Carboplatin 10mg /ml I njection, 10 mg Taj Phar ma : Use s, Side Effe cts, Intera ctions, Pictures , Warning s, Carboplatin

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CARBOPLATIN
INJECTION BP
Treatment with an anticancer medicine is
10MG/ML sometimes called cancer chemotherapy.
Carboplatin is used in the treatment of some types
Package leaflet: Information for the patient of lung cancer and ovarian cancer.
Carboplatin 10mg/ml Injection 2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CARBOPLATIN INJECTION
Read all of this leaflet carefully before you start Do not use Carboplatin Injection
taking this medicine because it contains
 if you have shown signs of hypersensitivity
important information for you.
(severe allergy) to carboplatin or similar platinum
- Keep this leaflet. You may need to read it again.
containing medicines in the past
- If you have any further questions, ask your
 if you have severe kidney disease
doctor or pharmacist.
 if you have fewer blood cells than normal (your
- This medicine has been prescribed for you only.
doctor will check this with a blood test)
Do not pass it on to others. It may harm them,
 if you have a tumour that bleeds
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or  if you plan to receive a yellow fever vaccination
pharmacist. This includes any possible side effects or have just received one
Tell your doctor if any of the above applies to you
not listed in this leaflet (see section 4).
before this medicine is used.
What is in this leaflet
1. What Carboplatin Injection is and what it is used Warnings and Precautions
for  if you are pregnant or if there is a chance you
2. What you need to know before you take may be pregnant
Carboplatin Injection  if you are breast-feeding
3. How to take Carboplatin Injection  if you have mild renal disease. Your doctor will
4. Possible side effects want to monitor you more regularly.
5. How to store Carboplatin Injection  if you are elderly (over 65 years old)
6. Contents of the pack and other information  if you have been treated with cisplatin or similar
anti-cancer medicines in the past, carboplatin may
1.WHAT CARBOPLATIN INJECTION IS AND cause abnormalities in your nervous system, such
WHAT IT IS USED FOR as pins and needles or hearing and vision
Carboplatin Injection is an anti-cancer medicine. problems. Your doctor may regularly assess you.
 if you have headache, altered mental
functioning, seizures and abnormal vision (from
blurriness to vision loss).
 if you develop extreme tiredness and shortness
of breath with decreased number of red blood
cells, (haemolytic anaemia), alone or combined
with low platelet count, abnormal bruising
(thrombocytopenia) and kidney disease where you
pass little or no urine (symptoms of Haemolytic-
uraemic syndrome).
 if you have fever (temperature greater than or
equal to 38°C), or chills, which could be signs of
infection. You may be at risk of getting an
infection of the blood.
Tell your doctor if any of the above applies to you
before this medicine is used.
Other medicines and Carboplatin Injection
Special care is needed if you are taking/using other
medicines as some could interact with carboplatin,
for example:
 medicines which can reduce the number of cells
in your blood, at the same time as carboplatin,
may require changes to the dosage and frequency
of your carboplatin treatment
 some antibiotics called aminoglycosides,
vancomycin or capreomycin, at the same time as
carboplatin, may increase the risk of kidney or
hearing problems
 some water tablets (diuretics), at the same time
as carboplatin, may increase the risk of kidney or
hearing problems
Carboplatin 10mg /ml I njection, 10 mg Taj Phar ma : Use s, Side Effe cts, Intera ctions, Pictures , Warning s, Carboplatin Dosag e & Rx Info | Car boplatin Uses, Side E ffects - Cancer, Car boplatin 1 0mg/ ml Inj ection, 10 mg: Indi cations, Side Effe cts, Warni ngs, Carboplatin - Dr ug Informati on - Taj Pharma , Carboplatin dose Taj phar mace uticals Car boplatin intera ctions , Taj Phar mace utical Carboplatin contraindi cations, Carboplatin pri ce, Carboplatin , Taj Phar ma Car boplatin 1 0mg /ml Inj ection, 10 mg, - Taj P harma . Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj phar mace uticals Hyderabad. Patient Infor mation Lea flets, PIL.

