If you need dental treatment or dental surgery, tell your dentist that you are being treated with MVASI (bevacizumab), especially if you are also receiving or have received intravenous bisphosphonates .<\/li><\/ul>\n\n\n\nYou may be advised to have your teeth examined before starting treatment with MVASI.<\/p>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
The use of MVASI 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
Bone tissue death ( osteonecrosis ) in bones other than the jaw has been reported in patients under 18 years of age treated with bevacizumab.<\/p>\n\n\n\n
Other medicines and MVASI<\/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
The combination of MVASI and 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 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 MVASI 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 MVASI if you are pregnant. MVASI can harm your unborn baby as it can prevent the formation of new blood vessels. Your doctor will advise you to use contraception during treatment with MVASI and for at least 6 months after the last dose of one of MVASI.<\/p>\n\n\n\n
Tell your doctor immediately if you are pregnant, become pregnant during treatment with this medicine, or plan to become pregnant shortly.<\/p>\n\n\n\n
You must not breastfeed during treatment with MVASI and for at least 6 months after the last\u00a0dose\u00a0of one of MVASI as this medicine may interfere with your baby’s growth and development.<\/p>\n\n\n\n
MVASI can impair\u00a0female\u00a0fertility.\u00a0Contact your doctor for more information.<\/p>\n\n\n\n
Consult a doctor, pharmacist, or nurse before taking any medicine.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
MVASI has not been shown to reduce the ability to drive or use tools or machines.\u00a0However, drowsiness and fainting have been reported with the use of MVASI.\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
MVASI contains sodium<\/h2>\n\n\n\n
MVASI 25 mg \/ ml concentrate for solution for infusion (4 ml)<\/p>\n\n\n\n
This medicine contains 5.4 mg of\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per 4 ml\u00a0vial.\u00a0This corresponds to 0.3% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n
MVASI 25 mg \/ ml concentrate for solution for infusion (16 ml)<\/p>\n\n\n\n
This medicine contains 21.7 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per 16 ml\u00a0vial.\u00a0This corresponds to 1.1% of the highest recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n
How to use MVASI<\/h2>\n\n\n\n
Dosage and dosing frequency<\/strong><\/p>\n\n\n\nDose\u00a0one of MVASI 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 MVASI\u00a0dose\u00a0that is right for you.\u00a0You will be treated with MVASI 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 MVASI can no longer prevent your\u00a0tumor\u00a0from growing.\u00a0Your doctor will discuss this with you.<\/p>\n\n\n\n
Method of administration<\/strong><\/p>\n\n\n\nMVASI is a concentrate for infusion solution. Depending on the dose prescribed by your doctor, some or all of the contents of the MVASI vial will be diluted with sodium chloride (saline) solution before use. A doctor or nurse will give you the diluted MVASI solution as an intravenous infusion (a drip into a vein). The first infusion will be given over 90 minutes. If you tolerate this well, the second infusion will be given for 60 minutes. Later infusions can be given for 30 minutes.<\/p>\n\n\n\n
MVASI treatment 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 having surgery.<\/li><\/ul>\n\n\n\n
Treatment with MVASI should be stopped completely if you develop<\/strong><\/p>\n\n\n\n- severe high blood pressure that can not be controlled with blood pressure medication; or a sudden increase in blood pressure,<\/li>
- protein in the urine and at the same time swelling in the body,<\/li>
- a hole in your intestinal wall,<\/li>
- an abnormal tubular 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 tissues that should not normally be connected to each other ( fistula ), and which your doctor considers serious,<\/li>
- severe infection of the skin or underlying layers of the skin,<\/li>
- a blood clot in your arteries ,<\/li>
- a blood clot in the blood vessels of the lungs,<\/li>
- any severe bleeding.<\/li><\/ul>\n\n\n\n
If you take more MVASI than you should<\/h2>\n\n\n\n- you may develop severe migraines . If this happens, talk to your doctor, pharmacist or nurse immediately.<\/li><\/ul>\n\n\n\n
If you miss a dose of MVASI<\/h2>\n\n\n\n- your doctor will decide when you should receive your next dose of MVASI . You should discuss this with your doctor.<\/li><\/ul>\n\n\n\n
