Vinblastine Sulphate 1mg/Ml Injection
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Hospira
Package Leaflet: Information for the User
Vinblastine Sulphate 1 mg/ml Injection
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.
What is in this leaflet:
1. What Vinblastine Sulphate Injection is and what it is used for
2. What you need to know before you use Vinblastine Sulphate Injection
3. How to use Vinblastine Sulphate Injection
4. Possible side effects
5. How to store Vinblastine Sulphate Injection
6. Contents of the pack and other information
1. What Vinblastine Sulphate Injection is and what it is used for
Vinblastine sulphate is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.
Vinblastine Sulphate Injection is sometimes used in the treatment of cancers of the lymph nodes, spleen, bone marrow, testicles, placenta, kidney and breasts It may be given alone or in combination with other anti-cancer medicines.
2. What you need to know before you use Vinblastine Sulphate Injection
Vinblastine Sulphate Injection must never be injected intrathecally (into the spine).
Do not use Vinblastine Sulphate Injection
• if you are allergic to vinblastine or to any of the other ingredients of this medicine (listed in section 6)
• if you have a bacterial infection which is not under control
• if your blood tests show that you do not have enough white blood cells to fight infection
Tell your doctor if any of the above applies to you before this medicine is used.
Warnings and precautions
Talk to your doctor or nurse before using Vinblastine Sulphate Injection
• if you are an elderly patient in poor health or with skin sores
• if you have liver disease, including inflammation of the liver (hepatitis) or yellowing of your skin or the whites of your eyes (jaundice)
If you notice any of the following, and they do not go away, this might also mean that you have liver problems:
• loss of appetite
• feeling itchy
• feeling tired, having no energy or feeling like you have flu
• feeling as though you are going to be sick or actually being sick
If in doubt, check with your doctor.
Tell your doctor if any of the above apply to you before this medicine is used.
Other medicines and Vinblastine Sulphate Injection
Special care is needed if you are taking/using other medicines as some could interact with vinblastine sulphate, for example:
• the use of mitomycin-C and/or progesterone (anti-cancer medicines), with vinblastine may cause breathing problems
• the use of bleomycin or cisplatin (anti-cancer medicines) with vinblastine may cause heart and circulation problems (e.g. Raynaud's phenomenon)
• the use of erythromycin (antibiotic), may increase the side effects of vinblastine
• vinblastine may reduce the effectiveness of medicines used to treat epilepsy
• if you are having radiotherapy in the liver area your doctor will delay giving you vinblastine
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine.
As there is a risk of birth defects, women of childbearing potential should use appropriate contraception methods during treatment with vinblastine sulphate.
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.
Driving and using machines
Do not drive or use machines if you experience any side effect which may lessen your ability to do so.
Vinblastine Sulphate Injection contains sodium
This medicinal product contains 1.5 mmol sodium (35 mg) per vial. To be taken into consideration by patients on a controlled sodium diet.
The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
3. How to use Vinblastine Sulphate Injection
This medicine is given by injection (using a syringe) into a vein. Alternatively, it may be injected into the line of a running infusion (drip).
Vinblastine sulphate is an irritant, if it accidentally gets into your eyes tell your doctor or nurse immediately so that it may be washed out.
You may be given medicines to prevent nausea and vomiting during treatment with vinblastine sulphate.
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The following information is intended for healthcare professionals only:
Cytotoxic Handling Guidelines
Administration: Should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents.
Preparation: Chemotherapeutic agents should be prepared for administration only by professionals who have been trained in the safe use of preparation.
Operations such as reconstitution of powder and transfer to syringes should be carried out only in the designated area.
The personnel carrying out these procedures should be adequately protected with clothing, gloves and eye shield.
Dosage
Your doctor will work out the correct dose of vinblastine sulphate for you and how often it must be given.
The dose will depend on your medical condition, your size and how well your liver is working. Your doctor will tell how well your liver is working using a blood sample. If your liver is not working properly the dose may be reduced.
Vinblastine sulphate is usually given once a week or less.
If you are given too much or too little Vinblastine Sulphate Injection
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.
4. Possible side effects
Like all medicines, this medicine can have side effects, although not everybody gets them.
If any of the following happen, tell your doctor immediately:
• severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.
• pain or swelling at the injection site during or immediately after the injection
These are serious side effects. You may need urgent medical attention.
If any of the following happen, tell your doctor as soon as possible:
• low blood cell count which may be present as anaemia, fever or infection, abnormal bleeding or bruising
• convulsions (fits)
• blood in the stools which may be accompanied by abdominal pain
• blistering of the skin
• mouth ulcers
• sore throat
• significant weight loss
• dizziness
• numbness or pins and needles
• changes or loss of your tendon reflexes tested by tapping your tendon
• mental depression
• stomach cramps, pain in the abdomen, constipation or diarrhoea
• nausea or vomiting
• loss of appetite
• pain where the tumour is
• pain in your bones or muscles or jaw
• headache
• deafness or hearing difficulty which may be temporary or permanent hearing difficulty
• problems with your balance
• uncontrolled movements of the eyes, usually from side to side
• heart attack or stroke
• high blood pressure
• shortness of breath
• weakness
• tiredness and generally feeling unwell
• hair loss
• a reduction in the production of semen
Vinblastine sulphate may lead to changes in your blood cells. Your doctor will take blood samples to monitor for these and also to check how well your liver is working.
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
UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vinblastine Sulphate Injection
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 label and carton after 'EXP'. The expiry date refers to the last day of that month.
The vials should be stored at 2 - 8°C.
The vials should be kept in the outer carton in order to protect from light.
6. Contents of the pack and other information
What Vinblastine Sulphate Injection contains
The active substance is vinblastine sulphate. Each millilitre (ml) of solution contains 1 milligram (mg) of vinblastine sulphate.
The other ingredients are sodium chloride and Water for Injections.
What Vinblastine Sulphate Injection looks like and contents of the pack
Vinblastine Sulphate Injection is a clear, colourless solution which comes in glass containers called vials.
It may be supplied in packs containing 1 x 10 mg/10 ml vial.
Marketing Authorisation Holder and Manufacturer
Hospira UK Limited
Horizon
Honey Lane
Hurley
Maidenhead
SL6 6RJ
This leaflet was last revised in 06/2016
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Pregnant personnel are advised not to handle chemotherapeutic agents.
Contamination: In the event of contact with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to treat the transient stinging of skin. Medical advice should be sought if the eyes are affected.
In the event of spillage, operators should put on gloves and mop the spilled material with a sponge kept in the area for that purpose. Rinse the area twice with water. Put all solutions and sponges into a plastic bag and seal it.
Disposal: Syringes, containers, absorbent materials, solution and any other contaminated material should be placed in a thick plastic bag or other impervious container and incinerated.
The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Hospira