Emsef 1000 (ceftriaxone) powder for solution for injections 1000 mg. №1 vial

Description

Emsef 1000 Storage
active substance: seftriaxone;

1 vial contains ceftriaxone 1000 mg as ceftriaxone sodium.

Emsef 1000 Dosage form
Powder for solution for injection.

Main physical and chemical properties: crystalline powder from white to yellow-orange color.

Pharmacotherapeutic group
Antibacterial agents for systemic use. Other beta-lactam antibiotics. Cephalosporins of the third generation. Ceftriaxone. ATX code J01D D04.

Pharmacological properties

Pharmacodynamics.

Mechanism of action

Ceftriaxone inhibits the synthesis of the bacterial cell wall after binding to penicillin-binding proteins, which stops the biosynthesis of the cell wall (peptidoglycan), which in turn leads to the lysis of the bacterial cell and its death.

Resistance

Bacterial resistance to ceftriaxone may develop due to one or more mechanisms:

Hydrolysis by β-lactamases, including extended-spectrum β-lactamases, carbapenemases, and Amp C enzymes, which may be induced or persistently inhibited in some aerobic gram-negative bacteria.
Decreased affinity of penicillin-binding proteins for ceftriaxone.
Impermeability of the outer membrane in gram-negative bacteria.
Bacterial efflux pump.

Indication
Emsef® is used to treat the following infections in adults and children, including full-term infants (from birth):

bacterial meningitis;
community-acquired pneumonia;
nosocomial pneumonia;
acute otitis media;
intra-abdominal infections;
complicated urinary tract infections (including pyelonephritis);
bone and joint infections;
complicated skin and soft tissue infections;
gonorrhea;
syphilis;
bacterial endocarditis.
Emsef® can be used for:

treatment of acute complications of chronic obstructive pulmonary disease in adults;
treatment of disseminated Lyme borreliosis [early (stage II) and late (stage III)] in adults and children, including newborns aged 15 days;
preoperative prevention of infections at the site of surgery;
management of patients with neutropenia who have developed fever and are suspected of having a bacterial infection;
treatment of patients with bacteremia that has arisen in connection with any of the above infections or if any of the above infections is suspected.
Emsef® should be prescribed together with other antibacterial drugs if the possible range of bacterial pathogens does not fall within its spectrum of action (see section “Special instructions”).

Official recommendations for the appropriate use of antibacterial agents should be taken into account.

Contraindication
Hypersensitivity to ceftriaxone or any other cephalosporin. Presence of a history of severe hypersensitivity reactions (eg anaphylactic reactions) to any other type of β-lactam antibacterial agents (penicillins, monobactams and carbapenems).

Ceftriaxone is contraindicated:

premature newborns ≤ 41 weeks taking into account the period of fetal development (gestational age + age after birth) *;
full-term newborns (age ≤ 28 days):
with hyperbilirubinemia, jaundice, hypoalbuminemia, or acidosis, as bilirubin binding is likely to be impaired in such conditions *;
which require (or are expected to require) intravenous calcium preparations or infusions of calcium-containing solutions, as there is a risk of formation of ceftriaxone calcium salt precipitates (see sections “Special warnings and special precautions for use” and “Adverse reactions”).
* In vitro studies have shown that ceftriaxone can displace bilirubin from binding to serum albumin, leading to a risk of developing bilirubin encephalopathy in such patients.

Before intramuscular administration of ceftriaxone, it is necessary to exclude the presence of contraindications to the use of lidocaine, if it is used as a solvent (see section “Special instructions”). See instructions for medical use of lidocaine, especially contraindications.

Ceftriaxone solutions containing lidocaine should never be administered intravenously.