Eloxatin. 50 mg. flacon
Concentrate for solution for infusion containing 5mg/ml oxaliplatin (oxaliplatin)
Eloxatin is used for the treatment of colon carcinoma (treatment of stage III colon cancer after complete resection of the primary tumor, metastatic cancer of the rectum and colon cancer).
Eloxatin. 50 mg. flacon
What Eloxatin and what it is used?
The active substance of Eloxatin is oxaliplatin .
Concentrate for solution for infusion containing 5mg/ml oxaliplatin (oxaliplatin)
Oxaliplatin is used for the treatment of colon carcinoma (treatment of stage III colon cancer after complete resection of the primary tumor , metastatic cancer of the rectum and colon cancer ) . Oxaliplatin is used in combination with other anticancer drugs , known as 5 -fluorouracil and folinic acid .
Oxaliplatin is an antineoplastic or antitumor agent and platinum .
2 . What you should know before taking Eloxatin ?
Do not take Eloxatin :
- If you are allergic (hypersensitive ) to the active substance or to any of the ingredients this medicine if you are breast-feeding
- If you have significantly reduced number of blood cells ( white blood cells or platelets)
- if you have tingling and numbness of the fingers and / or feet and have difficulty making fine movements such as buttoning buttons, if you have severe kidney problems
Warnings and Precautions
- If you have had an allergic reaction to platinum-containing drugs, such as carboplatin , cisplatin . - Allergic reactions can occur during each infusion of oxaliplatin
- If you have mild or moderate kidney problems
- If you have liver problems
- If you are pregnant or planning a pregnancy , it is very important to consult your doctor before starting treatment
Oxaliplatin can affect fertility in men, this effect could be irreversible. Therefore, male patients should be informed that within 6 months after treatment should not become parents, and to seek advice on conservation of sperm prior to treatment. Male patients should take appropriate contraceptive measures during and after cessation of treatment for 6 months.
Talk to your doctor or nurse before taking Eloxatin .
Other medicines and oxaliplatin
Please tell your doctor or pharmacist if you are taking , have recently taken or might take other medicines.
Pregnancy, lactation and fertility
Eloxatin should not be prescribed to pregnant women. If you are likely to get pregnant, you should use effective contraceptive measures. If you become pregnant despite the use of contraception , tell your doctor immediately.
Breastfeeding is contraindicated during treatment with oxaliplatin .
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.
Driving and using machines:
Oxaliplatin treatment can lead to an increased risk of dizziness , nausea and vomiting , and other neurological symptoms that affect the balance and gait . If this happens , you should not drive or operate machinery .
Visual disturbances , especially blackouts (reversible after completion of therapy ) may affect the ability to drive and use machines. Therefore, patients should be warned about the potential impact of these events on the ability to drive and use machines.
3 . How to take Eloxatin ?
FOR ADULTS ONLY
Eloxatin dose is based on body surface area . Determined based on your weight and height.
The usual adult dose is 85 mg/m2 body surface area. The dose you receive is also determined by the results of blood tests and if you have previously had any side effects with the use of oxaliplatin . If you have severe kidney problems , it is recommended starting dose of oxaliplatin 65 mg / m 2
Method of administration
Eloxatin will be prescribed by a specialist in the field of cancer treatment . You will be treated by specialized personnel to determine the required dose
Eloxatin is administered by slow injection into a vein ( intravenous infusion), for the infusion lasts for 2 to 6 hours.
Eloxatin will be applied at the same time with folinic acid before infusion of 5-fluorouracil
Frequency of administration
They will be determined by your doctor. Normally , the infusion is repeated once every two weeks.
Duration of treatment
The duration is determined by your doctor.
Your treatment will last for 6 months when administered after surgery for complete removal of the tumor.
If you take more than the amount of oxaliplatin
As this medicinal product is administered by trained personnel , it is unlikely to get too much or little of this product.
In case of overdose can occur more side effects . Your doctor will take appropriate measures.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them .
If you get any side effects, tell your doctor or nurse. This includes all listed in this leaflet .
Tell your doctor immediately if you notice the following:
- More often than normal bruising , bleeding, or signs of infection such as a sore throat and fever
- Constant or severe diarrhea or vomiting
- Presence of blood or dark brown particles in your vomit
- Inflammation of the gums and mucous membranes ( lips hurt or sores in the mouth)
- Respiratory symptoms such as unexplained cough , difficulty breathing or wheezing
- A group of symptoms such as headache, impaired mental activity , seizures, and visual disturbances - from blurred vision to vision loss (symptoms of the syndrome of reversible posterior leukoencephalopathy - a rare neurological disease).
