Linezolid 600mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Linezolid

Sẵn có từ:

Actavis UK Ltd

Mã ATC:

J01XX08

INN (Tên quốc tế):

Linezolid

Liều dùng:

600mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 05010700; GTIN: 5690528456011

Tờ rơi thông tin

Linezolid 600mg Tablets PIL - UK/Eire
item no: AAAI0127
print proof no: 5
origination date: 08.06.15
originated by: S.Anson
revision date: 26.08.15
revised by: S.Anson
dimensions: 190 x 380
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1.
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 08.06.15
supplier: Actavis Iceland
technically app. date: 11.06.15
min pt size: 9
TECHNICAL APPROVAL
Black
LINEZOLID 600MG FILM-COATED TABLETS
Linezolid
_Continued over page_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor,
pharmacist or nurse.
•
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
•
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
•
The full name of this medicine is Linezolid 600mg Film-
coated Tablets but within the leaflet it will be referred to
as Linezolid Tablets.
WHAT IS IN THIS LEAFLET
1
WHAT LINEZOLID TABLETS ARE AND WHAT THEY ARE
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LINEZOLID TABLETS
3
HOW TO TAKE LINEZOLID TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE LINEZOLID TABLETS
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT LINEZOLID TABLETS ARE AND WHAT THEY ARE
USED FOR
Linezolid Tablets are an antibiotic of the oxazolidinones group
that work by stopping the growth of certain bacteria (germs)
that cause infections. It is used to treat pneumonia and some
infections in the skin or under the skin. Your doctor will have
decided if Linezolid Tablets are suitable to treat your infection.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LINEZOLID TABLETS
DO NOT TAKE LINEZOLID TABLETS:
•
if you are allergic to linezolid or any of the other ingredients
of this medicine (listed in section 6).
•
if you are taki

Đặc tính sản phẩm

OBJECT 1
LINEZOLID 600MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 28-Jan-2016 | Accord-UK Ltd
1. Name of the medicinal product
Linezolid 600mg Film-coated Tablets
2. Qualitative and quantitative composition
Each tablet contains 600 mg linezolid.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White, biconvex oval tablet, 9.3 mm x 19 mm. The tablet has “L“ on
one side and “600“ on the
opposite side.
4. Clinical particulars
4.1 Therapeutic indications
Nosocomial pneumonia
Community acquired pneumonia
Linezolid is indicated in adults 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 linezolid 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)
Linezolid is indicated in adults 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 in a hospital environment and after
consultation with a re