Cabaz itaxel Injection 60 mg/ 1.

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Cabazitaxel is used to treat prostate cancer

Cabazitaxel Injection 60mg/ that has progressed after having had other
1.5ml Taj Pharma chemotherapy. It works by stopping cells
from growing and multiplying.
Cabazitaxel
As part of your treatment, you will also take
Package leaflet: Information for the a corticosteroid medicine (prednisone or
patient prednisolone) by mouth every day. Ask your
doctor to give you information about this
CABAZITAXEL 60 mg concentrate and
other medicine.
solvent for solution for infusion
Cabazitaxel 2. WHAT YOU NEED TO KNOW
BEFORE YOU ARE GIVEN
Read all of this leaflet carefully before CABAZITAXEL
you start using this medicine because it
contains important information for you. Do not use CABAZITAXEL if:

 Keep this leaflet. You may need to read  you are allergic (hypersensitive) to
it again. Cabazitaxel, to other taxanes, or
 If you have any further questions, ask polysorbate 80 or any of the other
your doctor, pharmacist or nurse. excipients of this medicine (listed in
 If you get any side effects talk to your section 6)
doctor, pharmacist or nurse. This  the number of your white blood cells is
includes any possible side effects not too low (neutrophil counts less than or
listed in this leaflet. See section 4 equal to 1,500 /mm3),
 you have severe abnormal liver
What is in this leaflet: function,
 you have recently received or are about
1. What cabazitaxel is and what it is used for to receive a vaccine against yellow
2. What you need to know before you are fever.
given cabazitaxel
3. How to use cabazitaxel You should not be given CABAZITAXEL if
4. Possible side effects any of the above apply to you. If you are not
5. How to store cabazitaxel sure, talk to your doctor before having
6. Contents of the pack and other CABAZITAXEL.
information
Warnings and precautions
1. WHAT CABAZITAXEL IS AND
WHAT IT IS USED FOR Before each treatment with cabazitaxel, you
will have blood tests to check that you have
The name of your medicine is cabazitaxel. enough blood cells and sufficient liver and
Its common name is "Cabazitaxel". It kidney functions to receive
belongs to a group of medicines called CABAZITAXEL.
"taxanes" used to treat cancers.
Tell your doctor immediately if:
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 you have fever. During treatment with Other medicines and CABAZITAXEL
CABAZITAXEL, it is more likely that
your white blood cell count may be Please tell your doctor, pharmacist or nurse
reduced. Your doctor will monitor your if you are taking or have recently taken any
blood and general condition for signs of other medicines. This includes medicines
infections. He/she may give you other obtained without a prescription. This is
medicines to maintain the number of because some medicines can affect the way
your blood cells. People with low blood CABAZITAXEL works or
counts can develop life-threatening CABAZITAXEL can affect how other
infections. The earliest sign of infection medicines work. These medicines include
may be fever, so if you experience the following:
fever, tell your doctor right away.
 you have ever had any allergies.  ketoconazole, rifampicin - for
Serious allergic reactions can occur infections;
during treatment with  carbamazepine, phenobarbital or
CABAZITAXEL. phenytoin - for seizures;
 St John's Wort (Hypericum perforatum)
 you have severe or long lasting
diarrhoea, you feel sick (nausea) or you - herbal remedy for depression and
are being sick (vomiting). Any of these other conditions.
 statins (such as simvastatin, lovastatin,
events could cause severe dehydration.
Your doctor may need to treat you. atorvastatin, rosuvastatin, or
 you have feeling of numbness, tingling, pravastatin) - for reducing the
burning or decreased sensation in your cholesterol in your blood
 valsartan - for hypertension
hands or feet.
 you have any bleeding problems from  repaglinide - for diabetes
the gut or have changes in the colour of
your stool or stomach pain. If the Talk to your doctor before getting
bleeding or pain is severe, your doctor vaccinations while you are receiving
will stop your treatment with CABAZITAXEL.
