Alvobak (ceftriaxone) powder for solution for injections 1g. №1 vial

Dosage

The dose of the drug depends on the severity, sensitivity, location and type of infection, as well as on the age and function of the liver and kidneys of the patient.

The doses below are generally accepted recommended for these indications. In especially severe cases, the highest dose from the recommended range should be used.

Table 1

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

* For documented bacteremia, consideration should be given to using the highest dose from the recommended range.

** In the case of doses exceeding 2 g per day, consideration should be given to administering the drug twice a day (with a 12-hour interval).

Indications in adults and children over 12 years of age (≥50 kg) requiring special dosing regimens

Acute otitis media

A single dose of 1-2 g of Alvobac can be used.

Some evidence suggests that in the case where the patient’s condition is severe, or previous therapy has been ineffective, Alvobac may be effective when administered at a dose of 1-2 g per day for 3 days.

Preoperative prevention of infections at the surgical site

2 g once before surgery.

Gonorrhea

Single dose of 500 mg.

Syphilis

The generally recommended doses are 500 mg-1 g once a day, increasing the dose to 2 g once a day for neurosyphilis for 10-14 days. Dosing recommendations for syphilis, including neurosyphilis, based on limited data. National or local councils should also be considered.

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

2 g once a day for 14-21 days. The recommended duration of treatment varies and national or local advice should also be taken into account.

Children

Neonates, infants and children aged 15 days to 12 years (<50 kg)

Children weighing 50 kg or more should use the usual adult doses.

table 2

* For documented bacteremia, consideration should be given to using the highest dose from the recommended range.

** In the case of doses exceeding 2 g per day, consideration should be given to administering the drug twice a day (with a 12-hour interval).

Indications in neonates, infants and children aged 15 days to 12 years (<50 kg) requiring special dosing regimens

Acute otitis media

For the initial treatment of acute otitis media, a single injection of Alvobak at a dose of 50 mg/kg can be used. Some evidence suggests that in the case where the child’s condition is severe or previous therapy has been ineffective, Alvobac may be effective when administered at a dose of 50 mg / kg for 3 days.

Preoperative prevention of infections at the surgical site

50-80 mg/kg once before surgery.

Syphilis

The generally recommended doses are 75-100 mg/kg (maximum 4 g) once a day for 10-14 days. Dosing recommendations for syphilis, including neurosyphilis, are based on very limited data. National or local councils should also be considered.

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

50-80 mg/kg once a day for 14-21 days. The recommended duration of treatment varies and national or local advice should also be taken into account.

Newborns 0-14 days

Alvobak is contraindicated in premature newborns from postmenstrual age up to 41 weeks (gestational age + calendar age).

Table 3

* For documented bacteremia, consideration should be given to using the highest dose from the recommended range.

The maximum daily dose of 50 mg/kg should not be exceeded.

Indications in neonates 0-14 days old requiring special dosing regimens

Acute otitis media

For the initial treatment of acute otitis media, a single injection of Alvobak at a dose of 50 mg/kg can be used.

Preoperative prevention of infections at the surgical site

20-50 mg/kg once before surgery.

Syphilis

The generally recommended dose is 50 mg/kg once daily for 10-14 days. Dosing recommendations for syphilis, including neurosyphilis, are based on very limited data. National or local councils should also be considered.

Duration of treatment

The duration of treatment depends on the course of the disease. Given the general recommendations for antibiotic therapy, the use of ceftriaxone should be continued for 48-72 hours after the disappearance of fever or confirmation of eradication of a bacterial infection.

Elderly patients

With satisfactory renal and hepatic function, dose adjustment in elderly patients is not required.

Patients with liver failure

The available data indicate that there is no need to adjust the dose in patients with mild or moderate hepatic insufficiency, if renal function is not impaired.

There are no studies on patients with severe hepatic insufficiency.

Patients with renal insufficiency

In patients with impaired renal function, there is no need to reduce the dose of ceftriaxone if renal function is not impaired. Only in case of renal insufficiency in the pre-terminal stage (creatinine clearance less than 10 ml / min), the daily dose of ceftriaxone should not exceed 2 g.

Patients on hemodialysis do not need additional administration of the drug after dialysis. Ceftriaxone is eliminated from the body by peritoneal dialysis or hemodialysis. Clinical monitoring of the safety and efficacy of the drug is recommended.

Patients with severely impaired liver and kidney function

With simultaneous severe impairment of renal and hepatic function, careful clinical monitoring of the safety and efficacy of the drug is recommended.

Method of administration

Intramuscular administration

Alvobac can be administered by deep intramuscular injection. The injection should be made in the center of a relatively large muscle. It is recommended to enter no more than 1 g in one site.

If lidocaine is used as a solvent, the resulting solution should never be administered (see Section “Contraindications”). For detailed information, it is recommended to read the instructions for use of lidocaine.

The use of lidocaine involves a preliminary test to determine individual sensitivity to this drug.

Intravenous administration

Alvobac can be administered by infusion over at least 30 minutes (preferred route) or by slow injection over 5 minutes. Intravenous intermittent administration should be carried out within 5 minutes, mainly in large veins. Doses of 50 mg/kg or more should be administered by infusion to neonates and children under 12 years of age. Newborns should be given doses within 60 minutes to reduce the potential risk of bilirubin encephalopathy (see sections “Contraindications” and “Peculiarities of use”). The question of m administration should be considered when the intravenous route of administration is not possible or less acceptable to the patient. Doses greater than 2 g should be administered intravenously.

Ceftriaxone is contraindicated in neonates (≤ 28 days of age) who need (or are expected to need) treatment with calcium-containing intravenous solutions, including infusion solutions containing calcium, such as parenteral nutrition, due to the risk of precipitation of ceftriaxone calcium salts (see section ” contraindications”).

Solvents containing calcium, such as Ringer’s solution or Hartmann’s solution, should not be used to dissolve ceftriaxone in vials or to further dilute the reconstituted intravenous solution, as a precipitate may form. Precipitation of ceftriaxone calcium salts can also occur when ceftriaxone is mixed with solutions containing calcium in the same intravenous infusion set. Therefore, it is impossible to mix or simultaneously administer ceftriaxone with solutions containing calcium.

For the purpose of preoperative prevention of infections at the surgical site, ceftriaxone should be administered 30-90 minutes before surgery.