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VELBE INJECTION 10MG

Active substance(s): VINBLASTINE SULPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Velbe Injection 10mg *
(Vinblastine Sulphate)
Read all of this leaflet carefully before you start taking this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
- If any of the side-effects get serious, or if you notice any sideeffects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Velbe is and what it is used for
4. Possible side-effects
2. Before you use Velbe
5. How to store Velbe
3. How to use Velbe
6. Further information
1. WHAT VELBE IS AND WHAT IT IS USED FOR
Velbe contains vinblastine sulphate. Velbe is a cytotoxic drug.
Cytotoxic drugs kill cells which are dividing, including cancer cells. It
is used to treat patients who have a cancer such as Hodgkin’s
Disease or a lymphoma, or a cancer of the breast, placenta, kidney,
testicle or blood. If your doctor gives you this medicine for anything
else, ask him or her if you have any questions.

2. BEFORE YOU USE VELBE
Do not use Velbe if you are:
• allergic (hypersensitive) to vinblastine sulphate or any of the
other ingredients in Velbe (see section 6 – Further information for
details)
• taking antibiotics, or you think you have an infection.
Take special care with Velbe if you:
• are having radiotherapy in the
• have liver trouble
liver area
• have problems with your
• suffer from constipation
breathing.
• have suffered from a peptic
ulcer
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Take care if you are taking any of the following medicines:
• phenytoin for treating epilepsy
• cytotoxic drugs called mitomycin, cisplatin or carboplatin.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking any
medicine.
3. HOW TO USE VELBE
Your doctor will only inject Velbe into a vein. It must never be