If you stop using MVASI<\/h2>\n\n\n\n
If you stop your treatment with MVASI, the effect on tumor growth may cease. Do not stop treatment with MVASI 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
If you get\u00a0any side effects, talk to your doctor, pharmacist, or nurse.\u00a0This also applies to any\u00a0side effects\u00a0not mentioned in this information.<\/p>\n\n\n\n
The side effects\u00a0listed below were seen when MVASI was co-administered with\u00a0chemotherapy drugs.\u00a0This does not necessarily mean that these\u00a0side effects\u00a0are caused by MVASI.<\/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.\u00a0These signs may 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\nThe serious\u00a0side effects, which can be\u00a0very common<\/strong>\u00a0(may affect more than 1 in 10 people), include:<\/p>\n\n\n\n- high blood pressure ,<\/li>
- feeling of numbness or tingling in the hands or feet,<\/li>
- decreased number of blood cells in the blood, including white blood cells that help protect against infection (this can occur along with fever), and platelets that help the blood to clot,<\/li>
- feeling weak and lacking in energy,<\/li>
- fatigue,<\/li>
- diarrhea, nausea, vomiting and abdominal pain.<\/li><\/ul>\n\n\n\n
The serious\u00a0side effects, which can be\u00a0common<\/strong>\u00a0(may affect up to 1 in 10 people), include:<\/p>\n\n\n\n- holes in the intestine,<\/li>
- haemorrhage, including haemorrhage in the lungs of patients with non- small cell lung cancer ,<\/li>
- blockage of the arteries with 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, scaly skin, tenderness, pain, or blisters on fingers or feet,<\/li>
- decreased number of red blood cells in the blood,<\/li>
- lack of energy,<\/li>
- gastrointestinal problems,<\/li>
- muscle and joint pain, muscle weakness,<\/li>
- dry mouth in combination with thirst and \/ or decreased or dark-colored urine,<\/li>
- inflammation of the mucous membranes of the mouth and stomach, lungs and respiratory tract, 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 infection of the blood or bladder,<\/li>
- decreased blood supply to the brain, or stroke (blood clot in the brain or cerebral hemorrhage),<\/li>
- somnolence,<\/li>
- nosebleed,<\/li>
- increase in heart rate ( pulse one),<\/li>
- blocked gastrointestinal passage,<\/li>
- abnormal urine samples ( protein in the urine),<\/li>
- shortness of breath or low oxygen levels in the blood,<\/li>
- skin infections or infection are in the deeper layers under the skin,<\/li>
- fistula: an abnormal tubular connection between internal organs and skin or other tissues that are not normally connected to each other, including connections between the vagina and the intestine in patients with cervical cancer.<\/li><\/ul>\n\n\n\n
Serious side effects with an unknown<\/strong> frequency (cannot be calculated from the available data) include:<\/p>\n\n\n\n- severe infections of the skin or deeper layers under the skin, especially if you have had holes in the abdominal wall or problems with wound healing,<\/li>
- allergic reactions (signs may include difficulty breathing, flushing, rash, low or high blood pressure , low blood oxygen level, chest pain, or nausea \/ vomiting),<\/li>
- a negative effect on women’s ability to have children (see section after the list of side effects for further recommendations),<\/li>
- a condition of the brain with symptoms that include seizures (seizures), headaches, confusion and changes in vision (posterior reversible encephalopathy syndrome or PRES),<\/li>
- signs indicating changes in normal brain function (headache, vision changes, confusion or seizures) and high blood pressure ,<\/li>
- blood clots in very small blood vessels in the kidney,<\/li>
- abnormally high blood pressure in 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 may be associated with pain and inflammation in the surrounding tissue (see section after the list of side effects for further recommendations),<\/li>
- holes in the gallbladder (symptoms and signs may include abdominal pain, fever and nausea \/ vomiting),<\/li>
- an enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections).<\/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\nThe\u00a0very common<\/strong>\u00a0(may affect more than 1 in 10 people)\u00a0side effects, which 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, scaly skin and inflammation of the skin, change in skin color,<\/li>
- weight loss,<\/li>
- nosebleeds.<\/li><\/ul>\n\n\n\n
The\u00a0common<\/strong>\u00a0(may affect up to 1 in 10 people)\u00a0side effects, which were not serious, include:<\/p>\n\n\n\n