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CMI for Linezolid Kabi July 2018 Linezolid Kabi

Linezolid

Consumer Medicine Information What is in this leaflet of medicine to treat depression, anxiety, panic attacks, obsessive-compulsive disorders This leaflet answers some common Before you are given or obesity (e.g. , questions about Linezolid Kabi. It Linezolid Kabi , , does not contain all the available , , information. It does not take the When you must not be given it , , place of talking to your doctor or , , pharmacist. Linezolid Kabi must not be given ) if you or your child: • tricyclic , which All medicines have risks and • are allergic to linezolid or any of are medicines to treat benefits. Your doctor has weighed the other ingredients listed at depression (e.g. , the risks of you or your child taking the end of this leaflet. Linezolid Kabi against the benefits , dothiepin, they expect it will have for you. Some of the symptoms of an , , allergic reaction may include: , ) shortness of breath, wheezing If you have any concerns about • some medicines to treat or difficulty breathing, swelling taking this medicine, ask your migraine (e.g. naratriptan, of the face, lips, tongue or other doctor or pharmacist. sumatriptan, zolmitriptan) parts of the body, rash, itching or hives on the . • , a medicine to treat Keep this leaflet. pain. You may need to read it again. • have uncontrolled high blood pressure • , a medicine to treat anxiety • have pheochromocytoma (a

type of tumour of the adrenal What Linezolid Kabi is Before you start to be given it used for gland) • have thyrotoxicosis (an Tell the doctor if you or your Linezolid Kabi contains the active overactive thyroid gland) child: ingredient, linezolid. • have flushing or other • have allergies to any other symptoms caused by a medicines or substances, such Linezolid is an (an agent carcinoid tumour as foods, preservatives or dyes used to destroy certain types of • are taking or have taken in the • are anaemic or have had any ). It is used in the treatment last two weeks any medicine abnormal blood test results (e.g. of bacterial such as that is a low haemoglobin or platelets) , skin infections or blood inhibitor (e.g. , infections. • are diabetic (Linezolid Kabi or contains glucose) to treat depression or • have diarrhoea. Depending on the type of bacteria, to treat Parkinson's disease) you may be given additional medicines. • any cold or flu medicine Tell the doctor if you: containing • are pregnant or planning to Your doctor, however, may • , a medicine used to become pregnant prescribe Linezolid Kabi for another treat severe allergic reactions purpose. • are breastfeeding or intend to • any other medicine that breastfeed. increases blood pressure (e.g. Ask your doctor if you have any noradrenaline, , If you are pregnant or questions about why Linezolid dobutamine) breastfeeding, the doctor may Kabi has been prescribed for decide not to prescribe Linezolid • are taking any medicine that is a you or your child. Kabi. re-uptake inhibitor

(SSRI or SNRI), which are types This medicine is not addictive.

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Talk to the doctor or pharmacist, • , a medicine to treat of age is 10 mg/kg three times daily if you have any concerns about tuberculosis and some other (every 8 hours). you or your child being given infections Linezolid Kabi. • any medicine that could reduce These doses are given the levels of haemoglobin (the intravenously by a "drip" over a Taking other medicines pigment in red blood cells which period of 30 to 120 minutes. carries oxygen) or platelets Tell your doctor if you are taking (blood cells which help blood to Treatment is usually given every any other medicines, including clot). day for 10 to 14 days, but may medicines that you buy without a given for up to 28 days. prescription from a pharmacy, Ask the doctor or pharmacist if supermarket or health food you are not sure about this list of Ask the doctor if you want more shop. medicines. information about the dose of

Linezolid Kabi and how it is In particular, tell the doctor if Also tell the doctor if your or given. you or your child have been your child's diet contains a lot of treated with or are taking: mature cheese, yeast extracts, If you are given too much • any medicine that inhibits meat extracts, soya bean (overdose) monoamine oxidase (e.g. extracts (e.g. soy sauce), Overdose is unlikely as treatment moclobemide, phenelzine or draught beers or wine. will be given by the doctor or nurse. tranylcypromine to treat The possible effects of overdose depression or selegiline to treat Linezolid may react with a are vomiting, tremors, Parkinson's disease) substance which is naturally unsteadiness or lack of present in these foods. • any cold or flu medicine coordination.

containing pseudoephedrine

• adrenaline, a medicine used to Tell the doctor or nurse treat severe allergic reactions How Linezolid Kabi is immediately if you or your child • any other medicine that given have any of these effects or if increases blood pressure (e.g. you or your child feel worse during or after treatment with noradrenaline, dopamine, It is recommended that treatment Linezolid Kabi. dobutamine) with Linezolid Kabi begin in a

hospital. • are taking any medicine that is a serotonin re-uptake inhibitor (SSRI and SNRI), which are Linezolid Kabi will be given to you While you are given types of medicine to treat or your child by the doctor or nurse. Linezolid Kabi depression, anxiety, panic Linezolid Kabi is a liquid which is attacks, obsessive-compulsive Things you must do disorders or obesity (e.g. given by slow injection into the citalopram, escitalopram, blood (known as an intravenous infusion or "drip"). Follow all instructions given by fluoxetine, fluvoxamine, the doctor. paroxetine, sertraline, If you or your child is on dialysis, duloxetine, sibutramine, Linezolid Kabi should be given after In some cases, additional blood venlafaxine, desvenlafaxine) dialysis. tests may be required. • tricyclic antidepressants, which are medicines to treat You or your child may be changed As part of the treatment, you or depression (e.g. amitriptyline, from Linezolid Kabi to an oral your child may be given other clomipramine, dothiepin, preparation of linezolid to complete medicines including other doxepin, imipramine, your course of treatment. . It is important to keep nortriptyline, trimipramine) taking these medicines as well as How much is given Linezolid Kabi unless you are told • some medicines to treat otherwise by your doctor or migraine (e.g. naratriptan, The recommended dose for adults pharmacist. sumatriptan, zolmitriptan) and adolescents 12 years and • pethidine, a medicine to treat older is 600 mg twice daily (every It is important to tell the doctor if pain. 12 hours). you develop diarrhoea during or • buspirone, a medicine to treat after treatment with Linezolid anxiety The recommended doses for Kabi. Do this even if it occurs babies and children up to 12 years several weeks after Linezolid Kabi has been stopped.

