Linezolid 600mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Linezolid

Доступна з:

Viatris UK Healthcare Ltd

Код атс:

J01XX08

ІПН (Міжнародна Ім'я):

Linezolid

Дозування:

600mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 05010700; GTIN: 5016695007052

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LINEZOLID 600 MG FILM-COATED TABLETS
linezolid
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 or pharmacist.

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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Linezolid is and what it is used for
2.
What you need to know before you take Linezolid
3.
How to take Linezolid
4.
Possible side effects
5.
How to store Linezolid
6.
Contents of the pack and other information
1.
WHAT LINEZOLID IS AND WHAT IT IS USED FOR
Linezolid is a medicine containing the active substance linezolid
which is an antibiotic of the oxazolidinones
group. This medicine works 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 is
suitable to treat your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID
DO NOT TAKE LINEZOLID
•
If you are allergic to linezolid or any of the other ingredients of
this medicine (listed in section 6).
•
If you are taking or have taken within the last 2 weeks any medicines
known as monoamine oxidase inhibitors
(MAOIs, for example phenelzine, isocarboxazid, selegiline,
moclobemide). These may be used to treat
depression or Parkinson’s disease.
•
If you are breast-feeding. This is because it passes into breast milk
and could affect the baby.
Linezolid may not be suitable for you if you answer yes
to any of the following questions. In this case tell your
doctor as he/she will need to check your general health and your blood
pressure before and durin

Характеристики продукта

OBJECT 1
LINEZOLID 600 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 31-May-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Linezolid 600 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 600 mg linezolid.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White to off-white, oblong (approximately 18 mm x 6 mm), biconvex film
coated tablets debossed with
“L9II 600” on one 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 envi