1 mg / ml solution for injection
vincristine sulphate
What Oncovin is and what it is used for
Oncovin contains the active substance vincristine sulphate. Oncovin is a cancer drug used in combination with other cancer drugs in the treatment of leukemia (blood cancer), malignant lymphoma (lymph node cancer) and small cell lung cancer . It works by inhibiting cell division.
Wine christine sulphate contained in Oncovin may also be approved for the treatment of 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 you use Oncovin
Do not use Oncovin
- if you are allergic to vincristine sulphate or any of the other ingredients of this medicine (listed in section 6)
- if you have Charcot-Marie-Tooth disease (disease that affects nerves or muscles)
- if you are being irradiated over an area that includes the liver.
Warnings and cautions
Treatment with Oncovin should be performed by a physician with extensive experience in the treatment of cancer. Oncovin should only be given intravenously (into a vein). Oncovin should never be given intrathecally (in the spinal canal).
Talk to your doctor or nurse before taking Oncovin if you have liver problems
Other medicines and Oncovin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important that you tell your doctor if you are taking or have recently taken:
- drugs that inhibit cytochrome P450 CYP 3A isoenzymes (eg itraconazole used to treat fungal infections).
- aminoglycoside type antibiotics , e.g. gentamicin
- other anticancer medicines (eg cisplatin, carboplatin and mitomycin).
Pregnancy, breastfeeding and fertility
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.
Pregnancy
Caution is required when using Oncovin during pregnancy. Vincristine is suspected of causing serious birth defects during pregnancy. During pregnancy, Oncovin should be given only in strict indication and after the mother’s needs have been weighed against the risks to the fetus.
Breast-feeding
There is no information on whether wine christine passes into breast milk.
Fertility
Women of childbearing potential should use effective contraception during treatment.
Driving and using machines
Oncovin, especially at the beginning of treatment and when increasing the dose , may, due to side effects , affect the ability to drive and use machines to a lesser or moderate extent.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Oncovin contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and sodium
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause an allergic reaction (possibly delayed) and exceptionally convulsions in the trachea.
This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’. is next to “sodium free”.
How to use Oncovin
Oncovin is given only under the supervision of a doctor who has experience in the treatment of cancer.
Dosage : Your doctor will decide what dose you will receive. Talk to your doctor about your dosage .
Oncovin should only be given intravenously (into a vein).
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
The side effects are generally dose dependent; The higher the dose , the greater the risk of side effects .
The most common side effect is hair loss.
Serious side effects that may occur during treatment with vincristine are:
- Intestinal knots (paralytic ileus ) can occur in up to 1 in 10 users.
- Severe allergic reaction ( hypersensitivity reaction with fever, rash, swelling and sometimes drop in blood pressure), may occur in up to 1 in 100 users.
- Convulsions followed by coma in children can occur in up to 1 in 1,000 users.
- Myocardial infarction has been reported in patients treated with vincristine in combination with other anticancer medicines when treatment is started after radiation over the space between the lungs ( mediastinum ).
If any of these conditions occur, immediate contact with healthcare is required.
The following side effects may occur.
Common (may affect up to 1 in 10 people):
- low white blood cell count ( leukopenia )
- platelet deficiency ( thrombocytopenia )
- high / low blood pressure (hypertension / hypotension ).
- loss of deep tendon reflexes
- numbness and tingling in fingers and toes
- difficulty coordinating body movements ( ataxia )
- effects on cerebral nerves
- trailing foot (drip foot)
- disorder of nerve function
- paralysis
- paralysis of the eye ( ocular paresis)
- constipation
- suspended intestinal function
- abdominal pain
- vocal cord paralysis (vocal cord paralysis)
- hair loss ( Alopecia )
- leg pain
- jaw pain
- sore throat
- local reactions at the injection site
Uncommon (may affect up to 1 in 100 people):
- seizures (especially in children)
- nausea
- vomiting
- inflammation of the oral mucosa ( stomatitis )
- diarrhea
- impaired ability to empty the bladder (bladder atony)
- burning, discomfort or pain when urinating ( dysuria )
- fever
- loss of appetite
- headache
Rare (may affect up to 1 in 1,000 people):
- low sodium levels in the blood due to decreased fluid secretion (SIADH)
- transient and permanent blindness
- rash
- cellulite
- partial or total deafness.
Other side effects are
Difficulty breathing has been reported in patients treated with Oncovin concomitantly with mitomycin.
Azoospermia (lack of semen) and amenorrhea (absence of menstruation) can occur in adolescents treated with several cancer drugs at the same time.
How to store Oncovin
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 label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
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 to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is vincristine sulphate. 1 ml Oncovin contains 1 mg vincristine sulphate.
- The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), mannitol and water for injections. Acetic acid and sodium acetate trihydrate may have been added to adjust the acidity.
What the medicine looks like and contents of the pack
Oncovin is a clear, colorless solution.
Glass vial containing 1 ml or 2 ml Oncovin.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark
Manufacturer:
STADApharm GmbH
Stadastrasse 2-18
61118 Bad Vilbel
Germany