Vinorelbine 10 Mg/Ml Concentrate For Solution For Infusion
Vinorelbine 10mg/ml Concentrate For Solution For Infusion
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
2.
What is in this leaflet:
1. What Vinorelbine is and what it is used for What you need to know before you use Vinorelbine How to use Vinorelbine Possible side effects How to store Vinorelbine Contents of the pack and other information
1. What Vinorelbine is and what it is used for
Vinorelbine is indicated for use in adults. Vinorelbine is used in the treatment of cancer and belongs to a group of medicines known as Vinca alkaloids.
Vinorelbine is used to treat certain types of lung cancer and breast cancer.
2. What you need to know before you use Vinorelbine
Do not use Vinorelbine
• if you are allergic to vinorelbine or other Vinca alkaloids
• if you have or recently had serious infection or severe decrease in white blood cells (neutropenia)
• if you have severe decrease in blood platelets
• if you are breast-feeding
• if you are a woman of childbearing potential not using effective contraception
• in combination with yellow fever vaccine
This medicine is strictly for intravenous use only and should not be injected into the spine.
Warnings and precautions
Talk to your doctor or nurse before using
Vinorelbine
• if you have had a heart disease involving lack of blood supply to the heart (ischaemic heart disease, angina)
• if you are having radiotherapy and the treatment field includes the liver
• if you present signs or symptoms suggestive of infection (such as fever, chills, sore throat), let your doctor know immediately, so that he/she can carry out any tests which may be needed
• if you have impaired liver function
• if you need a vaccination. You should inform your doctor of the treatment before any vaccination.
Other medicines and Vinorelbine
Tell your doctor if you are taking, have recently taken or might take any other medicines. This is especially important if you are using any of the following medicines:
other medicines which can affect the bone marrow e.g. cancer medicines carbamazepine, phenytoin and phenobarbital (medicines for the treatment of epilepsy) antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin
St John's Wort (Hypericum perforatum) ketoconazole and itraconazole (medicines for the treatment of fungal infections)
antiviral medicines to treat HIV-infection e.g. ritonavir (HIV protease inhibitors). nefazodon (medicines for the treatment of depression)
cyclosporine and tacrolimus (medicine which decrease the activity of the immune system)
other medicines for the treatment of cancer e.g. mitomycin C, cisplatin, lapatinib
blood thinning medicines e.g. warfarin yellow fever vaccine and other live vaccines. Please inform your doctor if you require any vaccinations, as it can cause serious side effects when used during treatment with Vinorelbine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Vinorelbine should not be given to pregnant women, because it can cause serious birth defects.
If you are a woman of childbearing age you must use an effective method of contraception during treatment and for 3 months after treatment has stopped. If pregnancy occurs during your treatment you must immediately inform your doctor. 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.
You must discontinue breast-feeding before treatment with Vinorelbine starts as it is not known whether it might pass into breast milk thereby affect the baby.
Ask your doctor or pharmacist for advice before taking any medicine.
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if you receive a cancer medicine named mitomycin C
if you are of Japanese origin, as you may be more vulnerable for lung problems during treatment with Vinorelbine.
Driving and using machines
Caution is advised due to possible side effects.
3. How to use Vinorelbine
Vinorelbine must not get into contact with the eye as there is a risk of severe irritation and even corneal ulceration. If this occurs, immediately rinse the eye with normal saline solution and contact an ophthalmologist.
Men and women who are treated with Vinorelbine should use an effective contraception during treatment. Men and women should BOTH read the information under pregnancy and breast-feeding below.
Vinorelbine will be given to you under the supervision of a doctor specialised in this type of treatment.
The recommended dose is
The dosage depends on the condition you are being treated for, your response to the therapy and other medication you are being given. Your general condition and your response to the treatment will be closely observed before, during and after the vinorelbine treatment.
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.
The usual dosage of vinorelbine is 25-30mg/m2 of body surface area given once a week.
The following information is intended for medical or healthcare professionals only:
Vinorelbine 10mg/ml Concentrate For Solution For Infusion
Instruction for use ANTINEOPLASTIC AGENT
Please refer to the Summary of Product Characteristics for detailed information regarding this product.
Handling and disposal
The preparation and administration of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used, in conditions that guarantee the protection of the environment and, in particular, the protection of the personnel handling the medicines. It requires a preparation area reserved for this purpose.
It is forbidden to smoke, eat or drink in this area.
Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection masks, caps, protective goggles, sterile single-use gloves, protective covers for the work area and collection bags for waste.
Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is recommended).
Spills and leakages must be wiped up.
Precautions should be taken to avoid exposing staff during pregnancy.
All contact with eyes must be strictly avoided. Immediate liberal washing of the eye with normal saline solution should be undertaken if any contact occurs. In case of irritation contact an ophthalmologist.
In case of skin contact, thoroughly wash the affected area with water.
On completion, any exposed surface should be thoroughly cleaned and hands and face washed.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities
Vinorelbine should not be diluted in alkaline solutions (risk of precipitation).
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section "Dilution and administration".
There is no incompatibility between Vinorelbine and glass vials, PVC bag, polyethylene vial or polypropylene syringe.
Dilution and administration
Vinorelbine must be given strictly intravenously and after dilution. Vinorelbine may be administered by slow bolus (6-10 minutes) after dilution in 2050ml of sodium chloride 9mg/ml (0.9%) solution for injection or glucose 50mg/ ml (5%) solution for injection or by a short infusion (20-30 minutes) after dilution in 125ml of sodium chloride 9mg/ml (0.9%) solution for injection or glucose 50mg/ml (5%) solution for injection. Administration should always be followed with at least
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5 mm
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Clinical experience has not identified 1 ^relevant differences with regards to how
10 mm elderly patients respond to Vinorelbine, however it is possible that some elderly patients could be more sensitive to this medicine.
