Ceftriaxone-Asteria Inj. 1g powder for solution for i/m and i/v injection

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

ceftriaxone (ceftriaxone sodium)

Disponibil de la:

Hankook Korus Pharm Co.

Codul ATC:

J01DD04

INN (nume internaţional):

ceftriaxone (ceftriaxone sodium)

Dozare:

1000mg

Forma farmaceutică:

powder for solution for i/m and i/v injection

Unități în pachet:

(1) glass vial, (10) glass vials

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2022-06-06

Prospect

Leaflet insert
To be prescribed
ATC Code: J01DD04
CEFTRIAXONE-ASTERIA INJ. 0.5G, 1G
(CEFTRIAXONE SODIUM)
POWDER FOR SOLUTION FOR I/M,I/V INJECTION
BROAD-SPECTRUM CEPHALOSPORIN ANTIBIOTIC
DESCRIPTION
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Ceftriaxone-Asteria Inj. is a long acting, broad spectrum
cephalosporin antibiotic for parenteral use.
TYPE OF DOSAGE FORM
Ceftriaxone sodium is a white to slightly yellowish crystalline
powder.
ROUTE OF ADMINISTRATION
• intramuscular injection
• intravenous injection
STERILE / RADIOACTIVE STATEMENT
Not applicable.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: ceftriaxone sodium in the form of the disodium
salt.
Vials containing dry substance equivalent to 0.5 g, 1 g ceftriaxone.
Solvent for parenteral use: The solvent ampoule for i.v. injection
contains sterile water for injections and for i.m.
injection contains 1% lidocaine hydrochloride solution. 1 ml solvent
for i.m. injection contains 10.66 mg lidocaine
hydrochloride monohydrate equivalent to 10 mg anhydrous lidocaine
hydrochloride.
Ceftriaxone-Asteria Inj. contains approximately 83 mg (3.6 mEq) of
sodium per gram of ceftriaxone.
CLINICAL PARTICULARS
THERAPEUTIC INDICATION(S)
Ceftriaxone-Asteria is indicated for the treatment of the following
infection in adults and children including term neonates
(from birth):

Bacterial meningitis

Community acquired pneumonia

Hospital acquired pneumonia

Acute otitis media

Intra-abdominal infection

Complicated urinary tract infections( including pyelonephritis)

Infections of bones and joints

Complicated skin and soft tissue infections

Gonorrhoea

Syphilis
Leaflet insert

Bacterial endocarditis
Ceftriaxone-Asteria 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 man

Caracteristicilor produsului

Summary of Product Characteristic
CEFTRIAXONE-ASTERIA INJ. 0.5G, 1G
(CEFTRIAXONE SODIUM)
POWDER FOR SOLUTION FOR I/M, I/V INJECTION
BROAD-SPECTRUM CEPHALOSPORIN ANTIBIOTIC
1. NAME OF THE MEDICINAL PRODUCT
Ceftriaxone-Asteria Inj. 1g
Ceftriaxone-Asteria Inj. 0.5 g
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1g or 0.5 g ceftriaxone as ceftriaxone sodium.
3. PHARMACEUTICAL FORM
Powder for solution for
intramuscular injection and intravenous injection.
Ceftriaxone sodium is a white to slightly yellowish crystalline
powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION(S)
Ceftriaxone-Asteria is indicated for the treatment of the following
infection in adults and children including term neonates
(from birth):

Bacterial meningitis

Community acquired pneumonia

Hospital acquired pneumonia

Acute otitis media

Intra-abdominal infection

Complicated urinary tract infections( including pyelonephritis)

Infections of bones and joints

Complicated skin and soft tissue infections

Gonorrhoea

Syphilis

Bacterial endocarditis
Ceftriaxone-Asteria 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.
Summary of Product Characteristic
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
infection listed above
Ceftriaxone-Asteria should be co administrated 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 DOSAGE AND ADMINISTRATION
The dose depends on the seve