NA LINEZOLID IE LINEZOLID NA Package leaflet: Information for the user Numbness, tingling or blurred vision have been reported by patients • Decrease of the blood cell count pathogens. Specific therapy against Gram negative organisms must be Patients with hepatic insufficiency: Patients with mild to moderate - medicines used to treat moderate to severe pain, such as pethidine are pregnant, think you may be pregnant or are planning to have a baby, who have been given Linezolid for more than 28 days. If you experience • Weakness and/or sensory changes initiated concomitantly if co-infection with a Gram negative pathogen is hepatic insufficiency (Child-Pugh class A or B): No dose adjustment is Linezolid 2 mg/ml solution for infusion - medicines used to treat anxiety disorders, such as buspirone ask your doctor or pharmacist for advice before taking this medicine. difficulties with your vision you should consult your doctor as soon as Reporting of side effects documented or suspected. required. - an antibiotic called rifampicin You should not breast-feed when taking Linezolid because it passes into possible. If you get any side effects, talk to your doctor or pharmacist or nurse. This Description Patients with severe hepatic insufficiency (Child-Pugh class C): As Linezolid Take special care with Linezolid breast milk and could affect the baby. Other side effects include: includes any possible side effects not listed in this leaflet. You can also For single use only. The bag holds 300 ml solution and is packaged in a linezolid is metabolised by a non-enzymatic process, impairment of report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, box. Each box contains 1 or 10 infusion bags. hepatic function would not be expected to significantly alter its metabolism prva stran Tell your doctor before you are treated with this medicine if you: Driving and using machines Common side effects (may affect up to 1 in 10 people): Read all of this leaflet carefully before this medicinal product is • bruise and bleed easily Linezolid may make you feel dizzy or experience problems with your • Fungal infections especially vaginal or oral “thrush” IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Linezolid 2 mg/ml solution for infusion contains linezolid 2 mg/ml in a and, therefore, no dose adjustment is recommended. However, there are given to you because it contains important information for you. • are anaemic (have low red blood cells) vision. If this happens, do not drive or operate any machinery. Remember • Headache Website: www.hpra.ie; E-mail: [email protected]. clear, colourless to yellow or to yellowish-brown solution. Other no pharmacokinetic data and limited clinical experience of linezolid in • Keep this leaflet. You may need to read it again. • are prone to getting infections that if you are unwell your ability to drive or operate machinery may be • Metallic taste in the mouth By reporting side effects you can help provide more information on the ingredients are glucose monohydrate, sodium citrate dihydrate, citric acid patients with severe hepatic insufficiency. Linezolid should be used with • If you have any further questions, ask your doctor or pharmacist or • have a history of seizures affected. • Diarrhoea, nausea or vomiting safety of this medicine. anhydrous, hydrochloric acid, sodium hydroxide and water for injection. special caution in patients with severe hepatic insufficiency and only when nurse. the anticipated benefit is considered to outweigh the theoretical risk. • have liver problems or kidney problems particularly if you are on dialysis Linezolid contains glucose. • Changes in some blood test results including those measuring your Dosage and method of administration 90 mm ± 0,5 mm - zaetek teksta • If you get any side effects, talk to your doctor or pharmacist or nurse. • have diarrhoea kidney or liver function or blood sugar levels 5. How to store Linezolid Linezolid should only be initiated in a hospital environment and after Contraindications This includes any possible side effects not listed in this leaflet. See 300 ml of solution for infusion contains 13.7 g glucose. This should be Tell your doctor immediately if during treatment you suffer from: taken into account in patients with diabetes mellitus. • Unexplained bleeding or bruising, which may be due to changes in the Keep this medicine out of the sight and reach of children. consultation with a relevant specialist such as a microbiologist or an Hypersensitivity to linezolid or to any of the excipients. section 4. numbers of certain cells in the blood which may affect blood clotting or infectious diseases specialist. • problems with your vision such as blurred vision, changes in colour Do not use this medicine after the expiry date which is stated on the Linezolid should not be used in patients taking any medicinal product Linezolid contains sodium. lead to anaemia What is in this leaflet vision, difficulty in seeing detail or if your field of vision