Linezolid 600mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Linezolid

Verfügbar ab:

Milpharm Ltd

ATC-Code:

J01XX08

INN (Internationale Bezeichnung):

Linezolid

Dosierung:

600mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 05010700; GTIN: 8901175028535

Gebrauchsinformation

500 mm
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Linezolid
LINEZOLID 600 MG
FILM-COATED TABLETS
•
recurrent nausea or vomiting, abdominal pain
or over breathing
CHILDREN AND ADOLESCENTS
Linezolid is not recommended for use in children
and adolescents under the age of 18.
OTHER MEDICINES AND LINEZOLID
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
There is a risk that Linezolid may sometimes
interact with certain other medicines to cause side
effects such as changes in blood pressure,
temperature or heart rate.
TELL YOUR DOCTOR IF YOU ARE TAKING OR HAVE TAKEN
WITHIN THE LAST 2 WEEKS the following medicines
as linezolid MUST NOT be taken if you are already
taking these medicines or have taken them
recently. (See also Section 2 above ‘Do not take
Linezolid’)
•
monoamine oxidase inhibitors ( MAOIs for
example phenelzine, isocarboxazid, selegiline,
moclobemide). These may be used to treat
depression or Parkinson’s disease.
Also tell your doctor if you are taking the following
medicines. Your doctor may still decide to give you
Linezolid, but will need to check your general
health and your blood pressure before and during
your treatment. In other cases, your doctor may
decide that another treatment is better for you.
•
Decongestant cold or flu remedies containing
pseudoephedrine or phenylpropanolamine.
•
Some medicines used to treat asthma such as
salbutamol, terbutaline, fenoterol.
•
Certain antidepressants known as tricyclics or
SSRIs (selective serotonin reuptake
inhibitors).There are many of these, including
amitriptyline, cipramil, clomipramine, dosulepin,
doxepin, fluoxetine, fluvoxamine, imipramine,
lofepramine, paroxetine, sertraline.
•
Medicines used to treat migraine such as
sumatriptan and zolmitriptan.
•
Medicines used to treat sudden, severe allergic
reactions such as adrenaline (epinephrine).
•
Medicines which increase your blood pressure,
such as noradrenaline (norepinephrine)
dopamine and dobutamine.
•
Medicines used to

Fachinformation

OBJECT 1
LINEZOLID 600MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 10-Jan-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Linezolid 600 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 600 mg of Linezolid
Excipient with known effect:
Each film-coated contains 25.2 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White, oval, biconvex tablets, 18.7±0.2 mm in length, 9.8±0.2 mm in
width and 6.7±0.3mm in thickness,
printed with “600” on one side in blue ink.
4. Clinical particulars
4.1 Therapeutic indications
Nosocomial pneumonia
Community acquired pneumonia
Linezolid 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
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 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 neg