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VINCRISTINE SULPHATE 1MG/ML INJECTION

Active substance(s): VINCRISTINE SULPHATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Vincristine Sulphate 1 mg/ml Injection
(1 mg/1 ml and 2 mg/2 ml vials)
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.
• If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Vincristine Sulphate Injection is and what it is used for
2. What you need to know before you use Vincristine Sulphate Injection
3. How to use Vincristine Sulphate Injection
4. Possible side effects
5. How to store Vincristine Sulphate Injection
6. Contents of the pack and other information

1. WHAT VINCRISTINE SULPHATE INJECTION IS AND WHAT IT IS USED
FOR
Vincristine sulphate is an anti-cancer medicine. Treatment with an
anti-cancer medicine is sometimes called cancer chemotherapy.
Vincristine Sulphate Injection is used in the treatment of cancers of the
blood (eg. leukaemia or lymphomas), breast, head and neck or lung. It may
be used to treat multiple myeloma (a cancer of plasma cells) and it may
also be used in the treatment of some cancers in children. It may be used in
a blood disorder known as idiopathic thrombocytopenic purpura (ITP) after
other treatments have not been successful.
Vincristine Sulphate Injection may be given alone or in combination with
other anti-cancer medicines.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE VINCRISTINE
SULPHATE INJECTION
Vincristine Sulphate Injection must never be injected intrathecally
(into the spine).

Do not use Vincristine Sulphate Injection
• if you have shown signs of hypersensitivity (severe allergy) to vincristine
or mannitol in the past
• if you have Charcot-Marie-Tooth syndrome (disease which causes
weakness in the leg muscles)
• if you have an infection that is not being treated
Tell your doctor if any of the above applies to you before this medicine is used.

Take special care with Vincristine Sulphate Injection
• to make sure that this medicine is only given to you through a vein (it
should not be given by any other route). If you notice any pain during, or
soon after the injection is given, tell your doctor or nurse immediately
• if you have a mental or nervous system disorder
• if you have liver trouble
• if you have kidney cancer
• if you are having radiotherapy
• if you have breathing problems
• if you have a low white blood cell count measured on blood test
• if you have an infection
Tell your doctor if any of the above applies to you before this medicine is used.
Special care is also needed if you are elderly.

Other medicines and vincristine Sulphate Injection
Tell your doctor if you are taking, have recently taken or might take any
other medicines.
Use of the following medicines may make the side effects of vincristine
sulphate worse:
• isoniazid (medicine used to treat tuberculosis)
• mitomycin-C (anti-cancer medicine)
• itraconazole (a medicine used to treat fungal infections)
• L-asparaginase (used for treating some types of cancer)
• dactinomycin (used for treating some types of cancer)
• some anti-cancer drugs (eg containing platinum) that may cause
problems with hearing or balance
• medicines which cause problems with passing water (urine). These
should be stopped before you start treatment with vincristine
• medicines which cause problems with your nervous system e.g. walking
difficulties, pins and needle or numbness
Phenytoin (medicine used to control fits) may not work as well when vincristine
sulphate is used, so blood levels of phenytoin will need to be monitored.
Methotrexate used in the treatment of cancer may work better when used
with vincristine.
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

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 for advice before taking this medicine.
Women of childbearing potential should use appropriate contraception
methods during treatment with vincristine sulphate.

Driving and using machines
Do not drive or use machines if you experience any side effect which may
lessen your ability to do so.

Vincristine Sulphate Injection contains Latex
The vial stopper contains dry natural rubber (a derivative of latex), which
may cause allergic reactions.

3. HOW TO USE VINCRISTINE SULPHATE INJECTION
This medicine is given by infusion (drip) into a vein.
Vincristine sulphate is an irritant, if it accidentally gets into your eye tell your
doctor or nurse immediately so that it may be washed out.
You may be given medicines to prevent constipation during treatment with
vincristine sulphate.

Dosage
Your doctor will work out the correct dose of vincristine 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.
Vincristine sulphate is usually given once a week.

If you are given too much or too little Vincristine 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 little or too much, however,
tell your doctor or nurse if you have any concerns.

Vincristine Sulphate 1 mg/ml Injection
The following information is intended for medical or healthcare
professionals only
Further to the information included in section 3, practical information on the
preparation/handling of the medicinal product is provided here.

