Etoposi de 20 mg/ml Conce ntrate For Sol ution F or Infusion Taj Phar ma : Use s, Side Effe cts, Interactions, Pi ctures, Warnings, Et opo side D osage & Rx I nfo | Etoposide U ses, Side E ffe cts - Cancer, Et oposide 2 0 mg/ml Concentrate For Solution For Infusi on: I ndi cations, Side Effects, Warnings, Et oposide - Drug Information - Taj P harma, Etoposi de dose Taj phar ma ceuticals Et oposide interacti ons, Taj P harma ceuti cal Etoposide contraindications, Etoposide price, Etoposi de , Taj Phar ma Et oposide 2 0 mg/ml Concentrate F or Soluti on For Infusi on - Taj Phar ma . Stay connecte d to all update d on Etoposi de Taj P harmaceuticals Taj pharma ce uticals Hydera bad. Patient I nformation Lea flets, PI L.
ETOPOSIDE FOR INJECTION 20 MG/ML Package leaflet: Information for the patient Etoposide 20 mg/ml Concentrate For Solution For Infusion Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1) What Etoposide Injection is and what it is used for 2) What you need to know before you take Etoposide Injection 3) How to take Etoposide Injection 4) Possible side effects 5) How to store Etoposide Injection 6) Contents of the pack and other information
1.What Etoposide Injection is and what it is used for This medicine contains the active substance etoposide. It works by interfering production cycle of DNA and slow or stop the growth of cancer cells. Etoposide Injection is used in combination with other anti-cancer medicines to treat: small-cell lung cancer. acute monoblastic & acute myelomonoblastic leukaemia (cancer of the blood-forming tissues of bone marrow). testicular tumours (cancer of testis). 2) What you need to know before you take Etoposide Injection Do not use Etoposide Injection if you are allergic to etoposide, podophyllotoxines or podophyllotoxinederivatives or any other ingredients of this medicine (listed in section 6). if your liver is not working properly. if your bone marrow does not produce enough blood cells. if you are breast-feeding. if you have a weak immune system and you are being vaccinated against yellow fever at the same time. Warnings and precautions Talk to your doctor or pharmacist or nurse before you use Etoposide Injection: if you have a low serum albumin level. if you have received other anticancer treatment
or radiotherapy, your doctor should check the number of blood cell in your blood before treatment starts. if you have a bacterial infection, it should be treated before Etoposide Injection is given. if you have allergic reactions such as low blood pressure, irregular heartbeat, difficulty in breathing, chills, fever, flushing. injection or infusion of Etoposide must be given carefully into a vein. before the start of therapy, during the therapy, and before each course of treatment, your blood should be tested (white blood cells, platelets, haemoglobin), kidney and liver function checked, and neurological functions should be investigated. your doctor will consider the function of your liver, kidney and peripheral nervous system for the decision of treatment with Etoposide Injection. acute leukemia can occur after the treatment of etoposide. Children Allergic reactions have been reported with Etoposide Injection in children. Safety and efficacy in children has not been systematically studied. Other medicines and Etoposide Injection Tell your doctor or pharmacist, if you are using other medicines, have recently used other medicines, or intend to use other medicines, such as: concurrent use of other myelosuppressive (inhibiting bone marrow activity) medicines may increase the effect.
Etoposi de 20 mg/ml Conce ntrate For Sol ution F or Infusion Taj Phar ma : Use s, Side Effe cts, Interactions, Pi ctures, Warnings, Et opo side D osage & Rx I nfo | Etoposide U ses, Side E ffe cts - Cancer, Et oposide 2 0 mg/ml Concentrate For Solution For Infusi on: I ndi cations, Side Effects, Warnings, Et oposide - Drug Information - Taj P harma, Etoposi de dose Taj phar ma ceuticals Et oposide interacti ons, Taj P harma ceuti cal Etoposide contraindications, Etoposide price, Etoposi de , Taj Phar ma Et oposide 2 0 mg/ml Concentrate F or Soluti on For Infusi on - Taj Phar ma . Stay connecte d to all update d on Etoposi de Taj P harmaceuticals Taj pharma ce uticals Hydera bad. Patient I nformation Lea flets, PI L.
you should not be vaccinated with live vaccines (e.g yellow fever) during treatment. phenylbutazone, sodium salicylate and aspirin (pain killers) may increase the effect of etoposide. the blood clotting effect of warfarin may be reduced. co-administration of medicine like phenytoin, phenobarbital can reduce efficacy of etoposide. the effect of anthracyclines may be reduced due to cross resistance between anthracyclines and etoposide. cisplatin can increase drug level which leads to increase toxicity. cyclosporine (i.e. used after transplantation) may increase the effect of etoposide as the excretion from the body is slower.
