Mitoxantrone 2 mg per ml concentrate for sol ution for infusion, Taj Phar ma : U ses, Side E ffe cts, Intera

ctions , Picture s, Warni ngs, Mitoxantrone Dosage & Rx Info | Mitoxa ntrone U ses, Side E ffe cts – Antifungal/ Antiba cterial, Mitoxa ntrone 2 mg per ml concentrate for s olution for i nfusion : Indi cations, Side Effe cts, War nings, Mitoxantrone - Drug I nformation - Taj P harma, Mitoxantrone dose Taj phar mace uticals Mitoxantrone interactions, Taj P harma ceutical Mitoxantrone contraindi cations , Mitoxa ntrone pri ce, Mitoxantrone , Taj Phar ma Mitoxa ntrone 2 mg per ml conce ntrate for s olution for infusion, - Taj Pharma . Stay conne cted to all updated on Mitoxantrone Taj Phar mace uticals Taj pharma ceutical s Hyderaba d. Patient Infor mation Leaflets , PIL.

2. Before you are given Mitoxantrone

MITOXANTRONE 5. How Mitoxantrone Solution is stored
6. Further Information Solution
CONCENTRATE FOR Do not use Mitoxantrone Solution
1. What Mitoxantrone Solution is and  if you are (allergic) to mitoxantrone or any
SOLUTION FOR what it is used for of the other ingredients of this medicine
(listed in section 6).
INFUSION Mitoxantrone Solution belongs to the group
of medicines known as antineoplastic or  if you are allergic to sulphite;
2 MG/ML anti-cancer drugs. It also belongs to the
subgroup of anti-cancer medicines called
 if you have a form of asthama (bronchial
asthama) with sulphite allergy;
anthracyclines. Mitoxantrone Solution  if you are breast-feeding (see section
Package leaflet: Information for the
prevents cancer cells from growing, as a “pregnancy and breast-feeding”).
patient
result of which they eventually die. The
Mitoxantrone 2 mg/ml Concentrate for
medicine also supresses the immune system For use as treatment of multiple sclerosis:
Solution for Infusion.
and is used because of this effect to treat a  if you are pregnant.
specific form of multiple sclerosis when
Read all of this leaflet carefully before you there are no alternative treatment options. Warnings and precautions
start taking this medicine because it Mitoxantrone Solution Should be
contains important information for you. Mitoxantrone 2 mg/ml is used in the administered under the supervision of a
- Keep this leaflet. You may need to read it treatment of: doctor experienced in the use of cancer
again.  Advanced stage (metastatic form) of medicines that are toxic to your cells
- If you have any further questions, ask your breast cancer. (cytotoxic xhemotherapy agents).
doctor or pharmacist.  A certain of lymph node cancer (non-
- This medicine has been prescribed for you Hodgkin’s lymphoma). Mitoxantrone Solution should be given by
only. Do not pass it on to others. It may slow and freely flowing infusion into the
 A cancer of the blood in which the bone
harm them, even if their signs of illness are vein.
marrow (the spongy tissue inside the large
the same as yours.
bones) makes too many white blood cells
- If any of the side effects gets serious, or if Mitoxantrone 2 mg/ml must not be
(acute myeloid leukaemia);
you notice any side effects not listed in this administered unde the skin (subcutaneous),
leaflet, please tell your doctor.  A cancer of white blood cells (chronic
in a muscle (intramuscular), or into the
myeloid leukaemia) at a stage where it is
artery (intra-arterial). Severe local tissue
difficult to control the number of white
What is in this leaflet damage may occur if Mitoxantrone Solution
blood cells (blast crisis). Mitoxantrone
leaks in surrounding tissue (extravasation)
Solution is used in the combination with
1. What Mitoxantrone Solution is and what during administration.
other medicinal products in this indication;
it is used for
 Pain caused by prostate cancer at an Mitoxantrone 2 mg/ml must also not be
2. Before you are given Mitoxantrone
advanced stage of prostate cancer in injected into the space under the brain or
Solution
combination with corticosteroids; spinal cord (intrathecal injection) as this can
3. How you will be given Mitoxantrone
Solution  Highly active relapsing multiple sclerosis result in severe injury with permanent
4. Possible side effects associated with rapidly evolving disability impairment.
where no alternative therapeutic options
exist (see sections 2 and 3).
Mitoxantrone 2 mg per ml concentrate for sol ution for infusion, Taj Phar ma : U ses, Side E ffe cts, Intera ctions , Picture s, Warni ngs, Mitoxantrone Dosage & Rx Info | Mitoxa ntrone U ses, Side E ffe cts – Antifungal/ Antiba cterial, Mitoxa ntrone 2 mg per ml concentrate for s olution for i nfusion : Indi cations, Side Effe cts, War nings, Mitoxantrone - Drug I nformation - Taj P harma, Mitoxantrone dose Taj phar mace uticals Mitoxantrone interactions, Taj P harma ceutical Mitoxantrone contraindi cations , Mitoxa ntrone pri ce, Mitoxantrone , Taj Phar ma Mitoxa ntrone 2 mg per ml conce ntrate for s olution for infusion, - Taj Pharma . Stay conne cted to all updated on Mitoxantrone Taj Phar mace uticals Taj pharma ceutical s Hyderaba d. Patient Infor mation Leaflets , PIL.

