Vinorelbine 10 Mg/Ml Concentrate For Solution For Infusion
advertising & communication services ltd.
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Artwork No. |
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Colours Used | |
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Customer |
Accord |
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Pantone Black |
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Description |
Vinorelbine Injection | ||
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Market |
UK-MT | ||
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Language |
English | ||
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Size |
170 x 550 mm PIL | ||
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Min. Font Size |
9 | ||
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Version No. |
2 (Page 1 of 2) | ||
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Date |
17/10/16 (Vinorelbine (ACC-UK-MT)-PIL) |
Checked By Regulatory Affairs
Approved By Quality Assurance
Prepared By Regulatory Affairs
a ccrd
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.
- 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 pharmacist. See section 4.
What is in this leaflet:
1. What Vinorelbine solution is and what it is used for
2. What you need to know before you use Vinorelbine solution
3. How to use Vinorelbine solution
4. Possible side effects
5. How to store Vinorelbine solution
6. Contents of the pack and other information
1. What Vinorelbine solution is and what it is used for
Vinorelbine solution is a concentrate for solution for infusion. The active substance vinorelbine belongs to a group of cytostatic agents. These agents interfere with the growth of malignant cells.
Vinorelbine solution is indicated in adults for the treatment of cancers, specifically non-small cell lung cancer and breast cancer.
2. What you need to know before you use Vinorelbine solution
Do not use Vinorelbine solution:
- if you are allergic to vinorelbine or any medicine in the family of medicines called vinca alkaloids;
- if you are allergic to any of the other ingredients of Vinorelbine solution (listed in section 6);
- if you are pregnant or think you may be pregnant;
- if you are breast-feeding;
- if you have a low white blood cell (neutrophil) count or a current or recent (in the past 2 weeks) serious infection;
- if you have a low platelet count;
- if you are planning to get (or have recently had) a 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 pharmacist before using Vinorelbine solution.
Tell your doctor:
- if you have a history of heart attacks or strong pain in your chest;
- if you have been treated with radiotherapy and the treated area included the liver;
- if you have symptoms of infection (such as fever, shivers, cough);
- if you are planning to get vaccinated;
- if your liver does not work normally.
- Vinorelbine solution 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 solution should use an effective contraception during treatment and after treatment; please refer to the section on pregnancy and breastfeeding. Men and women should BOTH read the information under pregnancy and breast-feeding below
Before each administration of Vinorelbine solution, 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.
Other medicines and Vinorelbine solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor needs to be particularly careful if you are taking any of the following medicines:
- medicines that make your blood more fluid (anticoagulants)
- an antiepileptic medicine called phenytoin
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 use
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).
- an antifungal medicine called itraconazole
- an anticancer medicine called mitomycin C
- medicines that affect your immune system, such as ciclosporin and tacrolimus.
- Simultaneous use with lapatinib (medicine used to treat cancer).
- St. John’s Wort (Hypericum perforatum)
- antibiotics such as rifampicine, erythromycin, clarithromycin, telithromycin
- antiviral medicines used for AIDS (HIV) such as ritonavir (HIV protease inhibitors)
- verapamil, quinidine (used for heart problems)
Vaccines (e. g. chicken pox, mumps, measles, etc.) and yellow fever vaccines are not recommended during treatment with Vinorelbine solution, as they can increase the risk of fatal systemic disease.
The simultaneous use of Vinorelbine solution and other medicines with known bone marrow toxicity (affecting your white and red blood cells and your platelets) can worsen some of the side effects.
Vinorelbine solution with food and drink
There are no known interactions with food and drink during treatment with Vinorelbine solution.
Use in children and adolescents The safety and efficacy in children and adolescents have not been determined
Pregnancy, breast-feeding and fertility
Pregnancy
• Do not take Vinorelbine solution if you are pregnant or think that you might be pregnant.
• If you have to start treatment with Vinorelbine solution and are pregnant or if pregnancy occurs during your treatment with Vinorelbine solution, you must immediately contact your doctor for advice.
Breast-feeding
• Do not take Vinorelbine solution if you are breast feeding.
• Breast-feeding must be discontinued if treatment with Vinorelbine solution is necessary.
Fertility
Men being treated with Vinorelbine solution are advised not to father a child during treatment and for up to 3 months after the end of the treatment and to seek advice on conservation of sperm prior to treatment because Vinorelbine solution may alter male fertility.
Women of child-bearing potential Women of childbearing potential must be advised to use effective contraception during treatment and three months thereafter and should inform their doctor if they become pregnant.
