ZALTRAP 25 mg/ml. 200mg./8 ml.

What is ZALTRAP and what it is used
What is ZALTRAP and how it works
ZALTRAP contains the active substance aflibersept, a protein that acts by blocking the growth of new blood vessels into the tumor. To grow the tumors in need of nutrients and oxygen from the blood. By blocking the growth of blood vessels, ZALTRAP helps stop or slow tumor growth.
What is ZALTRAP
ZALTRAP is a drug that is used for the treatment of advanced carcinoma of the colon or rectum (colon) in adults. It will be administered with other drugs called "chemotherapy" including "5-FU", "folinic acid" and "irinotecan".
2. What you need to know before you are given ZALTRAP
Do not use ZALTRAP:
if you are allergic to aflibersept or any of the other ingredients of this medicine (listed in section 6).
the eye as it can cause serious damage.
Please also read the package inserts of other drugs ( "chemotherapy") that are part of your treatment to see if they are suitable for you. If you are unsure, ask your doctor, pharmacist or nurse if there are any reasons why you can not use these drugs.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before you are given ZALTRAP and during treatment if you:
have problems associated with bleeding or notice any bleeding after treatment (see section 4) or if you experience excessive fatigue, weakness, dizziness or have discoloration of feces. If bleeding is severe, your doctor will stop your treatment with ZALTRAP. This is because ZALTRAP may increase the risk of bleeding.
have diseases associated with intestinal inflammation, such as an infected area of ​​the intestinal wall (also called "diverticulitis"), gastric ulcer or colitis. This is because ZALTRAP can increase the risk of perforation (hole) of the intestinal wall. If this happens to you, your doctor will stop your treatment with ZALTRAP.
your body was formed unnatural canal between internal organs and skin or other tissues (also called "fistula"). If you receive such a canal during treatment, your doctor will stop your treatment with ZALTRAP.
have high blood pressure. ZALTRAP can raise blood pressure (see section 4) and your doctor should monitor your blood pressure and may adjust medications for blood pressure are taking or dose of ZALTRAP. It is therefore important to tell your doctor, pharmacist or nurse if you have other heart problems as high blood pressure can make them worse.
have symptoms of a blood clot (see section 4). Symptoms of a blood clot may differ depending on where it occurs (eg. Lungs, legs, heart or brain) and may include symptoms such as chest pain, coughing, shortness of breath or difficulty breathing. Other symptoms may include swelling of one or both legs, pain or tenderness in one or both legs, discoloration and warming the skin of the affected foot or visible veins. It can also manifest as sudden numbness or weakness in the face, arms or legs. Other symptoms include confusion, vision problems, walking, coordination or balance problems uttering words or Slurred speech. If you get any of these symptoms, talk to your doctor immediately as your doctor may want to treat your symptoms and stop your treatment with
ZALTRAP.
have kidney problems (protein in urine), as your doctor will monitor your kidney function and may need to adjust the dose of ZALTRAP.
the number of white blood cells is very low. ZALTRAP can reduce the number of white cells in your blood and your doctor will monitor the number of white blood cells may give you additional medicines to his promotion. If your white blood cells are small, your doctor may delay your treatment.
have severe or persistent diarrhea, nausea or vomiting -this can lead to severe loss of body fluid (called "dehydration"). It may be necessary Your doctor may treat with other drugs and / or fluids administered intravenously.
ever had allergies - during treatment with ZALTRAP can be serious allergic reactions (see section 4). You may need your doctor to treat an allergic reaction or stop your treatment with ZALTRAP.
You tooth removed or have suffered another type of surgery in the past four weeks, or surgery or dental or medical procedure or have a wound after surgery, which is not healed. Your doctor will suspend treatment before and after surgery.
have seizures (convulsions). If you have vision changes or confusion, your doctor may stop your treatment with ZALTRAP.
are aged 65 years or more and have diarrhea, dizziness, weakness, weight loss or bereavement Mr.
If you are a woman may become pregnant should use effective contraception (see section "Contraception" below for details on contraception in male and female). This medicine may harm your unborn baby as it may stop the formation of new blood vessels.