Breast-feeding Breast-feeding must not be carried out during treatment.
not be given to premature babies or new born babies. It may cause toxic reactions and allergic reactions in infant and children upto 3 years old.
Fertility Etoposide can damage genes, so men being treated with Etoposide Injection are recommended to take advice before the start of treatment concerning semen preservation, as etoposide may cause infertility.
3) How to take Etoposide Injection Etoposide Injection will always be given to you by healthcare professionals only.
Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, or if you suspect that you are pregnant or are intending to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Etoposide Injection contains alcohol This medicine contains 30.5% alcohol (ethanol) which corresponds to 240.64 mg of ethanol per ml of concentrate i.e. up to 1.2 gm of ethanol per 5 ml vial, equivalent to 30 ml of beer or 12.55 ml of wine and up to 3 gm of ethanol per 12.5 ml vial, equivalent to 75 ml of beer or 31.4 ml of wine. This is harmful for patient suffering from alcoholism, brain damage, pregnant women, breastfeeding women, children and high-risk groups such as patients with liver disease, or epilepsy. The effect of other medicines may be reduced or increased.
Pregnancy Etoposide can cause malformation of embryo or foetus. Therefore Etoposide Injection should not normally be administered to pregnant women. If used during pregnancy, the patient must be aware of the potential risk to the foetus. Male and female patients should be advised during etoposide treatment and up to 6 months after treatment to take contraceptive precautions.
Driving and using machines After the administration of etoposide, weakness, sleepiness, nausea and vomiting and acute hypersensitivity reactions may occur due to a drop in blood pressure and this may impair the ability to drive and use machines.
Etoposide Injection contains benzyl alcohol and polysorbate 80 Etoposide Injection contains 30 mg/ml of benzyl alcohol and 80 mg/ml of polysorabte 80. It must
Adults The recommended dose of etoposide 60-120 mg/m2 intravenously per day for 5 subsequent days. Older patients The dosage does not need to be adjusted. Patients with impaired kidney function The dosage needs to be adjusted depending on your kidney function. How the medicine is used Etoposide Injection will be administered to you by doctors experienced in treating tumours. This medicine is for intravenous use. Injection adjacent to the vein must be carefully avoided. The dose will be individually calculated and prepared for you, depending on your type of cancer and general condition. Etoposide Injection is given to you in a vein over a period of not less than 30 minutes and not more than 2 hours. Duration of treatment The duration of therapy is set by the doctor, taking into account the underlying disease, the combination therapy being administered (if relevant), and the individual therapeutic
Etoposi de 20 mg/ml Conce ntrate For Sol ution F or Infusion Taj Phar ma : Use s, Side Effe cts, Interactions, Pi ctures, Warnings, Et opo side D osage & Rx I nfo | Etoposide U ses, Side E ffe cts - Cancer, Et oposide 2 0 mg/ml Concentrate For Solution For Infusi on: I ndi cations, Side Effects, Warnings, Et oposide - Drug Information - Taj P harma, Etoposi de dose Taj phar ma ceuticals Et oposide interacti ons, Taj P harma ceuti cal Etoposide contraindications, Etoposide price, Etoposi de , Taj Phar ma Et oposide 2 0 mg/ml Concentrate F or Soluti on For Infusi on - Taj Phar ma . Stay connecte d to all update d on Etoposi de Taj P harmaceuticals Taj pharma ce uticals Hydera bad. Patient I nformation Lea flets, PI L.
