Bleeding in the eye.<\/li><\/ul>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
The use of Oyavas in children and adolescents under 18 years of age is not recommended as safety and benefit have not been established in these patient groups.<\/p>\n\n\n\n
Other medicines and Oyavas<\/h2>\n\n\n\n
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n
Combining Oyavas with another medicine called sunitinib malate (prescribed for cancer of the kidneys and gastrointestinal tract) can cause serious\u00a0side effects.\u00a0Talk to your doctor to make sure you are not combining Oyavas with these medicines.<\/p>\n\n\n\n
Tell your doctor if you use platinum- or taxane-based treatment for lung or spread breast cancer.\u00a0These treatments in combination with Oyavas may increase the risk of serious\u00a0side effects.<\/p>\n\n\n\n
Tell your doctor if you have recently received, or are receiving, radiation therapy.<\/p>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
You must not use this medicine if you are pregnant.\u00a0Oyavas can harm your unborn baby as they can prevent the formation of new blood vessels.\u00a0Your doctor will advise you to use contraception during treatment with Oyavas and for at least 6 months after the last\u00a0dose\u00a0of one of Oyavas.<\/p>\n\n\n\n
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n
You must not breastfeed during treatment with Oyavas and for at least 6 months after the last\u00a0dose\u00a0of one of Oyavas as this medicine may interfere with the growth and development of your baby.<\/p>\n\n\n\n
Oyavas can impair female\u00a0fertility.\u00a0Contact your doctor for more information.<\/p>\n\n\n\n
Fertile women (women who have a regular menstrual cycle) may notice that their period becomes irregular or absent and may notice impaired\u00a0fertility.\u00a0If you are considering having children, discuss this with your doctor before starting treatment.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Oyavas has not been shown to reduce your ability to drive or use tools or machines.\u00a0However, drowsiness and fainting have been reported with the use of Oyavas.\u00a0If you experience symptoms that affect your vision, concentration, or ability to react, do not drive or use machines until the symptoms have disappeared.<\/p>\n\n\n\n
Oyavas contain sodium<\/h2>\n\n\n\n
This medicine contains less than 1 mmol\u00a0sodium\u00a0(23 mg) per\u00a0vial, ie essentially ‘sodium-free’.\u00a0is almost “sodium-free”.<\/p>\n\n\n\n
How to use Oyavas<\/h2>\n\n\n\n
Dosage and dosing frequency<\/strong><\/p>\n\n\n\nThe dose\u00a0of one Oyavas depends on your body weight and the type of cancer to be treated.\u00a0The recommended\u00a0dose\u00a0is 5 mg, 7.5 mg, 10 mg, or 15 mg per kg of your body weight.\u00a0Your doctor will\u00a0prescribe\u00a0the Oyavas dose that is right for you.\u00a0You will be treated with Oyavas once every two or three weeks.\u00a0The number of\u00a0infusions\u00a0you receive depends on how you respond to the treatment;\u00a0you should continue to use this medicine until Oyavas can no longer prevent your\u00a0tumor\u00a0from growing.\u00a0Your doctor will discuss this with you.<\/p>\n\n\n\n
Method of administration and route of administration<\/strong><\/p>\n\n\n\nOyavas is a concentrated solution for\u00a0infusion.\u00a0Depending on the\u00a0dose\u00a0prescribed by your doctor, some or all of the contents of the Oyavas vial will be diluted with sodium chloride (saline) solution before use.\u00a0A doctor or nurse will give you the diluted Oyavas solution as an\u00a0intravenous\u00a0infusion\u00a0(a drip into a vein).\u00a0The first\u00a0infusion\u00a0will be given over 90 minutes.\u00a0If you tolerate this well, the second\u00a0infusion\u00a0will be given for 60 minutes.\u00a0Later\u00a0infusions\u00a0can be given for 30 minutes.<\/p>\n\n\n\n
