Idarubicin 10 mg/10 ml soluti on for injection : Uses, Side Effects, I nteractions, Pi ctures, War nings, I darubi cin Dosage

& Rx I nfo | Idarubi cin U ses, Side E ffe cts - Cancer, Idaru bicin 250 mg Film-coated tablet: I ndi cations, Side E ffects, Warnings, I darubi cin - Drug Infor mation - Taj Phar ma, Idarubicin dos e Taj pharma ceutical s Idarubicin intera ctions, Taj Phar mace utical Idarubici n contraindicati ons, I darubi cin pri ce, Idarubici n , Taj Phar ma Idaru bicin 10 mg/10 ml solution for injection - Taj P harma . Stay conne cted to all updated on Idarubici n Taj Phar mace uticals Taj pharma ceutical s Hyderaba d. Patient Infor mation Leaflets, PIL.

IDARUBICIN 10MG/10ML
SOLUTION FOR INJECTION
Package leaflet: Information for the patient with topoisomerase II, having an inhibitory effect platelets;
Idarubicin 10 mg/10 ml solution for injection on the synthesis of nucleic acid. - If you have previously been treated with
idarubicin and/ or other anthracyclines or
Read all of this leaflet carefully before you start Idarubicin Injection is a medicine used for the anthracenediones.
taking this medicine because it contains treatment : - If you are breast-feeding.
important information for you.
Adults Warnings and Precautions
- Keep this leaflet. You may need to read it again.
-Acute non-lymphocytic leukaemia, for remission - if you have heart trouble. Heart function must be
- If you have any further questions, ask your
induction in untreated patients or for remission assessed before starting treatment with idarubicin
doctor or pharmacist.
induction in relapsed or refractory patients. and must be monitored during treatment to
- This medicine has been prescribed for you only.
-Acute lymphocytic leukaemia as second line minimise the risk of incurring severe heart failure;
Do not pass it on to others. It may harm them,
treatment. - if you have a reduced bone marrow blood cell
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or and platelet count;
Children - if you have a marked and permanent increase of
pharmacist. This includes any possible side effects -Acute non-lymphocytic leukaemia, in
not listed in this leaflet (see section 4). abnormal white cells in the blood. You may be
combination with cytarabine, for remission developing leukaemia;
induction in untreated patients. - if you have gastrointestinal problems;
What is in this leaflet -Acute lymphocytic leukaemia as second line - if you have liver problems;
1. What Idarubicin Injection is and what it is used treatment. Idarubicin Injection may also be used in - if you have kidney problems;
for combination with other anticancer agents. - this medicine can cause vomiting, may develop
2. What you need to know before you take
inflammation of the oral mucosa or inflammation
Idarubicin Injection 2. WHAT YOU NEED TO KNOW BEFORE YOU
of the mucosal lining of the digestive tract;
3. How to take Idarubicin Injection TAKE IDARUBICIN INJECTION
- you may develop reactions at the injection site;
4. Possible side effects Do not take Idarubicin Injection:
- if extravasation occurs during the injection, you
5. How to store Idarubicin Injection - if you are allergic to idarubicin or to any of the
may feel pain and extravasation may cause severe
6. Contents of the pack and other information other ingredients in this medicine (listed in section
tissue lesions. If extravasation occurs,
6);
administration of the medicine must be
1.WHAT IDARUBICIN INJECTION IS AND WHAT - if you are allergic to other anthracyclines or
discontinued immediately;
IT IS USED FOR anthracenediones;
- as happens with other cytotoxic agents,
Idarubicin Injection belongs to a group of - if you suffer from severe liver problems ;
inflammation of a vein wall may occur, with the
medicines called as citotoxics and antimitotics - if you suffer from sever kidneys problems;
formation of blood clots;
agents, which intercalate with DNA and interact - if you suffer from heart problems;
- if you have recently had or are thinking of having
- if you have low production of blood cells and
Idarubicin 10 mg/10 ml soluti on for injection : Uses, Side Effects, I nteractions, Pi ctures, War nings, I darubi cin Dosage & Rx I nfo | Idarubi cin U ses, Side E ffe cts - Cancer, Idaru bicin 250 mg Film-coated tablet: I ndi cations, Side E ffects, Warnings, I darubi cin - Drug Infor mation - Taj Phar ma, Idarubicin dos e Taj pharma ceutical s Idarubicin intera ctions, Taj Phar mace utical Idarubici n contraindicati ons, I darubi cin pri ce, Idarubici n , Taj Phar ma Idaru bicin 10 mg/10 ml solution for injection - Taj P harma . Stay conne cted to all updated on Idarubici n Taj Phar mace uticals Taj pharma ceutical s Hyderaba d. Patient Infor mation Leaflets, PIL.

