Vinorelbine 10 Mg/ Ml Concentrate For Solution For Infusion
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER Vinorelbine 10 mg/ml Concentrate for solution for infusion
Vinorelbine
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Vinorelbine is and what it is used for
2. Before you use Vinorelbine
3. How to use Vinorelbine
4. Possible side effects
5. How to store Vinorelbine
6. Further information
1. What Vinorelbine is and what it is used for
Vinorelbine is an anti-cancer medicine. It belongs to a group of drugs called vinca alkaloids. Vinorelbine is used for certain types of advanced lung and breast cancer.
2. Before you use Vinorelbine
This medicine will not be given as an injection to the spine.
Do not use Vinorelbine:
• if you are allergic (hypersensitive) to vinorelbine, other vinca alkaloids, or any of the other ingredients of this medicine (see section 6)
• if you have or have recently had a serious infection, or if you have a significant reduction of your white blood cells (neutropenia)
• if you have a significant reduction of your blood platelets
• if you are a woman of childbearing age not using effective contraception
• if you are breast feeding
• if you have a severe liver disease unrelated to your cancer
• if you have recently had or you are going to have a vaccine against yellow fever.
If any of the above applies to you, do not use this medicine and talk to your doctor.
Take special care with Vinorelbine:
• Tell your doctor if you have had a heart disease called “ischaemic heart disease”.
• Tell your doctor if you have liver problems.
• You should not have radiotherapy in the area of your liver while you are having this medicine.
• Tell your doctor immediately if you have symptoms of an infection (such as fever, chills, or sore throat), so that he can carry out any tests which may be needed.
• Tell your doctor if you have had a vaccination recently. Special care must be taken with live attenuated vaccines such as measles, mumps, rubella, polio, varicella, and tuberculosis (BCG).
• Any contact with the eye must be strictly avoided, since there is a risk of serious irritation or even ulceration of the surface of the eye (corneal ulcers). In case of contact, immediately rinse the eye with normal saline solution and contact the doctor.
• Men and women undergoing treatment with Vinorelbine should use effective contraception during treatment. Men and women should BOTH read the information under pregnancy and breast-feeding below.
• You should use contraceptives if you have sex while you are having this treatment.
• Men should not father a child during and for up to 6 months (minimum 3 months) after stopping this treatment.
• Take special care if you use mitomycin C, phenytoin, itraconazole, or any other medicine mentioned in the section “Using other medicines”
Before each administration of Vinorelbine, a blood sample will be taken for analysis of its components. If the results of this analysis are not satisfactory, your treatment may be delayed and further checks made until these values return to normal.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular if you take one of the following medicines:
• any medicine that may affect the bone marrow, such as anti-cancer medicines
• carbamazepine, phenytoin and phenobarbital (used to treat epilepsy)
• antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin
• St. John’s Wort (Hypericum perforatum)
• ketoconazole and itraconazole (medicines for fungal infections)
• antiviral medicines used for AIDS (HIV) such as ritonavir (HIV protease inhibitors)
• nefazodone (antidepressant)
• cyclosporine, tacrolimus (medicines that reduce the activity of the immune system)
• verapamil, quinidine (used for heart problems)
• anti-cancer medicines such as mitomycin C and cisplatin; there is an increased risk of difficulty breathing if Vinorelbine is used with mitomycin C (see section 4)
• blood thinning medicines (such as warfarin)
• vaccines (see “Take special care with [nationally completed name]”)
Pregnancy and breast-feeding
Vinorelbine should not be used during pregancy unless specifically recommended by your doctor, as it may harm your unborn baby. Women of childbearing age must use effective contraception during treatment with vinorelbine. Tell your doctor if you are pregnant or suspect that you may be pregnant. If you are or become pregnant during treatment with Vinorelbine, genetic counselling is recommended.
If you are a man, you should avoid fathering a child during treatment with Vinorelbine and for 6 months after treatment has stopped. There is also a risk that treatment with Vinorelbine will lead to male infertility and you may wish to seek advice about sperm storage before the treatment starts.
It is not known whether Vinorelbine is excreted into breast milk. You must therefore discontinue breast-feeding before treatment starts.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Side effects which may impair your ability to drive and/or operate machines may occur after treatment with Vinorelbine.
