Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Linezolid
Milpharm Ltd
J01XX08
Linezolid
600mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700; GTIN: 8901175028535
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 Lugege kogu dokumenti
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 Lugege kogu dokumenti