দেশ: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Linezolid
Panpharma UK Ltd
J01XX08
Linezolid
2mg/1ml
Infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700; GTIN: 3391135490017
LINEZOLID LINEZOLID - SOLUTION FOR INFUSION 2 MG/ML READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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. • Linezolid 2 mg/ml Solution for Infusion is called ‘Linezolid Infusion’ in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Linezolid Infusion is and what it is used for 2. What you need to know before you are given Linezolid Infusion 3. How to use Linezolid Infusion 4. Possible side effects 5. How to store Linezolid Infusion 6. Contents of the pack and other information 1. WHAT LINEZOLID INFUSION IS AND WHAT IT IS USED FOR Linezolid Infusion is an antibiotic of the oxazolidinones group. The active substance is linezolid. Linezolid 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LINEZOLID INFUSION YOU SHOULD NOT BE TREATED WITH LINEZOLID INFUSION: • If you are allergic (hypersensitive) 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 linezolid passes into breast milk and could affect your baby. • If you are taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 r সম্পূর্ণ নথি পড়ুন
OBJECT 1 LINEZOLID 2MG/ML SOLUTION FOR INFUSION Summary of Product Characteristics Updated 18-Jul-2016 | Panpharma UK Ltd 1. Name of the medicinal product Linezolid 2 mg/ml Solution for Infusion 2. Qualitative and quantitative composition Each ml contains 2 mg of linezolid. Each 300 ml infusion bag contains 600 mg of linezolid. Excipients with known effect: Each 300 ml bag contains approximately 13.7 g of glucose and 114 mg of sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for infusion. Linezolid 2 mg/ml Solution for Infusion is an isotonic, clear, colourless to yellowish solution, free from visible particles. The pH value of the solution for infusion ranges from 4.6 to 5.0 and the solution has an osmolality between 270 to 330 mOsm/kg. 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 2 mg/ml Solution for Infusion 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 sk সম্পূর্ণ নথি পড়ুন