Other side effects are:
Very common (more than 1 in 10 patients)
Eloxatin can affect the nerves (peripheral neuropathy) . You may feel tingling and / or numbness of the fingers , feet , disturbances in the mouth or throat , which can sometimes cause cramps .
These effects occur when exposed to low temperatures, opening the refrigerator or taking cold drinks. You may also have difficulty performing fine movements such as buttoning clothes . Although in most cases these conditions resolved without consequences , likelihood of occurrence of peripheral sensory neuropathy at the end of treatment.
Some patients have numbness, passage of current through the shoulder or body when in a stiff neck .
- Eloxatin can cause discomfort in the throat , especially when swallowing and a feeling of breathlessness . This sensation , if it occurs, usually occurs during or within several hours at the infusion or upon exposure to low temperatures. However , discomfort , it does not last long and do not need additional treatment. Your doctor will decide whether to change your treatment .
- Eloxatin can cause diarrhea , mild nausea (in sickness) and vomiting as a drug to prevent nausea commonly prescribed by your doctor before treatment and it can be continued after treatment.
- Eloxatin causes a temporary reduction in the number of blood cells. The decrease of red blood cells can cause anemia (reducing the amount of red blood cells) , without bleeding or cause bruising (reduced platelet count ) or infections , which are sometimes severe ( reducing the amount of white blood cells).
Your doctor will take blood to determine whether the number of your blood cells before treatment and before each subsequent course is sufficient.
Discomfort , near or around the injection site during the infusion ,
Fever , shaking ( tremor) , moderate to severe fatigue , pain, body weight changes, loss or lack of appetite, taste disturbances , constipation, headache , back pain
Swelling of the nerves , stiff neck , altered sensation of the tongue, which probably affects speech , stomatitis / mucositis ( inflamed lining of the mouth or mouth ulcers ), abdominal pain
Increased bleeding , including bleeding of the nose Coughing , difficulty breathing
Allergic reactions , skin rash, which may be red and itchy , slightly balding ( alopecia )
Changes in blood tests, including those related to abnormal liver function.
Common ( less than 1 in 10 patients)
Infection due to a decrease in white blood cells
Indigestion and heartburn , hiccups , flushing, dizziness, increased sweating and nail disorders , skin Chest pain
Abnormal lung fever and pain in the joints and bones
Blood in urine / feces , swollen veins , blood clots in the lungs Hypertension Depression and insomnia conjunctivitis and visual disorders Uncommon (less than 1 in 100 patients), obstruction or swelling of the colon nervousness
Rare ( less than 1 in 3000 patients), hearing loss
Tightening and thickening of the lungs with difficulty breathing , sometimes fatal ( interstitial lung disease) Reversible transient loss of vision
Rare ( less than 1 in 10 000 patients)
Presence of blood or dark in color, like coffee particles in the vomit on you. If this happens , immediately contact your doctor.
Not known ( data can not be determined) :
If any of the side effects gets serious , or you notice other effects not listed in this leaflet, please tell your pharmacist.
5 . How to store Eloxatin ?
Keep out of reach of children.
The vial should be stored in the outer carton to protect from light. Do not freeze .
After dilution with 5% glucose, physical - chemical stability of the resulting solution is 48 hours at +2 ° C to +8 ° C and for 24 hours at +25 ° C.
From a solution for infusion should be administered immediately. If not used immediately, storage times and conditions to use are the responsibility of the product. The storage of the solution must not be longer than 24 hours at +2 to +8 ° C, except in cases where the discharge occurs in a controlled and validated conditions ( not more than 48 hours ) .
Oxaliplatin should not come in contact with eyes or skin. If an incident involving his pouring, tell your doctor or nurse immediately .
When the infusion is complete, oxaliplatin should be discarded carefully by your doctor or nurse.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
6 . Package Contents and more information
What does Eloxatin ?
- Active substance is oxaliplatin (oxaliplatin). Each vial contains 50 mg, 100 mg or 200 mg of oxaliplatin .
- The other ingredients are as follows: water for injection.
How it looks Eloxatin and contents of the pack ?
Oxaliplatin vials containing concentrate for solution for infusion . Each vial contains :
10 ml of concentrate for solution for infusion contain 50mg oxaliplatin (oxaliplatin) 20 ml of concentrate for solution for infusion contain 1OOmg oxaliplatin (oxaliplatin) 40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatin (oxaliplatin) other ingredient is water for injections. Vials are supplied in cartons containing 1 vial.