VINCRISTINA 1 mg /Ml Injectable Solution

Зміст інструкції

1. Vincristina Teva Italia 1 mg/ml injectable solution
   1. What is Vincristina Teva Italia and what it is used for
   2. What you need to know before using Vincristina Teva Italia
   3. How to use Vincristina Teva Italia
   4. Possible side effects
   5. How to store Vincristina Teva Italia
   6. Contents of the pack and other information

Vincristina Teva Italia 1 mg/ml injectable solution

vincristine sulfate

Equivalent medicinal product

Read this leaflet carefully before you use this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Vincristina Teva Italia is and what it is used for
• 2. What you need to know before you use Vincristina Teva Italia
• 3. How to use Vincristina Teva Italia
• 4. Possible side effects
• 5. How to store Vincristina Teva Italia
• 6. Contents of the pack and other information

1. What is Vincristina Teva Italia and what it is used for

Vincristine sulfate belongs to a group of drugs called antimitotic cytotoxic agents. These are
drugs that inhibit the growth of cancer cells.
Vincristina Teva Italia is generally used together with other drugs in the treatment of:

• acute lymphocytic leukemia, a type of cancer with a very rapid course, in which the body produces a very high number of immature white blood cells.
• Hodgkin's lymphoma, a cancer of the lymphatic system.
• non-Hodgkin's lymphoma, a cancer of the lymph nodes not due to Hodgkin's lymphoma.
• small cell lung cancer.
• rhabdomyosarcoma, a cancer of the muscles.
• Ewing's sarcoma, a type of bone cancer.
• hematomas (internal bleeding) with reduced number of platelets (idiopathic thrombocytopenic purpura).
• adrenal cancer (part of the adrenal gland).
• primitive neuroectodermal tumor, a cancer of a part of the nervous system.
• Wilms' tumor, a type of kidney cancer.
• breast cancer that has spread to other parts of the body.
• multiple myeloma, a cancer of the cells of the immune system.
• retinoblastoma, a type of eye cancer.

2. What you need to know before using Vincristina Teva Italia

DO NOT use Vincristina Teva Italia if:

• you are allergic to vincristine sulfate or to any of the other ingredients of this medicine (listed in section 6).
• you suffer from a nerve and muscle disordercalled Charcot-Marie-Tooth syndrome.
• the function of your liver is severely impaired.
• you suffer from constipationor are at risk of bowel obstruction(ileus), especiallyin children.
• you are undergoing radiotherapyto the liver.

Warnings and precautions
Vincristina Teva Italia must be administered exclusively under the strict supervision of doctors experienced
in the treatment with cytotoxic drugs (antineoplastic drugs).
Vincristina Teva Italia must be administered onlyby intravenous route(directly into a vein), not
by other routes. Other routes of administration may be fatal.
Care must be taken to avoid leakage into the surrounding tissue (extravasation) as this can cause
significant irritation. The injection must be stopped immediately.
Contact of vincristine sulfate with the eyes must be avoided. If vincristine enters the eye, it should
be rinsed immediately with plenty of water and a doctor should be consulted if irritation persists.
In case of accidental contact with the skin, wash with plenty of water, then with a mild soap
and rinse thoroughly again.
Talk to your doctor or pharmacist before using Vincristina Teva Italia:

• if you suffer from disorders of the nervous system.
• if your liveris not functioning properly; see also section “How to use Vincristina Teva Italia”.
• if you are taking medicines that may be harmful to the nervous system; your doctor will monitor you closely during therapy.
• if you experience constipationdue to treatment, your doctor will take the necessary measures to prevent constipation, for example with a regulated diet or the use of products that improve bowel movement (laxatives, in particular lactulose).
• if you suffer from heart disorders, such as ischemic heart disease(problems with the heart and blood circulation).
• if you have or develop an infection; inform your doctor if this occurs.
• if you have an active sex life, during treatment and for 6 months after stopping therapy, you and your partner must take precautions to avoid pregnancy.