becomes 300 ml of solution for infusion contains 114 mg sodium (5 mmol). To be packaging after EXP. The expiry date refers to the last day of that month. Patients who commence treatment on the parenteral formulation may be which inhibits monoamine oxidases A or B (e.g. phenelzine, restricted. • Difficulty in sleeping switched to either oral presentation when clinically indicated. In such isocarboxazid, selegiline, moclobemide) or within two weeks of taking any 1. What Linezolid is and what it is used for taken into consideration by patients on a controlled sodium diet. Do not store above 30°C. • loss of sensitivity in your arms or legs or a sensation of tingling or • Increased blood pressure circumstances, no dose adjustment is required as linezolid has an oral such medicinal drug. 2. What you need to know before you are treated with Linezolid • Anaemia (low red blood cell) Store in the original package in order to protect from light. 3. How Linezolid is given pricking in your arms or legs. bioavailability of approximately 100 %. Unless there are facilities available for close observation and monitoring smer branja kode 3. How Linezolid is given • Changes in numbers of certain cells in the blood which may affect your After opening: Chemical and physical in-use stability has been 4. Possible side effects • You may develop diarrhoea while taking or after taking antibiotics, The solution for infusion should be administered over a period of 30 to 120 of blood pressure, linezolid should not be administered to patients with Adults ability to fight infection demonstrated for 24 hours at room temperature in primary bag after 5. How to store Linezolid including Linezolid. If this becomes severe or persistent or you notice minutes. the following underlying clinical conditions or on the following types of This medicine will be given to you through a drip (by infusion into a vein) • Skin rash removal of the secondary pack (pouch). From a microbiological point of 6. Contents of the pack and other information that your stools contains blood or mucus, you should stop taking The recommended linezolid dosage should be administered IV twice daily. concomitant medications: Linezolid immediately and consult your doctor. In this situation, you by a doctor or healthcare professional. The usual dose for adults (18 • Itching skin view, the product should be used immediately. If not used immediately, Linezolid Recommended dosage and duration for adults: • Patients with uncontrolled hypertension, phaeochromocytoma, should not take medicines that stop or slow bowel movement. years and older) is 300 ml (600 mg linezolid) twice daily which is given • Dizziness in-use storage times and conditions prior to use are the responsibility of The duration of treatment is dependent on the pathogen, the site of carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder, Linezolid 1. What Linezolid is and what it is used for • recurrent nausea or vomiting, abdominal pain or rapid breathing. directly into the blood stream (intravenously) by a drip over a period of 30 • Localised or general abdominal pain the user. Linezolid is an antibiotic of the oxazolidinones group that works by to 120 minutes. • Constipation infection and its severity, and on the patient’s clinical response. acute confusional states. Other medicines and Linezolid Do not use this medicine if you notice that solution is not clear, colourless stopping the growth of certain bacteria (germs) that cause infections in • Indigestion The following recommendations for duration of therapy reflect those used • Patients taking any of the following medications: Serotonin re-uptake There is a risk that Linezolid may sometimes interact with certain other If you are on kidney dialysis, you should be given Linezolid after dialysis. to yellow or to yellowish-brown. adults. It is used to treat pneumonia and some infections in the skin or • Localised pain in the clinical trials. Shorter treatment regimens may be suitable for some inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists medicines to cause side effects such as changes in blood pressure, A course of treatment usually lasts 10 to 14 days, but can last up to 28 Do not throw away any medicines via wastewater or household waste. under the skin. Your doctor will have decided if Linezolid is suitable to • Fever types of infection but have not been evaluated in clinical trials. (triptans), directly and indirectly acting sympathomimetic agents temperature or heart rate. days. The safety and effectiveness of this medicine have not been Ask your pharmacist how to throw away medicines you no longer use. (including the adrenergic bronchodilators, pseudoephedrine and smer branja kode treat your infection. Uncommon side effects (may affect up to 1 in 100 people): The maximum treatment duration is 28 days. The safety and effectiveness Tell your doctor if you are taking or have taken within the last 2 established for treatment periods longer than 28 days.