Patients with liver impairment
Dosage will be reduced if you have severe liver problems.
Patients with renal impairment
Dosage does not need to be reduced in patients with renal impairment.
Use in children
Safety and efficacy in children younger than 18 years have not been established and administration is therefore not recommended.
Method of administration
The medicine should be diluted before use with a solution of sodium chloride or glucose and given into a vein as an injection over 6-10 minutes or by infusion (drip) over 20-30 minutes. Following your treatment, a solution of sodium chloride will be used to flush the vein.
If you use more Vinorelbine than you should
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects - if any of the following side effects occur, immediately contact a doctor:
Uncommon (may affect up to 1 in 100 people): Severe infections with different organ failure or blood poisoning. Shortness of breath, narrowing of the airways (bronchospasm).
Rare (may affect up to 1 in 1000 people): Chest pain which may spread to the back of your neck and arm, due to lack of blood supply to the heart (angina pectoris). Heart attack (myocardial infarction).
Not known (frequency cannot be estimated from the available data): Widespread and very serious allergic reactions. Symptoms may include sudden wheezing, swelling of your lips, tongue and throat or body, difficulties to swallow, rash, light-headedness, fainting (anaphylaxis/ anaphylactic shock/anaphylactoid reaction).
These are very serious side effects. You may need immediate medical care.
Other side effects - if any of the following side effects occur, contact your doctor as soon as possible:
Very common (may affect more than 1 in 10 people): Low count of white blood cells, which may increase the risk of infection.
Low count of red blood cells (anaemia), which may make you feel tired. Loss of deep tendon reflexes. Weakness of the lower extremities. Inflammation of the mouth or the gullet. Nausea and vomiting. Constipation. Abnormal results of liver function tests. Hair loss. Redness (erythema), burning pain, vein discolouration and/or inflammation of the veins (local phlebitis) on the injection site.
Common (may affect up to 1 in 10 people): Infections (bacterial, viral or fungal infections) in your body (respiratory, urinary, gastro-intestinal systems and possibly others) with symptoms such as fever, pain and chills. Low count of blood platelets (risk of bleeding). Diarrhoea. Pain in muscles and joints, including jaw pain. Change in kidney function (increased creatinine values). Weakness, fatigue, fever, pain in different locations.
Uncommon (may affect up to 1 in 100
people): Severe numbness (paraesthesia). Low blood pressure, high blood pressure, flushing and peripheral coldness.
Rare (may affect up to 1 in 1,000 people): Low levels of sodium in the blood (which can cause symptoms of tiredness, confusion, muscle twitching and coma). Changes in the activity of the heart (ECG changes). Seriously low blood pressure or collapse. Lung disease (interstitial pnuemopathy). Inflammation of the pancreas. Paralytic intestinal blockage (ileus). Skin reactions such as rash, itch and hives. Injection site necrosis.
Very rare (may affect up to 1 in 10,000 people): Blood poisoning which may be life threatening. Strong heartbeat, rapid heartbeat, heart rhythm disorders.
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Not known (frequency cannot be estimated from the available data):
A general infection in combination with a fall in white blood cell count (neutropenic sepsis). A fall in white blood cell count with fever (febrile neutropenia). Reduction in number of white and red blood cells, as well as blood platelets. Low sodium level due to an overproduction of a hormone causing fluid retention and resulting in weakness, tiredness or confusion (SIADH syndrome). Decreased appetite (anorexia). Redness (erythema) of hands and feet.
As with other vinca-alkaloids Vinorelbine is a moderate blister agent.
As changes in the blood may occur, your doctor may order blood samples to be taken to control this (low count of white blood cells, anaemia and/or low count of blood platelets, influence on the liver- or kidney function and the electrolyte balance in your body).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard . By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vinorelbine
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C). DO NOT FREEZE.
Keep the vial in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Vinorelbine contains
The active substance is vinorelbine. One ml concentrate for solution for infusion contains 10mg vinorelbine (as tartrate).
Each 1ml vial contains 10mg of vinorelbine (as tartrate).
Each 5ml vial contains 50mg of vinorelbine (as tartrate).
The other ingredient is water for injections.
What Vinorelbine looks like and contents of the pack
Vinorelbine 10mg/ml Concentrate For Solution For Infusion is a clear, colourless to slightly yellow solution.
Pack-sizes:
1 x 1ml vial 10 x 1ml vial 1 x 5ml vial 10 x 5ml vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.,
Reykjavfkurvegi 76-78,
220 Hafnarfjordur, Iceland
Manufacturers
Actavis Nordic A/S 0rnegardsvej 16,
2820 Gentofte Denmark
Actavis Italy S.p.A.
Via Pasteur 10 20014 Nerviano (MI)
Italy
This leaflet was last revised in April 2014
If you would like a leaflet with larger text, please contact 01271 385257.
actavis
Actavis, Barnstaple, EX32 8NS, UK
250ml of sodium chloride 9mg/ml (0.9%) solution for injection to flush the vein.
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.
Excreta and vomit must be handled with care.
Storage
As packaged for sale: Store in a refrigerator (2°C - 8°C). Store the vial in the outer carton in order to protect from light. DO NOT FREEZE.
Do not use Vinorelbine after the expiry date which is stated on the vial label and carton. After opening
The contents of the vial should be used immediately after the first breakage of vial. After dilution:The physicochemical and microbiological stability of the drug product after dilution in the recommended solutions for infusion has been demonstrated for 24 hours at 2-8°C and 25°C.
From a microbiological point of view the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
^actavis
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Actavis, Barnstaple, EX32 8NS, UK