 live or live-attenuated vaccines (for yellow fever doctor or pharmacist for advice before taking any you will be given too much or too little, however,
vaccine see section 2, Do not use Carboplatin medicine. tell your doctor or nurse if you have any concerns.
Injection)
Driving and using machines 4.POSSIBLE SIDE EFFECTS
 blood thinning medicines e.g. warfarin, at the
Do not drive or use machines if you experience any Like all medicines, this medicine can cause side
same time as carboplatin, may require an increase
side effect which may lessen your ability to do so effects, although not everybody gets them.
in frequency of blood coagulation monitoring
such as nausea, vomiting, worsening of eyesight, If any of the following happen, tell your doctor
 phenytoin and fosphenytoin (used to treat
or changes to your vision and hearing. immediately:
various types of convulsions and seizures), at the
 abnormal bruising, bleeding, or signs of infection
same time as carboplatin, may increase the risk of
The Carboplatin Injection vial stopper contains such as a sore throat and high temperature
a seizure
dry natural rubber  severe allergic reaction (anaphylaxis/
 other medicines which decrease the activity of
The vial stopper contains dry natural rubber (a anaphylactic reactions) - you may experience a
the immune system (e.g.ciclosporin, tacrolimus,
derivative of latex), which may cause allergic sudden itchy rash (hives), swelling of the hands,
sirolimus)
reactions. feet, ankles, face, lips, mouth or throat (which may
Tell your doctor if you are taking, have recently
cause difficulty in swallowing or breathing), and
taken or might take any other medicines, 3. HOW TO TAKE CARBOPLATIN INJECTION you may feel you are going to faint
including medicines obtained without a This medicine will be given by infusion (drip) into a These are serious side effects. You may need
prescription. vein over 15-60 minutes. urgent medical attention.
Dose
Pregnancy, breast-feeding and fertility Very common side effects (may affect more than
Your doctor will work out the correct dose of
If you are pregnant or breast-feeding, think you 1 in 10 people)
carboplatin for you and how often it must be
may be pregnant or are planning to have a baby,  tiredness, shortness of breath and paleness
given.
ask your doctor for advice before taking this caused by anaemia (a condition in which there is a
The dose will depend on your medical condition,
medicine. Due to the possible risk of birth defects, decreased number of red blood cells)
your size and how well your kidneys are working.
female patients of childbearing potential should  feeling sick (nausea) or being sick (vomiting)
Your doctor will tell how well your kidneys are
take contraceptive measures before and during
working using blood or urine samples.  stomach pain and cramp
treatment with carboplatin. Men treated with this
You will have regular blood tests after your dose of Tests may also show:
medicine are advised not to father a child during,
carboplatin. You may also have checks for nerve  changes in your red and white blood cells and
and up to 6 months after treatment. Advice on
damage and hearing loss. platelets (myelosuppresion)
conservation of sperm should be sought prior to
There is likely to be about 4 weeks between each  increase in the level of urea in your blood
treatment because of the possibility of irreversible
dose of carboplatin.  decrease in the level of sodium, potassium,
infertility.
calcium and magnesium in your blood
If you are given too much or too little
Effects on fertility  decrease in renal creatinine clearance
Carboplatin Injection
Treatment with carboplatin may temporarily or This medicine will be given to you in a hospital,  abnormal liver enzyme levels
permanently reduce fertility in men and women. under the supervision of a doctor. It is unlikely that Common side effects (may affect up to 1 in 10
Tell your doctor if you have concerns. Ask your
people)
Carboplatin 10mg /ml I njection, 10 mg Taj Phar ma : Use s, Side Effe cts, Intera ctions, Pictures , Warning s, Carboplatin Dosag e & Rx Info | Car boplatin Uses, Side E ffects - Cancer, Car boplatin 1 0mg/ ml Inj ection, 10 mg: Indi cations, Side Effe cts, Warni ngs, Carboplatin - Dr ug Informati on - Taj Pharma , Carboplatin dose Taj phar mace uticals Car boplatin intera ctions , Taj Phar mace utical Carboplatin contraindi cations, Carboplatin pri ce, Carboplatin , Taj Phar ma Car boplatin 1 0mg /ml Inj ection, 10 mg, - Taj P harma . Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj phar mace uticals Hyderabad. Patient Infor mation Lea flets, PIL.