Do not drive or use machines if you feel drowsy, or if you experience any other effect which may impair your ability to drive or use machines.
Discuss with your doctor if you are unsure about your treatment and its effects.
3. How to use Vinorelbine
Your doctor will decide how much Vinorelbine you will have.
The dosage you are given will depend on your general medical condition. It will also depend on any other treatment you may have received for your cancer.
The preparation and administration of Vinorelbine, must only be carried out by a trained healthcare professional - please refer to the information for healthcare professionals (below) for detailed information.
The usual dose is 25 to 30 milligrams weekly for every square metre of your body’s surface area.
Your nurse will measure your height and weight and work out the surface area of your body from these measurements. Your doctor will use this body surface area to work out the right dose for you.
The medicine will be diluted with a solution such as physiologic saline or glucose 5% before it is given to you.
Vinorelbine is always administered intravenously. This may be by injection over a 5 to 10 minute period or by infusion over 20 to 30 minutes.
At the end of the injection or infusion, the vein will be flushed with physiologic saline.
Your doctor will ensure that the correct dose for your condition is given, however tell your doctor or pharmacist if you have any concerns.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, Vinorelbine can cause side effects, although not everybody gets them.
Some side effects that have been reported following treatment with vinorelbine are listed below. Frequency:
Very common side effects occur in more than 1 out of 10 patients
Common side effects occur in less than 1 out of 10 patients but in more than 1 out of 100
patients
Uncommon side effects occur in less than 1 out of 100 patients but in more than 1 out of 1,000 patients
Rare side effects occur in less than 1 out of 1,000 patients but in more than 1 out of 10,000 patients
Very rare side effects occur in less than 1 out of 10,000 patients Serious side effects:
If any of the following rare side effects occur contact your doctor or nearest accident and emergency department immediately.
Serious allergic reaction (anaphylaxis), the symptoms of which include:
• swelling of the face, lips, mouth or windpipe (angioedema)
• sudden wheezing or tightening of the chest
• skin lumps or hives
• collapse
• Heart attack, the symptoms of which include:pain in the chest that spreads to the back of the neck and arm
• difficulty breathing
• sweating
• collapse
If you develop symptoms of an infection such as fever, feeling cold or shivering, being sick, aching muscles or fainting contact your doctor as in rare cases this can be a sign of the serious bacterial infection septicaemia.
|
Very common |
• decrease in the number of a type of white blood cell (neuthopenia) which may increase the risk of infection • low levels of red blood cells (anaemia) which may make you feel tired • nausea (feeling sick) • vomiting (being sick) • constipation • diarrhoea • inflammation of the mouth or food pipe (stomatitis or oesophagitis) • loss of appetite • raised levels of liver enzymes - detected during a blood test • loss of deep tendon reflexes - detected during tests by your doctor • feeling tired • high temperature (fever) • pain • weakness • pain, redness, colour change or inflammation of veins at the site of injection |
|
Common |
• bacterial, fungal or viral infections • decreased number of a type of blood cell known as platelets (thrombocytopenia) • fever combined with a decrease in the number of a type of white blood cell (febrile neutropenia). This may develop into a serious infection (neutropenic sepsis) • allergic reactions, the symptoms of which include redness, itching or swelling of the skin or difficulty breathing • tingling, pricking or numbness of the skin • shortness of breath or difficulty catching your breath • skin reactions such as rash, redness or itching • muscle or joint pains • change in kidney function - detected during tests |
|
Uncommon |
• a serious infection that causes inflammation of the whole body and organ failure • low levels of sodium in your blood - detected during blood test • paralysis of the small intestine (paralytic ileus) which causes difficulty passing waste • increased or decreased blood pressure • flushing • coldness of your fingers and toes |
|
Rare |
• a serious bacterial infection of the blood (septicaemia) • weakness of the legs • development of diseases that cause reduced blood supply to the heart such as angina • changes to your heartbeat - detected during tests • serious low blood pressure • collapse • development of lung disease that causes shortness of breath and a dry cough (interstitial lung disease) • inflammation of the pancreas (pancreatitis) which causes pain in the abdomen • jaw pain • death of the tissue surrounding the site of injection (necrosis) |
a serious bacterial infection of the blood with complications (septicaemia complicated) which in some cases can be fatal
heavy or fast breathing or shortness of breath (respiratory insufficiency) development of SIADH syndrome (syndrome of inappropriate antidiuretic hormone secretion), the symptoms of which include weight gain, feeling or being sick, muscle cramps, confusion and seizures (fits) development of Guillain-Barre syndrome which causes muscle weakness a fast or irregular heartbeat or feeling your heart beating (palpitations)
Alterations in the blood may also occur, your doctor will arrange for you to have specific blood tests to monitor for these changes. These may include low white blood cell number, anaemia and/or platelets, liver function, kidney function and a change in certain salts in your body.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Vinorelbine
Keep out of the reach and sight of children.