a vaccine; In the case of association of oral anticoagulants recommended dose is 12 mg/m2 IV a day for 3
- if you are a man, idarubicin can cause irreversible and anticancer chemotherapy, greater frequency days in combination with cytarabine. Another
infertility. in monitoring the International Normalised Ratio dose pattern that can be used in acute non-
(INR) is recommended. lymphocytic leukaemia, as a single agent or in
Idarubicin must be administered only under the
combination, is 8 mg/m2 IV a day for 5 days.
supervision of a doctor with experience in Pregnancy, breast-feeding and fertility
Children: The recommended dose range is 10-12
cytotoxic chemotherapy. If you are pregnant or breast-feeding, think you
mg/m2 IV a day for 3 days in combination with
may be pregnant or are planning to have a baby,
This medicine can cause red colouration of urine cytarabine.
ask your doctor or pharmacist for advice before
for one to two days after its administration.
you are given this medicine. Acute lymphocytic leukaemia
Before and during the treatment with Idarubicin Men subject to treatment with idarubicin must use Adults: As a single agent in acute lymphocytic
Injection, regular exams should be made to the effective contraceptive methods up to 3 months leukaemia, the recommended dose is 12 mg/m2 IV
blood, liver, kidneys and heart. Babies and after treatment. a day for 3 days.
children seem to have a greater sensitivity to There are no adequate and controlled studies in Children: As a single agent in acute lymphocytic
cardiac toxicity induced by anthracyclines. Thus, in pregnant women. Idarubicin should only be used leukaemia, the recommended dose is 10 mg/m2 IV
these patients, it is necessary to do regular during pregnancy if the potential benefits justify a day for 3 days.
examination to the heart for a long period of time. the potential risks to the foetus.
All these dosage regimens must take into account
Other medicines and Idarubicin Injection Breast-feeding the patient’s blood condition and the doses of the
Tell your doctor if you are taking, have recently It is not known if idarubicin is excreted in the other cytotoxic agents when used in association.
taken, or might take any other medicines. mother’s milk. Since many drugs are, mothers
If you are given more Idarubicin Injection than
Idarubicin is used mainly in association with other must stop breast-feeding before starting
you should have received
cytotoxic agents, and additive toxicity may occur, treatment.
Very high doses of idarubicin can cause acute
especially with regard to bone marrow, blood and
Driving and using machines toxicity of the heart muscle in the first 24 hours
gastrointestinal. The risk of cardiac toxicity may
The effect of idarubicin on the ability to drive and and severe suppression of blood cell production
increase in patients who have received at the same
use machines has not been systematically through the bone marrow within one to two
time other medicines with toxic properties to the
assessed. weeks. The occurrence of delayed heart failure
heart.
with anthracyclines has been observed, up to
Since idarubicin is extensively metabolised by the 3. HOW TO TAKE IDARUBICIN INJECTION
several months after an overdose.
liver, impairments in liver function caused by other Always use this medicine exactly as your doctor or
medicines may affect idarubicin metabolism, pharmacist has told you. Check with your doctor If you forgot to use Idarubicin Injection
pharmacokinetics and therapeutic efficacy and/ or or pharmacist if you are not sure. Do not take a double dose to make up for a
toxicity. The dosage is normally calculated taking into forgotten dose. If you have any further questions
account the body surface area (mg/m2 ). on the use of this medicine, ask your doctor or
Anthracyclines, including idarubicin, must not be
Administration is usually intravenous. pharmacist.