Before starting therapy and during treatment, and before each treatment cycle, the doctor will perform
tests to check your liver and kidney function, blood count and neurological functions. Based on the
results, it may be necessary to reduce the dose, suspend or stop treatment.

Other medicines and Vincristina Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
An interaction may occur when this medicine is used at the same time as

• some medicines that inhibit liver enzymes, for example ritonavir (used to treat HIV), nelfinavir (used to treat HIV), ketoconazole (used to treat fungal infections), itraconazole (used to treat fungal infections), erythromycin (used to treat infections) and nefazodone (used to treat depression); concomitant administration with vincristine may determine an early and/or greater severity of muscle diseases.
• some medicines for the treatment of high blood pressure, for example nifedipine: the amount of vincristine in the blood may increase. This, in turn, can cause further side effects.
• some medicines for the treatment of epilepsy, for example (phos)phenytoin; vincristine may reduce the amount of phenytoin in the blood.
• some medicines used for the treatment of cancer and other drugs inhibiting the bone marrow, such as doxorubicin (especially in combination with prednisone); the effect, side effects and inhibitory effects on the bone marrow may be potentiated.
• some medicinesthat may be harmful to the nervous systemsuch as isoniazid (a drug for the treatment of tuberculosis), L-asparaginase (a drug used for the treatment of blood cancer) and cyclosporine A (a drug that suppresses the immune system); these products can potentiate the harmful effects of vincristine on the nervous system.
• vaccines (vaccinations); vincristine suppresses the immune system and can affect the body's ability to react to the vaccine.
• digoxin(a medicine used to treat reduced heart function and heart arrhythmias); vincristine may reduce the effect of digoxin.
• mitomycin C(a medicine used to treat some forms of cancer); concomitant administration may cause breathing problems.
• radiotherapy(treatment of diseases with the help of radiation); radiotherapy may potentiate the side effects of vincristine on the nervous system.
• cyclosporine, tacrolimus; when used together, the immune system may not be able to protect the body from diseases (immunosuppression), with the risk of growth of some cells (lymphoproliferation).
• GM-CSF and G-CSF(drugs used to stimulate the growth of blood cells after chemotherapy); when used together, they can cause a nerve disorder (neuropathy).
• dactinomycin;in patients with renal carcinoma (Wilms' tumor), severe liver damage has been reported.
• bleomycin;this combination can cause a disorder affecting blood flow to the extremities, including toes, fingers, nose and ears when exposed to temperature changes or stress (Raynaud's syndrome).
• azole antimycotics (a group of medicines used to treat fungal infections such as e.g. itraconazole, posaconazole, fluconazole, isavuconazole or voriconazole);
• ketoconazole (used to treat Cushing's syndrome, a disease characterized by excessive production of the hormone cortisol).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

• Therapy with vincristine is not recommended during pregnancy.
• During therapy and for 6 months after the end of therapy, men and women must use contraceptive measures.
• If you suspect you are pregnant or wish to become pregnant, you should consult your doctor.
• Adequate data on the use of vincristine sulfate in pregnant women are not available to determine any harmful effects. This medicine has proven harmful in animal tests.

Breastfeeding

• DO NOT breastfeed during therapy with Vincristina Teva Italia.

Fertility

• Vincristine may damage fertility irreversibly. Male patients must be warned not to conceive children either during therapy or within 6 months after stopping therapy; they are also invited to contact a sperm bank before starting therapy in order to obtain information on sperm preservation.

Driving and operating machinery

• Therapy with Vincristina Teva Italia can sometimes cause side effects affecting the nervous system, such as reduced reflexes, muscle weakness and problems with vision and the gastrointestinal tract (see section “Possible side effects”). If you notice the occurrence of one or more of these side effects, DO NOT drive vehicles and DO NOT use machinery that requires an unaltered state of vigilance.

Vincristina Teva Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially
“sodium-free”.

3. How to use Vincristina Teva Italia

Follow your doctor’s instructions for the use of Vincristina Teva Italia strictly. If you have any doubts,

consult your doctor or pharmacist.

