1 g\u00a0powder for concentrate for\u00a0infusion liquid, solution
streptozocin<\/p>\n\n\n\n
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). – if you are allergic to the active substance (streptozocin) or any other ingredient in this medicine (listed in section 6)<\/p>\n\n\n\n – if you suffer from severely impaired kidney function ( kidney failure )<\/p>\n\n\n\n – in combination with certain vaccines (called live or live attenuated vaccines)<\/p>\n\n\n\n – when breastfeeding<\/a><\/p>\n\n\n\n Because this medicine can damage the kidneys, you must tell your doctor if you have kidney problems.\u00a0Your kidney function will always be monitored regularly with blood and urine tests before, during, and after treatment.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Zanosar can cause nausea and vomiting. Therefore, your doctor may prescribe you some anti-nausea drugs.<\/p>\n\n\n\n When it is combined with another drug belonging to the same class, additional appropriate investigations are carried out.<\/p>\n\n\n\n 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.).<\/p>\n\n\n\n Men and women must use an effective contraceptive method during and after treatment. Please see “Pregnancy, Breastfeeding and Fertility” below.<\/p>\n\n\n\n Monitoring during treatment<\/em><\/p>\n\n\n\n This medicine can only be used\u00a0under strict medical supervision<\/strong>: medical examination and blood tests are required during treatment.\u00a0If you are unsure, do not hesitate to ask your doctor or pharmacist for advice.<\/p>\n\n\n\n The safety and efficacy of Zanosar have not been investigated in children and adolescents under 18 years of age.<\/a><\/p>\n\n\n\n Combinations that must not be used<\/em><\/p>\n\n\n\n This medicine MUST NOT BE USED in the following situations:<\/p>\n\n\n\n – In combination with or subsequent use with other drugs that are harmful to the kidneys (unless recommended by your doctor).<\/p>\n\n\n\n – Combination with certain vaccines (called live or live attenuated vaccines).<\/p>\n\n\n\n Combinations requiring precautions<\/em><\/p>\n\n\n\n Warn your doctor:<\/p>\n\n\n\n – If you take a medicine that reduces or puts the immune system out of action (immunosuppression),<\/p>\n\n\n\n – If you take medicines that counteract the blood’s ability to clot, e.g.\u00a0in tablet form (oral\u00a0anticoagulants,\u00a0vitamin\u00a0K\u00a0antagonist\u00a0).<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Contraceptives for men and women<\/em><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Pregnancy<\/em><\/p>\n\n\n\n You should not use this medicine if you are pregnant or planning to become pregnant or if you are not using contraception.<\/p>\n\n\n\n Breast-feeding<\/em><\/p>\n\n\n\n It has not been determined whether this medicine passes into breast milk. As a precaution, you should stop breastfeeding during treatment.<\/p>\n\n\n\n Fertility<\/em><\/p>\n\n\n\n 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\u00a0fertility.<\/p>\n\n\n\n If you are a woman, you must continue your contraception for 30 days after treatment.<\/a><\/p>\n\n\n\n Zanosar can cause confusion, tiredness, or depression, so you should not drive or use machines if you experience any of these effects.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n This medicine contains 30.1 mg of\u00a0sodium\u00a0(the main ingredient in common\/table salt) per\u00a0vial.\u00a0This corresponds to 1.5% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults. This medicine must only be prepared and given by healthcare professionals.<\/p>\n\n\n\n Your doctor will determine the dose you will receive based on your body surface area and general condition.<\/p>\n\n\n\n The treatment will be injected by infusion into one of your veins ( intravenous use). Infusion one will take from 30 minutes to 4 hours.<\/p>\n\n\n\n Two dosage schedules are generally used:<\/p>\n\n\n\n – Treatment every 6 weeks: 5 consecutive days every 6 weeks.<\/p>\n\n\n\n – Treatment every 3 weeks: 5 consecutive days during the first week and then 1 infusion every 3 weeks.<\/p>\n\n\n\n Adjustment of\u00a0dosage\u00a0or interruption of the treatment may be required if you experience serious\u00a0side effects.<\/p>\n\n\n\n
<\/a><\/p>\n\n\n\nWhat you need to know before you use Zanosar<\/h2>\n\n\n\n
Do not use Zanosar<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Zanosar<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Zanosar contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Zanosar<\/h2>\n\n\n\n