administered in association with other cardiotoxic
agents, unless heart function is carefully Acute non-lymphocytic leukaemia
monitored. Adults: In acute non-lymphocytic leukaemia, the
Idarubicin 10 mg/10 ml soluti on for injection : Uses, Side Effects, I nteractions, Pi ctures, War nings, I darubi cin Dosage & Rx I nfo | Idarubi cin U ses, Side E ffe cts - Cancer, Idaru bicin 250 mg Film-coated tablet: I ndi cations, Side E ffects, Warnings, I darubi cin - Drug Infor mation - Taj Phar ma, Idarubicin dos e Taj pharma ceutical s Idarubicin intera ctions, Taj Phar mace utical Idarubici n contraindicati ons, I darubi cin pri ce, Idarubici n , Taj Phar ma Idaru bicin 10 mg/10 ml solution for injection - Taj P harma . Stay conne cted to all updated on Idarubici n Taj Phar mace uticals Taj pharma ceutical s Hyderaba d. Patient Infor mation Leaflets, PIL.

4.POSSIBLE SIDE EFFECTS redness, gastric ulcers, skin reddening particularly - Each vial of 20 ml contains 20 mg of idarubicin
Like all medicines, this medicine can cause side in the limbs. hydrochloride.
effects, although not everybody gets them. - The other ingredients are: glycerol, hydrochloric
Cases of pancytopoenia, tumourallysis syndrome acid concentrate, sodium hydroxide (for pH
The following side effects can occur very and local reaction have also been reported. adjustment) and water for injection.
commonly: - infections; decrease in number of red
blood cells, white blood cells and platelet counts in Reporting side effects What Idarubicin Injection look like and contents
circulatory blood; marked reduction or loss of If you get any side effects, talk to your doctor or of the pack
appetite; nausea, vomiting, diarrhoea, abdominal pharmacist. This includes any possible side effects Clear, orange red solution, free of visible
pain, burning sensation, inflammation of mucosa not listed in this leaflet. suspended particles.
in the mouth; hair loss; reddish colouring of urine By reporting side effects you can help provide Each vial of Type I colourless glass for injection
1-2 days after taking the medicine: fever, more information on the safety of this medicine. contains ready to use solution of 5 mg, 10 mg or 20
headache and chills. mg of idarubicin hydrochloride for injection
5.HOW TO STORE IDARUBICIN INJECTION solution.
The following side effects can occur commonly: Keep this medicine out of the sight and reach of Vials of 5 ml or 10 ml or 20 ml of solution. Box of 1
- increase or decrease in heart rate, increase and children. vial.
irregular heart rhythm, heart function impairment; Do not use this medicine after the expiry date Not all pack sizes may be marketed.
inflammation of the vein, inflammation of the vein which is stated on the label or carton after EXP.
associated with thrombosis, bleeding; The expiry date refers to the last day of that
haemorrhage of the gastrointestinal tract, month.
stomach ache; increase in liver enzymes and Store in a refrigerator (2°C - 8°C). Store in the
bilirubin; skin rash, itching, hypersensitivity of original package in order to protect from light.
irradiated skin. Do not throw away any medicines via wastewater Manufactured in India by:
or household waste. Ask your pharmacist how to TAJ PHARMACEUTICALS LTD.
The following side effects can occur uncommonly: throw away medicines you no longer use. These Mumbai, India
- general infection; secondary leukaemia; increase measures will help protect the environment. at SURVEY NO. 188/1, 190/1TO 4, ATHIYAWAD ,
in blood uric acid concentration;
DABHEL, DAMAN- 396210 (INDIA)
electrocardiogram irregularities; shock; 6. CONTENTS OF THE PACK AND FURTHER Mfg. Lic. No: DD/xxxxxxx/2018-A
inflammation of the oesophagus, inflammation of INFORMATION
the colon, hyperpigmentation of skin and nails, What Idarubicin Injection contain This leaflet was last revised in Nov 2018
cellulitis, tissue necrosis. - The active substance is idarubicin hydrochloride.
- One ml of solution contains 1 mg idarubicin
The following side effects can occur rarely: - brain hydrochloride.
haemorrhage. - Each vial of 5 ml contains 5 mg of idarubicin
hydrochloride.
The following side effects can occur very rarely:
- Each vial of 10 ml contains 10 mg of idarubicin
- general severe allergic reaction; heart infection
hydrochloride.
and other disorders, occlusion of a blood vessel,