TRIUMEQ Film-coated tablets 50 mg (as dolutegravir sodium) / 600 mg (as abacavir sulfate) / 300mg Consumer Medicine Information

PATIENTS TAKING TRIUMEQ, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH TRIUMEQ IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING TRIUMEQ IF: 1) YOU GET A SKIN RASH OR 2) YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING GROUPS: − FEVER − SHORTNESS OF BREATH, SORE THROAT OR COUGH − NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN − SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO TRIUMEQ TABLETS, NEVER TAKE TRIUMEQ, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA, TRIZIVIR & ZIAGEN) AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE FATAL. THERE IS AN ALERT CARD INCLUDED IN THE TRIUMEQ PACK, TO REMIND YOU AND MEDICAL STAFF ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED FROM THE PACK AND KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER BEFORE YOU TAKE TRIUMEQ.

What is in this leaflet? cells that are important in helping your body to fight infection. Please read this leaflet carefully To control your HIV infection, and to before you take TRIUMEQ. This What is TRIUMEQ stop your illness from getting worse, leaflet answers some common used for? you must keep taking all your questions about TRIUMEQ medicines, unless your doctor tells TRIUMEQ contains three active (dolutegravir/abacavir/lamivudine). It you to stop taking any. ingredients that are used to treat HIV does not contain all of the available infection in adults and children over Ask your doctor if you have any information. It does not take the 12 years old: dolutegravir, abacavir, questions about why this medicine place of talking to your doctor or and lamivudine. Dolutegravir has been prescribed for you. pharmacist. belongs to a group of anti-retroviral TRIUMEQ is not addictive. All medicines have risks and medicines called integrase inhibitors TRIUMEQ is not recommended for benefits. Your doctor has weighed (INIs). Abacavir and lamivudine children under the age of 12 years as the expected benefits of you taking belong to a group of anti-retroviral the dosage cannot be modified. TRIUMEQ against the risks this medicines called nucleoside analogue medicine could have for you. reverse transcriptase inhibitors This medicine is available only with a doctor's prescription. If you have any concerns about (NRTIs). taking this medicine, ask your TRIUMEQ does not cure HIV doctor or pharmacist. infection; it reduces the amount of Keep this leaflet with the medicine. virus in your body, and keeps it at a low level. TRIUMEQ also increases You may need to read it again. the CD4 cell count in your blood. CD4 cells are a type of white blood