Information for the Health Care Professional
SUMMARY OF PRODUCT CHARACTERISTICS

VELBE*
WARNING

FATAL IF GIVEN BY OTHER ROUTES. FOR INTRAVENOUS USE ONLY.
1 Name of the Medicinal Product Velbe injection 10 mg.
2 Qualitative and Quantitative Composition Vinblastine Sulphate Ph. Eur. 10 mg as the base.
3 Pharmaceutical Form Powder for solution for intravenous injection.
4 Clinical Particulars
4.1 Therapeutic Indications Velbe is an anti-neoplastic drug for intravenous use. Information available
at present suggests that Velbe may be useful, either alone or in combination with other oncolytic
drugs for the treatment of: Hodgkin’s disease; non-Hodgkin’s lymphoma; carcinoma of the breast;
methotrexate-resistant choriocarcinoma; renal cell carcinoma; testicular teratoma and seminoma;
histiocytosis X. Other neoplasms occasionally show a marked response to Velbe, but less frequently
than the more susceptible conditions listed above.
4.2 Posology and method of administration This preparation is for intravenous use only. It should be
administered only by individuals experienced in vinblastine administration.
FATAL IF GIVEN BY OTHER ROUTES. FOR INTRAVENOUS USE ONLY.
In case of mistaken administration by the intrathecal route, see section 4.4.
The recommended dose for adults, the elderly and children is 6 mg/m2 usually administered no more
frequently than once every seven days. For testicular tumours, the dosage may be increased to 0.2
mg/kg administered on each of two consecutive days every three weeks. As vinblastine is excreted
principally by the liver, toxicity may be increased when there is hepatic insufficiency and it may be
necessary to reduce initial doses in the presence of significantly impaired hepatic or biliary function.
A reduction of 50% in the dose is recommended for patients having a direct serum bilirubin value
above 3 mg/100 ml. Since metabolism and excretion are primarily hepatic, no modification is
recommended for patients with impaired renal function.
The metabolism of vinca alkaloids has been shown to be mediated by hepatic cytochrome P450
isoenzymes in the CYP 3A subfamily. This metabolic pathway may be impaired in patients with
hepatic dysfunction or who are taking concomitant potent inhibitors of these isoenzymes. (See
‘Interaction with other medicinal products and other forms of interaction’).
To prepare a solution containing 1 mg/ml, add 10 ml of sterile 0.9% sodium chloride intravenous
infusion to the 10 mg vial. The drug dissolves rapidly to give a clear solution.
The dose of Velbe solution may be injected either into the tubing of a running intravenous infusion of
sodium chloride 0.9% or directly into a vein. In either case, the injection should be completed in about
1 minute. If care is taken to ensure that the needle is securely within the vein and that no solution
containing vinblastine is spilled extravascularly, cellulitis and/or phlebitis will not occur. To minimise
further the possibility of extravascular spillage, it is suggested that the syringe and needle be rinsed
with venous blood before withdrawal. The dose should not be diluted in large volumes of diluent (ie,
100 to 250 ml) or given intravenously for prolonged periods (ranging from 30 to 60 minutes or more),
since this frequently results in irritation of the vein and increases the chance of extravasation.
Because of the enhanced possibility of thrombosis, it is considered inadvisable to inject a solution of
Velbe into an extremity in which the circulation is impaired, or potentially impaired, by such conditions
as compressing or invading neoplasm, phlebitis or varicosity.
Caution: If leakage into surrounding tissue should occur during intravenous administration of
vinblastine, 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 help disperse the drug and
are thought to minimise discomfort and the possibility of cellulitis.
4.3 Contra-indications
FATAL IF GIVEN BY OTHER ROUTES. FOR INTRAVENOUS USE ONLY.
In case of mistaken administration by the intrathecal route, see section 4.4.
Vinblastine is contra-indicated in patients who are leucopenic unless this is the result of the disease
being treated. It should not be used in the presence of bacterial infection. Such infections must be
brought under control with antiseptics or antibiotics before using vinblastine.
4.4 Special Warnings and Precautions for Use
Warnings: This product is for intravenous use only. It should be administered by individuals
experienced in the administration of vinblastine sulphate. The intrathecal administration of vinblastine
sulphate usually results in death. Syringes containing this product should be labelled “FATAL IF
GIVEN BY OTHER ROUTES FOR INTRAVENOUS USE ONLY” An auxiliary sticker is provided in the
pack with this warning. Extemporaneously prepared syringes containing this product must be
packaged in an overwrap which is labelled ‘DO NOT REMOVE COVERING UNTIL MOMENT OF
INJECTION. FATAL IF GIVEN BY OTHER ROUTES. FOR INTRAVENOUS USE ONLY’. After
inadvertent intrathecal administration of vinca alkaloids, immediate neurosurgical intervention is
required in order to prevent ascending paralysis leading to death. In a very small number of patients,
life-threatening paralysis and subsequent death was averted but resulted in devastating neurological
sequelae, with limited recovery afterwards.
Based on the published management of survival cases involving the related vinca alkaloid vincristine
sulphate, if vinblastine is mistakenly given by the intrathecal route, the following treatment should be
initiated immediately after the injection:
1. Removal of as much CSF as is safely possible through the lumbar access.
2. Insertion of an epidural catheter into the subarachnoid space via the intervertebral space above
initial lumbar access and CSF irrigation with lactated Ringer's solution. Fresh frozen plasma
should be requested and, when available 25ml should be added to every 1 litre of lactated
Ringer's solution.
3. Insertion of an intraventricular drain or catheter by a neurosurgeon and continuation of CSF
irrigation with fluid removal through the lumbar access connected to a closed drainage system.
Lactated Ringer’s solution should be given by continuous infusion at 150 ml/h, or at a rate of 75
ml/h when fresh frozen plasma has been added as above.
Please read the back of this leaflet!

Format: 300 x 420 mm
Satzspiegel: 280 x 400 mm

injected intrathecally (into your back with the needle going into your
spine). If you have a bacterial infection, your doctor will probably treat
the infection, before starting treatment with Velbe.
Velbe and most other cytotoxic drugs may affect the cells in your
bone marrow. These cells divide quickly to make new blood cells.
Your doctor or nurse will take samples of your blood when you are
treated with Velbe. The hospital’s laboratory will then count the
numbers of different types of blood cells (platelets, white cells and red
cells). Your doctor may decide to change the dose or put off treating
you if your blood cell counts are too low. Your blood cell counts soon
improve as the bone marrow makes new cells.
A lot of injections (more than one a week) may cause more
side-effects.
Velbe works by sticking to certain molecules in dividing cells to stop
the cells dividing. It also sticks to the same sort of molecule in nerves
and causes side-effects to your nervous system (please see section 4
– Possible side-effects.) You may not notice the start of these
side-effects until you have had several injections. Your doctor may
also decide to change the dose or put off treating you if these
side-effects are severe. The effects on your nervous system usually
get better when you stop being treated with Velbe.
Your doctor or nurse will take great care that the Velbe solution does
not leak out of your vein when it is being injected. Please tell them
immediately if you have pain or swelling during the injection or later. If
this is not treated quickly, Velbe can cause your tissue to be inflamed
where the solution leaked out. They will also be very careful that Velbe
does not get into anyone’s eyes.

