10 mg powder for solution for injection Vinblastine
sulfate
What Valve is and what it is used for
The active ingredient is vinblastine. Vinblastine is a cytostatic drug that disrupts the cells’ internal metabolism and inhibits cell division. The effect is seen especially in cells that grow and divide quickly, such as e.g. in cancer cells.
The vinblastine contained in Velbe may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Velbe
Do not use Velbe
- if you are allergic to vinblastine or any of the other ingredients of this medicine (listed in section 6)
- if you have a bacterial infection that needs to be treated first
- if the number of white blood cells is very low unless this is due to the disease being treated that causes the lack of white blood cells.
Warnings and precautions
- Talk to a doctor or nurse before receiving Velbe if you have ischemic heart disease or impaired liver function
- Tell your doctor immediately if you have a sore throat, fever, chills, or mouth sores.
Other medicines and Velbe
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The dose of phenytoin, which is used against epilepsy, should possibly be controlled during treatment with vinblastine, as the simultaneous use of cancer drugs and phenytoin increases the risk of seizures.
Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking any medicine. Use of Velbe is not recommended during pregnancy, for women considering pregnancy, or during breastfeeding.
Driving ability and use of machinery
Some side effects can affect the ability to react. Do not drive or use machines until you know the effect of treatment with Velde.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Velbe contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. is almost “sodium-free”.
How to use Velbe
The doctor prescribes you an individual dose that is suitable for you. Velbe injection should only be given by healthcare professionals experienced with vinblastine.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are dose-dependent. Apart from hair loss, reduction of white blood cells, and neurological (affecting the nervous system) side effects usually do not last more than 24 hours. Neurological side effects are rare, but they usually last more than a day.
The following side effects have been observed during treatment with vinblastine:
Common (may affect up to 1 in 10 users):
- decrease in white blood cells and platelets
- blood deficiency ( anemia )
- constipation
- loss of appetite
- nausea, vomiting (can be treated with anti-nausea drugs)
- abdominal pain
- hair loss (often partial and in some cases, the hair grows during the maintenance treatment)
- local reactions at the injection site
- leg pain
- weakness
- pain at the tumor site
- jaw pain.
Uncommon (may affect up to 1 in 100 users):
- disturbed secretion of antidiuretic hormone (SIADH) which can lead to sodium deficiency
- high blood pressure ( hypertension )
- headache
- oral blisters
- inflammation of the throat
- sensory disturbances
- bowel obstruction.
Rare (may affect up to 1 in 1,000 users):
- hearing loss or dizziness, caused by damage to the auditory nerve, especially if the drug is used in combination with other cancer drugs that damage the auditory nerve (e.g. cisplatin)
- cramps
- bleeding in the gastrointestinal tract.
Has been reported (occurring in an unknown number of users):
- heart attack, spasms in external blood vessels, especially in the fingers ( Raynaud’s disease ), and effects on the central nervous system which can give rise to a feeling of electric disturbances in the arms and/or legs if Velbe is given at the same time as another cancer medicine, e.g. cisplatin and bleomycin.
- azoospermia (semen lacking sperm) and amenorrhoea (absence of menstruation) may occur in adults and adolescents treated with several cancer medicines at the same time.
- bronchospasm and shortness of breath if Velbe is given in combination with another cancer medicine, e.g. mitomycin.
How Velbe should be stored
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C)
The prepared solution is stored for 24 hours in a refrigerator (2°C – 8°C).
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is vinblastine sulfate.
- Other ingredients are sodium hydroxide and sulfuric acid (to adjust pH ).
Appearance and package sizes of the medicine
Velbe is an almost white powder.
Packaging: Powder for injection bag, solution 1 x 10 mg
STADA Nordic Apps
Marielundvej 46 A
2730 Herlev
Denmark
Manufacturer
STADApharm GmbH
Stadastrasse 2-18
61118 Bad Vilbel
Germany