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Avastin 25 mg. / Ml. 400mg.

Brand: roche
Product Code: Avastin 25 mg. / Ml. 400mg.
Availability: In Stock
Product viewed: 1094

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What Avastin is and what it is used
Avastin contains the active substance bevacizumab, which e humanized monoclonal antibody (a type of protein that is normally produced by the immune system to help protect the body from infection and cancer). Bevacizumab binds selectively to a protein called human vascular endothelial growth factor (VEGF), which is located on the inner surface of blood and lymphatic vessels in the body. Protein VEGF induces sprouting of blood vessels into the tumor, such as blood vessels supplying the tumor with nutrients and oxygen. Once bevacizumab bind to VEGF, the tumor growth is prevented by the blocking the growth of blood vessels supplying the tumor with nutrients and oxygen.
Avastin is a drug that is used for treating cancer of the colon or rectum in the advanced stages. Avastin will be administered in combination with a chemotherapeutic treatment comprising a medicine of the fluoropyrimidines.
Avastin is also used to treat metastatic breast cancer. When used in patients with breast cancer, it will be administered with a chemotherapy medicine called paclitaxel or capecitabine.
Avastin is also used for treatment of non-small cell lung cancer at an advanced stage. Avastin will be administered together with a chemotherapy regimen containing platinum.
Avastin is also used to treat kidney cancer at advanced stage. When used in patients with kidney cancer, it will be administered with another type of drug called interferon.
Avastin is also used for treatment of advanced epithelial ovarian cancer, fallopian tube, or primary peritoneal carcinoma. When used in patients with epithelial ovarian cancer, fallopian tube, or primary peritoneal carcinoma, it would be administered in combination with carboplatin and paclitaxel.
When used in patients with advanced epithelial ovarian carcinoma, of the fallopian tubes, or primary peritoneal carcinoma whose disease has recurred at least 6 months after the last chemotherapy agent-containing platinum, Avastin will be administered in combination with carboplatin and gemcitabine.
When used in patients with advanced epithelial ovarian cancer, fallopian tube, or primary peritoneal carcinoma whose disease has returned before the end of 6 months after the last treatment with chemotherapy regimen containing platinum, Avastin will be administered in combination with paclitaxel, topotecan or PLD.

2. What you need to know before you use Avastin
Do not use Avastin:
are allergic (hypersensitivity) to bevacizumab or any of the other ingredients of this medicine (listed in Section 6);
are allergic (hypersensitivity) to cellular products from the cells of the Chinese hamster ovary (CHO) cells or other recombinant human or humanized antibodies;
if you are pregnant.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Avastin:
It is possible that Avastin can increase the risk of perforations in the intestinal wall. If you have a disease causing inflammation inside the abdomen (eg. Diverticulitis, stomach ulcers, colitis associated with chemotherapy), please discuss this with your doctor;
Avastin can increase the risk of pathological canal or move between two organs or blood vessels;
This medicine may increase the risk of bleeding or a risk of problems with wound healing after surgery. If you have an operation, if you have had major surgery within the last 28 days or if you still have unhealed wound after surgery, should not be treated with this medicine;
Avastin can increase the risk of developing serious infections of the skin and deeper subcutaneous layers, especially if you have a perforation of the intestinal wall or problems with wound healing;
Avastin can increase the incidence of high blood pressure. If you have high blood pressure that is not well controlled with medicines for blood pressure, please consult your doctor as it is important to make sure that your blood pressure is under control before starting treatment with Avastin;
This medicine may increase the risk of protein in the urine, particularly if you already have high blood pressure;
The risk of blood clots in the arteries (a type of blood vessels) can be increased if you are over the age of 65 if you have diabetes or if you have previously had blood clots in the arteries. Please talk to your doctor since blood clots can lead to heart attack and stroke (stroke);
Avastin may also increase the risk of developing blood clots in the veins (blood vessels form);
This medicine may cause bleeding, especially associated with the tumor. Please consult your doctor if you or in your family is bleeding or if vz
This medicine can cause infections, and reduction in the number of neutrophils (a type of blood cells that are important for protecting you from bacteria);
It is possible that Avastin cause hypersensitivity and / or infusion reactions (reactions associated with the injection of the drug). Please tell your doctor, pharmacist or nurse if you have previously had problems after an injection, for example. dizziness / fainting, shortness of breath, swelling or skin rash;
Rare neurological side effect called syndrome Posterior reversible encephalopathy, is connected to the treatment with Avastin. If you have a headache, vision changes, confusion or seizures with or without high blood pressure, please contact your doctor.
Please consult your doctor, even if any of these statements were applicable to you in the past.

Before you are given Avastin or while being treated with Avastin:
tell your doctor and dentist if you have or have had pain in the mouth, teeth and / or jaw, swelling or sores in the mouth, numbness or a feeling of heaviness in the jaw or loosening of a tooth;
If you have to undergo invasive dental treatment or dental surgery, tell your dentist that you are being treated with Avastin, especially when you receive or have received well injection of bisphosphonate in the blood.
You may be advised to undergo a dental examination before starting treatment with Avastin.