Talk to your doctor or, pharmacist or nurse heart beat). This may occur either during or anthracyclines or anthracenediones, such as
before using Mitoxantrone Solution: months to years after therapy with daunorubicin or doxorubicin.
Mitoxantrone Solution.
 if you have liver problems; Your doctor will do heart function tests
 if you have kidney problems; Your doctor may need to adjust your before you start Mitoxantrone Solution and
 if you have used Mitoxantrone Solution treatment or stop Mitoxantrone Solution at regular intervals during therapy. If you
before; temporarily or permanently. receive Mitoxantrone Solution to treat
 if your heart is not working well; multiple sclerosis your doctor will test your
Blood tests prior and during treatment heart function before the start of therapy,
 if you had prior radiotherapy of the chest; with Mitoxantrone Solution prior to each subsequent dose and yearly
 if you already use other medicines that Mitoxantrone Solution may affect your for up to 5 years after the end of therapy.
affect your heart; blood cell counts. Before you start
 if you had previous therapies with Mitoxantrone Solution and during Acute myeloid leukemia (AML) and
anthracyclines or anthracenediones, such as treatment, your doctor will do ablood test to Myelodysplastic syndrome
daunorubicin or doxorubicin; count the number of your blood cells. Your A group of anticancer medicines
 if your bone marrow is not working well (is doctor will carry out blood tests more often, (topoisomerase II inhibitors), including
depressed) or if you are in generally poor in which he will in particular monitor the Mitoxantrone Solution, may cause the
health; number of white blood cells (neutrophilic following diseases when used alone but
 if you have an infection. This infection leucocytes) in the blood: especially in combination with other
should be treated before taking  if you have a low count of a specific type of chemotherapy and/or radiotherapy:
Mitoxantrone Solution; white blood cells (neutrophils) (less than  cancer of white blood cells (acute myeloid
 if you plan a vaccination or immunisation 1,500 cells/mm3); leukaemia, AML)
during treatment. vacinations and  if you use Mitoxantrone Solution in high  a bone marrow disorder that causes
immunisations may not work during doses (>14 mg/m2 per day x 3 days). abnormally shaped blood cells and leads to
treatment with Mitoxantrone Solution and leukaemia (myelodysplastic syndrome)
for 3 months after the end of treatment; Heart function tests prior and during
 if you are pregnant or if you and your treatment with Mitoxantrone Solution Discolouration of urine and other tissues
partner are trying to become pregnant; Mitoxantrone Solution may damage your Mitoxantrone Solution may cause a blue-
 if you are breast-feeding. You should stop heart and cause a deterioration of your green colouration to the urine for 24 hours
breast-feeding before taking Mitoxantrone heart function or in more severe cases heart after administration. A bluish discolouration
Solution. failure. You are more prone to these side of the whites of your eyes, skin and nails
Tell your doctor or pharmacist or nurse effects if you take higher doses of may also occur.
immediately if you get any of the following Mitoxantrone Solution or;
signs or symptoms during treatment with  if your heart is not working well; Contraception in men and women
Mitoxantrone Solution:  if you had prior treatment of the chest Men must not father a child and should use
with radiation; contraceptive measures during and at least
 fever, infections, unexplained bleeding or
 if you already use other medicines that 6 months after therapy. Women of
bruising, weakness and easy fatigability;
affect your heart; childbearing potential should have a
 breathlessness (including breathlessness negative pregnancy test prior to each dose,
at night), cough, fluid retention (swelling) in  if you had previous therapies with
and use effective contraception during
the ankles or legs, heart fluttering (irregular therapy and for at least 4 months after
Mitoxantrone 2 mg per ml concentrate for sol ution for infusion, Taj Phar ma : U ses, Side E ffe cts, Intera ctions , Picture s, Warni ngs, Mitoxantrone Dosage & Rx Info | Mitoxa ntrone U ses, Side E ffe cts – Antifungal/ Antiba cterial, Mitoxa ntrone 2 mg per ml concentrate for s olution for i nfusion : Indi cations, Side Effe cts, War nings, Mitoxantrone - Drug I nformation - Taj P harma, Mitoxantrone dose Taj phar mace uticals Mitoxantrone interactions, Taj P harma ceutical Mitoxantrone contraindi cations , Mitoxa ntrone pri ce, Mitoxantrone , Taj Phar ma Mitoxa ntrone 2 mg per ml conce ntrate for s olution for infusion, - Taj Pharma . Stay conne cted to all updated on Mitoxantrone Taj Phar mace uticals Taj pharma ceutical s Hyderaba d. Patient Infor mation Leaflets , PIL.

