1 g powder for concentrate for infusion liquid, solution
streptozocin
What Zanosar is and what it is used for
This is a cytostatic drug, which means it prevents the growth of certain cells. It is used especially in adults to treat certain tumors of the pancreas (neuroendocrine tumors ). This medicine, which is injected through a vein, can be combined with the medicine 5-fluorouracil (5-FU).
What you need to know before you use Zanosar
Do not use Zanosar
– if you are allergic to the active substance (streptozocin) or any other ingredient in this medicine (listed in section 6)
– if you suffer from severely impaired kidney function ( kidney failure )
– in combination with certain vaccines (called live or live attenuated vaccines)
Warnings and precautions
Because this medicine can damage the kidneys, you must tell your doctor if you have kidney problems. Your kidney function will always be monitored regularly with blood and urine tests before, during, and after treatment.
This medicine can have harmful effects on the liver and blood. Liver function should be tested regularly to detect possible harmful effects on the liver.
Zanosar can cause nausea and vomiting. Therefore, your doctor may prescribe you some anti-nausea drugs.
When it is combined with another drug belonging to the same class, additional appropriate investigations are carried out.
Your treatment is given under the supervision of a doctor experienced in cytostatic drugs. He will decide how to monitor how well you tolerate the treatment (laboratory tests, etc.).
Men and women must use an effective contraceptive method during and after treatment. Please see “Pregnancy, Breastfeeding and Fertility” below.
Monitoring during treatment
This medicine can only be used under strict medical supervision: medical examination and blood tests are required during treatment. If you are unsure, do not hesitate to ask your doctor or pharmacist for advice.
Children and young people
The safety and efficacy of Zanosar have not been investigated in children and adolescents under 18 years of age.
Other medicines and Zanosar
Combinations that must not be used
This medicine MUST NOT BE USED in the following situations:
– In combination with or subsequent use with other drugs that are harmful to the kidneys (unless recommended by your doctor).
– Combination with certain vaccines (called live or live attenuated vaccines).
Combinations requiring precautions
Warn your doctor:
– If you take a medicine that reduces or puts the immune system out of action (immunosuppression),
– If you take medicines that counteract the blood’s ability to clot, e.g. in tablet form (oral anticoagulants, vitamin K antagonist ).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Contraceptives for men and women
You must use an effective method of contraception during treatment. During a period after treatment, contraception must be used: 90 days for men and 30 days for women.
Pregnancy
You should not use this medicine if you are pregnant or planning to become pregnant or if you are not using contraception.
Breast-feeding
It has not been determined whether this medicine passes into breast milk. As a precaution, you should stop breastfeeding during treatment.
Fertility
If you are a man being treated with Zanosar, you should avoid fathering a child for 90 days after treatment and seek sperm preservation advice before treatment, as streptozocin may affect male fertility.
If you are a woman, you must continue your contraception for 30 days after treatment.
Driving ability and use of machinery
Zanosar can cause confusion, tiredness, or depression, so you should not drive or use machines if you experience any of these effects.
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.
Zanosar contains sodium
This medicine contains 30.1 mg of sodium (the main ingredient in common/table salt) per vial. This corresponds to 1.5% of the maximum recommended daily intake of sodium for adults.
How to use Zanosar
This medicine must only be prepared and given by healthcare professionals.
Your doctor will determine the dose you will receive based on your body surface area and general condition.
The treatment will be injected by infusion into one of your veins ( intravenous use). Infusion one will take from 30 minutes to 4 hours.
Two dosage schedules are generally used:
– Treatment every 6 weeks: 5 consecutive days every 6 weeks.
– Treatment every 3 weeks: 5 consecutive days during the first week and then 1 infusion every 3 weeks.
Adjustment of dosage or interruption of the treatment may be required if you experience serious side effects.
Zanosar can cause nausea and vomiting. Therefore, your doctor may prescribe you some anti-nausea drugs.
If you use too much Zanosar
If you have been given too much Zanosar, appropriate care will be given to you.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
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.
Very common side effects ( may affect up to 1 in 10 people)
– Severe nausea and vomiting which have sometimes required discontinuation of treatment. Cases of diarrhea have also been reported.
Common side effects ( may affect up to 1 in 10 people)
– Impaired kidney function ( kidney failure ) which can be serious. Your doctor may order blood and urine samples to be taken before, during, and then repeated after the end of treatment.
Side effects with unknown frequency (incidence cannot be calculated from available data)
– Haematological toxicity ( adverse effects on the blood) which usually means a decrease in hematocrit values (the proportion of red blood cells compared to the total blood volume), white blood cells, and platelets. It can also increase your susceptibility to infection.
– Glucose intolerance (effect on blood sugar levels), usually mild to moderate and usually transient.
– Confusion, fatigue, depression.
– Nephrogenic diabetes insipidus (inability of the kidneys to concentrate urine).
– Hepatotoxicity (damage to the liver): increase in certain liver enzymes, abnormally low level of albumin in the blood (hypoalbuminemia).
– Reactions at the injection site: necrosis (decomposition) of tissue if the medicine accidentally gets outside the vein. Burning sensations that extend from the injection site to the arm.
– Fever.
How to store Zanosar
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the bottle after EXP. The expiration date is the last day of the specified month.
Before opening: Store in a refrigerator (2–8 °C). Store the vial in the outer carton. Light sensitive.
After opening, preparation, and dilution: The prepared solution must be diluted immediately. The in-use chemical and physical in-use stability of the resulting solution has been demonstrated for 24 hours at 25°C.
The medicine does not contain any preservatives and is for single use only. From a microbiological point of view, unless the method of opening/preparation/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, conditions of use are the responsibility of the user.
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 protect the environment.
Contents of the packaging and other information
Contents declaration
– The active substance is streptozocin. One bottle contains 1 g of streptozocin.
– Other ingredients are anhydrous citric acid and sodium hydroxide (for pH adjustment).
Appearance and package sizes of the medicine
This medicinal product is a sterile white to pale yellow powder for infusion. Carton with 1 vial.
Marketing Authorization Holder:
ESTEVE PHARMACEUTICALS SAS
106, avenue Marx-Dormoy
92120 Montrouge
France
Manufacturer:
VALDEPHARM
Incarville Industrial Park
27100 Val de Reuil
France
This medicine is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the names:
| BelgiumStreptozocine Keocyt 1g, poeder voor concentraat voor oplossing voor infusion | DenmarkZanosar |
| GermanyZanosar 1 g, powder for ein Konzentrat Zur Herstellung einer Infusionslösung | NetherlandsZanosar 1 g, poeder voor concentraat voor oplossing voor infusion |
| SpainZanosar 1 g, polvo para concentrado para solución para perfusion | NorwayZanosar 1 g, Powder for concentrate for infusion, solution |
| FranceZanosar 1 g, poudre pour solution à diluter pour perfusion | ItalyStreptozocin Keocyte |
| FinlandZanosar 1 g, kuiva-aine välikonsentratiksi infüzionesestättä värten, liuos | SwedenZanosar 1 g, powder for concentrate for infusion, solution |
| Great Britain (Northern Ireland)Zanosar 1 g, powder for concentrate for solution for infusion |