If you are breastfeeding, talk to your doctor before you are given this medicine. This is because it is not known whether the drug passes into breast milk.
ZALTRAP can affect male and female fertility. Ask your doctor if you are planning to have a child or to become a father.
contraception
Men and women who may become fathers or bear children should use effective contraception:
during treatment with ZALTRAP and
at least 6 months after the last dose of treatment.
Driving and using machines
You may have side effects that affect your vision, concentration and ability to react. If this happens, do not drive or operate machinery.
3. How to apply ZALTRAP
ZALTRAP will be given by a doctor or nurse experienced in the use of "chemotherapy". ZALTRAP is applied through a drip (infusion) into one of the veins ( "i.v."). ZALTRAP should not be injected into the eye, as it can cause serious damage.
The drug must be diluted before use. This leaflet provides practical information for handling and administration of ZALTRAP for doctors, nurses and pharmacists using this medicine.
How much and how often you get treatment
Infusion (infusion) lasts about 1 hour.
Usually you will be given an infusion once every two weeks.
The recommended dose is 4 mg per kilogram of body weight. Your doctor will determine the correct dose for you.
Your doctor will decide how often you will be given the drug and whether there is need for a change in dosage.
ZALTRAP will be administered in combination with other chemotherapy drugs, including "5-FU", "folinic acid" and "irinotecan". Your doctor will determine the appropriate dosage for these other chemotherapy drugs.
Treatment will continue for as long as your doctor thinks it is beneficial for you and the side effects are acceptable.
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.
Adverse reactions listed below have been observed following administration of ZALTRAP in combination with chemotherapy.
Serious side effects
Talk to your doctor immediately if you notice any of the following serious side effects - you may need urgent medical treatment:
Bleeding: Very common (may affect more than 1 in 10 people) - this includes nosebleeds, but may also include heavy bleeding in the intestines and other parts of the body, which can lead to death. Symptoms include excessive tiredness, weakness and / or dizziness, or changes in the color of stool.
Breakthrough of the intestine (also called "gastro-intestinal tract"): Uncommon (may affect up to 1 in 100 people) - this is a breakthrough of the stomach, esophagus, small intestine or colon. This can lead to death. Symptoms may include abdominal pain, vomiting, fever or chills.
Groove between internal organs and skin or other tissue (also called "fistula").
Common (may affect up to 1 in 10 people) - these abnormal channels may be formed, for example, between the gut and skin. Sometimes, depending on where the form, you may have unusual expiration of this place. If you are unsure, contact your doctor.
High blood pressure (also called "hypertension"): Very common (may affect more than 1 in 10 people) - it may develop or worsen. If blood pressure is not controlled, can lead to stroke, heart problems and kidney. Your doctor should check your blood pressure during treatment.
Clogged arteries by blood clot (also called "arterial thromboembolic events"): Common (may affect up to 1 in 10 people) - this can lead to a stroke or heart attack. Symptoms may include chest pain or heaviness in the chest, sudden numbness or weakness in the face, arms or legs. Other symptoms include confusion, vision problems, walking, coordination or balance, or trouble speaking words or Slurred speech.
Blockage of veins by a blood clot (also called "venous thromboembolic events"): Common (may affect up to 1 in 10 people) - this can include blood clot in the lungs or legs. Symptoms may include chest pain, coughing, shortness of breath, difficulty breathing or coughing up blood. Other symptoms include swelling of one or both legs, pain or tenderness in one or both feet when standing or walking, the heating of the skin of the affected leg, redness
headache
nosebleeds
voice changes, for example. hoarseness of voice
difficulty breathing
painful sores in the mouth
stomach ache
swelling and numbness in hands and feet that occurs with chemotherapy (called "palmar-plantar erythrodysesthesia")
tiredness or weakness
weight loss
kidney problems with increased creatinine (an indicator of renal function)
liver problems with elevation of liver enzymes.
Common (may affect up to 1 in 10 people)
urinary infection
inflammation of the nose and upper throat
pain in the mouth or throat
catarrh
hemorrhoids, bleeding or pain in the anus
inflammation in the mouth
toothache
changes in skin color.
