Cefepime-Asteria Inj. 1g 1000mg powder for solution for injection

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

cefepime (cefepime hydrochloride)

Disponível em:

Hankook Korus Pharm Co.

Código ATC:

J01DE01

DCI (Denominação Comum Internacional):

cefepime (cefepime hydrochloride)

Dosagem:

1000mg

Forma farmacêutica:

powder for solution for injection

Unidades em pacote:

(1) and (10) glass vial

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2016-11-10

Folheto informativo - Bula

CEFEPIME-ASTERIA INJ. 1G
120*390
[COMPOSITION]
1 VIAL CONTAINS
CEFEPIME HCL 1G(POTENCY)
EXCIPIENTS : L-ARGININE
To be prescribed
ATC Code : J01DE01
[INDICATIONS]
STRAINS
Streptococcus
pneumoniae,
Pseudomonas
aeruginosa,
Klebsiella
pneumoniae,
Enterobacter
species,
Escherichia
coli,
Proteus
mirabilis, Staphylococcus aureus (methicillin-susceptible strains
only) or Streptococcus pyogenes. viridans group streptococci,
Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species,
or Bacteroides fragilis.
INDICATION
Pneumonia (moderate to severe), Empiric therapy for febrile
neutropenia (The drug is not recommended in patients at high risk for
severe
infection
(e.g.,
patients
with
sepsis,
severe
prolonged
neutropenia,
recent
bone
marrow
transplantation,
hematologic
malignancies, etc..), Uncomplicated and complicated Urinary Tract
Infections (including pyelonephritis), Complicated Intra-abdominal
Infections (used in combination with metronidazole)
* including cases associated with concurrent bacteremia.
[DOSAGE & ADMINISTRATION]
The recommended adult and pediatric dosages and routes of
administration are outlined in the following table Cefepime HCl for
injection should be administered intravenously over approximately 30
minutes. Before administration ensure that the powder has
been fully dissolved in the solution.
Administration duration should be within 10 days
Adults
- including cases associated with concurrent bacteremia. or until
resolution of neutropenia. In patients whose fever resolves but who
remain neutropenic for more than 7 days, the need for continued
antimicrobial therapy should be re-evaluated frequently.
- IM route of administration is indicated only for mild to moderate,
uncomplicated or complicated UTIs due to E. coli when the IM route
is considered to be a more appropriate route of drug administration.
PEDIATRIC PATIENTS (2 MONTHS UP TO 16 YEARS)
The maximum dose for pediatric patients should not exceed the
recommended adult dose. The usual recommended dosage in
pediatric patients up to 40 kg i