Ceftriaxone 1000mg powder for solution for injection/infusion

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

ceftriaxone (ceftriaxone sodium)

Disponible desde:

Arpimed LLC

Código ATC:

J01DD04

Designación común internacional (DCI):

ceftriaxone (ceftriaxone sodium)

Dosis:

1000mg

formulario farmacéutico:

powder for solution for injection/infusion

Unidades en paquete:

(10) glass vials

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2023-03-21

Ficha técnica

SUMMARY PRODUCT CHARACTERISTIC (SPC)
1.
NAME OF THE MEDICINAL PRODUCT
CEFTRIAXONE 500 MG,
powder for solution for i/m, i/v injection
and i/v infusion
CEFTRIAXONE 1000 MG,
powder for solution for i/m, i/v injection
and i/v infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 500 mg vial contains:
_ACTIVE INGREDIENT_:
ceftriaxone (as sodium salt) – 500 mg.
Each 1000 mg vial contains:
_ACTIVE INGREDIENT_:
ceftriaxone (as sodium salt) – 1000 mg.
_For a full list of excipients, see section 6.1._
3.
PHARMACEUTICAL FORM
Ceftriaxone 500 mg, powder for solution for i/m, i/v
injection and i/v infusion
Powder for solution for
injection and infusion.
White to yellowish-orange crystalline powder.
Ceftriaxone 1000 mg, powder for solution for i/m, i/v injection and
i/v infusion
Powder for solution for injection and infusion.
White to yellowish-orange crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 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 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 due to a bacterial
infection
In the treatment of patients with bacteraemia that occurs in
association with, or is suspected to
be associated with, any of the infections listed above
Ceftriaxone
should
be
coadministered
with
other
antibacterial
agents whenever the possible
range of c