CEFTRIAXONE-VIT

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

CEFTRIAXONE AS DISODIUM HEMIHEPTAHYDRATE

Disponível em:

VITAMED PHARMACEUTICAL INDUSTRIES LTD

Código ATC:

J01DD04

Forma farmacêutica:

POWDER FOR SOLUTION FOR INJECTION

Composição:

CEFTRIAXONE AS DISODIUM HEMIHEPTAHYDRATE 1.0 G/VIAL

Via de administração:

I.M, I.V

Tipo de prescrição:

Required

Fabricado por:

ACS DOBFAR S.P. A, ITALY

Área terapêutica:

CEFTRIAXONE

Indicações terapêuticas:

Ceftriaxone VIT is indicated for the treatment of the following infections in adults andchildren 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 endocarditisCeftriaxone VIT may be used:- For treatment of acute exacerbations of chronic obstructive pulmonary diseasein adults- For treatment of disseminated Lyme borreliosis (early (stage II) and late (stageIII) in adults and children including neonates from 15 days of age.- For pre-operative prophylaxis of surgical site infections-In the management of neutropenic patients with fever that is suspected to be dueto a ceftriaxone – susceptible bacterial infection- In the treatment of patients with bacteraemia that occurs in association with, oris suspected to be associated with, any of the infections listed aboveCeftriaxone VIT should be co-administered with other antibacterial agents whenever thepossible range of causative bacteria would not fall within its spectrum.

Data de autorização:

2022-09-30

Características técnicas

1. NAME OF THE MEDICINAL PRODUCT
CEFTRIAXONE-VIT POWDER FOR SOLUTION FOR INJECTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Ceftriaxone contains:
Ceftriaxone Disodium Hemiheptahydrate 1.193g
Corresponding to Ceftriaxone 1.000g
Excipient with known effect: Sodium
1g vial contains 3.6 mmol (or 83 mg) of sodium
per vial. For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
1 g powder for solution for injection
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceftriaxone VIT 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 VIT may be used:
− For treatment of acute exacerbations of chronic obstructive
pulmonary disease in adults
− For treatment of disseminated Lyme borreliosis (early (stage II)
and late (stage III) in adults and children including neon
ates from
15 days of age.
− For pre
-operative prophylaxis of surgical site infections
−
In the management of neutropenic patients with fever that is suspected
to be due to a ceftriaxone
–
susceptible bacterial infection
− In the treatment of patients with bacteraemia that occurs in
association with, or is suspected to be associated with, any o
f the
infections listed above
Ceftriaxone VIT should be co-administered with other antibacterial
agents whenever the possible range of causative bacteria would
not fall within its spectrum (see section 4.4).
Consideration should be given to official guidelines on the
appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose depends on the severity, susceptibility, site and type of
infection and on the age and hepa