The rate of infusion should be adjusted to maintain a spinal fluid protein level of 150 mg/dl.
The following measures have also been used in addition but may not be essential:
Glutamic acid has been given IV 10 gm over 24 hours, followed by 500 mg tds by mouth for 1 month.
Folinic acid has been administered intravenously as a 100 mg bolus and then infused at a rate of 25
mg/h for 24 hours, then bolus doses of 25 mg 6-hourly for 1 week. Pyridoxine has been given at a
dose of 50 mg 8-hourly by intravenous infusion over 30 minutes. Their roles in the reduction of
neurotoxicity are unclear.
Aspermia has been reported in men. Animal studies show metaphase arrest and degenerative
changes in germ cells. Amenorrhoea has occurred in some patients treated with vinblastine in
combination with other drugs.
Recovery of menses was frequent.
Stomatitis and neurological toxicity, although not common or permanent, can be disabling.
Precautions: Care must be taken to avoid contamination of the eye with concentrations of Velbe used
clinically. If accidental contamination occurs, severe irritation (or, if the drug was delivered under
pressure, even corneal ulceration) may result. The eye should be washed with water immediately and
thoroughly. Sperm abnormalities have been noticed in mice. Additional studies in mice demonstrated
no reduction in fertility in males.
Myelosuppression: The dose-limiting factor is myelosuppression. Effective therapy with vinblastine is
more likely to be followed by leucopenia than is the case with Oncovin (vincristine sulphate).
In general, the larger the dose employed, the more profound and longer lasting the leucopenia will be.
The fact that the granulocyte count returns to normal levels after drug-induced leucopenia is an
indication that the granulocyte producing mechanism is not permanently depressed. Following
therapy with vinblastine, the nadir in the granulocyte count may be expected to occur five to ten days
after the last day of drug administration.
Recovery of the granulocyte count is fairly rapid thereafter and is usually complete within another
seven to fourteen days. If granulocytopenia with less than 1,000 granulocytes/mm3 occurs following
a dose of vinblastine, the patient should be watched carefully for evidence of infection until the
granulocyte count has returned to a safe level. Any infection must be brought under control
immediately. When cachexia or ulcerated areas of the skin surface are present, there may be a more
profound granulocytopenic response to the drug; therefore, its use should be avoided in older
persons suffering from either of these conditions. Although the thrombocyte count is not usually
significantly lowered by therapy with vinblastine, patients whose bone marrow has been recently
impaired by prior therapy with radiation or with other oncolytic drugs may show thrombocytopenia
(less than 150,000 platelets/mm3). When other chemotherapy or radiation has not been employed
previously, thrombocyte reduction below the level of 150,000/mm3 is rarely encountered, even when
vinblastine may be causing significant granulocytopenia. Rapid recovery from thrombocytopenia
within a few days is the rule.
The effect of vinblastine upon the red blood cell count and haemoglobin is usually insignificant when
other treatment does not complicate the picture. In patients with malignant-cell infiltration of the bone
marrow, the granulocyte and platelet counts have sometimes fallen drastically after moderate doses
of vinblastine. Further use of the drug in such patients is inadvisable. Breaks and aberrations were not
observed on chromosome analysis of marrow cells from patients treated with vinblastine although
chromosomal changes have been noted in some hamster lung cell in vitro tests. There is no currently
available evidence to indicate that vinblastine itself has been carcinogenic in humans although some
patients have developed leukaemia following radiation therapy and the administration of vinblastine
in combination with alkylating agents.
Pharmaceutical precautions
Special dispensing information: When dispensing vinblastine in other than the original container, it is
imperative that it be packed in an overwrap bearing the statement ‘DO NOT REMOVE COVERING
UNTIL MOMENT OF INJECTION. FATAL IF GIVEN BY OTHER ROUTES. FOR INTRAVENOUS
USE ONLY’. A syringe containing a specific dose must be labelled, using the auxiliary sticker
provided in the pack with this warning.
Guidelines for the safe handling of antineoplastic agents: cytotoxic preparations should not be
handled by pregnant staff. Trained personnel should reconstitute and administer the drug. This
should be performed in a designated area. The work surface should be covered with disposable
plastic-backed absorbent paper.
Adequate protective gloves, mask and clothing should be worn. Precautions should be taken to avoid
the drug accidentally coming into contact with the eyes. If accidental contamination occurs, the eyes
should be washed with water thoroughly and immediately.
Use Luer-Iock fitting on all syringes and sets. Large bore needles are recommended to minimise
pressure and the possible formation of aerosols. The latter may also be reduced by the use of a
venting needle. Adequate care and precaution should be taken in the disposal of items (syringes,
needles, etc.) used to reconstitute cytotoxic drugs.
Vials of Velbe should be stored in a refrigerator between 2° and 8°C.
After reconstitution: after a portion of the solution has been removed from a vial, the remainder of the
contents of the vial may be stored in a refrigerator for further use for 24 hours without significant loss
of potency. When the reconstituted vial of Velbe is to be stored for more than 24 hours, it is essential
to reconstitute with sterile 0.9% sodium chloride intravenous infusion preserved with 2.0% benzyl
alcohol. Where preserved diluent is used, the reconstituted solution may be stored in a refrigerator for
up to 28 days without significant loss of potency.
Whenever solution and container permit, parental drug products should be inspected visually for
particulate matter and discolouration prior to administration.
4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
When chemotherapy is being given in conjunction with radiation therapy through portals which
include the liver, the use of vinblastine should be delayed until radiation therapy has been completed.
Acute shortness of breath and severe bronchospasm have been reported following the administration
of the vinca alkaloids. These reactions have been encountered most frequently when the vinca
alkaloid was used in combination with mitomycin-C and may be serious when there is pre-existing
pulmonary dysfunction. The onset may be within minutes, or several hours after the vinca is injected,
and may occur up to 2 weeks following a dose of mitomycin.
Progressive dyspnoea, requiring chronic therapy, may occur. Vinblastine should not be
re-administered. The simultaneous oral or intravenous administration of phenytoin and
anti-neoplastic chemotherapy combinations, that included vinblastine sulphate, have been

