Vinorelbine 10 Mg/Ml Concentrate For Solution For Infusion
Vinorelbine 10 mg/ml • 90070-VP1GB • DA • 05.14 • Pharma-Code: 433
Format: 592 x 112 mm • HKS 44 • Corrective action: KV01_jem_08.05.14 / KV02Jem_09.05.14
Package 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 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, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Vinorelbine 10 mg/ml is and what it is used for
2. What you need to know before you use Vinorelbine 10 mg/ml
3. How to use Vinorelbine 10 mg/ml
4. Possible side effects
5. How to store Vinorelbine 10 mg/ml
6. Contents of the pack and other information
1. What Vinorelbine 10 mg/ml is and what it is used for
Vinorelbine 10 mg/ml is a concentrate for solution for infusion which contains 10 mg in 1 ml vinorelbine as its active ingredient. The product also contains water for injections.
Vinorelbine is an antitumour agent. It is intended for the treatment of cancer, specifically advanced non-small cell lung cancer and advanced breast cancer.
2. What you need to know before you use Vinorelbine 10 mg/ml
Vinorelbine 10 mg/ml will not be used:
• if you are allergic to the active substance vinorelbine or any of the related family of medicinal products for the treatment of cancer called vinca alkaloids.
• if you have a low count of certain white blood cells or a severe current or recent (within the last 2 weeks) infection.
• if you have a low platelet count.
• if you have a severe liver disease unrelated to the cancer which is treated by vinorelbine.
• if you are receiving yellow fever vaccine.
• if you are pregnant.
• if you are breast-feeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Vinorelbine 10 mg/ml
• if you have received radiotherapy where the treatment field includes the liver.
• if you have a severe liver disease unrelated to the cancer which is treated by vinorelbine.
• if you receive certain forms of vaccines (live attenuated vaccines).
• if you receive an antiepileptic medication called phenytoin or an antifungal medication called itraconazol at the same time.
• if you have a severe liver disease related to your cancer.
• if you have a history of heart attack or severe chest pain.
• if you present signs or symptoms of infection (fever, chills, etc.). Let your doctor know immediately, so that he can carry out any tests which may be needed.
• if you belong to the Japanese population, because there is an increased risk to develop diseases of the connective tissue of the lung.
All contact with the eyes must be strictly avoided. There is a risk of severe irritation and even corneal ulceration.
If any contact with the eyes occurs, they must immediately be rinsed with normal saline solution.
Children and adolescents
The safety and efficacy in children have not been established and administration is therefore not recommended.
Other medicines and Vinorelbine 10 mg/ml
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Your doctor should take special attention if you are taking the following medicines:
• medicines used to thin your blood (anticoagulants),
• anti-epileptic medicine like phenytoin, phenobarbital and carbamazepin,
• anti-bacterial medicine like rifampicin, clarithromycin, erythromycin,
• anti-viral drugs like ritonavir,
• antifungal medicines such as itraconazole and ketaconazole,
• an anti-cancer medicine called mitomycin C,
• medicines that impair your immune system such as ciclosporin and tacrolimus,
• medicines for the treatment of heart diseases like verapamil and quinidine,
• a herbal medication called St. John’s wort.
Live attenuated vaccines (e.g. measles vaccine, mumps vaccine, rubella vaccine) are not recommended with Vinorelbine 10 mg/ml as they may increase the risk of life-threatening vaccine disease. You must not be given yellow fever vaccines in combination with Vinorelbine 10 mg/ml.
Pregnancy, breast-feeding and fertility
You must not be given Vinorelbine 10 mg/ml if you are pregnant unless clearly indicated.
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.
You must not be given Vinorelbine 10 mg/ml if you are breast-feeding. If treatment is necessary, you must stop breast-feeding.
Women should take measures to avoid pregnancy during treatment and for at least three months after the end of the treatment.
Men should ensure that their partner will not become pregnant during treatment and up to six months thereafter.
Prior to treatment advice should be sought for conserving sperm due to the chance of irreversible infertility as a consequence of treatment with vinorelbine.
Driving and using machines
Side effects which may impair your ability to drive and/ or operate machines may occur after treatment with vinorelbine. If you do start to feel unwell you should not perform tasks that require mental concentration such as driving a car or operating machinery.
