Before you are given Oncozar
You should not be given Oncozar:
- If you are allergic (hypersensitive) to gemcitabine or to any of the other ingredients of Oncozar listed in Section 6.
- If you are pregnant or breast-feeding.
Warnings and precautions
Before the first infusion you will have sample of your blood taken to evaluate if you have sufficient kidneys and liver function. Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Oncozar. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. Periodically you will have sample of your blood taken to evaluate your kidneys and liver function. Tell your doctor if:
- You have, or have previously had liver disease, heart disease or vascular disease.
- You have recently had, or are going to have radiotherapy.
- You have been vaccinated recently.
- You develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney failure).
- You develop generalised swelling, shortness of breath or weight gain, as this may be a sign of fluid leaking from your small blood vessels into the tissue, and symptoms of a serious condition called Capillary Leak Syndrome (CLS).
- You during treatment with this medicine get symptoms such as headache with confusion, seizures (fits) or changes in vision. You should contact your doctor right away, as this could be a very rare nervous system side effect named posterior reversible encephalopathy syndrome (PRES).
Children and adolescents
This medicine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
Other medicines and Oncozar
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Oncozar should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Oncozar during pregnancy.
If you are breast-feeding, tell your doctor. You must discontinue breast-feeding during Oncozar treatment. Because of the potential risk to a fetus, females of reproductive potential should use effective contraception during treatment with Oncozar and for 6 months after the final dose.
Because of the potential genotoxicity, males with female partners of reproductive potential should use effective contraception during treatment with Oncozar and for 3 months after the final dose.
If you are a man being treated with Oncozar you are advised not to father a child during treatment and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because Oncozar may alter male fertility.
Driving and using machines
Oncozar may make you feel sleepy, particularly if you have consumed any alcohol. Do not drive a car or use machinery until you are sure that Oncozar treatment has not made you feel sleepy.
Oncozar contains Sodium
Oncozar contains 2.11 mg (< 1 mmol) of sodium in each 200 mg vial and 10.56 mg (< 1 mmol) sodium in each 1 g vial, which it is required to be taken into consideration by patients on a controlled sodium diet.