25196601

Adults and children
The usual dose is 6 milligrams for every square metre of your body
surface. This dose may be increased for testicular cancers or reduced
if you suffer from liver problems.
Your nurse will measure your height and weight and work out your
body surface area from the measurements. Your doctor will use your
body surface area to work out the right dose for you.
Your doctor or nurse will inject the correct amount of Velbe - usually
once a week. Velbe must only go into a vein. You may have an
injection every week and your doctor may treat you with other
cytotoxic drugs at the same time.
If you are being treated as an out-patient it is important that you go to
the clinic for all your appointments.
If you receive more Velbe Injection than you should
As a doctor or nurse will usually give this medicine to you, it is unlikely
that you will be given too much or that you will miss a dose. However,
if you are worried tell the doctor or nurse.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Velbe can cause side-effects, although not everybody gets them.
Very rare side-effects include:
• heart attack or a stroke when receiving Velbe with other cytotoxic
drugs.
Rare side-effects include:
• hearing difficulty – sometimes with dizziness or eyeball movements
• fits.

Other side-effects that have been reported:
• a low blood cell count causing
• numbness or tingling in your
a fever, abnormal bleeding
fingers or toes
or bruising
• feet slapping the ground
• loss of reflexes
when walking
• nerve, muscle, bone, jaw pain
• a headache or depression
or pain in the tumour
• feeling or being sick
• constipation, which may
• losing your appetite
be severe
• bleeding from your rectum or
• abdominal pain
in your stools
• sore mouth
• diarrhoea
• pain or swelling where you have • losing hair (the hair may
the injection
regrow while you are still
• being short of breath
being treated)
• feeling weak, confused or
• feeling weak or unwell
drowsy (due to lack of sodium
• high blood pressure
in the blood)
• being less fertile.
If any of the side-effects get serious or if you notice any side-effects
not listed in this leaflet, please tell your doctor or pharmacist.
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 the Yellow Card Scheme at:
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 VELBE
Keep out of the sight and reach of children.
The hospital pharmacy should keep the bottles of Velbe in a fridge
(2-8°C). When Velbe has been dissolved, the hospital should keep the
Velbe solution in a fridge.
The bottle should not be used after the expiry date printed on the
bottle label. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help protect the environment
6. FURTHER INFORMATION
The active substance in Velbe is vinblastine sulphate.
What Velbe looks like and the contents of the pack
Velbe is a white crystalline powder, supplied as a lyophilised plug in a
rubber stoppered 10ml glass vial.
POM
PL 06831/0116
Velbe Injection 10mg
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Genus Pharmaceuticals,
Linthwaite, Huddersfield, HD7 5QH, UK.
Manufacturer: Cellpharm GmbH, Feodor-Lynen-Str. 35, D – 30625
Hannover, Germany.
This leaflet was last approved in September 2014
* Velbe (vinblastine sulphate) is a registered trademark of Genus Pharmaceuticals
Limited