Consult your doctor if you feel that the action of Vincristina Teva Italia is too strong or too

weak.

Vincristine must be administered only intravenously.
The recommended dose is

• AdultsThe usual dose for adults is 1.4 mg per square meter of body surface area (the surface of your body) (up to a maximum of 2 mg) once a week.
• ChildrenFor children weighing more than 10 kg, the usual dose is 1.5-2.0 mg per square meter of body surface area once a week. For children weighing 10 kg or less, the initial dose is 0.05 mg per kg of body weight once a week. Note: in newborns, the dose is calculated based on individual body weight (not based on body surface area).
• Patients with reduced liver functionIf your liver is not functioning properly, your doctor will adjust the dose if necessary.

Method of administration
Vincristina Teva Italia is injected by means of an infusion or a slow injection directly into a vein
(intravenously) through the tubing of a continuous infusion. Vincristine sulfate must be
administered only under the strict supervision of doctors experienced in the treatment with cytotoxic drugs.

If you receive more Vincristina Teva Italia than you should
If you suspect you have received an excessive dose of Vincristina Teva Italia, contact your
doctor or pharmacist immediately.
If you have received an excessive dose of Vincristina Teva Italia, the side effects described may
be potentiated or result in more serious consequences.
There is no effective treatment for a vincristine overdose. In case of overdose
the doctor will take supportive measures and keep you under strict control.

If you forget to take a dose of Vincristina Teva Italia
The doctor will decide the timing for taking the medication. If you think you have missed a dose,
contact your doctor as soon as possible.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be pronounced in patients with hepatic insufficiency.
The following side effects may occur at the approximate frequencies indicated:

Very common(may affect more than 1 in 10 people)

Common(may affect up to 1 in 10 people)

Uncommon(may affect up to 1 in 100 people)

Rare(may affect up to 1 in 1,000 people)

Very rare(may affect up to 1 in 10,000 people)

Not known:frequency cannot be estimated based on the available data.

Immune system

• RareHypersensitivity reaction with a sharp drop in blood pressure, paleness, restlessness, rapid and weak pulse, moist skin and reduced state of consciousness (anaphylaxis), skin rash and fluid accumulation.

Blood

• CommonTemporary increase in the number of platelets; headache, dizziness, tingling in the hands, fingers or feet, bluish nose, bruising or bleeding gums may occur.
• UncommonInhibition of bone marrow function, blood changes such as anemia (may manifest as weakness, fatigue and/or general malaise), white blood cell deficiency (associated with an increased risk of infections) and platelet deficiency (may cause a tendency to bruise and bleed).

Nervous system

• CommonPeripheral neuropathy, which includes damage to the peripheral nervous system, the nerves that carry electrical signals from the brain and spinal cord to the rest of the body and vice versa. It can affect movement, sensation and body functions; effects such as sensory disturbances, tingling, itching or pins and needles without any apparent cause, nerve pain (including in the jaw/mandible or testicles), movement problems, loss of some reflexes (deep tendon reflexes), paralysis or muscle weakness in the feet (foot drop), muscle weakness, coordination problems (e.g., walking as if intoxicated) and paralysis may occur. The cranial nerve may be affected and this event can cause paralysis of some muscles, weakness of the laryngeal muscles, hoarseness, paralysis of the vocal cords, weakness of the external eye muscles, drooping eyelids (ptosis), double vision, disturbances of the optic nerves, disturbances of the external nerves of the eye, blindness (transient).
• UncommonSeizures, often with increased blood pressure. In children, some cases of seizures followed by coma have been reported. Altered state of consciousness and mental disorders, such as depression, agitation, insomnia, confusion, severe mental illnesses in which control of behavior and actions is disturbed (psychosis), perception of non-existent things (hallucinations).
• Not knownWhite matter disease of the brain (leukoencephalopathy). Symptoms include mental dysfunction and seizures.

Heart

• UncommonIn some patients treated with vincristine in combination with other anticancer products and previously undergoing radiotherapy in the area around the heart, disturbances of the cardiac blood vessels and heart attacks have occurred.
• RareIncrease or decrease in blood pressure.

