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

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ceftriaxone (ceftriaxone sodium)

Available from:

Reyoung Pharmaceutical Co. Ltd.

ATC code:

J01DD04

INN (International Name):

ceftriaxone (ceftriaxone sodium)

Dosage:

1000mg

Pharmaceutical form:

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

Units in package:

(10) glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-11-07

Patient Information leaflet

_ CEFTRIAXONE FOR INJECTION_ POWDER FOR SOLUTION FOR INJECTION
COMPOSITION:
Each vial contains: Ceftriaxone Sodium equivalent to 250mg/500mg/1g
Ceftriaxone base.
INDICATIONS:
_CEFTRIAXONE_ is indicated for the treatment of infections due to
susceptible organisms, including lower respiratory tract infections,
urinary tract and biliary tract infections, abdominal
infections, pelvic infections, infections of the skin, soft tissue,
bone and joints, sepsis, meningitis and preoperative prophylaxis of
infections. Single administration of _CEFTRIAXONE_ can be
used in the treatment of uncomplicated gonorrhoea.
SKIN AND SKIN STRUCTURE INFECTIONS: by Staphylococci and/or
Streptococcus pyogenes, Viridans group Streptococci, Escherichia coli,
Enterobacter cloacae, Staphylococcus aureus,
Staphylococcus epidermidis, Klebsiella pneumoniae, Klebsiella oxytoca,
Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens,
Acinetobacter calcoaceticus, Bacteroides fragilis or
Peptostreptococcus species.
LOWER RESPIRATORY TRACT INFECTIONS: by Group A and B haemolytic
Streptococci, Haemophilus influenzae, Haemophilus parainfluenzae,
Klebsiella pneumoniae, Streptococcus pneumoniae,
Staphylococcus aureus, Escherichia coli, Enterobacter aerogenes,
Proteus mirabilis, or Serratia marcescens.
PELVIC INFLAMMATORY DISEASES: by Neisseria gonorrhoeae. _CEFTRIAXONE_,
like other cephalosporins, has not activity against Chlamydia
trachomatis. Therefore, when cephalosporins are
use in the treatment of patients with pelvic inflammatory disease and
Chlamydia trachomatis is one of the suspected pathogens, appropriate
antichlamydial coverage should be added.
BACTERIAL SEPTICAEMIA: by Staphylococcus aureus, Streptococcus
pneumoniae, Escherichia coli, Haemophilus influenzae, or Klebsiella
pneumoniae.
BONE AND JOINT INFECTIONS: by Staphylococcus aureus, Streptococcus
pneumoniae, Escherichia coli, Klebsiella pneumoniae, or
Enterobacteriaceae.
INTRA-ABDOMINAL
INFECTIONS:
by
Klebsiella
pneumoniae,
Escherichia
coli,
Bacteroides
fragilis,
Clostridium
species

Summary of Product characteristics

瑞
阳
制
药
有
限
公
司 REYOUNG PHARMACEUTICAL CO., LTD.
ADD.: NO.1, RUIYANG ROAD, YIYUAN COUNTY, SHANDONG PROVINCE, P.R.
CHINA.
Tel: [phone]
Fax: [phone]
E-mail:[e-mail]
http://www.reyoung.cn
REYOUNG
SUMMARY OF THE PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ceftriaxone for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains ceftriaxone sodium equivalent to 1.0g of
ceftriaxone
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM & PACKAGE
Powder for solution for injection ; 1,0g x 10vials
White to yellowish-orange crystalline powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceftriaxone sodium is a broad-spectrum bactericidal cephalosporin
antibiotic. Ceftriaxone is
active
_in vitro_
against a wide range of Gram-positive and Gram-negative organisms,
which
include
β
-lactamase producing strains.
Ceftriaxone is indicated in the treatment of the following infections
either before the infecting
organism has been identified or when known to be caused by bacteria of
established sensitivity.
Pneumonia
Septicaemia
Meningitis
Skin and soft tissue infections
Infections in neutropenic patients
Gonorrhoea
Peri-operative prophylaxis of infections associated with surgery
Treatment may be started before the results of susceptibility tests
are known.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
瑞
阳
制
药
有
限
公
司 REYOUNG PHARMACEUTICAL CO., LTD.
ADD.: NO.1, RUIYANG ROAD, YIYUAN COUNTY, SHANDONG PROVINCE, P.R.
CHINA.
Tel: [phone]
Fax: [phone]
E-mail:[e-mail]
http://www.reyoung.cn
REYOUNG
Ceftriaxone may be administered by deep intramuscular injection, or as
a slow intravenous
injection
_, _
after reconstitution of the solution according to the directions given
below. The dosage
and mode of administration should be determined by the severity of the
infection, susceptibility of
the