Children and adolescents
The safety and efficacy of Avastin in children and adolescents has not been established.
Other medicines and Avastin
Tell your doctor, pharmacist or nurse if you are taking, you have recently taken or might take any other medicines.
The combination of Avastin with another drug - sunitinib malate (prescribed in kidney cancer and gastrointestinal tract) may lead to severe side effects. Discuss this with your doctor to make sure that you do not combine these drugs.
Tell your doctor if you are being treated with chemotherapy based on platinum or taxane for lung cancer or metastatic breast cancer. These types of therapy in combination with Avastin may increase the risk of severe side effects.
Tell your doctor if you have recently been implemented or are given radiotherapy.

Pregnancy, lactation and fertility
You should not use this medication if you are pregnant. Avastin may harm your unborn baby as it may stop the process of formation of new blood vessels. Your doctor will advise you to apply measures to avoid pregnancy during treatment with Avastin and for at least 6 months following the last dose of Avastin.
Tell your doctor if you are pregnant, if you become pregnant during treatment with this medicine, or plan to become pregnant in the near future. Avastin may impair fertility in women. Please consult your doctor for more information.
You should not breast-feed during treatment with Avastin and for at least 6 months after the last dose of Avastin, as this medicine may interfere with the growth and development of your baby.
Ask your doctor, pharmacist or nurse before taking any medicine.

Driving and using machines
There is no evidence that Avastin impairs the ability to drive or operate machinery.

3. How to use Avastin
Dosage and frequency of administration
The required dose of Avastin depends on body weight and type of the cancer to be treated. The recommended dose is 5 mg; 7,5 mg; 10 mg or 15 mg per kilogram body weight. Your doctor will prescribe a dose of Avastin, which is suitable for you. You will receive Avastin once every 2 or 3 weeks. The number of infusions that will make depends on how you respond to treatment; You should continue your treatment with this medicine as Avastin cease hindering tumor growth. Your doctor will discuss this with
You.

Route and method of administration
Avastin is a concentrate for solution for infusion. Depending on the dose that has been prescribed, part or the entire contents of the vial Avastin will be diluted with sodium chloride solution before use. Doctor or nurse will apply this diluted Avastin as an intravenous infusion (intravenous drip). The first infusion will be applied for 90 minutes. If it is well tolerated, the second infusion may be applied for 60 minutes. The following infusions can you apply for 30 minutes.
The administration of Avastin should be temporarily discontinued:
if blood pressure rises heavily and need treatment with drugs for blood pressure;
if you have problems with wound healing after surgery;
if you undergo surgery.
The administration of Avastin should be permanently terminated if you experience:
strong increase in blood pressure, which can not be controlled with medications for blood pressure; or sudden severe rise in blood pressure;
presence of protein in urine, accompanied by swelling of the body;
perforation of the intestinal wall;
abnormal tube-like connection or passage between the windpipe and gullet, or between internal organs and skin or other tissues that are not generally associated (fistula) and the treating physician considered a serious deviation from the normal state;
serious infections of the skin or deeper subcutaneous layers;
blood clot in the arteries;
blood clot in the blood vessels of the lungs;
heavy bleeding.
If you are given more than the required dose of Avastin
you may get severe migraines. If this happens, you should immediately notify your doctor, pharmacist or nurse.
If you missed Avastin
Your doctor will decide when you give the next dose of Avastin. You should discuss this with your doctor.
If you stop use of Avastin
Discontinuation of treatment with Avastin may stop the effect on tumor growth. Do not stop your treatment with Avastin before discussing this with your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
As with all drugs, this drug may cause side effects, although not everyone gets them.
If you get any side effects, contact your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet.
Adverse reactions listed below were seen when Avastin was administered concomitantly with chemotherapy. This does not necessarily mean that these side effects are caused directly by Avastin.

allergic reactions
If you have an allergic reaction, tell your doctor immediately or someone from the medical staff. The signs may include: difficulty in breathing or chest pain. You can also get redness or flushing of the skin or rash, chills and fever, nausea or vomiting.
You should immediately seek help if you experience any of the following side effects.

