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

Страна: Вірменія

мова: англійська

Джерело: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активний інгредієнт:

ceftriaxone (ceftriaxone sodium)

Доступна з:

Hankook Korus Pharm Co.

Код атс:

J01DD04

ІПН (Міжнародна Ім'я):

ceftriaxone (ceftriaxone sodium)

Дозування:

1000mg

Фармацевтична форма:

powder for solution for i/m injection

Одиниць в упаковці:

(1) glass vial and 3,5ml solvent in ampoule

Тип рецепту:

Prescription

Статус Авторизація:

Registered

Дата Авторизація:

2019-07-18

інформаційний буклет

[ COMPOSITION ]
Each vial contains:
Ceftriaxone sodium
-----------------------------------------------------------------------
1.0g(Potency)
[ INDICATIONS ]
Ceftriaxone-Asteria Inj. 1g 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-Asteria Inj. 1g 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-Asteria Inj. 1g should be co-administered with other
antibacterial agents whenever the possible range of causative bacteria
would
not fall within its spectrum.
Consideration should be given to official guidelines on the
appropriate use of antibacterial agents.
[ ADMINISTRATION ]
The dose depends on the severity, susceptibility, site and type of
infection and on the age and hepato-renal function of the patient.
The doses recommended in the tables below are the generally
recommended doses in these indications. In particularly severe cases,
doses at
the higher end of the recommended range should be considered.
_Adults and children over 12 years of age (≥ 50kg)_
Ceftriaxone
Dosage*
Treatment
frequency**
Indications
1 - 2 g
Once daily
Community acquired pneumonia
Acute exacerbations of chronic obstructive
pulmonary diseas

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTIC (SPC)
OF
CEFTRIAXONE-ASTERIA INJ. 1G
HANKOOK KORUS PHARM. CO., LTD.
11, GEODUDANJI 1-GIL, DONGNAE-MYEON, CHUNCHEON-SI, GANGWON-DO, KOREA
1. NAME OF THE MEDICINAL PRODUCT
Ceftriaxone-Asteria Inj. 1g
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/vial
Use
1
Ceftriaxone sodium
1g (potency)
Active
ingredient
ATC Code: J01DD04
Excipient(s)
None
3. PHARMACEUTICAL FORM
Power for Solution for I/M injection
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Ceftriaxone-Asteria Inj. 1g 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-Asteria Inj. 1g 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-Asteria Inj. 1g should be co-administered 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 Posology and method of administration
Posology
The dose depends on the severity, susceptibility, site and type of
infection and on the age and
hepato-renal function of the pa