What is Biotrakson used for?

Ceftriaxone is indicated for the treatment of the following infections in adults and children including term neonates (from birth): • Bacterial Meningitis • Community acquired pneumonia • Hospital acquired pneumonia • Acute otitis media • Intra-abdominal infections • Complicated urinary tract infections (including pyelonephritis) • Infections of bones and joints • Complicated skin and soft tissue infections • Gonorrhoea • Syphilis • Bacterial endocarditis Ceftriaxone may be use

What pharmaceutical form is Biotrakson available in?

Biotrakson: Proszek do sporządzania roztworu do wstrzykiwań i infuzji 2 g (domięśniowa, dożylna)

Is Biotrakson OTC or prescription only?

Biotrakson requires a doctor's prescription.

What are the side effects of Biotrakson?

The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased. Data to determine the frequency of ceftriaxone ADRs was derived from clinical trials. The following convention has been used for the classification of frequency: Very common (≥ 1/10) Common (≥ 1/100 - < 1/10) Uncommon (≥ 1/1000 - < 1/100) Rare (≥ 1/10000 - < 1/1000) Not known (cannot be estimated from the available data) System Organ Class

Who should NOT take Biotrakson?

Hypersensitivity to ceftriaxone, to any other cephalosporin or to any of the excipients listed in section 6.1. History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems). Ceftriaxone is contraindicated in: Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)* Full-term neonates (up to 28 days of age): - with hyperbilirubinaemia, jaundice

Does Biotrakson interact with other medications?

Calcium-containing diluents, such as Ringer's solution or Hartmann's solution, should not be used to reconstitute Ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calciumcontaining solutions in the same intravenous administration line. Ceftriaxone must not be administered simultaneously with calcium-containing intravenous s

Can Biotrakson be used during pregnancy?

Pregnancy Ceftriaxone crosses the placental barrier. There are limited amounts of data from the use of ceftriaxone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal, perinatal and postnatal development (see section 5.3). Ceftriaxone should only be administered during pregnancy and in particular in the first trimester of pregnancy if the benefit outweighs the risk. Breastfeeding Ceftriaxone is excreted into huma

Who manufactures Biotrakson?

Zakłady Farmaceutyczne POLPHARMA S.A. (Polska)

What ATC class does Biotrakson belong to?

Biotrakson: ATC J01DD04. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Biotrakson

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: Antibacterials for systemic use, Third-generation cephalosporins. ATC code: J01DD04. Mode of action Ceftriaxone inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs).‍‍‍‍‍‍‍ This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death. Resistance Bacterial resistance to ceftriaxone may be due to one or more of the following mechanisms: • hydrolysis by beta-lactamases, including extended-spectrum beta-lactamases (ESBLs), carbapenemases and Amp C enzymes that may be induced or stably derepressed in certain aerobic Gram-negative bacterial species. • reduced affinity of penicillin-binding proteins for ceftriaxone. • outer membrane impermeability in Gram-negative organisms. • bacterial efflux pumps. Susceptibility testing breakpoints Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows: Pathogen Dilution Test (MIC, mg/L) Susceptible Resistant Enterobacteriaceae ≤ 1 > 2 Staphylococcus spp. a. a. Streptococcus spp. ( Groups A, B, C and G) b. b. Streptococcus pneumoniae ≤ 0.5 c. > 2 Viridans group Streptococci ≤0.5 >0.5 Haemophilus influenzae ≤ 0.12 c. > 0.12 Moraxella catarrhalis ≤ 1 > 2 Neisseria gonorrhoeae ≤ 0.12 > 0.12 Neisseria meningitidis ≤ 0.12 c. > 0.12 Non-species related ≤ 1 d. > 2 a. Susceptibility inferred from cefoxitin susceptibility. b. Susceptibility inferred from penicillin susceptibility. c. Isolates with a ceftriaxone MIC above the susceptible breakpoint are rare and, if found, should be re-tested and, if confirmed, should be sent to a reference laboratory. d. Breakpoints apply to a daily intravenous dose of 1 g x 1 and a high dose of at least 2 g x 1. Clinical efficacy against specific pathogens The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of ceftriaxone in at least some types of infections is questionable. Commonly susceptible species Gram-positive aerobes Staphylococcus aureus (methicillin-susceptible) £ Staphylococci coagulase-negative (methicillin-susceptible) £ Streptococcus pyogenes (Group A) Streptococcus agalactiae (Group B) Streptococcus pneumoniae Viridans Group Streptococci Gram-negative aerobes Borrelia burgdorferi Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis Neisseria gonorrhoea Neisseria meningitidis Proteus mirabilis Providencia spp. Treponema pallidum Species for which acquired resistance may be a problem Gram-positive aerobes Staphylococcus epidermidis + Staphylococcus haemolyticus + Staphylococcus hominis + Gram-negative aerobes Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli % Klebsiella pneumoniae % Klebsiella oxytoca % Morganella morganii Proteus vulgaris Serratia marcescens Anaerobes Bacteroides spp . Fusobacterium spp. Peptostreptococcus spp. Clostridium perfringens Inherently resistant organisms Gram-positive aerobes Enterococcus spp. Listeria monocytogenes Gram-negative aerobes Acinetobacter baumannii Pseudomonas aeruginosa Stenotrophomonas maltophilia Anaerobes Clostridium difficile Others: Chlamydia spp. Chlamydophila spp. Mycoplasma spp. Legionella spp. Ureaplasma urealyticum £ All methicillin-resistant staphylococci are resistant to ceftriaxone. + Resistance rates >50% in at least one region % ESBL producing strains are always resistant

⚠️ Warnings

Concentrations for the intravenous injection: 100 mg/ml, Concentrations for the intravenous infusion: 50 mg/ml (Please refer to section 4.2 for further information). Preparation of solutions for injection and infusion The use of freshly prepared solutions is recommended.‍‍‍‍‍‍‍ For storage conditions of the reconstituted medicinal product, see section 6.3. Ceftriaxone should not be mixed in the same syringe with any drug other than 1% Lidocaine Hydrochloride solution (for intramuscular injection only). The infusion line should be flushed after each administration. Ceftriaxone 1 g Powder for Solution for Injection or Infusion For IV injection 1 g Ceftriaxone is dissolved in 10 ml of water for injections; which produces a clear solution. The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion. For IM injection 1 g Ceftriaxone is dissolved in 3.5 ml of 1% Lidocaine Hydrochloride solution; which produces a clear solution. The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site. The displacement volume of 1 g of Ceftriaxone is 0.71 ml in water for injections and 1% lidocaine hydrochloride solution. When adding 10 ml of water for injections, the final concentration of the reconstituted solution is 93.37 mg/ml. When adding 3.5 ml of 1% lidocaine hydrochloride solution, the final concentration of the reconstituted solution is 237.53 mg/ml. Ceftriaxone 2 g Powder for Solution for Injection or Infusion For IV infusion 2 g Ceftriaxone is dissolved in 40 ml of one of the following calciumfree infusion fluids: sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose 5%, dextrose 10%, dextran 6% in dextrose 5%, hydroxyethly-starch 6 – 10%, water for injections; which produces a clear solution. The infusion should be administered over at least 30 minutes. See also the information in section 6.2. The displacement volume of 2 g of Ceftriaxone is 1.37 ml in water for injections. When adding 40 ml of water for injections, the final concentration of the reconstituted solution is 48.34 mg/ml. In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy.

Biotrakson

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