ZYVOX 600 MG FILM-COATED TABLETS
Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Характеристики продукта
(SPC)
07-06-2024
Некоторые документы для этого продукта в настоящее время недоступны, вы можете отправить запрос в нашу службу поддержки, и мы сообщим вам, как только мы сможем их получить.
Послать запрос.
Послать запрос.
Активный ингредиент:
LINEZOLID
Доступна с:
Pharmacia Ireland
дозировка:
600 Milligram
Фармацевтическая форма:
Film Coated Tablet
Дата Авторизация:
2001-07-27
Характеристики продукта
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zyvox 600 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg linezolid.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, ovaloid tablet with Zyvox 600mg printed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Zyvox is indicated for the treatment of community acquired pneumonia and nosocomial pneumonia when known or
suspected to be caused by susceptible Gram positive bacteria. In determining whether Zyvox is an appropriate
treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents
among Gram positive bacteria should be taken into consideration. (See section 5.1 for the appropriate organisms).
Linezolid is not active against infections caused by Gram negative pathogens. Specific therapy against Gram negative
organisms must be initiated concomitantly if a Gram negative pathogen is documented or suspected.
Complicated skin and soft tissue infections (see section 4.4)
Zyvox is indicated for the treatment of complicated skin and soft tissue infections ONLY when microbiological testing
has established that the infection is known to be caused by susceptible Gram positive bacteria.
Linezolid is not active against infections caused by Gram negative pathogens. Linezolid should only be used in patients
with complicated skin and soft tissue infections with known or possible co-infection with Gram negative organisms if
there are no alternative treatment options available (see section 4.4). In these circumstances treatment against Gram
negative organisms must be initiated concomitantly.
Linezolid should only be initiated i
Прочитать полный документ