TRIUMEQ 1 Before you take gene type, be sure to tell your who had no symptoms of TRIUMEQ doctor before you take abacavir. hypersensitivity before stopping. The most common symptoms of If you have stopped taking When you must not take it this reaction include high TRIUMEQ tablets for any reason temperature (fever) and a skin it is important that you contact You must not take TRIUMEQ if: rash. Other most frequently seen your doctor before restarting. This • you have ever had an allergic symptoms include nausea, is especially so if you think you are reaction to abacavir, which is vomiting, diarrhoea or abdominal having side-effects from other also included in medicines pain; severe tiredness or body medicines or have another illness. called KIVEXA, TRIZIVIR aches or generally feeling ill; Your doctor will check whether and ZIAGEN headache; shortness of breath, sore any symptoms you had before throat or cough. If you develop any stopping may be related to this • if you are allergic to the active of these symptoms call your doctor hypersensitivity reaction. If your ingredients dolutegravir or IMMEDIATELY WHO WILL doctor thinks there is a possibility lamivudine, or any of the other ADVISE YOU WHETHER YOU that they were related, you may be ingredients listed toward the SHOULD STOP TAKING told never to take TRIUMEQ end of this leaflet. TRIUMEQ TABLETS. If your tablets again. It is important that • if you're taking another doctor is not available you must you follow this advice. medicine called dofetilide, urgently seek other medical advice If you are hypersensitive to pilsicainide (to treat heart (e.g. the Accident and Emergency TRIUMEQ tablets you should conditions) or fampridine (used unit of the nearest hospital) before return all of your unused in multiple sclerosis) taking the next dose. TRIUMEQ tablets to your doctor • if you have a serious liver Other symptoms may include joint or pharmacist for proper disposal. disease TRIUMEQ may not be or muscle pain, swelling of the The TRIUMEQ pack includes an suitable for you. neck or itchy skin. Occasionally Alert Card, to remind you and Do not take this medicine after the inflammation of the eye medical staff about abacavir expiry date printed on the pack or if (conjunctivitis), ulcers in the hypersensitivity. Detach this card and the packaging is torn or shows signs mouth or low blood pressure may keep it with you at all times. of tampering. occur. The symptoms of this If it has expired or is damaged, return allergic reaction can occur at any Before you start to take it it to your pharmacist for disposal. time during treatment with TRIUMEQ tablets. However they Some other conditions may develop If you are not sure whether you usually occur in the first six weeks during HIV treatment. should start taking this medicine, talk of treatment, and get worse with Old infections may flare up to your doctor. continued treatment. People with advanced HIV infection Special Warning - If you have had this serious (AIDS) have weak immune systems, reaction to TRIUMEQ tablets, Hypersensitivity Reactions and are more likely to develop NEVER take TRIUMEQ or any serious infections (opportunistic TRIUMEQ contains abacavir and other medicinal product containing infections). When these people start dolutegravir. Both of these active abacavir (ZIAGEN, KIVEXA, treatment, they may find that old, substances can cause a serious TRIZIVIR) again as within hours hidden infections flare up, causing allergic reaction known as a you may experience a life- signs and symptoms of inflammation. hypersensitivity reaction. threatening lowering of your blood These symptoms are probably caused Abacavir hypersensitivity reactions pressure or death. by the body's immune system can be life-threatening if treatment Occasionally life threatening becoming stronger, so that the body with abacavir containing products is hypersensitivity reactions have starts to fight these infections. not stopped. occurred when medicine If you get any symptoms of Research has found that people containing abacavir was restarted infection while you're taking with a gene called HLA-B (type in patients who reported only one TRIUMEQ: 5701) are more likely to have a of the symptoms on the Alert Card Tell your doctor immediately. Don't hypersensitivity reaction to before stopping. take other medicines for the infection abacavir. However, even if you do On very rare occasions, without your doctor's advice. not have this gene type it is still hypersensitivity has been reported Tell your doctor if you have allergies possible for you to get this when treatment containing to any other medicines, foods, reaction. If you know you have this abacavir was re-started in patients preservatives or dyes.