3. How to use Vinorelbine 10 mg/ml
The preparation and administration of Vinorelbine 10 mg/ml must only be carried out by a trained healthcare professional specialised in oncology.
Before each administration a blood sample will be taken for analysis of its components in order to check if you have enough blood cells to receive Vinorelbine 10 mg/ml. If the results of this analysis are not satisfactory, your treatment may be delayed and further checks made until these values return to normal.
Vinorelbine is normally administered once a week.
The usual dose for adults is 25-30 mg/m2.
Always follow your doctor’s instructions.
Vinorelbine 10 mg/ml should always be administered into a vein. The use of intrathecal route is contraindicated.
This may be by injection over a 6 to 10 minute period or by a short infusion over 20 to 30 minutes.
After administration the vein will be rinsed with saline so that the drug is dispersed.
Dose adjustment
• In the case of significant liver insufficiency the dose may be changed by your doctor. Please follow your doctor’s instructions.
• In the case of renal insufficiency it is not necessary to adjust the dose. Please follow your doctor’s instruction.
If more Vinorelbine 10 mg/ml was used than described in the package leaflet
Your doctor will ensure that the correct dose for your condition is given. However, contact your doctor, emergency services or pharmacist if you have any concerns or present symptoms of a potential overdose like fever, signs of infection or constipation.
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.
The following side effects may occur:
|
Very common |
• Inhibition of bone marrow function with |
|
(may affect |
decrease in the number of red blood |
|
more |
cells (erythrocytes) which can make |
|
than 1 in |
the skin pale and cause weakness |
|
10 people) |
or breathlessness and certain type of white blood cells (neutrophils), reversible within 5 to 7 days. |
|
Very common (may affect more than 1 in 10 people) |
• Being unable to pass stools (constipation), vomiting, inflammation of the mucous membrane of the mouth (stomatitis), inflammation of the oesophagus (oesophagitis). • Loss of some reflex reactions (deep tendon reflex), weakness of the lower extremities has been reported after a prolonged chemotherapy. • Transient elevations of blood tests which show changes in the way the liver is working, without clinical symptoms were reported. • Hair loss (alopecia), usually mild. • Reactions at the injection site like redness of the skin (erythema), burning pain, changes of the colour of the vein (vein discoloration) and local inflammation of the vein (phlebitis). • Feeling of weakness (asthenia), fatigue (lethargy), fever, pain in different locations including chest pain and pain at the tumour site. |
|
Common (may affect up to 1 in 10 people) |
• Decreased number of platelets (thrombocytes) in the blood which help to stop bleeding, seldom severe. |
|
Common (may affect up to 1 in 10 people) |
• Bacterial, viral or fungal infections at different parts of the body like in the respiratory, urinary or gastrointestinal tract, mild to moderate and usually reversible with an appropriate treatment. • Breathing difficulties or skin reactions as a result of a hypersensitivity reaction to vinorelbine. • Watery stools (diarrhoea), usually mild to moderate. • Muscle pain (myalgia), joint pain (arthralgia), jaw pain. • An increase in a chemical in the blood that reflects kidney function (creatinine increased). |
|
Uncommon (may affect up to 1 in 100 people) |
• Severe blood poisoning leading to organ failure (sepsis). • Blood poisoning (septicaemia). • Difficulty in breathing (dyspnoea), difficulty in breathing caused by constriction of the airways (bronchospasm). • Problems with the nerves like feeling of tingling or prickling and increased or decreased muscle tension (paraesthesia). • Low blood pressure (hypotension). |
|
Uncommon (may affect up to 1 in 100 people) |
• High blood pressure (hypertension). • A sudden feeling of heat and skin redness of the face and neck (flushing). • Feeling cold in hands and feet (peripheral coldness). |
|
Rare (may affect up to 1 in 1,000 people) |
• Severe low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits or coma (hyponatraemia). • Inflammation of the pancreas (organ which regulates glucose in the blood) which causes severe pain in the abdomen and back (pancreatitis). • Bowel is inactive (paralytic ileus). • Heart diseases like angina pectoris (severe chest pain), heart attack (myocardial infarction), transitory changes in a graph showing the electrical activity of the heart, including the heartbeat (transitory electrocardiogram changes). • Problems with breathing due to diseases of the connective tissue of the lung (interstitial lung disease). • Severe drop in blood pressure (hypotension). • Fainting (collapse). |
|
Rare (may affect up to 1 in 1,000 people) |
• Generalised skin reactions. • Severe disorders of the skin at the injection site like death of tissue (injection site necrosis). |
|
Very rare (may affect up to 1 in 10,000 people) |
• Blood poisoning with complications (septicaemia complicated) and blood poisoning leading to death (septicaemia fatal). • Disorders of the heart like rapid heart rate (tachycardia), feeling your heartbeat (palpitations) and irregular heartbeats (heart rhythm disorders). • Impaired lung function (respiratory insufficiency). • Guillain Barre syndrome (symptoms of this include e.g. weakness or paralysis of legs and arms, problems with breathing and blood pressure). |
|
Not known (frequency cannot be estimated from the available data) |
• Low level of certain white blood cells accompanied by fever (febrile neutropenia). • Severe reduction in all blood cells which can cause weakness, bruising or make infections more likely (pancytopenia). |
• Systemic infection with fever and an unusually low count of certain white blood cells (neutropenic sepsis) with potential fatal outcome.
