usual. The doctor will determine the appropriate dose of Biotrakson for the individual patient and will closely monitor the patient's condition depending on the severity of liver and kidney disease.

Use of a higher than recommended dose of Biotrakson
If a dose higher than prescribed by the doctor is accidentally administered, contact the doctor or nearest hospital immediately.

Missing a dose of Biotrakson
If the patient misses an injection, it should be administered as soon as possible. However, if it is almost time for the next injection, the missed dose should not be given. Do not use a double dose (two injections at the same time) to make up for a missed dose.

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

4. Possible side effects

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

Severe allergic reactions (frequency unknown – cannot be estimated from available data)
If a severe allergic reaction occurs, inform your doctor immediately.
Symptoms may include:

• 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);
• chest pain associated with an allergic reaction, which may be a sign of an allergy-induced heart attack (Kounis syndrome).

Severe skin reactions (frequency unknown – cannot be estimated from available data)
If a severe skin reaction occurs, inform your doctor immediately.
Symptoms of such a reaction may include:

• rapidly developing severe rash, with blisters or peeling skin and possible blisters in the mouth (Stevens-Johnson syndrome (erythema multiforme bullosum) and Lyell's syndrome (toxic epidermal necrolysis), also known as SJS and TEN);
• any of the following symptoms: spreading rash, high body temperature, 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 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 (affecting up to 1 in 10 patients)

• blood disorders involving 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 (affecting up to 1 in 100 patients)

• fungal infections (e.g. candidiasis),
• decreased white blood cell count (granulocytopenia),
• decreased red blood cell count (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 into which Biotrakson was administered; pain at the injection site,
• high body temperature (fever),
• abnormal kidney function test results (increased blood creatinine concentration).

Rare (affecting up to 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 the urine,
• oedema (fluid retention),
• chills. Treatment with ceftriaxone – especially in elderly patients with serious kidney or nervous system disorders – may rarely cause decreased level of consciousness, abnormal movements, agitation, and seizures.

Frequency not known (cannot be estimated from available data)

• secondary infection resistant to previously prescribed antibiotics,
• a certain type of anaemia in which red blood cells are destroyed (haemolytic anaemia),
• marked decrease in white blood cells (agranulocytosis),
• seizures,
• severe dizziness (spinning sensation),
• pancreatitis; symptoms include severe abdominal pain radiating to the back,
• inflammation of the mucous membrane lining the mouth (stomatitis),
• inflammation of the tongue; symptoms include swelling, redness, and pain of the tongue,
• problems affecting the gallbladder and/or liver, 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 salts of ceftriaxone; may manifest as pain during urination or production of small amounts of urine,
• false positive Coombs test result (a test detecting certain blood disorders),
• false positive galactosemia test result (abnormal accumulation in the body of a sugar called galactose),
• Biotrakson may affect the results of certain blood glucose tests – please consult your doctor about this.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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 responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Biotrakson

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 25°C. Protect from light.
According to good practice guidelines, solutions should be prepared immediately before administration.
The prepared solution may be stored for 24 hours in a refrigerator, i.e. at a temperature between 2°C and 8°C.
Infusion solutions for intravenous use prepared simultaneously with sodium chloride and glucose must not be stored in a refrigerator (2–8°C) due to physical incompatibility of components at low temperatures.
Do not use this medicine after the expiry date stated on the packaging.
The label on the packaging shows the expiry date after the abbreviation EXP and the batch number after the abbreviation Lot.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Biotrakson contains

• The active substance 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 contents of the pack
The medicine is a white or yellowish crystalline powder.
Biotrakson, 1 g: a 26 ml glass vial, closed with a rubber stopper and sealed with an aluminium cap or an aluminium cap with a flip-off seal, packed in a cardboard box.
Biotrakson, 2 g: a colourless 26 ml glass vial, closed with a bromobutyl rubber stopper and sealed with an aluminium cap or an aluminium cap with a flip-off seal, packed in a cardboard box.
The cardboard box contains 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Duchnica
Ożarowska Street 28/30, 05-850 Ożarów Mazowiecki

INFORMATION INTENDED EXCLUSIVELY FOR MEDICAL PROFESSIONALS
Vial puncture method

To puncture the stopper, use a needle with a diameter not exceeding 0.8 mm (21 G on the Gauge [G] scale).
The needle should be inserted at a 90° angle into the centrally marked area.
Administration method
Biotrakson may be administered as an intravenous infusion lasting at least 30 minutes (recommended
route of administration), or as a slow intravenous injection over 5 minutes, or as a deep intramuscular
injection. For intermittent intravenous injection, the drug should be administered over 5 minutes,
preferably into a large vein. Intravenous doses of 50 mg/kg body weight or higher in infants and
children under 12 years of age should be given by infusion. In neonates, intravenous doses should be
administered over a period longer than 60 minutes to reduce the risk of bilirubin encephalopathy.
Intramuscular injections should be administered deeply into a relatively large muscle mass; no more
than 1 g should be injected at a single site. Intramuscular administration should be considered only
when intravenous administration is not feasible or less appropriate for the individual patient.
Doses exceeding 2 g must be administered intravenously.
Do not use calcium-containing diluents (e.g. Ringer's solution or Hartmann's solution) for
reconstitution of Biotrakson or for further dilution of the prepared intravenous solution, due to the
risk of precipitate formation. Calcium salt of ceftriaxone may also precipitate if ceftriaxone is mixed
with a calcium-containing solution in the same intravenous administration set. Therefore, ceftriaxone
must not be mixed or co-administered simultaneously with calcium-containing solutions.
The displacement volume of Biotrakson 1 g is 0.68 ml, both in water for injection and in 1% lidocaine
solution.
After adding 10 ml of water for injection, 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 displacement volume of Biotrakson 2 g is 1.36 ml in water for injection.
To avoid precipitation in patients over 28 days of age, ceftriaxone and calcium-containing solutions
may be administered consecutively, provided that infusion lines are inserted at different sites or are
replaced, or that lines are thoroughly flushed with physiological saline solution between infusions.
If continuous infusion of calcium-containing total parenteral nutrition (TPN) solutions is required in
patients, the medical professional may consider alternative antibacterial therapies that do not carry
the risk of precipitation. If the use of ceftriaxone in patients requiring continuous parenteral nutrition
is deemed necessary, ceftriaxone and TPN solutions may be administered simultaneously, but via
separate infusion lines inserted at different sites. Alternatively, TPN administration may be paused
during ceftriaxone infusion, with thorough flushing of the infusion line between administrations.
Preparation of injection and infusion solutions

Before administering the drug, check whether the solution is clear and free of
insoluble particles.
Intramuscular injection
The drug should be administered deep intramuscularly after dissolving in an appropriate volume of water for injections or 1% lidocaine hydrochloride solution.
The drug must not be mixed in the same syringe with any other drugs except 1% lidocaine hydrochloride solution.
Do not administer intravenously the drug solution containing lidocaine.
Doses exceeding 1 g should be divided and injected at more than one site.
Doses exceeding 2 g should be administered intravenously.
Intravenous injection (over 5 minutes)
The vial contents should be dissolved in water for injections, in a volume depending on the dose, as indicated in the table above. Do not administer intravenously the drug solution containing lidocaine.
Intravenous infusion (at least 30 minutes)
To prepare infusion solutions for intravenous administration with ceftriaxone concentrations ranging from 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 in 5% glucose solution;
0.45% sodium chloride in 2.5% glucose solution.
Do not administer intravenously the drug solution containing lidocaine.
The Biotrakson drug solution may be colorless or pale yellow; the intensity of coloration depends on the type of solvent and ceftriaxone concentration.