swallowed, activated charcoal in a water slurry may be given by mouth along with a cathartic. The use
reported to reduce blood levels of the anticonvulsant and to increase seizure activity. Although the
of cholestyramine in this situation has not been reported.
contribution of the vinca alkaloids has not been established, dosage adjustment of phenytoin, based
on serial blood level monitoring, may need to be made when it is used in combination with vinblastine. 5 Pharmacological Properties
Caution should be exercised in patients concurrently taking drugs known to inhibit drug metabolism
5.1 Pharmacodynamic Properties. Studies suggest that vinblastine sulphate acts by interfering with
by hepatic cytochrome P450 isoenzymes in the CYP 3A subfamily, or in patients with hepatic
metabolic pathways of amino acids. Other studies have demonstrated that vinblastine sulphate
dysfunction. Concurrent administration of vinblastine sulphate with an inhibitor of this metabolic
produces a stathmokinetic effect and various atypical mitotic figures. The therapeutic responses,
pathway may cause an earlier onset and/or an increased severity of side-effects.
however, are not fully explained by the cytologic changes, since these changes are sometimes
4.6 Pregnancy and lactation
observed clinically and experimentally in the absence of any oncolytic effects. Reversal of the
Usage in pregnancy: Caution is necessary with the use of all oncolytic drugs during pregnancy.
anti-tumour effect of vinblastine sulphate by glutamic acid or tryptophan has been observed. In
Information on the use of vinblastine during human pregnancy is very limited but vinblastine can cause
addition, glutamic acid and aspartic acid have protected mice from lethal doses of vinblastine
foetal harm when administered to a pregnant woman. There are no adequate and well-controlled
sulphate. Aspartic acid was relatively ineffective in reversing the anti-tumour effect. Some studies
studies in pregnant women.
indicate that vinblastine sulphate has an effect on cell-energy production required for mitosis and
Animal studies with vinblastine suggest that teratogenic effects may occur. Laboratory animals given
interferes with nucleic acid synthesis. The mechanism of Velbe has been related to the inhibition of
this drug early in pregnancy suffer resorption of the conceptus; surviving foetuses demonstrate gross
microtubule formation in the mitotic spindle, resulting in an arrest of dividing cells at the metaphase
deformities.
stage.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving
5.2 Pharmacokinetic properties. Pharmacokinetic studies in patients with cancer have shown a
vinblastine. If Velbe is used during pregnancy or if the patient becomes pregnant while receiving this
triphasic serum decay pattern following rapid intravenous injection. The initial, middle, and terminal
drug she should be informed of the potential hazard to the foetus.
half-lives are 3.7 minutes, 1.6 hours, and 24.8 hours respectively. The volume of the central
Usage in nursing mothers: It is not known whether vinblastine is excreted in human milk. Because of
compartment is 70% of body weight, probably reflecting very rapid tissue binding to formed elements
the potential for serious adverse reactions due to Velbe in nursing infants, a decision should be made
of the blood. Extensive reversible tissue binding occurs.
whether to discontinue nursing or the drug taking into account the importance of the drug to the
Low body stores are present at 48 and 72 hours after injection. Since the major route of excretion may
mother.
be through the biliary system, toxicity from this drug may be increased when there is hepatic
4.7 Effects on the Ability to Drive and Use Machines None known.

