Vinorelbine 10 Mg/Ml Concentrate For Solution For Infusion
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 or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
- The full name of the medicinal product is Vinorelbine 10 mg/ml concentrate for solution for infusion but it will be referred to as Vinorelbine in the rest of the leaflet.
In this leaflet:
1. What Vinorelbine is and what it is used for
2. What you need to know before you use Vinorelbine
3. How to use Vinorelbine
4. Possible side effects
5. How to store Vinorelbine
6. Contents of the pack and other information
1. What Vinorelbine is and what it is used for
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 (hypersensitive) 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 pregnant
- if you are breast-feeding
- if you are a woman of childbearing potential not using effective contraception
- if you have a severe liver disease not caused by cancer
- 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
- 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.
- if you receive a cancer medicine named mitomycin C
Vinorelbine must not get into contact with the eye as there is a risk of severe irritation and even comeal 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.
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.
Children and adolescents
Vinorelbine is not recommended for use by children younger than 18 years.
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)
- verapamil, quinidine (medicines for the treatment of heart diseases)
- other medicines for the treatment of cancer e.g. mitomycin C, cisplatin
- blood thinning medicines e.g. warfarin
- yellow fever vaccine and other live vaccines
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. 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.
Driving and using machines
No studies of the effects on the ability to drive and use machines have been performed.
3. How to use Vinorelbine
Vinorelbine will be given to you under the supervision of a doctor specialized in this type of treatment.
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.
The usual dosage of vinorelbine is 25-30 mg/m2 of body surface area given once a week.
The medicine should be diluted before use with a solution of sodium chloride or glucose and given into a vein as an injection over 5-10 minutes or by infusion (drip) over 20-30 minutes. Following your treatment, a solution of sodium chloride will be used to flush the vein.
Dosage will be reduced if you have severe liver problems.
Use in children and adolescents
Vinorelbine is not recommended for use by children younger than 18 years. The safety and efficacy in children have not been determined.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 you doctor:
Common: Narrowing of the airways (bronchospasm), shortness of breath, respiratory reactions due to allergy.
Rare: Chest pain which spreads to the back of the neck and arm, due to lack of blood supply to the heart. Heart attack, lung disease.
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. Inflammation of the mouth or the gullet. Nausea and vomiting. Anorexia (decreased appetite), constipation, diarrhoea. Hair loss. Oedema, tenderness, pain and/or rash on the injection site. Fatigue, fever, pain, weakness, abnormal results of liver function tests, loss of deep tendon reflexes.
Common: may affect up to 1 in 10 people
Numbness (paraesthesia). Pain in joints and muscles. Increased creatinine values (change in renal function). Symptoms of infection e.g. fever, pain. Skin reactions. Low count of a special type of white blood cells, which can cause fever. Low count of blood platelets (risk of bleeding).
Rare: may affect up to 1 in 1,000 people
Inflammation of the pancreas, paralytic intestinal blockage (ileus). Weakness of lower extremities. Low levels of sodium in the blood. Changes in the activity of the heart (ECG changes). Jaw pain. Injection site necrosis.
Very rare: may affect up to 1 in 10, 000 people
Guillain-Barres syndrome (inflammation in peripheral nerves which may cause weakness). SIADH syndrome, which may include symptoms of increased weight, nausea (feeling sick), vomiting, muscle cramps, confusion and seizures (fits).
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).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via
Yellow Card Scheme,
Website: 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 VIN ORELBINE
Keep this medicine out of the reach and sight 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.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. FURTHER INFORMATION What Vinorelbine contains
The active substance is vinorelbine. One ml concentrate for solution for infusion contains 10 mg 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 10 mg/ml concentrate for solution for infusion is a clear, colourless to slightly yellow solution.
Pack-sizes:
1 x 1 ml vial 10 x 1 ml vial 1 x 5 ml vial 10 x 5 ml vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing
London
W5 5TL
Manufacturer
Actavis Nordic A/S 0megardsvej 16,
2820 Gentofte Denmark
S.C Sindan-Pharma S.R.L.
11th, Ion Mihalache Blvd.
Bucharest, 011171 Romania
This leaflet was last revised in October 2013.
Detailed information on this medicine is available on the web site of {MA/Agency}
The following information is intended for medical or healthcare professionals only:
Vinorelbine 10 mg/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 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 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 10 mg/ml concentrate for solution for infusion 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 10 mg/ml concentrate for solution for infusion should only be given intravenously and after dilution.
Vinorelbine 10 mg/ml concentrate for solution for infusion 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.
It is very important to make sure that the cannula is accurately placed in the vein before the injection is commenced. If Vinorelbine 10 mg/ml concentrate for solution for infusion 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 10 mg/ml concentrate for solution for infusion after the expiry date which is stated on the vial label and carton.
After opening
The content 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.
6