TRIUMEQ 2 If you are pregnant, or think you Taking other medicines or iron supplement at the same could be, or if you are planning to time as TRIUMEQ. have a baby, don’t take TRIUMEQ Tell your doctor or pharmacist if without checking with your doctor. you are taking any other • etravirine, efavirenz, medicines, including any that you /ritonavir, Your doctor will consider the get without a prescription from nevirapine or tipranavir/ritonavir, benefit to you and the risk to your your pharmacy, supermarket or to treat HIV infection baby of taking TRIUMEQ while you're pregnant health food shop. • rifampicin, to treat tuberculosis Don't take TRIUMEQ with these (TB) and other bacterial If you could get pregnant while medicines: infections taking TRIUMEQ, you need to use • co-trimoxazole, an antibiotic used a reliable method of contraception • dofetilide or pilsicainide, to to prevent pregnancy. treat heart conditions to treat Pneumocystis jiroveci pneumonia (often referred to as • fampridine, used in multiple Taking dolutegravir (one of the PCP) or toxoplasmosis components of TRIUMEQ) at the sclerosis • phenytoin and phenobarbital, to time of becoming pregnant, or during These medicines should not be treat epilepsy the first twelve weeks of pregnancy, used with TRIUMEQ: may increase the risk of a type of • carbamazepine, to treat epilepsy • emtricitabine, to treat HIV birth defect, called neural tube and bipolar disorder defect, such as spina bifida infection • St. John's wort, (Hypericum (malformed spinal cord). • sorbitol-containing medicines perforatum), a herbal remedy to Your doctor can discuss with you the (usually liquids) used regularly risks and benefits involved. treat depression Tell your doctor if you're being Tell your doctor or pharmacist if you Abacavir and lamivudine belong to a treated with any of these. group of anti-retroviral medicines are taking any of these. Your doctor called nucleoside analogue reverse Methadone and TRIUMEQ may decide to adjust your dose or transcriptase inhibitors (NRTIs). In If you are taking methadone, your that you need extra checkups. babies and infants exposed to NRTIs doctor may need to adjust your Your doctor and pharmacist have during pregnancy or labour small methadone dose, as abacavir (one of more information on medicines to be temporary increases in blood levels the active substances in TRIUMEQ) careful with or avoid while taking of a substance called lactate have increases the rate at which this medicine. been observed. Additionally there methadone leaves your body. This is have been very rare reports of unlikely to affect most methadone diseases that affect the nervous users. system such as a delayed Tell your doctor if you are taking: How do I take development and seizures. Overall, in • metformin, to treat diabetes TRIUMEQ? children whose mothers took NRTIs • medicines called antacids, to treat during pregnancy, the benefit from Follow all directions given to you indigestion and heartburn. Do not the reduced chance of being infected by your doctor or pharmacist take an antacid that contains with HIV is likely to be greater than carefully, and take great care not aluminium, calcium or the risk of suffering from side to miss any doses if at all possible. effects. magnesium during the 6 hours before you take TRIUMEQ, or If you do not understand the Where possible, women who are for at least 2 hours after you take instructions on the box/bottle, ask HIV-positive should not breast feed. it. These antacids, readily your doctor or pharmacist for This is because HIV infection can be available over the counter, will help. passed on to the baby in breast milk. decrease the effectiveness of If formula feeding is not possible, TRIUMEQ if taken at the same How much to take you should get advice from your time as TRIUMEQ. doctor. The usual dose of TRIUMEQ in • calcium and iron supplements. Do adults and in children over the age of A small amount of the ingredients in not take a calcium or iron 12 years weighing at least 40 kg is TRIUMEQ can also pass into your supplement during the 6 hours one combined tablet (50 mg breast-milk. before you take TRIUMEQ, or dolutegravir, 600 mg abacavir, 300 If you have not told your doctor for at least 2 hours after you take mg lamivudine) taken once a day. about any of the above, tell it. If you take food with your If you weigh less than 40kg, you him/her before you start taking medicine you can take a calcium cannot take TRIUMEQ, because the TRIUMEQ.

TRIUMEQ 3 dose of each component of this If you have trouble remembering to Stay in regular contact with your medicine cannot be adjusted to your take your medicine, ask your doctor weight. Your doctor might prescribe pharmacist for some hints. TRIUMEQ helps to control your the components separately for you. condition, but it is not a cure for HIV If you take too much infection. You need to keep taking it How to take it (overdose) every day to stop your illness from Swallow the tablets whole with a Immediately telephone your doctor getting worse. Because TRIUMEQ full glass of water. or Poisons Information Centre (In does not cure HIV infection, you Australia call 131126. In New may still develop other infections and Antacid medicines Zealand call 0800 POISON or 0800 illnesses linked to HIV infection. 764 766) for advice if you think you Antacids which contain calcium, Keep in touch with your doctor, and or anyone else may have taken too aluminium or magnesium will don't stop taking TRIUMEQ without reduce the effectiveness of much TRIUMEQ, even if there are your doctor's advice. no signs of discomfort or TRIUMEQ during the 6 hours Protect other people poisoning. If you are not sure what before you take TRIUMEQ, or for HIV infection is spread by sexual to do, contact your doctor or at least 2 hours after you take it. contact with someone who has the pharmacist. Other acid-lowering medicines like infection, or by transfer of infected You may need urgent medical blood (for example, by sharing and omeprazole can be attention. injection needles). You can still pass taken at the same time as on HIV when taking this medicine, TRIUMEQ. TALK TO YOUR Don't stop TRIUMEQ without although the risk is lowered by DOCTOR FOR FURTHER effective antiretroviral therapy. ADVICE BEFORE TAKING advice Discuss with your doctor the ACID-LOWERING MEDICINES Take TRIUMEQ for as long as your precautions needed to avoid WITH TRIUMEQ. doctor recommends. Don't stop infecting other people, which may unless your doctor advises you to. include: When to take it If you have stopped taking • Use a condom when you have Take your medicine at about the TRIUMEQ for any reason, oral or penetrative sex. same time each day. particularly because you think you • Don't risk blood transfer - for Taking it at the same time each day are having or for other example, don't share needles. will have the best effect. It will also illness, it is important that you help you remember when to take it. contact your doctor before restarting. Things you must do In some cases your doctor will ask If you are about to be started on It does not matter if you take this you to restart TRIUMEQ in a place medicine before or after food. any new medicine, remind your where you will be able to get ready doctor and pharmacist that you access to medical care if needed. How long to take it for are taking TRIUMEQ. If you have hepatitis B infection, you Tell any other doctors, dentists, Continue taking your medicine for should not stop TRIUMEQ tablets and pharmacists who treat you as long as your doctor tells you. without instructions from your that you are taking this medicine. doctor, as you may have a recurrence If you forget to take it of your hepatitis. This may occur due If you are going to have surgery, If you miss a dose, take it as soon as to you suddenly stopping lamivudine. tell the surgeon or anaesthetist that you remember. But if your next dose you are taking this medicine. is due within 4 hours, skip the dose If you become pregnant while you missed and take the next one at taking this medicine, tell your the usual time. Then continue your While you are using doctor immediately. treatment as before. TRIUMEQ Keep all of your doctor's Don't take a double dose to make up appointments so that your progress for a missed dose. Just take it as soon You will need regular blood tests can be checked. as you remember. For as long as you're taking TRIUMEQ, your doctor will arrange If you are not sure what to do, ask Things you must not do regular blood tests to check for side your doctor or pharmacist. Do not give your medicine to effects. anyone else, even if they have the same condition as you.