4.8 Undesirable effects. Leucopenia is the most common adverse reaction and is usually the doselimiting factor.
In general, the incidence of side effects attending the use of Velbe appears to be related to the size
of dosage employed. Symptoms commonly encountered when high doses are employed include
constipation, abdominal pain, ileus and myalgia. The use of small amounts of vinblastine daily for long
periods is not advisable, even though the resulting total dosage may be similar to the recommended
dosage. Little or no therapeutic advantage has been demonstrated when such regimens have been
used and side effects are increased. The constipation which may be encountered responds well to
such usual measures as enemas and laxatives.
Constipation may take the form of upper colon impaction and the rectum may be found to be empty
on physical examination. A flat film of the abdomen is useful in demonstrating this condition. A routine
prophylactic regimen against constipation is recommended for patients receiving high doses of
vinblastine.
The following symptoms may occur after usual doses of vinblastine:
Haematological: Leucopenia, thrombocytopenia, anaemia.
Gastro-intestinal: Nausea, vomiting, constipation, ileus, diarrhoea, anorexia, abdominal pain, rectal
bleeding, pharyngitis, haemorrhagic enterocolitis, bleeding from an old peptic ulcer.
Neurological: Numbness, paraesthesiae, peripheral neuritis, mental depression, loss of deep tendon
reflexes, headache, convulsions. Treatment with vinca alkaloids has resulted rarely in both vestibular
and auditory damage to the eighth cranial nerve. Manifestations include partial or total deafness,
which may be temporary or permanent, and difficulties with balance, including dizziness, nystagmus
and vertigo. Particular caution is warranted when vinblastine sulphate is used in combination with
other agents known to be ototoxic, such as the platinum-containing oncolytics.
Pulmonary: See under ‘Interaction with other medicinal products and other forms of interaction’.
Cutaneous: Stomatitis, ulceration of the skin and alopecia. When alopecia develops it is frequently not
total and, in some cases, hair regrows while maintenance therapy continues.
Cardiovascular: Hypertension. Cases of unexpected myocardial infarction and cerebrovascular
accidents have occurred in patients undergoing combination chemotherapy with vinblastine,
bleomycin and cisplatin.
Miscellaneous: Malaise, weakness, dizziness, bone pain, jaw pain, and pain in tumour-containing
tissue.
Injection site reaction (see ‘Posology and Method of Administration’). Syndrome of inappropriate ADH
secretion has been reported with higher than recommended doses. Raynaud's phenomenon has
occurred when patients are being treated with vinblastine in combination with bleomycin and cisplatin
for testicular cancer.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
4.9 Overdose. Side effects following the use of vinblastine are dose related. Therefore, following
administration of more than the recommended dose, patients can be expected to experience these
effects in an exaggerated fashion. Any dose that results in elimination of platelets and neutrophils
from blood and marrow and their precursors from marrow is life-threatening. Overdoses occurring
during prolonged, consecutive day infusions may be more toxic than the same total dose given by
rapid IV injection. In addition, neurotoxicity similar to that seen with Oncovin (vincristine sulphate) may
be observed. Supportive care should include: (a) prevention of the side effects that result from the
syndrome of inappropriate secretion of antidiuretic hormone. This includes restriction of fluid intake
and perhaps the use of a diuretic acting on the loop of Henle and distal tubule function; (b)
administration of an anticonvulsant; (c) prevention and treatment of ileus; (d) monitoring the patient's
cardiovascular system; (e) daily blood counts for guidance in transfusion requirement and assessing
the risk of infection. The major effect of excessive doses of vinblastine will be on granulocytopoiesis,
and this may be life-threatening.
There is no specific antidote. The use of folinic acid in addition to the other supportive measures
recommended may be considered although, unlike vincristine, studies have not been conducted to
confirm its protective action. There is no information regarding the effectiveness of dialysis nor of
cholestyramine for the treatment of overdosage.
Vinblastine in the dry state is irregularly and unpredictably absorbed from the gastro-intestinal tract
following oral administration. Absorption of the solution has not been studied. If vinblastine is

