Tavanic 5 Mg / 1 Ml I.V Infusion 100 Ml

1. What this product is and what it is used for The name of your medicine is Tavanic. Tavanic contains a medicine called levofloxacin. This belongs to a group of medicines called antibiotics. Levofloxacin is a ‘quinolone’ antibiotic. It works by killing the bacteria that cause infections in your body. Tavanic can be used to treat infections of the: • Lungs, in people with pneumonia • Urinary tract, including your kidneys and bladder • Prostate gland, where you have a long-lasting infection • Skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’. In some special situations, Tavanic may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax. 2. What you need to know before you use this product Contraindications Do not use this medicine and tell your doctor if: • You are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin, or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • You have ever had epilepsy. • You have ever had a problem with your tendons such as tendonitis that was related to treatment with a “quinolone antibiotic”. A tendon is the cord that joins your muscle to your skeleton • You are a child or a growing teenager. • You are pregnant, might become pregnant, or think you may be pregnant. • You are breast-feeding. Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given Tavanic. Warnings and precautions Talk to your doctor, pharmacist or nurse before you have your medicine if: • You are 60 years of age or older • You are using corticosteroids, sometimes called steroids (see section “Other medicines and Tavanic”) • You have received a transplantation • You have ever had a fit (seizure) • You have had damage to your brain due to a stroke or other brain injury • You have kidney problems • You have a disease known as “glucose-6-phosphate-dehydrogenase deficiency”. You are more likely to have serious problems with your blood when using this medicine • You have ever had mental health problems • You have ever had heart problems: caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section “Other medicines and Tavanic”) • You are diabetic • You have ever had liver problems • You have myasthenia gravis (muscle weakness) • You have nerve problems (peripheral neuropathy) • You have been diagnosed with an enlargement or “bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm) • You have experienced a previous episode of aortic dissection (a tear in the aorta wall) • You have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, high blood pressure, or known atherosclerosis). • You have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking levofloxacin. Serious skin reactions Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of levofloxacin. • SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal. • DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. If you develop a serious rash or another of these skin symptoms, stop taking levofloxacin and contact your doctor or seek medical attention immediately. You should not take fluoroquinolone/quinolone antibacterial medicines, including Tavanic, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible. Talk to your doctor, nurse or pharmacist when you are taking fluoroquinolones if: • You feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room. Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Tavanic therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Tavanic, contact your doctor and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture. You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking Tavanic and inform your doctor immediately in order to prevent the development of potentially irreversible condition. Prolonged, disabling and potentially irreversible serious side effects Fluoroquinolone/quinolone antibacterial medicines, including Tavanic, have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paresthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders. If you experience any of these side effects after taking Tavanic, contact your doctor immediately prior to continuing treatment. You and your doctor will decide on continuing the treatment considering also an antibiotic from another class. If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before being given Tavanic. Other medicines and Tavanic Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Tavanic can affect the way other medicines work. Also, some medicines can affect the way Tavanic works. In particular, tell your doctor if you are taking any of the following medicines. This is because they can increase the chance of you getting side effects, when taken with Tavanic: • Corticosteroids, sometimes called steroids – used for inflammation. You may be more likely to have inflammation and/or rupture of your tendons. • Warfarin – used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot. • Theophylline – used for breathing problems. You are more likely to have a fit (seizure) if taken with Tavanic. • Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. You are more likely to have a fit (seizure) if taken with Tavanic. • Ciclosporin - used after organ transplants. You may be more likely to get the side effects of ciclosporin. • Medicines known to affect the way your heart beats. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide and ibutilide), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for bacterial infections (certain “macrolide” antibiotics such as erythromycin, azithromycin and clarithromycin) and for psychiatric disorders (certain antipsychotics). • Probenecid – used for gout. Your doctor may reduce the dose if you have kidney problems. • Cimetidine – used for ulcers and heartburn. Your doctor may reduce the dose if you have kidney problems. Tell your doctor if any of the above applies to you. Urine tests for opiates Urine tests may show “false positive” results for strong painkillers called “opiates” in people receiving Tavanic. If your doctor has prescribed a urine test, tell your doctor you are currently receiving Tavanic. Tuberculosis tests This medicine may cause “false negative” results for some laboratory tests that search for the bacteria that cause tuberculosis. Pregnancy and breast-feeding You must not be given this medicine if • You are pregnant, might become pregnant or think you may be pregnant • You are breast-feeding or planning to breast-feed Driving and using machines You may get side effects after being given this medicine, including feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight. Some of these side effects can affect you being able to concentrate and your reaction speed. If this happens, do not drive or carry out any work that requires a high level of attention. Tavanic contains sodium. This medicine contains 181 mg of sodium per 250 mg dose. This should be taken into consideration by patients on a controlled sodium diet. 3. How to use this product. How to use Tavanic • Tavanic solution for infusion is a medicine for use in hospitals. • It will be given to you by a doctor or nurse as an injection. The injection will be given into one of your veins and be given over a period of time (this is called an intravenous infusion). • For the 500 mg Tavanic, the infusion time should be 60 minutes or more. • Your heart rate and blood pressure should be closely monitored. This is because an unusual fast beating of the heart and a temporary lowering of blood pressure are possible side effects that have been seen during the infusion of a similar antibiotic. If your blood pressure drops significantly during the infusion, it will be stopped straight away. How much Tavanic is given If you are not sure why you are being given Tavanic or have any questions about how much Tavanic is being given to you, talk to your doctor, nurse or pharmacist. • Your doctor will decide on how much Tavanic you should have. • The dose will depend on the type of infection you have and where the infection is in your body. • The length of your treatment will depend on how serious your infection is. - Adults and the elderly - Pneumonia: 500 mg once or twice each day - Infections of the urinary tract, including your kidneys or bladder: 500 mg once each day - Prostate gland infection: 500 mg once each day - Infections of skin and underneath the skin, including muscles: 500 mg once or twice each day - Adults and the elderly with kidney problems Your doctor may need to give you a lower dose. - Children and teenagers This medicine must not be given to children and teenagers. Protect your skin from sunlight Keep out of direct sunlight while having this medicine and for 2 days after the end of treatment. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions: • Make sure you use high factor sun cream • Always wear a hat and clothes which cover your arms and legs • Avoid artificial UV rays (sun beds) If you have more Tavanic than you should It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress and will check the medicine you are given. Always ask if you are not sure why you are getting a dose of medicine. Having too much Tavanic may cause the following effects to happen: fits (seizures), feeling confused, dizzy, less conscious, having tremor and heart problems - leading to uneven heart beats, as well as feeling sick. If you miss a dose of Tavanic Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you do think you have missed a dose, tell your doctor or nurse. If you stop using Tavanic Your doctor or nurse will continue giving you Tavanic, even if you feel better. If the treatment is stopped too soon, the infection may return, your condition may get worse, or the bacteria may become resistant to the medicine. After a few days of treatment with the solution for infusion, your doctor may decide to switch you to the tablet form of this medicine to complete your course of treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects are normally mild or moderate and often disappear after a short time. Stop having Tavanic and tell a doctor or nurse straight away if you notice the following side effect: Very rare (may affect up to 1 in 10 000 treated patients) • Allergic reactions. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue. Stop having Tavanic and tell a doctor or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment: Rare (may affect up to 1 in 1000 treated patients) • Watery diarrhea which may have blood in it, possibly with stomach cramps and a high temperature. These could be signs of a serious bowel problem. • Pain and inflammation in your tendons or ligaments which could lead to rupture. The Achilles tendon is affected most often. • Fits (convulsions). • Seeing or hearing things that are not there (hallucinations, paranoia), change in your opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions. • Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares. • Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome). See also section 2. • Syndrome associated with impaired water excretion and low levels of sodium (SIADH) • Lowering of your blood sugar levels (hypoglycaemia) or lowering of your blood sugar levels leading to coma (hypoglycaemic coma). This is important for people that have diabetes. Very rare (may affect up to 1 in 10 000 treated patients) • Burning, tingling, pain or numbness. These may be signs of something called “neuropathy”. Not known (frequency cannot be estimated from the available data) • Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. See also section 2. • Loss of appetite, skin and eyes becoming yellow in color, dark-colored urine, itching, or tender stomach. These may be signs of liver problems which may include a fatal failure of the liver. If your eyesight becomes impaired or if you have any other eye disturbances whilst having Tavanic, you must consult an eye specialist immediately. Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors. Tell your doctor if any of the following side effects gets serious or lasts longer than a few days: Common (may affect up to 1 in 10 treated patients) • Sleeping problems, • Headache, feeling dizzy, • Feeling sick (nausea, vomiting) and diarrhea, • Increase in the level of some liver enzymes in your blood, • Reactions at the site of the infusion, • Inflammation of a vein. Uncommon (may affect up to 1 in 100 treated patients) • Increase in the number of other bacteria or fungi, infection by fungi named Candida, which may need to be treated, • Changes in the number of white blood cells shown up in the results of some blood tests (leukopenia, eosinophilia), • Feeling stressed (anxiety), feeling confused, feeling nervous, feeling sleepy, trembling, a spinning feeling (vertigo), • Shortness of breath (dyspnea), • Changes in the way things taste, loss of appetite, stomach upset or indigestion (dyspepsia), pain in your stomach area, feeling bloated or constipation, • Itching and skin rash, severe itching or hives (urticaria), sweating too much (hyperhidrosis), • Joint pain or muscle pain, • Blood tests may show unusual results due to liver (bilirubin increased) or kidney (creatinine increased) problems, • General weakness. Rare (may affect up to 1 in 1000 treated patients) • Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopenia), • Low number of white blood cells (neutropenia), • Exaggerated immune response (hypersensitivity), • Tingly feeling in your hands and feet (paresthesia), • Problems with your hearing (tinnitus) or eyesight (blurred vision), • Unusual fast beating of your heart (tachycardia) or low blood pressure (hypotension), • Muscle weakness. This is important in people with myasthenia gravis (a rare disease of the nervous system), • Changes in the way your kidney works and occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis, • Fever, • Sharply demarcated, erythematous patches with/without blistering that develop within hours of administration of levofloxacin and heals with postinflammatory residual hyperpigmentation; it usually recurs at the same site of the skin or mucous membrane upon subsequent exposure to levofloxacin, • Memory impairment. Not known (frequency cannot be estimated from the available data) • Lowering in red blood cells (anemia): this can make the skin pale or yellow due to damage of the red blood cells; lowering in the number of all types of blood cells (pancytopenia), • Fever, sore throat and a general feeling of being unwell that does not go away. This may be due to a lowering in the number of white blood cells (agranulocytosis), • Loss of circulation (anaphylactic-like shock), • Increase of your blood sugar levels (hyperglycemia). This is important for people that have diabetes, • Changes in the way things smell, loss of smell or taste (parosmia, anosmia, ageusia), • Problems moving and walking (dyskinesia, extrapyramidal disorders), • Temporary loss of consciousness or posture (syncope), • Temporary loss of vision, inflammation of the eye, • Impairment or loss of hearing, • Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart), • Difficulty breathing or wheezing (bronchospasm), • Allergic lung reactions, • Inflammation of the pancreas (pancreatitis), • Inflammation of the liver (hepatitis), • Increased sensitivity of your skin to sun and ultraviolet light (UV light) (photosensitivity), • Inflammation of the vessels that carry blood around your body due to an allergic reaction (vasculitis), • Inflammation of the tissue inside the mouth (stomatitis), • Muscle rupture and muscle destruction (rhabdomyolysis), • Joint redness and swelling (arthritis), • Pain, including pain in the back, chest and extremities, • Attacks of porphyria in people who already have porphyria (a very rare metabolic disease), • Persistent headache with or without blurred vision (benign intracranial hypertension). To report any side effect(s): • Saudi Arabia: - The National Pharmacovigilance and Drug Safety Centre (NPC) • SFDA call center : 19999 • E-mail: [email protected] • Website: https://ade.sfda.gov.sa/ • Sanofi- Pharmacovigilance: [email protected] 5. How to store this product Keep this medicine out of the sight and reach of children. Do not store above 30°C. Keep the bottle in the outer carton in order to protect it from light. No protection from light is required during the infusion. Once the infusion bottle has been opened (rubber stopper perforated), the solution should be used immediately (within 3 hours) in order to prevent any bacterial contamination. Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month. Do not use Tavanic if the solution is not clear, is not greenish yellow in color and/or has particles in it. Do not throw away any medicines via wastewater or household waste. Ask your nurse or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.