TRIUMEQ 4 Do not stop taking your medicine allergic reaction known as a • shortness of breath, sore throat or or lower the dosage without hypersensitivity reaction. cough checking with your doctor. These hypersensitivity reactions have • nausea or vomiting, diarrhoea or been seen more frequently in people stomach pain Things to be careful of taking medicines that contain • severe tiredness or achiness, or TRIUMEQ can make you dizzy abacavir. generally feeling ill. and have other side effects that Who gets these reactions? Your doctor may advise you to stop make you less alert. Anyone taking TRIUMEQ could taking TRIUMEQ. Don't drive or use machines unless develop a hypersensitivity reaction, Always carry your Alert Card you are sure you're not affected. which could be life threatening if while you are taking TRIUMEQ. they continue to take TRIUMEQ. If you have stopped taking You are more likely to develop such TRIUMEQ: a reaction if you have a gene called If you have stopped taking Side effects HLA-B*5701 (but you can get a reaction even if you don't have this TRIUMEQ because of a hypersensitivity reaction, you must Tell your doctor or pharmacist as gene). If possible, you will have been NEVER AGAIN take TRIUMEQ, or soon as possible if you do not feel tested for this gene before well while you are taking TRIUMEQ was prescribed for you. If any other medicine containing abacavir (ZIAGEN, KIVEXA or TRIUMEQ. you know you have this gene, tell TRIZIVIR). If you do, within hours, This medicine helps most people your doctor before you take with HIV, but it may have unwanted TRIUMEQ. your blood pressure could fall side effects in a few people. All dangerously low, which could result What are the symptoms? medicines can have side effects. in death. You should also never again Sometimes they are serious, most of The most common symptoms are: take medicines containing the time they are not. You may need • fever (high temperature) and dolutegravir. medical attention if you get some of skin rash. If you have stopped taking the side effects. Other common symptoms are: TRIUMEQ for any reason, especially because you think you are having When you're being treated for HIV, it • nausea (feeling sick), vomiting side effects, or because you have can be hard to tell whether a (being sick), diarrhoea, another illness: symptom is a side effect of abdominal (stomach) pain, severe TRIUMEQ or other medicines you tiredness, shortness of breath, Talk to your doctor before you start are taking, or an effect of the HIV cough, headache, muscle pain and again. Your doctor will check disease itself. So it is very important discomfort. whether your symptoms were related to talk to your doctor about any to a hypersensitivity reaction. If the Other less common symptoms can changes in your health. doctor thinks they may have been, include: Some side effects may only be seen you will then be told never again to • pains in the joints, swelling of the in your blood tests and may not take TRIUMEQ, or any other appear immediately after you start neck, serious breathing problems, medicine containing abacavir. You sore throat taking TRIUMEQ. If you get any of may also be told never again to take these effects, and if they are severe, • occasionally, inflammation of the any other medicine containing your doctor may advise you to stop eye (conjunctivitis), mouth ulcers, dolutegravir. It is important that you taking TRIUMEQ. low blood pressure, tingling or follow this advice. numbness of the hands or feet. Do not be alarmed by the following Occasionally, reactions have lists of side effects. You may not When do these reactions happen? developed in people who start taking abacavir again and had only one experience any of them. Hypersensitivity reactions can start at symptom on the Alert Card before any time during treatment with Ask your doctor or pharmacist to they stopped taking it. answer any questions you may TRIUMEQ but are more likely have. during the first 6 weeks of treatment. Very rarely, reactions have developed in people who start taking Contact your doctor immediately: Hypersensitivity reactions abacavir again, but who had no 1 if you get a skin rash, OR symptoms before they stopped taking TRIUMEQ contains abacavir and 2 if you get symptoms from at least it. dolutegravir. Both of these active 2 of the following groups: If your doctor advises that you can substances can cause a serious • fever start taking TRIUMEQ again, you