Incompatibilities
Vincristine Sulphate Injection should not be mixed with any other drug and
should not be diluted in solutions that raise or lower the pH outside the range
3.5 to 5.5. Furosemide both in syringe and injected sequentially into Y-site with
no flush between, results in immediate precipitation.
Instructions for use
This preparation is for intravenous use only. Fatal if given by any other route.
It should only be administered by individuals experienced in vincristine
administration.
It is recommended to infuse vincristine sulphate over 5 to 10 minutes after
dilution in a 50 ml infusion bag with Sodium Chloride 9 mg/ml (0.9%) Solution
for Injection. After administration the vein must be flushed through thoroughly.
Care should be taken to avoid extravasation. If leakage into surrounding
tissue should occur it may cause considerable irritation. The injection should
be discontinued immediately and any remaining portion of the dose should
then be introduced into another vein. Local injection of hyaluronidase and the
application of moderate heat to the area of leakage may help to disperse the
drug and are thought to minimise discomfort and the possibility of cellulitis.
P10009035

4. POSSIBLE SIDE EFFECTS
Like all medicines, vincristine sulphate 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
• severe chest pains possibly radiating to the jaw or arm, sweating,
breathlessness and nausea
• severe breathing problems or shortness of breath
• symptoms suggestive of sepsis – these may include a high fever or low
temperature, shivering, fast heartbeat, rapid breathing, feeling faint, skin
changes (cold, clammy and mottled or pale), altered mental state such
as confusion or disorientation, decreased urination, nausea, vomiting etc.
The presence of a few or several of these symptoms coupled with a rapid
deterioration of general condition might indicate sepsis and immediate
medical attention should be sought.
These are serious side effects. You may need urgent medical attention.
All of these serious side effects are rare.

If any of the following happen, tell your doctor as soon as possible:





convulsions (fits)
deafness or hearing loss
worsening eyesight
pain (may involve the side of the face, jaw, throat, neck, bones or
muscles)
• dizziness
• fever, sore throat, skin rashes, or sores on your body and mouth ulcers
(may indicate a drop in white blood cells)
• significant weight loss
• numbness or pins and needles
• difficulty in walking
• muscle weakness or muscle wasting
• difficulty with speech
• unusual eye movements
• problems with passing water (more or less urine than normal, or pain
when passing urine)
• mild breathing problems
• raised or lowered blood pressure
• headache
• tiredness
• unexpected bruises
• stomach cramps, constipation or diarrhoea
• being sick or feeling sick
• hair loss
• soreness around the injection site after the injection
• infections with germs
• loss of appetite
Vincristine sulphate may lead to changes in your blood cells, including
a type of anaemia in which red blood cells are destroyed (haemolytic
anaemia). Your doctor may take blood samples to monitor for these and
also to check how well your liver is working.
There have been reports of other malignancies (cancers) occurring at
a later date after vincristine has been used in combination with other
anti-cancer drugs. This happens rarely.

Effects on fertility
Treatment with vincristine sulphate may permanently reduce fertility in men
and women. Tell your doctor if you have concerns.

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:
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 VINCRISTINE SULPHATE INJECTION
Keep this medicine out of the sight and reach of children

Expiry
This medicine must not be used after the expiry date which is stated on the
vial label and carton after ‘EXP’. Where only a month and year is stated,
the expiry date refers to the last day of that month.

Storage Conditions
Store in a refrigerator (2ºC - 8 ºC). The vials should be kept in the outer
carton, in order to protect from light.
Medicines should not be disposed of via waste water or household waste.
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 Vincristine Sulphate Injection contains
The active substance is vincristine sulphate. Each millilitre (ml) of solution
contains 1 milligram (mg) of vincristine sulphate.
The other ingredients are mannitol and Water for Injections.

What Vincristine Sulphate Injection looks like and contents of the
pack
Vincristine Sulphate Injection is a colourless solution which comes in glass
containers called vials.
It may be supplied in packs containing 5 x 1 mg/1ml vials or 5 x 2 mg/2ml
vials.

Marketing authorisation holder and manufacturer responsible for
batch release in Europe
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK

Manufacturer
Hospira Australia Pty Ltd,
1-5, 7-23 and 25-39 Lexia Place
MULGRAVE VIC 3170,
Australia
This leaflet was last revised in 05/2017
Ref: gxVC 2_0

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.
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 then 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.
Ref: gxVC 2_0

P10009035

P10009035

Vincristine for intravenous
use only
Fatal if given by other routes

P10009035

Vincristine for intravenous
use only
Fatal if given by other routes

P10009035

Vincristine for intravenous
use only
Fatal if given by other routes

P10009035

Vincristine for intravenous
use only
Fatal if given by other routes

P10009035

Vincristine for intravenous
use only
Fatal if given by other routes

P10009035

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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