CABAZITAXEL. This is because Pregnancy, breast-feeding and fertility
CABAZITAXEL may increase the risk
of bleeding or developing holes in the CABAZITAXEL should not be used in
gut wall. pregnant women or women of childbearing
 you have kidney problems. age not using contraception.
 liver problems occur during the
CABAZITAXEL should not be used during
treatment.
breast feeding.
 you experience any significant increase
or decrease in daily urinary volume. Use a condom during sex if your partner is
 you have blood in your urine. or could become pregnant. CABAZITAXEL
could be present in your semen and may
If any of the above applies to you, tell your affect the foetus. You are advised not to
doctor immediately. Your doctor may father a child during and up to 6 months
reduce the dose of CABAZITAXEL or stop after treatment and to seek advice on
the treatment. conservation of sperm prior to treatment
 Cabaz itaxel Injection 60 mg/ 1.5ml Taj Pha rma: U s es , Side Effec ts , Inte ractions , Pictu res , W arnings , Cabaz itaxel Injecti on 60mg/ 1.5 ml Taj Pha rma Dos age & Rx Info | Cabaz itaxel Injectio n 60mg/ 1.5ml Taj Phar ma U s es , Side Effects , Cabaz itaxel Injecti on 60mg/ 1.5 ml Taj Pha rma : In dications , Side Ef fects , W arnings , Cabaz itaxel Injec tion 60 mg/ 1.5ml Taj Pha rma - D rug Inf orma tion - TajPhar ma, Cabaz itaxel Injec tion 60mg/ 1.5 ml Taj Pha rma dos e Taj phar maceuticals Cabaz itaxel Injection 60mg/ 1.5ml Taj Phar ma inte ractions , Taj Pha rmaceu tical Cabaz itaxel Injectio n 60mg/ 1.5ml Taj Phar ma cont rain dications , Cabaz itaxel Injectio n 60mg/ 1.5ml Taj Phar ma price, Cabaz itaxel Injection 60mg/ 1.5ml Taj Phar maTajPhar ma Cabaz itaxel Injec tion 60 mg/ 1.5ml Taj Pha rma PIL - TajPhar ma Stay connec ted to all upda ted on Cabaz itaxel Injection 60mg/ 1.5ml Taj Phar maTa j
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because CABAZITAXEL may alter male How much and how often to have
fertility.
 The usual dose depends on your body
Driving and using machines surface area. Your doctor will calculate
You may feel tired or dizzy when having your body surface area in square meters
this medicine. If this happens, do not drive (m2) and will decide the dose you
or use any tools or machines until you feel should have.
better.  You will usually have an infusion once
every 3 weeks.
CABAZITAXEL contains ethanol
(alcohol) If you have any further questions on the use
of this medicine, ask your doctor,
This medicine contains 15% v/v ethanol
pharmacist or nurse.
(alcohol), equivalent to 14 ml of beer or 6
ml of wine. This medicine may be harmful 4. POSSIBLE SIDE EFFECTS
for those suffering from alcoholism.
Like all medicines, this medicine can cause
To be taken into account if you are in a high side effects, although not everybody gets
risk group such as patients with liver them. Your doctor will discuss these with
disease, or epilepsy. you and will explain the potential risks and
benefits of your treatment.
3. HOW TO USE CABAZITAXEL
See a doctor immediately if you notice
Instructions for use
any of the following side effects:
Anti-allergic medicines will be given to you
before you have CABAZITAXEL to reduce  fever (high temperature). This is very
the risk of allergic reactions. common (may affect more than 1 in 10
people).