 signs of infection such as fever or sore throat Rare side effects (may affect up to 1 in 1,000 given
 flu-like symptoms people)  lung infection
 symptoms of severe allergic reaction include  temporary sight loss Carboplatin may lead to problems with your
sudden wheeziness or tightness of chest, swelling blood, liver and kidneys. Your doctor will take
Very rare side effects (may affect up to 1 in
of the eyelids, face or lips, facial flushing, low blood samples to check for these problems.
10,000 people)
blood pressure, rapid heartbeat, hives, shortness
 scarring of the lungs which causes shortness of Reporting of side effects
of breath, dizziness and anaphylactic shock
breath and/or cough (pulmonary fibrosis) If you get any side effects, talk to your doctor. This
 tingling or numbness in your hands, feet, arms or
includes any possible side effects not listed in this
legs Not known: frequency cannot be estimated from leaflet. By reporting side effects you can help
 burning or prickling sensation available data provide more information on the safety of this
 decreased tendon reflex  cancers caused by treatment with carboplatin medicine.
 taste disturbance or loss of taste (secondary malignancies)
 temporary worsening of eyesight or changes to  feeling unwell with high temperature due to low 5.HOW TO STORE CARBOPLATIN INJECTION
your vision levels of white blood cells (febrile neutropenia) Keep out of the sight and reach of children.
 ringing in the ears or changes in your hearing  haemolytic-uraemic syndrome (a disease Expiry
 heart disorders characterised by acute renal failure) Do not use this medicine after the expiry date
 tightness of the chest or wheezing  a group of symptoms such as headache, altered which is stated on the vial label and carton after
 interstitial lung disease (a group of lung mental functioning, seizures and abnormal vision 'EXP'. Where only a month and year is stated, the
disorders in which the deep lung tissues become (from blurriness to vision loss). These are expiry date refers to the last day of that month.
inflamed) symptoms of reversible posterior Storage
 diarrhoea or constipation leukoencephalopathy syndrome, a rare This medicine comes in two types of vial, ONCO-
 sore lips or mouth ulcers (mucous membrane neurological disorder, VIAL® and standard vials. The ONCO-VIAL®
disorders)  dry mouth, tiredness, and headache due to should be stored at 2 to 8°C. The standard vials
should not be stored above 25°C.
 hair loss excessive loss of body water (dehydration)
 loss of appetite, anorexia The vials should be kept in the outer carton in
 rash and/or itchy skin
 pancreatitis, order to protect from light.
 pain or discomfort in your bones, joints,
 stroke If Carboplatin for Intravenous Infusion is diluted
muscles, or surrounding structures
before use, the diluted solution should be used
(musculoskeletal disorder)  severely impaired liver function, damage or
immediately. If not used immediately it should not
 problems with your kidneys or urine death of liver cells
normally be stored for longer than 24 hours at 2 to
 extreme tiredness/weakness (asthenia)  heart failure
8ºC.
Tests may also show:  obstruction in blood vessel (embolism)
 increased level of bilirubin and creatinine in your  changes in blood pressure (hypertension or 6. CONTENTS OF THE PACK AND FURTHER
blood hypotension) INFORMATION
 increased level of uric acid in your blood which  skin disorders such as hives, rash, skin redness
may lead to gout (erythema), and itching What Carboplatin Injection contain
 swelling or soreness where the injection was The active substance is carboplatin. Each millilitre
Carboplatin 10mg /ml I njection, 10 mg Taj Phar ma : Use s, Side Effe cts, Intera ctions, Pictures , Warning s, Carboplatin Dosag e & Rx Info | Car boplatin Uses, Side E ffects - Cancer, Car boplatin 1 0mg/ ml Inj ection, 10 mg: Indi cations, Side Effe cts, Warni ngs, Carboplatin - Dr ug Informati on - Taj Pharma , Carboplatin dose Taj phar mace uticals Car boplatin intera ctions , Taj Phar mace utical Carboplatin contraindi cations, Carboplatin pri ce, Carboplatin , Taj Phar ma Car boplatin 1 0mg /ml Inj ection, 10 mg, - Taj P harma . Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj phar mace uticals Hyderabad. Patient Infor mation Lea flets, PIL.

(ml) of solution contains 10 milligrams (mg) of

carboplatin.
The other ingredient is Water for Injections.

What Carboplatin Injection look like and

contents of the pack
Carboplatin Injection is a clear, colourless solution
for infusion which comes in glass containers called
vials.
It may be supplied in packs containing:
1 x 50 mg/5 ml vial or ONCO-VIAL®
1 x 150 mg/15 ml vial or ONCO-VIAL®
1 x 450 mg/45 ml vial or ONCO-VIAL®
1 x 600 mg/60 ml vial or ONCO-VIAL®
Not all packs may be marketed.

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