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This is because Linezolid Kabi may given the next dose of Linezolid Do not take any medicine to treat react with a substance which is Kabi if you notice any of the diarrhoea without first checking naturally present in these foods. following: with the doctor. • skin reactions (hives, rash or If you or your child develop a itching) Diarrhoea may be caused by a throbbing after eating, serious condition affecting the tell your doctor or health care • visual disturbances or bowel. You or your child may need professional. numbness or weakness of the urgent medical care. arms and legs (rare side effects that have been primarily reported in patients treated for If you or your child gets a sore Side Effects white mouth or tongue during or longer than 28 days) soon after treatment with • tiredness, , being Tell the doctor or pharmacist as Linezolid Kabi tell your doctor. short of breath when exercising, soon as possible if you or your dizziness, looking pale, fever child do not feel well while you Tell the doctor if you or your and chills, sore throat or are taking Linezolid Kabi. child gets vaginal itching or bruising (these symptoms may discharge. indicate a decrease in the level This medicine helps most people, of your blood cells) but it may have unwanted side This may mean you or your child effects in a few people. All • sweating, feeling drunk and have a fungal called medicines can have side effects. If dizzy, muscle twitching, fever thrush. they occur, most are likely to be and shivering, confusion.

minor and temporary. However, These may be symptoms of the Sometimes the use of Linezolid some may be serious and need , which is a Kabi allows fungi to grow which medical attention. rare but serious side effect. causes the symptoms described above. Linezolid Kabi does not Do not be alarmed by the If any of the following happen, work against fungi. following lists of side effects. tell your or your child's doctor

immediately or go to Accident Things you must not do You or your child may not and Emergency at your nearest hospital: Do not start taking any other experience any of them. medicines, prescription or not, • without first telling your doctor Ask the doctor or pharmacist to • shortness of breath answer any questions you may or pharmacist. • wheezing or difficulty breathing have. Do not give your child any other • swelling of the face, lips, tongue medicines, prescription or While taking it or other parts of the body purchased from a health food • rash, severe itching or hives or shop, pharmacy or supermarket Tell the doctor or pharmacist if blisters on the skin. without first telling your doctor you notice any of the following and they worry you: These may be signs of a serious or pharmacist. allergic reaction or side effect. You • headache or your child may need urgent Do not take any medicine to treat • sore, white mouth or tongue medical attention or hospitalization. diarrhoea without first checking (oral thrush) These side effects are rare. with the doctor. • vaginal itching or discharge (vaginal thrush) After finishing it Diarrhoea may be caused by a serious condition affecting the • pain, cramping or bloating of the Tell your or your child's doctor bowel. You or your child may need abdomen or pharmacist if you notice any urgent medical care. • or vomiting of the following side effects,

• metallic taste particularly if they occur several Avoid eating too much mature weeks after stopping treatment cheese, yeast extracts, meat • change in the colour of the with Linezolid Kabi: extracts or soya bean extracts tongue • severe stomach cramps (e.g. soy sauce). Avoid drinking • change in the colour of teeth. alcohol, especially draught beers This may be reversible. • watery and severe diarrhoea and wine. (which may be bloody), fever, in Tell your doctor immediately and combination with one or both of before you or your child are the above.

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Linezolid Kabi can cause some bacteria, which are normally Supplier present in the bowel and normally harmless, to multiply and therefore Linezolid Kabi is supplied in cause the above symptoms. You Australia by: may need urgent medical attention. Fresenius Kabi Australia Pty Tell your or your child's doctor if Limited you notice any other side Level 2, 2 Woodland Way effects. Mount Kuring-gai NSW 2080 Australia Other side effects not listed above Telephone: (02) 9391 5555 may also occur in some people. Linezolid Kabi is supplied in New Zealand by: After being given Fresenius Kabi New Zealand Linezolid Kabi Limited 60 Pavilion Drive Storage Airport Oaks, Auckland 2022 New Zealand Linezolid Kabi will normally be Freecall: 0800 144 892 stored in a hospital. It should be stored below 25°C and should be Australian Registration Number kept in its carton before being used. AUST R 277696 (freeflex®) AUST R 277697 (KabiPac®) Hospital staff will make sure the medicine is not used after the ® = Registered Trademark expiry date printed on the infusion bag or the infusion bottle. This leaflet was prepared in: July 2018. Product Description

What it looks like

Linezolid Kabi is a sterile, clear, colourless to yellow fluid (solution) for injection, supplied as 300mL in an infusion bag or an infusion bottle. Each bag or bottle is for single use only and is packaged within a carton.

Ingredients

The active ingredient in Linezolid Kabi is linezolid. There are 2 mg of linezolid in each 1 mL of Linezolid Kabi.

Other ingredients are: • glucose monohydrate • sodium citrate • citric acid • hydrochloric acid / sodium hydroxide • water for injections.

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