 CABAZITAXEL will be given to you  severe loss of body fluids
by a doctor or a nurse. (dehydration). This is common (may
 CABAZITAXEL must be prepared affect up to 1 in 10 people). This can
(diluted) before it is given. Practical occur if you have severe or long-lasting
information for handling and diarrhoea, or fever, or if you are being
administration of CABAZITAXEL for sick (vomiting).
doctors, nurses and pharmacists is  severe stomach pain or stomach pain
provided with this leaflet. that doesn't go away. This can occur if
 CABAZITAXEL will be given by a you have a hole in the stomach, food
drip (infusion) into one of your veins pipe, gut or bowel (gastrointestinal
(intravenous use) in hospital for about perforation). This can lead to death.
an hour.
 As part of your treatment, you will also If any of the above applies to you, tell your
take a corticosteroid medicine doctor immediately.
(prednisone or prednisolone) by mouth
Other side-effects include:
every day.
 Cabaz itaxel Injection 60 mg/ 1.5ml Taj Pha rma: U s es , Side Effec ts , Inte ractions , Pictu res , W arnings , Cabaz itaxel Injecti on 60mg/ 1.5 ml Taj Pha rma Dos age & Rx Info | Cabaz itaxel Injectio n 60mg/ 1.5ml Taj Phar ma U s es , Side Effects , Cabaz itaxel Injecti on 60mg/ 1.5 ml Taj Pha rma : In dications , Side Ef fects , W arnings , Cabaz itaxel Injec tion 60 mg/ 1.5ml Taj Pha rma - D rug Inf orma tion - TajPhar ma, Cabaz itaxel Injec tion 60mg/ 1.5 ml Taj Pha rma dos e Taj phar maceuticals Cabaz itaxel Injection 60mg/ 1.5ml Taj Phar ma inte ractions , Taj Pha rmaceu tical Cabaz itaxel Injectio n 60mg/ 1.5ml Taj Phar ma cont rain dications , Cabaz itaxel Injectio n 60mg/ 1.5ml Taj Phar ma price, Cabaz itaxel Injection 60mg/ 1.5ml Taj Phar maTajPhar ma Cabaz itaxel Injec tion 60 mg/ 1.5ml Taj Pha rma PIL - TajPhar ma Stay connec ted to all upda ted on Cabaz itaxel Injection 60mg/ 1.5ml Taj Phar maTa j
Pharmaceu ticals Taj pharmaceuticals . Patien t Info rma tion Leaflets , PIL.

Very common (may affect more than 1 in  high blood sugar

10 people):  low blood potassium
 mental confusion
 decrease in the number of red (anaemia),  feeling anxious
or white blood cells (which are  abnormal feeling or loss of sensation or
important in fighting infection) pain in hands and feet
 decrease in the number of platelets  ringing in the ear
(which results in increased risk of  trouble with balance
bleeding)  rapid or irregular heartbeat
 loss of appetite (anorexia)  blood clot in the leg
 alteration in sense of taste  skin feeling hot or flushed
 shortness of breath  pain in mouth or throat
 cough  rectal bleeding
 stomach upsets including feeling sick  redness of the skin
(nausea), being sick (vomiting),  muscle discomfort, aches or pain
diarrhoea or constipation  swelling of the feet or legs
 abdominal pain  chills.
 short term hair loss (in most cases
normal hair growth should return) Uncommon (may affect up to 1 in 100
 back pain people):
 joint pain
 blood in the urine  inflammation of the bladder, which can
 feeling tired, weak or lack of energy. occur when your bladder has been
previously exposed to radiation therapy
Common (may affect up to 1 in 10 people): (cystitis due to radiation recall
phenomenon).
 urinary tract infection
 lack of white blood cells associated with Frequency not known (cannot be estimated
fever and infection from the available data;
 feeling of numbness, tingling, burning or
decreased sensations in hands and feet  interstitial lung disease (inflammation
 dizziness of the lungs causing coughing and
 headache difficulty breathing).
 decrease or increase in blood pressure
 uncomfortable feeling in the stomach, Reporting of side effects
heart burn or belching
 stomach pain If you get any side effects, talk to your
 haemorrhoids doctor. This includes any possible side
 muscle spasm effects not listed in this leaflet.
