Ceftriaxone-Asteria powder for solution for i/m injection

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

ceftriaxone (ceftriaxone sodium)

Доступна с:

Hankook Korus Pharm Co.

код АТС:

J01DD04

ИНН (Международная Имя):

ceftriaxone (ceftriaxone sodium)

дозировка:

1000mg

Фармацевтическая форма:

powder for solution for i/m injection

Штук в упаковке:

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

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2015-12-17

Характеристики продукта

_Summary of Product Characteristics_
1.
NAME OF THE MEDICINAL PRODUCT
Ceftriaxone-Asteria Inj. 1g
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION Active ingredient
No.
Chemical Name
Quantity/vial
Use
Active
1
Cetriaxone sodium
1g (potency)
ingredient
Excipient(s)
None
3.
PHARMACEUTICAL FORM
Power for Injection
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Ceftriaxone is indicated for the treatment of the following infections
caused by susceptible
organisms :
Lower Respiratory tract infection such as pneumonia, bronchitis, etc.
Ear, nose and throat infection; renal and urinary tract injection;
Sepsis, meningitis; pre-
operative prophylaxis of infection; Infection of bones and joints;
infection of skin, wounds and
soft tissue; peritonitis, cholecystitis, cholangitis and infection of
gastrointestinal tract; general
infections such as gonorrhea etc.; infection in patients with impaired
defence mechanisms.
4.2 Posology and method of administration
Ceftriaxone may be administrated intravenously or intramuscularly.
For IM injection
: Ceftriaxone sodium 250mg or 500mg is dissolved in 2ml, and
ceftriaxone 1g
in 3.5ml of 1% lidocaine HCl solution and injected well within the
body of a relatively large
_Summary of Product Characteristics_
muscle. It is recommended that not more than 1g be injected at one
side. IM injection without
lidocaine is painful. The lidocaine solution must never be
administered IV.
For
IV
injection
:
for
IV
injection,
Ceftriaxone
250mg
or
500mg
is
dissolved
in
5ml,
ceftriaxone1g in 10ml water for injection. The IV administration
should be given over 2-4
minutes.
Adults
: the usual daily dose for adults is 1 to 2 grams given once a day (or
in equally divided
doses twice a day) depending on the type and severity of the
infection. The total daily dose
should not exceed 4 grams.
Children
: depending on the infection 50-100mg/kg should be administered up to
2g/day.
The usual duration of therapy is 4-14 days; generally therapy should
be continued for 2 days
after the symptoms of infection have disappeare