Treatment with Oyavas should be temporarily discontinued<\/strong><\/p>\n\n\n\n- if you develop severe high blood pressure that requires treatment with blood pressure medication,<\/li>
- if you have problems with wound healing after surgery,<\/li>
- if you are going to have surgery.<\/li><\/ul>\n\n\n\n
The treatment with Oyavas should be stopped completely if you develop<\/strong><\/p>\n\n\n\n- severe high\u00a0blood pressure\u00a0that can not be controlled with blood pressure medication;\u00a0or a sudden increase in blood pressure,<\/li>
- protein\u00a0in the urine and at the same time swelling in the body,<\/li>
- a hole in your intestinal wall,<\/li>
- an abnormal tube-like connection or passage between the trachea and esophagus, between internal organs and the skin, between the vagina and any part of the intestine or between other\u00a0tissues\u00a0that should not normally be connected (\u00a0fistula\u00a0), and which your doctor considers serious,<\/li>
- severe\u00a0infection\u00a0of the skin or underlying layers of the skin,<\/li>
- a blood clot in your\u00a0arteries,<\/li>
- a blood clot in the blood vessels of the lungs,<\/li>
- any severe bleeding.<\/li><\/ul>\n\n\n\n
If you get more Oyavas than you should<\/h2>\n\n\n\n- you may develop severe\u00a0migraines.\u00a0If this happens, talk to a doctor, pharmacist, or nurse immediately.<\/li><\/ul>\n\n\n\n
If an Oyavasdos is missed<\/h2>\n\n\n\n- Your doctor will decide when to take your next dose of Oyavas. You should discuss this with your doctor.<\/li><\/ul>\n\n\n\n
If you stop using Oyavas<\/h2>\n\n\n\n
Discontinuation of your treatment with Oyavas may stop the effect on tumor growth. Do not stop treatment with Oyavas unless you have discussed this with your doctor.<\/p>\n\n\n\n
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n
The side effects\u00a0listed below were seen when Oyavas was given chemotherapy.\u00a0This does not necessarily mean that these\u00a0side effects\u00a0are caused by Oyavas.<\/p>\n\n\n\n
Allergic reactions<\/strong><\/p>\n\n\n\nIf you get an\u00a0allergic reaction, tell your doctor or healthcare professional immediately.\u00a0Signs of an\u00a0allergic reaction\u00a0may include difficulty breathing or chest pain.\u00a0You may also get\u00a0redness\u00a0on the skin or rash, chills, tremors, nausea, or vomiting.<\/p>\n\n\n\n
You should seek immediate help if you get any of the side effects\u00a0listed below.<\/strong><\/p>\n\n\n\nSerious\u00a0side effects, which can be\u00a0very common<\/strong>\u00a0(may affect more than 1 in 10 people), include:<\/p>\n\n\n\n- high\u00a0blood pressure,<\/li>
- feeling of numbness or tingling in the hands or feet,<\/li>
- decreased number of\u00a0blood cells\u00a0in the blood, including\u00a0white blood cells\u00a0that help protect against\u00a0infection\u00a0(this can occur along with fever), and\u00a0platelets\u00a0that help the blood clot,<\/li>
- feeling weak and lacking in energy,<\/li>
- fatigue,<\/li>
- diarrhea, nausea, vomiting, and abdominal pain.<\/li><\/ul>\n\n\n\n
Serious\u00a0side effects, which may be\u00a0common<\/strong>\u00a0(may affect up to 1 in 10 people), include:<\/p>\n\n\n\n- holes in the intestine,<\/li>
- hemorrhage, including hemorrhage in the lungs of patients with non-small cell lung cancer,<\/li>
- blockage of the\u00a0arteries\u00a0with a blood clot,<\/li>
- blockage of the veins with a blood clot,<\/li>
- blockage of the blood vessels in the lungs with a blood clot,<\/li>
- blockage of the veins in the legs with a blood clot,<\/li>
- heart failure,<\/li>
- problems with wound healing after surgery,<\/li>
- redness, flaking of the skin, tenderness, pain, or blisters on fingers or feet,<\/li>
- decreased number of\u00a0red blood cells\u00a0in the blood,<\/li>
- lack of energy,<\/li>
- gastrointestinal problems,<\/li>
- muscle and joint pain, muscle weakness,<\/li>
- dry mouth\u00a0in combination with thirst and\/or decreased or dark-colored urine,<\/li>