 painful or frequent urination 5. How to store CABAZITAXEL
 urinary incontinence
 kidney disease or problems Keep this medicine out of the sight and
 sore in the mouth or on lips reach of children.
 infections or risk of infections
 Cabaz itaxel Injection 60 mg/ 1.5ml Taj Pha rma: U s es , Side Effec ts , Inte ractions , Pictu res , W arnings , Cabaz itaxel Injecti on 60mg/ 1.5 ml Taj Pha rma Dos age & Rx Info | Cabaz itaxel Injectio n 60mg/ 1.5ml Taj Phar ma U s es , Side Effects , Cabaz itaxel Injecti on 60mg/ 1.5 ml Taj Pha rma : In dications , Side Ef fects , W arnings , Cabaz itaxel Injec tion 60 mg/ 1.5ml Taj Pha rma - D rug Inf orma tion - TajPhar ma, Cabaz itaxel Injec tion 60mg/ 1.5 ml Taj Pha rma dos e Taj phar maceuticals Cabaz itaxel Injection 60mg/ 1.5ml Taj Phar ma inte ractions , Taj Pha rmaceu tical Cabaz itaxel Injectio n 60mg/ 1.5ml Taj Phar ma cont rain dications , Cabaz itaxel Injectio n 60mg/ 1.5ml Taj Phar ma price, Cabaz itaxel Injection 60mg/ 1.5ml Taj Phar maTajPhar ma Cabaz itaxel Injec tion 60 mg/ 1.5ml Taj Pha rma PIL - TajPhar ma Stay connec ted to all upda ted on Cabaz itaxel Injection 60mg/ 1.5ml Taj Phar maTa j
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Do not use this medicine after the expiry What CABAZITAXEL looks like and
date which is stated on the outer carton and contents of the pack
on the label of the vials after EXP. The
expiry date refers to the last day of that CABAZITAXEL is a concentrate and
month. solvent for solution for infusion (sterile
concentrate).
Do not store above 30°C. Do not refrigerate.
The concentrate is a clear yellow to
Information about storage and the time to brownish yellow oily solution.
use CABAZITAXEL, once it has been
diluted and is ready to use, are described in The solvent is a clear and colourless
the section "practical information for solution.
medical or healthcare professionals on One pack of CABAZITAXEL contains:
preparation, administration and handling of
cabazitaxel". One single use clear glass vial, closed with a
grey chlorobutyl rubber closure sealed by an
Any unused product or waste material aluminium cap with a light green plastic
should be disposed of in accordance with flip-off cover containing 1.5ml (nominal
local requirements. These measures will volume) concentrate.
help to protect the environment.
 One single use clear glass vial, closed
6. CONTENTS OF THE PACK AND
with a grey chlorobutyl rubber closure
OTHER INFORMATION
sealed by a gold colour aluminium cap
What CABAZITAXEL contains with a colourless plastic flip-off cover,
containing 4.5ml (nominal volume)
The active substance is Cabazitaxel. One ml solvent.
of concentrate contains 40 mg Cabazitaxel.
Each vial of concentrate contains 60 mg 7. Manufactured in India By:
Cabazitaxel. TAJ PHARMACEUTICALS LIMITED
at SURVEY NO.188/1 TO 189/1,190/1 TO 4,
The other ingredients are polysorbate 80 and ATHIYAWAD, DABHEL, DAMAN- 396210
citric acid in the concentrate, and ethanol (INDIA)
96% and water for injections in the solvent
(see section 2 "CABAZITAXEL contains
alcohol").
Note: Both the CABAZITAXEL
60mg/1.5ml concentrate vial (fill volume:
73.2 mg of Cabazitaxel/1.83ml) and the
solvent vial (fill volume: 5.67ml) contain an
overfill to compensate for liquid loss during
preparation. This overfill ensures that after
dilution with the ENTIRE contents of the
accompanying solvent, there is solution
containing 10mg/ml Cabazitaxel.