Driving and using machines
No studies have been conducted on the effect of Vinorelbine solution on the ability to drive or use machines. Therefore, do not drive if your doctor has recommended not driving or if you feel unwell.
3. How to use Vinorelbine solution
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
Vinorelbine solution can only be prepared and administered by a qualified healthcare professional specialised in oncology.
Before each administration, a new blood sample will be taken to check its components, in order to confirm that the patient has enough blood cells to receive Vinorelbine solution. If the results of these tests are not satisfactory, treatment may be postponed and new tests will be conducted until these values return to normal.
The usual dose for adults is 25 to 30 mg/m2.
Frequency of administration
Vinorelbine solution is scheduled once a week. The frequency will be determined by your doctor.
Always follow your doctor's instructions.
Dose adjustment:
- In case of significant liver failure, the dose can be adjusted by your doctor. You must follow your doctor's instructions.
- In case of kidney failure, dose adjustment is not necessary. You must follow your doctor's instructions.
Spills and leakages must be wiped up, wearing protective gloves.
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. Preparation of the solution for infusion.
There is no incompatibility between Vinorelbine solution and glass vials, PVC bag, vinyl acetate bag or polypropylene syringe.
In case of polychemotherapy, Vinorelbine solution should not be mixed with other agents.
The intra-thecal route is contraindicated. Vinorelbine solution must only be administered by the intravenous route as an infusion. Vinorelbine solution may be administered by slow bolus (6-10 minutes) after dilution in 20-50ml of normal saline or glucose 50mg/ml (5%) solution
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Artwork No. |
- |
Colours Used | |||||
|
Customer |
Accord |
■ |
Pantone Black | ||||
|
Description |
Vinorelbine Injection | ||||||
|
nd4 |
Market |
UK-MT | |||||
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£ (j |
Language |
English | |||||
|
SP |
Size |
170 x 550 mm PIL | |||||
|
advertising & communication services ltd. |
Min. Font Size |
9 | |||||
|
Version No. |
2(Page 2 of 2) | ||||||
|
Date |
17/10/16 (Vinorelbine (ACC-UK-MT)-PIL) | ||||||
Prepared By Regulatory Affairs
Checked By Regulatory Affairs
Approved By Quality Assurance
L
Method and route of administration
Vinorelbine solution must be diluted before administration
Vinorelbine solution must only be administered into a vein. It will be given by an infusion into one of your veins. It will take between 6 to 10 minutes.
After administration the vein will be rinsed thoroughly with a sterile solution.
If you take more Vinorelbine solution than you should
Your doctor must always ensure that you receive the dose that is suitable for your situation. However, you should contact your doctor, the emergency department or your pharmacist if you have any suspicions or if you have symptoms of a potential overdose, such as fever, signs of infection or constipation.
If you have any further questions, 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 a doctor:
Uncommon (may affect up to 1 in 100 people) Severe infections with different organ failure or blood poisoning. Shortness of breath and narrowing of the airways (bronchospasm).
Rare (may affect up to 1 in 1,000 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 pneumopathy). 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.
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 or nurse. 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 Vinorelbine solution
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and outer packaging, 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 in the original package in order to protect from light
Shelf-life after dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Do not freeze.
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 protect the environment.
6. Contents of the pack and other information
What Vinorelbine solution contains
The active substance is vinorelbine (in the form of tartrate). 1 ml of solution contains 10 mg vinorelbine (as vinorelbine tartrate) .
The other ingredient is water for injection.
Each 1-ml vial contains a total of 10 mg vinorelbine (as tartrate)
Each 5-ml vial contains a total of 50 mg vinorelbine (as tartrate)What Vinorelbine solution looks like and contents of the pack
Clear, colourless to light yellow solution. Vinorelbine solution is packaged in Type I clear glass vial with bromobutyl rubber stopper and aluminium flip off blue seal.
Vinorelbine solution is available in:
Vial - 1 unit(s) - 1 ml Vial - 1 unit(s) - 5 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Accord Healthcare Limited Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF United Kingdom
This leaflet was last revised in 10/2016.
INP001
10 00000 0000000
or by a short infusion (20-30 minutes) after dilution in 125ml of normal saline or glucose 50mg/ml (5%) solution. Administration should always be followed with at least 250 ml of a isotonic solution 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.
Excreta and vomit must be handled with care. Storage
Store in a refrigerator (2°C - 8°C). Do not freeze. Store in the original package in order to protect from light
Shelf-life after dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Do not freeze.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.