BEZOLIN [Benzathine benzylpenicillin] 2.4 million IU Powder for solution for intramuscular administration

TRANCEF

instructions for medical use of the medicinal product

Tradename

Trancef, Транцеф

International non-proprietary name

Сeftriaxone, Цефтриаксон

Compound

Transcef 0.5 g for intramuscular injection

Each vial contains:

Ceftriaxone sodium 0.596 g

equivalent to Ceftriaxone 0.5 g

Solvent (for the release form complete with solvent):

1% Lidocaine hydrochloride solution 2 ml

Transcef 1 g for IM injection

Each vial contains:

Ceftriaxone sodium 1.192 g

equivalent to Ceftriaxone 1 g

Solvent (for the release form complete with solvent):

1% solution of Lidocaine hydrochloride 3.5 ml

Transcef 1 g for intravenous injection .

Each vial contains:

Ceftriaxone sodium 1.192 g

equivalent to Ceftriaxone 1 g

Solvent (for the release form complete with solvent):

Water for injections 5 ml

Dosage form

Powder for solution for injection.

Pharmacotherapeutic group

Antibiotic, 3rd generation cephalosporins .

Pharmacological properties

Transcef is a broad-spectrum cephalosporin antibiotic of the third generation for parenteral administration.

The bactericidal activity of ceftriaxone is due to the suppression of the synthesis of cell membranes. The drug is highly resistant to the action of beta-lactamases (penicillinase and cephalosporinase) of gram-positive and gram-negative microorganisms.

Indications for use

Trancef is indicated for the treatment of the following infections in adults and children, including term newborns:

- bacterial meningitis;

– community-acquired pneumonia;

– nosocomial pneumonia;

- acute otitis media;

- intra-abdominal infections;

- complicated urinary tract infections, including pyelonephritis;

– infections of bones and joints;

- Complicated infections of the skin and soft tissues;

- gonorrhea;

- syphilis;

- bacterial endocarditis.

Transcef can be used for:

- treatment of exacerbation of chronic obstructive pulmonary disease in adults;

- treatment of disseminated Lyme borreliosis (in the early (stage II) and late (stage III) periods of the disease) in adults and children, including newborns from 15 days of age;

– preoperative prevention of surgical infections;

- treatment of patients with neutropenia and fever, which is presumably associated with a bacterial infection;

- treatment of patients with bacteremia caused or suspected to be caused by any of the above infections.

Contraindications

• Hypersensitivity to ceftriaxone, other cephalosporins or any of the excipients.

• History of severe hypersensitivity reactions (eg, anaphylactic reactions) to any other type of beta-lactam antibiotics (penicillins, monobactams, carbapenems).

• Preterm infants up to 41 weeks of age (gestational age + chronological age).

• Full-term newborns (up to 28 days of life):

- in the presence of hyperbilirubinemia, jaundice, hypoalbuminemia or acidosis, conditions in which a violation of bilirubin binding is possible,

- if they require (or may require) intravenous administration of calcium or calcium-containing solutions due to the risk of precipitation of ceftriaxone calcium salt.

A solution containing ceftriaxone with lidocaine hydrochloride should not be administered intravenously.

Use during pregnancy or lactation

During pregnancy, Trancef should be prescribed only under strict indications, provided that the intended benefit to the mother outweighs the potential risk to the fetus. During treatment with Trancef, stop breastfeeding due to the development of diarrhea in the child, fungal infections of the mucous membranes and hypersensitivity reactions.

Interaction with other drugs

Ceftriaxone should not be administered concomitantly with calcium-containing intravenous solutions, including as continuous infusions of calcium-containing solutions, such as parenteral nutrition solutions through Y-junctions.

Simultaneous use of ceftriaxone with oral anticoagulants (drugs of the antivitamin K group) may enhance their effect and increase the risk of bleeding.

Do not mix ceftriaxone in the same vial or syringe with other antibiotics.

Special instructions and precautions

Before starting treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftriaxone, to other cephalosporins, or to other beta-lactams.

Calcium-containing solutions should not be used as solvents for dilution of ceftriaxone for intravenous administration.

As in the case of the use of other antibacterial agents, superinfections caused by non-susceptible microorganisms may occur during treatment with Trancef.

In severe renal and hepatic insufficiency, clinical monitoring of safety and efficacy is recommended.

Ceftriaxone has a limited spectrum of antibacterial activity, additional antibiotics should be considered.

Due to the content of sodium salts in the composition, it is necessary to take into account the appointment of the drug to patients who are on a diet due to salts.

If lidocaine hydrochloride solution is used as a solvent, then Trancef solution is used only for intramuscular injection. Lidocaine hydrochloride should not be administered intravenously.

Dosage and administration

As an intravenous infusion over at least 30 minutes (preferred route), intravenous bolus slowly over 5 minutes, or intramuscularly (deep injections).

For doses greater than 2 g, the intravenous route should be used.

For preoperative prevention of surgical infections, Trancef should be administered 30-90 minutes before surgery.

The dose depends on the type, location and severity of the infection, the sensitivity of the pathogen, the age of the patient and the state of the functions of his liver and kidneys.

Adults and children over 12 years of age (body weight ≥50 kg)

*When bacteremia is established, the highest doses from the above range are considered.

**When prescribing the drug at a dose of more than 2 g per day, the possibility of using the drug 2 times a day is considered.

Indications for adults and children over 12 years of age (body weight ≥50 kg) that require a special regimen for the administration of the drug:

Acute otitis media

A single intramuscular injection of the drug at a dose of 1-2 g. In severe cases or in the absence of effect, intramuscular administration of ceftriaxone at a dose of 1-2 g per day for 3 days.

Preoperative prophylaxis of surgical infections

Single administration before surgery at a dose of 2 g.

Gonorrhea

Single intramuscular injection at a dose of 0.5 g.

Syphilis

The recommended doses of 0.5 g or 1 g once a day are increased to 2 g once a day for neurosyphilis, the duration of treatment is 10-14 days.

Disseminated Lyme borreliosis (early (II) and late (III) stage)

Apply at a dose of 2 g once a day for 14-21 days. The recommended duration of treatment varies.

Use in children

For children weighing 50 kg or more, the doses correspond to the doses of adult patients.

Neonates, infants and children 15 days to 12 years of age (body weight <50 kg)

*When bacteremia is established, the highest doses from the above range are considered. Do not exceed the maximum daily dose of 50 mg/kg body weight.

**When prescribing a dose of more than 2 g per day, the possibility of using the drug 2 times a day is considered.

Indications for neonates, infants and children from 15 days to 12 years of age (body weight <50 kg) that require a special regimen of administration of the drug:

Acute otitis media

Single intramuscular injection of the drug at a dose of 50 mg/kg of body weight.

Preoperative prophylaxis of surgical infections

Single injection before surgery at a dose of 50-80 mg/kg of body weight.

Syphilis

The recommended doses are 75-100 mg/kg (maximum 4 g) of body weight once a day, the duration of treatment is 10-14 days.

Disseminated Lyme borreliosis (early (II) and late (III) stage)

Apply at a dose of 50-80 mg / kg of body weight once a day for 14-21 days. The recommended duration of treatment varies.

Preparation of solutions

Intramuscular injections. To prepare the solution, the contents of the vial (0.5 g or 1 g) are dissolved in 2 ml or 3.5 ml of lidocine hydrochloride, respectively. The injection is done deep into the gluteal muscle. It is recommended to enter no more than 1 g in one buttock.

Intravenous injections. The concentration of the solution for intravenous injection is 100 mg/ml. To prepare a solution for intravenous injection