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

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cefepime (cefepime hydrochloride)

Available from:

Hankook Korus Pharm Co.

ATC code:

J01DE01

INN (International Name):

cefepime (cefepime hydrochloride)

Dosage:

1000mg

Pharmaceutical form:

powder for solution for injection

Units in package:

(1) and (10) glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-07-23

Patient Information leaflet

To be prescribed
ATC Code : J01DE01
Fourth-generation cephalosporin
CEFEPIME-ASTERIA
INJ. 1G
Cefepime HCI 1g
POWDER FOR SOLUTION FOR INJECTION
[COMPOSITION]
1 VIAL CONTAINS
CEFEPIME
HCL---------------------------------------------------------------------------------------------------------------------1G
(POTENCY)
EXCIPIENTS : L-ARGININE
DESCRIPTION
White to yellowish crystalline powder in clear vials
INDICATIONS
Cefepime-Asteria is indicated in the treatment of infections caused by
bacteria that are cefepime-sensitive:
- lower respiratory tract infections, including nosocomial pneumonia
and community acquired pneumonia, acute
bacterial exacerbation of chronic bronchitis and secondary bacterial
infection of acute bronchitis;
- uncomplicated and complicated urinary tract infections, including
pyelonephritis;
- skin and subcutaneous infections;
- intra-abdominal infections, including peritonitis and biliary tract
infections;
- gynaecological infections;
- bacterial meningitis in infants and children;
- In combination with other antibacterial agents in the management of
neutropenic patients with fever that is
suspected to be due to a bacterial infection;
- Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated with, any of
the infections listed above.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
DOSAGE AND ADMINISTRATION
Cefepime-Asteria can be administered via intravenous use or
intramuscular use.
After reconstitution, the solution is yellow to yellow-brown.
The usual dose and the route of administration vary in accordance with
the severity of the infection, the renal
function and the general conditions of the patient.
The IV route of administration is preferable in the patients with
severe infections or in a life-threatening situation,
particularly if there is the possibility of shock.
Adults and children weighing > 40 kg with normal renal function:
SEVERITY OF THE INFECTION
DOSAGE AND ROUTE OF ADMINISTRATION
INT

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT
Cefepime-Asteria Inj. 1g
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical
Name
Quantity/vial
Use
1
_ _
Cefepime
Hydrochloride
1g
(potency)
Active
ingredient
_ _
Excipients
No.
Chemical
Name
Quantity/vial
Use
1
_ _
L-arginine
q.s.
pH
Adjuster
_ _ 3. PHARMACEUTICAL FORM
Powder for solution for injection
3.1 DESCRIPTION
White to yellowish crystalline powder in clear vials
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefepime-Asteria is indicated in the treatment of infections caused by
bacteria that are cefepime-sensitive:
- lower respiratory tract infections, including nosocomial pneumonia
and community acquired pneumonia, acute
bacterial exacerbation of chronic bronchitis and secondary bacterial
infection of acute bronchitis;
- uncomplicated and complicated urinary tract infections, including
pyelonephritis;
- skin and subcutaneous infections;
- intra-abdominal infections, including peritonitis and biliary tract
infections;
- gynaecological infections;
- bacterial meningitis in infants and children;
- In combination with other antibacterial agents in the management of
neutropenic patients with fever that is
suspected to be due to a bacterial infection;
- Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated with, any of
the infections listed above.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cefepime-Asteria can be administered via intravenous use or
intramuscular use.
After reconstitution, the solution is yellow to yellow-brown.
The usual dose and the route of administration vary in accordance with
the severity of the infection, the renal
function and the general conditions of the patient.
The IV route of administration is preferable in the patients with
severe infections or in a life-threatening situation,
particularly if there is the possibility of shock.
Adults and