TRIUMEQ 5 may be asked to take your first doses Fat loss or fat gain These may affect up to 1 in 10 in a place where you will have ready people: Fat loss or fat gain has been observed access to medical care if you need it. with combined antiretroviral therapy. • being sick (vomiting) If you are hypersensitive to A causal relationship for this has not • stomach pains (abdominal pain) TRIUMEQ, return all your unused been established. Should any change and bloating (abdominal TRIUMEQ tablets for safe disposal. in body shape be noticed, seek distension) Ask your doctor or pharmacist for medical advice. • stomach (abdominal) discomfort advice. • wind (flatulence) The TRIUMEQ pack includes an Lactic acidosis is a rare but Alert Card, to remind you and serious side effect • indigestion (dyspepsia) medical staff about hypersensitivity Some people taking TRIUMEQ, or • gastro-oesophageal reflux disease reactions. Detach this card and keep other medicines like it (NRTIs), • loss of appetite it with you at all times. develop a condition called lactic • feeling drowsy acidosis, together with an enlarged Symptoms of infection and liver. • tiredness, lack of energy inflammation Lactic acidosis is caused by a build- • general feeling of being unwell People with advanced HIV infection up of lactic acid in the body. It is • high temperature (fever) (AIDS) have weak immune systems rare; if it happens, it usually develops • dizziness and are more likely to develop after a few months of treatment. It • nightmares and abnormal dreams serious infections (opportunistic can be life-threatening, causing infections). When they start failure of internal organs. • sleep disorder treatment, the immune system Lactic acidosis is more likely to • depression (feelings of deep becomes stronger, so the body starts develop in people who have liver sadness and unworthiness) to fight infections. disease, especially in women. • anxiety Symptoms of infection and Signs of lactic acidosis include: inflammation may develop, caused • hair loss by either: • deep, rapid, difficult breathing • abacavir hypersensitivity reaction • old, hidden infections flaring up • drowsiness (See hypersensitivity reactions' earlier in this section) again as the body fights them • numbness or weakness in the • the immune system attacking limbs • skin rash healthy body tissue (autoimmune • feeling sick (nausea), being sick • itching (pruritis) disorders) (vomiting) • joint pain The symptoms of autoimmune • stomach pain. • muscle pain and discomfort disorders may develop many months During your treatment, your doctor after you start taking medicine to Common side effects that may show will monitor you for signs of lactic treat your HIV infection. up in blood tests are: acidosis. If you have any of the • increase in triglycerides (type of Symptoms may include: symptoms listed above or any other fat) in the blood • muscle weakness and/or muscle symptoms that worry you see your pain doctor as soon as possible. • increase in glucose (sugar) in the blood • joint pain or swelling As well as the conditions listed above, other side effects can develop • weakness beginning in the hands Uncommon side effects during combination therapy for HIV. and feet and moving up towards These may affect up to 1 in 100 the trunk of the body Very common side effects people: • palpitations or tremor These may affect more than 1 in 10 • dolutegravir allergic reaction (See • hyperactivity (excessive people: 'allergic reactions' earlier in this restlessness and movement). section) • headache If you get any symptoms of infection • inflammation of the liver • diarrhoea while you're taking TRIUMEQ: (hepatitis) • feeling sick (nausea) Tell your doctor immediately. Don't • suicidal thoughts and behaviours take other medicines for the infection Common side effects (mainly in patients who have had without your doctor's advice.