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excretory insufficiency.
Following injection of tritiated vinblastine in the human cancer patient, 10% of the radioactivity was
found in the faeces and 14% in the urine; the remaining activity was not accounted for. Similar studies
in dogs demonstrated that, over 9 days, 30% to 36%of radioactivity was found in the bile and 12%
to 17%in the urine.
A similar study in the rat demonstrated that the highest concentrations of radioactivity were found in
the lung, liver, spleen and kidney 2 hours after injection.
5.3 Preclinical safety data Sperm abnormalities have been noted in mice. Additional studies in mice
demonstrated no reduction in fertility of males. Breaks and aberrations were not observed on
chromosome analysis of marrow cells from patients treated with vinblastine although chromosomal
changes have been noted in some hamster lung cell in vitro tests.
6. Pharmaceutical Particulars
6.1 List of excipient(s). None
6.2 Incompatibilities. Velbe should never be mixed with any other drug and should not be diluted with
solvents that raise or lower the pH from between 3.5 and 5.
6.3 Shelf-life. 3 years
6.4 Special precautions for storage Vials of Velbe should be stored in a refrigerator between 2° and
8°C.
After Reconstitution: After a portion of the solution has been removed from a vial, the remainder of the
contents of the vial may be stored in a refrigerator for future use for 24 hours without significant loss
of potency. When the reconstituted vial is to be stored for more than 24 hours, it is essential to
reconstitute with sterile 0.9% sodium chloride intravenous infusion preserved with 2.0% benzyl
alcohol. Where preserved diluent is used, the reconstituted solution may be stored in a refrigerator for
up to 28 days without significant loss of potency.
6.5 Nature and contents of container Type 1 10 ml glass vial with rubber stopper, aluminium seal and
polypropylene cap containing 10 mg of vinblastine sulphate powder for solution for intravenous
injection.
6.6 Special Precautions for Disposal
Special dispensing information: When dispensing vinblastine sulphate in other than the original
container, it is imperative that it be packaged in an overwrap bearing the statement ‘DO NOT
REMOVE COVERING UNTIL MOMENT OF INJECTION. FATAL IF GIVEN BY OTHER ROUTES.
FOR INTRAVENOUS USE ONLY.’
A syringe containing a specific dose must be labelled, using the auxiliary sticker provided in the pack,
with this warning.
Guidelines for the safe handling of anti-neoplastic agents: Cytotoxic preparations should not be
handled by pregnant staff.
Trained personnel should reconstitute and administer the drug. This should be performed in a
designated area.The work surface should be covered with disposable plastic-backed absorbent
paper. Adequate protective gloves, masks and clothing should be worn. Precautions should be taken
to avoid the drug accidentally coming into contact with the eyes. If accidental contamination occurs,
the eye should be washed with water thoroughly and immediately. Use Luer-lock fittings on all
syringes and sets. Large bore needles are recommended to minimise pressure and the possible
formation of aerosols. The latter may also be reduced by the use of a venting needle. Adequate care
and precaution should be taken in the disposal of items (syringes, needles, etc) used to reconstitute
cytotoxic drugs. Whenever solution and container permit, parenteral drug products should be
inspected visually for particulate matter and discolouration prior to administration.
7 Marketing Authorisation Holder Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.
8 Marketing Authorisation Number PL 06831/0116
9 Date of First Authorisation/Renewal of the Authorisation
Date of first authorisation:
13th July 2004
10 Date of Revision of the Text
September 2014
Legal Category POM

* Velbe (vinblastine sulphate) is a registered Trademark of Genus Pharmaceuticals Limited.
923 5408 1409

25196601

MHRA Header Box
Product
Title

Velbe Injection 10mg

Component

Leaflet

Pack Size

10mg per 10ml

IG code

25196601

Dimensions

300 x 420 mm

Proof No

04

Colours used
Black

Fonts used
Helvetica Neue 55 Reg 9pt
Helvetica Neue 75 Bold 9pt

Date

30/09/2014

PCP Header Box
Operator

David Heaton

Artwork No

GEN-VLB-PIL-278

CRN

11368

Reason
for Change

Change to address and addition of
reporting of side effects statement

Suffix

MHRA/IMB
submission
required

Yes

Product Title:
Strength/Form:
Size:
Type of Print:

VELBE Injection
10 mg
300 x 420 mm
Litho

No of Colours:

1

Approved by

Date

Issued by

Date

C

Date Created:
Format:
Client:
Market:
Job No.

19/08/2014
Leaflet
Genus
UK
GEN-VLB-PIL-278

BLACK

Typeface:

Helvetica Neue 9 pt

Artwork prepared by David Heaton +44 (0)1462 431277 dc.heaton@ntlworld.com

No. of Draft
_01
_02
_03
_04

Date
19/08/2014
04/09/2014
09/09/2014
30/09/2014

Reason for Draft
New file
New page size
Corrections
Delete code

Important
Please ensure that the texts and layout are to your satisfaction as the studio cannot
accept liability for any errors overlooked.
All Bar Codes and Braille text must be verified by the client/manufacturer/
printer. The studio is unable to do this and cannot accept liability for any errors.
Colours may not reproduce accurately on this proof. You should refer to Pantone
Reference Guides for accurate colour match.

Expand view ⇕

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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