PRODUCT MONOGRAPH. Pr. JEVTANA. ®. Cabazitaxel for injection. Concentrated Solution 40 mg/mL. (60 mg/ mL). Antineoplastic Agent. JEVTANA in combination with prednisone or prednisolone is indicated for the The printed package leaflet of the medicinal product must state the name and. Package leaflet: Information for the patient. JEVTANA® 60 mg concentrate and solvent for solution for infusion. cabazitaxel. Read all of this leaflet carefully.
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It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The product code s for this leaflet is: Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Possible side effects 5. Contents of the pack and other information. Its common name is “cabazitaxel”. It belongs to a group of medicines called “taxanes” used to treat cancers.
It works by stopping cells from growing and multiplying. As part of your treatment, you will also take a corticosteroid medicine prednisone or prednisolone by mouth every day. Ask your doctor to give you information about this other medicine. If any of the above applies to you, tell your doctor immediately. Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription.
These medicines include the following:. Use a condom during sex if your partner is or could become pregnant.
Jevtana – Patient Information Leaflet (PIL) – (eMC)
You are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because JEVTANA may alter male fertility. You may feel tired or dizzy when having this medicine. If this happens, do not drive or use any tools or machines until you feel better.
This medicine may be harmful for those suffering from alcoholism. To be insdrt into account if you are in a high risk group such as patients with liver disease, or epilepsy.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will discuss these with you cabazitaxrl will explain the potential risks and benefits of your treatment. See a doctor immediately if you notice any of the following side effects:.
If you get packaage side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the contact details listed below. By reporting side effects you can help provide more information on the safety of this medicine. Do not use this medicine after the expiry date which is stated on inserrt outer carton and on the label of the vials after EXP.
The expiry date refers to the last day of that month. Any unused product or waste material should be disposed of in accordance with local requirements. These measures will help to protect the environment. The active substance is cabazitaxel. One ml of concentrate contains 40 mg cabazitaxel.
Each vial of concentrate contains 60 mg cabazitaxel. One single use clear glass vial, closed with a grey chlorobutyl rubber closure sealed by an aluminium cap with a light green plastic flip-off cover containing 1.
Last updated on eMC: What is a Patient Information Leaflet and why is it useful? You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. If you get any side effects talk to your doctor, pharmacist or nurse. What is in this leaflet: Tell your doctor immediately if: Your doctor will monitor your blood and general condition for signs of infections. People with low blood counts can develop life-threatening infections.
The earliest sign of infection may be fever, so if you experience fever, tell your doctor right away. Any of these events could cause severe dehydration. Your doctor may need to treat you. These medicines include the following: Pregnancy, breast-feeding and fertility JEVTANA should not be used in pregnant women or women of childbearing age not using contraception.
Driving and using machines You may feel tired or dizzy when having this medicine. How much and how often to have The usual dose depends on your body surface area.
Your doctor will calculate your body surface area in square meters m 2 and will decide the dose you should have. You will usually have an infusion once every 3 weeks. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Packagd a doctor immediately if you notice any of the following side effects: This is very common may affect more cabazitsxel 1 in 10 people. This is common may affect up to packkage in 10 people. This can occur if you have severe or long-lasting diarrhoea, or fever, or if you are being sick vomiting.
This can occur if you have a hole in the stomach, food pipe, gut or bowel gastrointestinal perforation. This can lead to death.
Dosing and Dose Modifications
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 people: Frequency not known cannot be estimated from the available data; interstitial lung disease inflammation of the lungs causing coughing and difficulty breathing. Reporting of side effects If you get any side effects, talk to your doctor. The concentrate is a clear yellow to brownish yellow oily solution. The solvent is a clear and colourless solution.
One single use clear glass vial, closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap with a colourless plastic flip-off cover, containing 4. Company contact details Genzyme Therapeutics.
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