Do not use Vinorelbine after the expiry date which is stated on the outer carton after ‘EXP’. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Store the vial in the outer carton in order to protect from light.
In-use: After opening, the contents should be reconstituted and used immediately. If prepared aseptically, the diluted solution can be stored for maximum 24 hours in a refrigerator (2°C -8°C). Do not freeze. Protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Vinorelbine contains
- The active substance is vinorelbine
Each 1 ml vial contains vinorelbine tartrate equivalent to 10 mg vinorelbine.
Each 5 ml vial contains vinorelbine tartrate equivalent to 50 mg vinorelbine.
- The other ingredient is water for injections
What Vinorelbine looks like and contents of the pack
Vinorelbine is a clear, colourless to pale yellow solution, and free from visible particles.
Vinorelbine is packed in type I clear glass vials, with grey elastomer stoppers covered by blue aluminium caps.
Pack sizes: 1x1 ml vial and 1x5 ml vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Flynn Pharma Limited
Alton House 4 Herbert Street Dublin 2
Republic of Ireland.
Manufacturer
National and Kapodistrian University of Athens - Department of Chemistry Service laboratory
Chemical Analysis- Quality control Panepistimiopolis Greece
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Vinorelbin Axton 10 mg/ml Konzentrat zur Herstellung einer Infusionslosung Germany Vinorelbin Vilex 10 mg/ml Konzentrat zur Herstellung einer Infusionslosung Portugal Vinorrelbina Axton 10 mg/ml Concentrado para soluqao para perfusao
This leaflet was last approved in 12/2012
The following information is intended for medical or healthcare professionals only:
Special precautions
Only trained staff should carry out the preparation and administration of Vinorelbine.
Suitable safety equipment, disposable gloves, facemask and disposable apron should be worn. Spills and leakages must be wiped up.
All contact with the eye must be strictly avoided. Immediate washing of the eye with normal saline solution should be undertaken if any contact occurs.
On completion, any exposed surface should be thoroughly cleaned and hands and face washed.
Only for intravenous administration. Must be diluted before use immediately after opening the vial.
Incompatibility
Vinorelbine should not be diluted in alkaline solutions (risk of precipitation).
Vinorelbine must not be mixed with other medicinal products except normal saline or glucose (5%) solution.
There is no incompatibility between Vinorelbine and clear glass vials, PVC or vinyl acetate bags, or infusion sets with PVC tubing.
Administration
Vinorelbine may be administered by slow bolus (5-10 minutes) after dilution in 20-50 ml of normal saline or glucose 50 mg/ml (5%) solution or by a short infusion (20-30 minutes) after dilution in 125 ml of normal saline or glucose 50 mg/ml (5%) solution. Administration should always be followed by a normal saline infusion to flush the vein.
Vinorelbine should only be given intravenously. It is very important to make sure that the cannula is accurately placed in the vein before the injection is commenced. If Vinorelbine infiltrates the surrounding tissue during intravenous administration, a substantial irritation may occur. In this case, the injection should be stopped, the vein flushed with saline solution and the rest of the dose should be administered in another vein. In the event of extravasation, glucocorticoids could be given intravenously to reduce the risk of phlebitis.
Storage
Store in a refrigerator (2°C - 8°C). Do not freeze. Store the vial in the outer carton in order to protect from light.
In-use: After opening, the contents should be reconstituted and used immediately. If prepared aseptically, the diluted solution can be stored for maximum 24 hours in a refrigerator (2°C -8°C). Do not freeze. Protect from light.
For more information read the SPC.