circumstances. Etoposide should be discontinued if the tumour does not respond to treatment and/or progresses or if intolerable undesirable effects occur. If you use more Etoposide Injection than you should As this medicine is given to you by healthcare professional, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive. If you have any further questions on the use of this product, ask your doctor or pharmacist or nurse. 4) Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or nurse immediately if you noticed any of the following: severe allergic reactions such as fever, loss of heat, rapid heartbeat, abnormal contraction of muscles of bronchioles, shortness of breathing, stopping of breathing, low muscles tone and low blood pressure. itching, reddish or purple patches on skin, infection and bleeding. Frequencies of side effects are defined using the following convention: Very common (may affects more than 1 in 10 people) myelosuppression (decreased production of blood cells and platelets),
leucopenia (few blood cell), thrombocytopenia (decreased platelet count), neutropenia (low number of white blood cell) reduction of haemoglobin, nausea, vomiting, loss of appetite, abdominal pain and constipation, alopecia (temporary hair loss), liver toxicity, pigmentation, weakness and feeling discomfort. Common (may affect up to 1 in 10 people) acute leukaemia (severe blood cancer), arrhythmias (irregular heart rhythm) and myocardial infarction, dizziness, high blood pressure, redness of skin, mucositis (inflammation of mucosal membrane), stomatitis, oesophagitis (heart burn), diarrhea, skin irritation, inflammation of vein (phlebitis). Uncommon (may affect up to 1 in 100people) peripheral neuropathy (numbness or weakness of limbs), swelling of face. Rare (may affect up to 1 in 1000 people) increase the level of uric acid in blood, Seizures,
transitory loss of vision, inflammation of optic nerve, tiredness, somnolence, confusion, interstitial pneumonitis (lung inflammation), pulmonary fibrosis, taste impairment, swallowing difficulties, Stevens–Johnson syndrome(allergic skin reaction), toxic epidermal necrolysis, radiation recall dermatitis (i.e skin redness, swelling and/or blistering of skin). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine. 5) How to store Etoposide Injection Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiry date refers to the last day of that month. Keep the vial in the outer carton in order to protect from light. Do not refrigerate or freeze. Chemical and physical in-use stability of the solution diluted to a concentration of 0.2 mg/ml and 0.4 mg/ml has been demonstrated in sodium
Etoposi de 20 mg/ml Conce ntrate For Sol ution F or Infusion Taj Phar ma : Use s, Side Effe cts, Interactions, Pi ctures, Warnings, Et opo side D osage & Rx I nfo | Etoposide U ses, Side E ffe cts - Cancer, Et oposide 2 0 mg/ml Concentrate For Solution For Infusi on: I ndi cations, Side Effects, Warnings, Et oposide - Drug Information - Taj P harma, Etoposi de dose Taj phar ma ceuticals Et oposide interacti ons, Taj P harma ceuti cal Etoposide contraindications, Etoposide price, Etoposi de , Taj Phar ma Et oposide 2 0 mg/ml Concentrate F or Soluti on For Infusi on - Taj Phar ma . Stay connecte d to all update d on Etoposi de Taj P harmaceuticals Taj pharma ce uticals Hydera bad. Patient I nformation Lea flets, PI L.
chloride injection (0.9 % w/v) and glucose injection (5% w/v) for up to 96 hours and 48 hours at temperature 20°- 25° C respectively. From a microbiological point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user. Do not store the diluted product in a refrigerator (2-8 °C) as this might cause precipitation. Do not use Etoposide Injection if you notice sign of precipitation or contains visible particles. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
etoposide. Each 50 ml vial contains 1000 mg of etoposide. The other ingredients are citric acid anhydrous, benzyl alcohol, polysorbate 80, Macrogol 300 and ethanol anhydrous. What Etoposide Injection looks like and the contents of the pack Etoposide Injection is a clear, colourless to pale yellow solution for infusion. Pack sizes: 1 x 5 ml vial 1 x 10 ml vial 1 x 12.5 ml vial 1 x 20 ml vial 1 x 25 ml vial 1 x 50 ml vial
6. Further Information Not all pack sizes may be marketed. What Etoposide Injection contains Etoposide Injection contains the active ingredient etoposide. 1 ml contains 20 mg Etoposide. Each 5 ml vial contains 100 mg of etoposide. Each 10 ml vial contains 200 mg of etoposide. Each 12.5 ml vial contains 250 mg of etoposide. Each 20 ml vial contains 400 mg of etoposide. Each 25 ml vial contains 500 mg of
Manufactured in India by: TAJ PHARMACEUTICALS LTD. Mumbai, India at SURVEY NO. 188/1, 190/1TO 4, ATHIYAWAD , DABHEL, DAMAN- 396210 (INDIA) Mfg. Lic. No: DD/xxxxxxx/2018-A This leaflet was last revised in Nov 2018