- inflammation\u00a0of the mucous membranes of the mouth and intestines, lungs and airways, reproductive organs and urinary tract,<\/li>
- sores in the mouth and esophagus, which can be painful and cause difficulty swallowing,<\/li>
- pain, including headache, back pain, and pain in the pelvis and anal region,<\/li>
- localized warp formation,<\/li>
- infection, and in particular\u00a0infection\u00a0of the blood or bladder,<\/li>
- decreased blood supply to the brain or\u00a0stroke\u00a0(blood clot in the brain or cerebral hemorrhage),<\/li>
- somnolence,<\/li>
- nosebleed,<\/li>
- increase in heart rate (\u00a0pulse\u00a0one),<\/li>
- blocked gastrointestinal passage,<\/li>
- abnormal urine samples (\u00a0protein\u00a0in the urine),<\/li>
- shortness of breath or low oxygen levels in the blood,<\/li>
- skin infections or\u00a0infections\u00a0are in the deeper layers under the skin,<\/li>
- fistula: an abnormal tube-like connection between internal organs and skin or other\u00a0tissues\u00a0that are not normally connected, including connections between the\u00a0vagina\u00a0and intestines in patients with cervical cancer.<\/li><\/ul>\n\n\n\n
Serious adverse reactions with an unknown frequency that have been reported<\/strong> (occurring in an unknown number of users) include:<\/p>\n\n\n\n- severe\u00a0infection\u00a0of the skin or underlying layers of the skin, especially if you have had a hole in the intestinal wall or problems with wound healing,<\/li>
- allergic reactions (signs may include difficulty breathing, flushing, rash, low or high\u00a0blood pressure, low blood oxygen level, chest pain, or nausea\/vomiting),<\/li>
- a negative effect on women’s ability to have children (see below for a list of\u00a0side effects\u00a0for further recommendations),<\/li>
- a condition of the brain with symptoms that include seizures (seizures), headaches, confusion, and changes in vision (posterior\u00a0reversible\u00a0encephalopathy syndrome or PRES),<\/li>
- signs indicating changes in normal brain function (headache, vision changes, confusion or seizures) and high\u00a0blood pressure,<\/li>
- an enlargement and weakening of a vessel wall or a rupture in a vessel wall (\u00a0aneurysms\u00a0and arterial dissections),<\/li>
- blood clots in very small blood vessels in the kidney,<\/li>
- abnormally high\u00a0blood pressure\u00a0in the blood vessels in the lungs, which causes the right side of the heart to work harder than normal,<\/li>
- a hole in the septum (the cartilage wall that separates the nostrils) in the nose,<\/li>
- a hole in the stomach or intestine,<\/li>
- an open wound or hole in the lining of the stomach or small intestine (signs may include abdominal pain, feeling of bloating, black tarry stools or blood in the stools, or bloody vomiting),<\/li>
- bleeding from the lower part of the colon,<\/li>
- gums in the gums with an exposed jawbone that does not heal and which may be associated with pain and\u00a0inflammation\u00a0in the surrounding\u00a0tissue\u00a0(see the list of\u00a0side effects\u00a0below for further recommendations),<\/li>
- holes in the gallbladder (symptoms and signs may include abdominal pain, fever, and nausea\/vomiting).<\/li><\/ul>\n\n\n\n
You should seek help as soon as possible if you get any of the following\u00a0side effects.<\/strong><\/p>\n\n\n\nVery common<\/strong> (may affect more than 1 user in 10) side effects that were not serious include:<\/p>\n\n\n\n- constipation,<\/li>
- loss of appetite,<\/li>
- fever,<\/li>
- eye problems (including increased tear flow),<\/li>
- speech disorders,<\/li>
- change of taste,<\/li>
- Runny nose,<\/li>
- dry skin, flaking, and\u00a0inflammation\u00a0of the skin, change in skin color,<\/li>
- weight loss,<\/li>
- nosebleed.<\/li><\/ul>\n\n\n\n
Common<\/strong> (may affect up to 1 in 10 people) side effects that were not serious include:<\/p>\n\n\n\n