• Systemic hypersensitivity/allergic reactions which can include swelling of the face or throat (angioedema), sudden life threatening allergic reaction (anaphylactic reaction or shock), allergy-like reaction (anaphylactoid reaction).
• SIADH-syndrome (symptoms of this include e.g. weight gain, nausea, muscle cramps).
• Loss/lack of appetite (anorexia).
• Palmar-plantar erythrodysesthesia syndrome (symptoms of this include e.g. numbness, tingling, burning, or itching sensation, redness (resembling a sunburn), swelling, discomfort, tenderness, rash.
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. If any side effects occur, please discuss with your doctor immediately how to proceed.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
Not known
(frequency
cannot be
estimated
from the
available
data)
effects not listed in this leaflet. You can also report side effects directly via 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 10 mg/ml
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C-8 °C). Keep the vial in the original package in order to protect from light. Do not freeze.
This medicine should not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Vinorelbine 10 mg/ml contains
The active substance is vinorelbine (as tartrate), 10 mg/ml. The other ingredient is water for injections.
What Vinorelbine 10 mg/ml looks like and contents of the pack
Vinorelbine 10 mg/ml is a clear, colourless to slightly yellow solution which is supplied in glass vials.
Each 1 ml vial contains a total content of vinorelbine (as tartrate) of 10 mg
Each 5 ml vial contains a total content of vinorelbine (as tartrate) of 50 mg
Pack sizes: 1 ml or 5 ml concentrate in packs of 1 or 10 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
medac
Gesellschaft fur klinische Spezialpraparate mbH Theaterstr. 6 22880 Wedel Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark Vinorelbine ’’medac”
koncentrat til infusionsvaeske, oplosning United Kingdom Vinorelbine 10 mg/ml
concentrate for solution for infusion
This leaflet was last revised in 05/2014.
The following information is intended for healthcare professionals only:
How to use Vinorelbine 10 mg/ml
The preparation and administration of vinorelbine should be carried out only by trained personnel. Suitable protective goggles, disposable gloves, face mask and disposable clothing must be worn. Spills and leakages must be wiped up.
Any contact with the eyes must be strictly avoided. If the solution does come into contact with the eyes they must be rinsed immediately with plenty of physiological saline.
After preparation, any exposed surface must be thoroughly cleaned and hands and face washed.
There is no incompatibility between the contents and container for Vinorelbine 10 mg/ml concentrate for solution for infusion and a neutral glass bottle, PVC bag, vinylacetate bag or infusion set with PVC tubes. Vinorelbine may be administered by slow bolus (6-10 minutes) after dilution in 20-50 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection or in 5 % (w/v) glucose solution for injection or by a short infusion (20-30 minutes) after dilution in 125 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection or in 5 % (w/v) glucose solution for injection. Administration should always be followed by a normal saline infusion with at least 250 ml to flush the vein.
How to store Vinorelbine 10 mg/ml
Reconstituted solutions: 24 hours when stored at 25 °C or in a refrigerator (2 °C-8 °C).
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2-8 °C, unless opening and dilution has taken place in controlled and validated aseptic conditions.
Do not use Vinorelbine 10 mg/ml if you notice that the concentrate is not a clear, colourless to pale yellow solution free from visible particles.
90070-VP1GB
DA