Respiratory system

• CommonSudden onset of shortness of breath and difficulty breathing due to spasm of the airway muscles (bronchospasm), especially if the drug is used in conjunction with mitomycin C.

Gastrointestinal system

• CommonConstipation, abdominal pain, painful abdominal attacks due to cramps in the intestine and biliary system (organs and ducts, such as bile ducts, gallbladder and associated structures, involved in the production and transport of bile) abdominal pain similar to colic, nausea, vomiting.
• UncommonLoss of appetite, weight loss, diarrhea, reduced intestinal function caused by paralysis (paralytic ileus, in which the intestine ceases to function and there is no peristalsis), especially in young children.
• RareInflammation of the mucous membrane of the mouth, death of the tissue of the small intestine and/or damage to the intestinal walls.
• Very rareInflammation of the pancreas (pancreatitis).

Liver or bile

• RareLiver disorders as a result of blockage of veins in the liver, especially in children.

Skin

• Very commonHair loss (reversible after discontinuation of treatment).

Ears and balance organs

• UncommonDeafness.

Kidneys and urinary tract
Elderly patients who are also taking medicines that cause poor urinary capacity
(urinary retention) should discontinue taking such medicines shortly after
administration of vincristine.

• UncommonProblems with urination (painful urination, frequent urination or inability to urinate normally). Presence of high levels of a certain waste product (uric acid) in the blood (hyperuricemia).
• RareInappropriate release of the antidiuretic hormone (ADH), which causes a drop in blood pressure, dehydration, abnormal levels of nitrogen-containing compounds (dry mouth, confusion, fatigue may occur), fluid retention, which may in turn cause edema and sodium deficiency (syndrome of inappropriate antidiuretic hormone secretion - SIADH).
• Very rareIncontinence.

Sex organs
Irreversible infertility is more common in men than in women.

• CommonSeminal fluid deficiency, testicular nerve pain.
• UncommonCessation of menstruation.

Other
Cancer related to therapy. In some patients treated with vincristine in combination with other anticancer drugs, another form of cancer has appeared after treatment.

• CommonIrritation at the injection site.
• UncommonPain and inflammation of the veins and subcutaneous connective tissue during intravenous injection, fever.
• RareHeadache.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Vincristina Teva Italia

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C -8°C).
Keep the vial in its original packaging to protect the medicine from light.
Do not use Vincristina Teva Italia after the expiry date which is stated on the vial label and
on the carton after “Exp.”. The expiry date refers to the last day of that month.
Do not use Vincristina Teva Italia if you notice that the solution is not clear and colourless or pale yellow.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Vincristina Teva Italia contains
The active ingredient is vincristine sulfate, 1 mg per each ml of injectable liquid.
The other components are mannitol, sulfuric acid and/or sodium hydroxide, water for
injections.

Description of the appearance of Vincristina Teva Italia and contents of the pack
Vincristina Teva Italia is a clear, colorless or pale yellow solution, free from particles
except for gas bubbles.
Pack sizes
1 vial of 1 ml containing 1 mg of vincristine sulfate
1 vial of 2 ml containing 2 mg of vincristine sulfate
1 vial of 5 ml containing 5 mg of vincristine sulfate
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan

Manufacturer
Pharmachemie B.V. - Swensweg 5, P.O Box 552 - 2003 RN Haarlem, Netherlands

This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following denominations:
Czech Republic Vincristin-Teva
France VINCRISTINE TEVA 1 mg/ml, injectable solution
Germany Vincristinsulfat-TEVA 1 mg / ml Injection solution
Italy Vincristina Teva Italia
Latvia Vincristine Teva
Lithuania Vincristine Teva 1 mg/ml injection solution
Poland Vincristine Teva
Spain Vincristina Teva 1mg/ml solution for injection EFG
Netherlands Vincristinesulfaat Teva1 mg/ml
United Kingdom (Northern Ireland) Vincristine sulfate, solution for injection 1 mg/ml