TRIUMEQ 6 depression or mental health peeling in more than 30% of the and are available in bottles of 30 problems before) body surface (toxic epidermal tablets with child-resistant closure. • weight gain necrolysis). Ingredients Uncommon side effects that may Very rare side effects that may show show up in blood tests are: up in blood tests are: TRIUMEQ contains 50 mg of • dolutegravir (as dolutegravir • a low red blood cell count failure of the bone marrow to sodium), 600 mg of abacavir (as (anaemia) or low white blood cell produce new red blood cells (pure abacavir sulfate) and 300 mg count (neutropenia) red cell aplasia) lamivudine as the active ingredients. • a decrease in the number of cells Tell your doctor or pharmacist if TRIUMEQ tablets also contain the involved in blood clotting you notice anything that is making following inactive ingredients: (thrombocytopenia) you feel unwell. • mannitol • an increase in the level of liver Other side effects not listed above enzymes may also occur in some people. • microcrystalline cellulose • povidone Rare side effects • sodium starch glycolate These may affect up to 1 in 1000 After using TRIUMEQ • magnesium stearate people: • polyvinyl alcohol • lactic acidosis (see 'lactic acidosis Storage • is a rare but serious side effect' titanium dioxide earlier in this section) Store in the original package in • macrogol 3350 order to protect from moisture. • liver failure (signs may include • talc Keep the bottle tightly closed. Do yellowing of the skin and the not remove the desiccant. • iron oxide red whites of the eyes or unusually • iron oxide black dark urine) Keep your tablets in a cool dry place where the temperature stays • inflammation of the pancreas below 30°C. Supplier (pancreatitis) Do not store TRIUMEQ or any ViiV Healthcare Pty Ltd • breakdown of muscle tissue other medicine in the bathroom or Level 4, 436 Johnston St, Rare side effects that may show up in near a sink. Do not leave it on a Abbotsford, Victoria, 3067 blood tests are: window sill or in the car. Australia. • increase in an enzyme called Keep it where children cannot amylase reach it. Where to go for further A locked cupboard at least one-and- Very rare side effects information: a-half metres above the ground is a These may affect up to 1 in 10,000 good place to store medicines. Pharmaceutical companies are not in people: a position to give people an individual diagnosis or medical • tingling or numbness of the hands Disposal advice. Your doctor or pharmacist is and feet (paraesthesiae) If your doctor tells you to stop the best person to give you advice on • numbness, tingling or weakness taking this medicine or the expiry the treatment of your condition. You of the arms and legs (peripheral date has passed, ask your may also be able to find general neuropathy) pharmacist what to do with any information about your disease and medicine that is left over. • skin rash, which may form its treatment from patient information blisters and looks like small groups and product specific targets (central dark spots organisations. surrounded by a paler area, with a dark ring around the edge) Product description Trade marks are owned by or (erythema multiforme) licensed to the ViiV Healthcare What it looks like • widespread rash with blisters and group of companies. peeling skin, particularly around TRIUMEQ tablets are purple, oval,

the mouth, nose, eyes and genitals biconvex film-coated tablets (Stevens-Johnson syndrome), and debossed with '572 Trı' on one side This leaflet was prepared on a more severe form causing skin

TRIUMEQ 7 29 October 2019

TRIUMEQ tablets: AUST R 218644

© 2019 ViiV Healthcare group of companies or its licensor.

Version 11.0

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