Severe side effects which can be very common (affects more than 1 user in 10) include:
high blood pressure;
numbness or tingling in the arms or legs;
reduced number of blood cells, including white blood cells that help fight against infections (this may be accompanied by fever), as well as cells that promote blood clotting;
fatigue and lack of energy;
fatigue;
diarrhea, nausea and vomiting.
Severe side effects which may be common (affects 1 to 10 users in 100) include:
perforation of the intestine;
bleeding, including bleeding from the lungs in patients with non-small cell lung carcinoma;
clogged arteries by blood clot;
occlusion of the vein by a blood clot;
blockage of blood vessels in the lungs by a blood clot;
blockage in the veins of the legs of a blood clot;
heart failure;
problems with wound healing after surgery;
redness, peeling, soreness, pain or blisters on the fingers or toes;
a decreased number of red blood cells;
lack of energy;
stomach ache;
gastric and intestinal disorder;
muscle and joint pain, muscle weakness;
dry mouth, combined with a thirst and / or decrease the amount of urine or darkening thereof;
inflammation of the oral mucosa and intestine, lungs and respiratory tract, reproductive organs and urinary;
sores in the mouth and esophagus (the tube from the mouth to the stomach) which may be painful and cause difficulty swallowing;
pain, including headache;
localized collection of pus;
infection, in particular infection in the blood or bladder;
reduced blood supply to brain or stroke;
drowsiness;
nosebleed;
heart rate (pulse rate);
bowel obstruction;
deviations in the assay of urine (protein in urine);
shortness of breath or low levels of oxygen in the blood.
Severe side effects not known (from the available data can not be assessed), include:
serious infections of the skin or deeper layers under the skin, especially if you have opened in the intestinal wall, or problems associated with wound healing;
allergic reactions (the signs may include difficulty in breathing, flushing, rash, low blood pressure or high blood pressure, a small amount of oxygen in the blood, chest pain, or nausea / vomiting);
negative effect on women's ability to have children (see below list of side effects for additional recommendations);
state of the brain with symptoms including convulsions (seizures), headache, confusion, and changes in vision (syndrome Posterior reversible encephalopathy or PRES);
symptoms that suggest changes in normal brain function (headache, visual changes, confusion, or seizures), and high blood pressure;
plugging of very small (s) blood (us) vessel (s) in the kidney;
abnormally high blood pressure in the blood vessels of the lungs, which makes working on the right side of the heart harder than normal;
an opening in the cartilage wall that divides the nostrils;
opening in the stomach or intestines;
open wound or opening in the lining of the stomach or the small intestine (symptoms may include abdominal pain, sense of abdominal distension, black tarry stools or blood in the stool (feces) or blood in vomit);
bleeding from the lower sections of the colon;
pathological binding, similar to the tube between internal organs and skin or other tissues that are not normally connected;
lesions of gingiva with stripping of the jaw bone, which do not heal and can be associated with pain and inflammation of the surrounding tissue (see below list of side effects for additional recommendations);
an opening in the gallbladder (signs and symptoms may include abdominal pain, fever, and nausea / vomiting).
You should seek help if you experience any of the below mentioned side effects.
Very common (affects more than 1 user in 10) side effects which were not severe, include:
constipation;
loss of appetite;
fever;
eye problems (including increased tear);
changes in speech;
changes in taste;
fever;
dry skin, flaking and inflammation of the skin, change in skin color.
Common (affects 1 to 10 users in 100) side effects which were not severe, include:
changes in voice and hoarseness.
Patients aged over 65 are at increased risk of occurrence of the following side reactions:
formation of blood clots in the arteries, which can lead to stroke or myocardial infarction;
decrease the number of white blood cells as well as cells that promote blood clotting;
diarrhea;
nausea;
headache;
fatigue;
high blood pressure.
Avastin may also cause changes in laboratory tests appointed by your doctor. These include a reduced number of white blood cells, particularly neutrophils in the blood (white blood cells that help protect against infections); presence of protein in the urine; reduced concentrations of potassium, sodium or phosphorus (mineral) in the blood; elevated blood glucose; elevated alkaline phosphatase (an enzyme) in the blood; decreased hemoglobin (found in red blood cells that carry oxygen), which may be severe.
Pain in the mouth, teeth and / or jaw, swelling or sores in the mouth, tingling or a feeling of heaviness in the jaw or loosening of a tooth. This can be signs and symptoms of damage to the bone of the jaw (osteonecrosis). Tell your doctor immediately or dentist if you experience any of them.
Menopausal women (women who have menstruation) may notice that their menstruation became irregular or absent and can get impaired fertility. If you intend to have children, you should discuss this with your doctor before starting treatment.

Avastin is designed to treat cancer by injecting it into the bloodstream. The product is not intended for injection into the eye. It is therefore not permitted to be used in this way. Upon direct injection of Avastin in the eye (unapproved use) may occur following side effects:
infection or inflammation of the eyeball;
redness of the eye, small dots or spots in the visual field (floating particles), eye pain;
seeing flashes of light floating particles progressing to partial loss of your vision;
elevated intraocular pressure;
bleeding in the eye.
How to store Avastin
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial label or after "EXP" and "EXP". The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C).
Do not freeze.
Keep the vial in the outer carton to protect from light.
Infusion solutions should be used immediately after dilution. Do not use Avastin, if you notice any visible particles or discoloration before use.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Avastin
The active substance is bevacizumab. Each ml of concentrate contains 25 mg of bevacizumab, corresponding to 1,4 to 16,5 mg / ml, when diluted as recommended.
Each 4 ml vial contains 100 mg bevacizumab, corresponding to 1,4 mg / ml when diluted as recommended.
Each vial of 16 ml contains 400 mg bevacizumab, corresponding to 16,5 mg / ml when diluted as recommended.
The other ingredients are trehalose dihydrate, sodium phosphate, polysorbate 20 and water for injections.

Avastin looks like and contents of the pack:
Avastin is a concentrate for solution for infusion. The concentrate is a clear, colorless to pale brown liquid in a glass vial with a rubber stopper. Each vial contains 100 mg bevacizumab in 4 ml of solution or 400 mg bevacizumab in 16 ml of solution. Each pack contains one vial of Avastin.

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