Uncommon (may affect up to 1 in 100 people)
increased protein in the urine, an increase in blood cholesterol and swelling due to accumulation of excess fluid (edema) (also called "nephrotic syndrome")
blood clot in very small blood vessels (also called "thrombotic microangiopathy").
Adverse event reporting
If you get any side effects, contact your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can do your bit for obtaining more information on the safety of this medicine.
How to store ZALTRAP
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).
Store in the original container to protect from light.
Information storage and time of use of ZALTRAP, after being diluted and ready for use, is given in "Practical information for health care professionals for the preparation and handling ZALTRAP 25 mg / ml concentrate for solution for infusion" in the end of the leaflet.
Do not use ZALTRAP, if you notice particulate matter and discoloration of the drug in vials or infusion bag.
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 ZALTRAP
The active substance is aflibersept. One ml of concentrate contains 25 mg aflibersept. One 4 ml vial of concentrate contains 100 mg aflibersept. One vial of 8 ml of concentrate contains 200 mg aflibersept.
The other excipients are sucrose, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sodium hydrogen phosphate heptahydrate, sodium phosphate monobasic monohydrate, sodium hydroxide and / or hydrochloric acid and water for injections.
ZALTRAP looks like and contents of the pack
ZALTRAP is a concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colorless to pale yellow solution.
4 ml of concentrate in 5 ml vial of transparent borosilicate glass (type I), sealed with a flip-off cap and the sealing disc embedded with a coating. Pack of 1 vial or 3 vials.
8 ml of concentrate in a 10 ml vial of transparent borosilicate glass (type I), sealed with a flip-off cap and the sealing disc embedded with a coating. Pack of 1 vial.
Not all pack sizes may be marketed.
ZALTRAP is a sterile, non-pyrogenic, preservative-free concentrate, therefore, the infusion solution should be prepared by a medical professional using procedures for safe handling and aseptic technique.
Caution should be exercised when working with ZALTRAP, considering the use of safety devices, personal protective equipment (eg. Gloves), and preparation procedures.
Preparation of the infusion solution
Visually check the vial with ZALTRAP before use. Concentrate for solution for infusion should be clear and free from particles.
Based on the dose required for the patient, withdraw the necessary volume ZALTRAP concentrate vial. To prepare the solution for infusion may be needed more than one vial.
Dilute it to the required volume for administration of 9 mg / ml (0,9%) solution for infusion sodium chloride or 5% glucose solution. The concentration of the final solution of ZALTRAP for intravenous infusion should be in the range of 0,6 mg / ml to 8 mg / ml aflibersept.
You need to use infusion bags of PVC, containing DEHP or infusion bags of polyolefin.
Prior to administration, the diluted solution should be inspected visually for particulate matter and discoloration. If there is a change in color or particulate matter, the reconstituted solution should be discarded.
ZALTRAP is a single-use vial. Do not re-enter the needle in the vial after initial drilling. Any unused concentrate should be discarded.
Shelf life after dilution in the infusion bag
The chemical and physical stability during use has been demonstrated for 24 hours at 2 ° C to 8 ° C and for 8 hours at 25 ° C.
From a microbiological point of view, the infusion solution should be used immediately.
If not used immediately, time and storage conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 ° C to 8 ° C, unless dilution has taken place in controlled and validated aseptic conditions.
Method of administration
ZALTRAP should be administered only by intravenous infusion over 1 hour. Due hyperosmolality (1000 mOsmol / kg) of ZALTRAP concentrate undiluted ZALTRAP concentrate should not be administered as an intravenous push or bolus. ZALTRAP should not be administered as an intravitreal injection (see section 2 of the leaflet).
Each vial of concentrate for solution for infusion is for single use (single dose).
Diluted solutions of ZALTRAP should be administered using infusion sets comprising filter polyethersulfone having a pore size of 0.2 microns.
Infusion sets must be made by one of the following materials:
polyvinyl chloride (PVC), containing di (2-ethylhexyl) phthalate (DEHP)
PVC, free of DEHP, containing trioktiltrimelitat (TOTM)
polypropylene
PVC, polyethylene coating
polyurethane

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