cessation of therapy. If this medicine is used - Topoisomerase II inhibitors (a group of Pregnancy

during pregnancy or if you become anti-cancer medicines, including Mitoxantrone Solution may cause damage
pregnant while taking this medicine, inform mitoxantrone) in combination with other to your unborn child. Therefore you should
your doctor as there may be risks to the chemotherapy and/or radiotherapy.These avoid becoming pregnant
foetus. can cause: Mitoxantrone Solution must nor be used
- cancer of the white blood cells (acute during pregnancy for treatment of multiple
Fertility myeloid leukaemia, AML); sclerosis (specifically in the first three
This medicine might increase the risk for - A bone marrow disorder that months of the pregnancy).
transitory or persistent absence of causes abnormally shaped blood If you become pregnant during the
menstruation (amenorrhoea) in women of cells and leads to leukaemia treatment with Mitoxantrone Solution , you
childbearing age. (myelodysplastic syndrome ). must tell your doctor immediately and stop
the treatment with Mitoxantrone Solution .
Children and adolescents Ask your doctor or pharmacist if you are not You should avoid becoming pregnant. Men
There is little experience in children and sure whether your medicine is one of the must use an effective method of
adolescents. medicines listed above. contraception during the treatment and for
Do not give this medicine to children and These medicines should be used with care at least 6 months after discontinuing the
adolescents from birth up to age of 18 years or may need to be avoided during your treatment. Women of child-bearing
as safety and efficacy in children and treatment with Mitoxantrone Solution. If potential should have a negative pregnancy
adolescents have not ben established. you are taking any of these, your doctor test prior to each dose and must practise
might need to prescribe an alternative effective contraception for at least 4 months
Other medicines and Mitoxantrone medicine for you. after stopping the treatment with
Solution Mitoxantone 2 mg/ml solution.
Tell your doctor or pharmacist if you are You should also tell your doctor if you are
using, have recently used or might use any already taking Mitoxantrone Solution and Breast-feeding
other medicines. It is particularly important you are prescribed a new medicine that you Mitoxantrone Solution is secreted into
that you mention any of the following have not already taken at the same time as breast milk and may cause serious adverse
medicines. Mitoxantrone Solution. reactions in your baby. You must not breast-
feed while using mitoxantrone and for up to
Medicines which may increase the risk of Vaccinations and immunisation (protection one month after the last administration.
side effects with Mitoxantrone Solution: against the vaccination substances) may not
- Medicines that can damage your heart (e.g. work during treatment with Mitoxantrone Fertility
anthracyclines). and for three months after the end of Mitoxantrone Solution might increase the
- Medicines that supress the bone marrow’s treatment. risk for transient or persistent absence of
production of blood cells and platelets menstruation (amenorrhoea) in women of
(myelosuppressive agents). Pregnancy, breast-feeding and fertility childbearing age. Therefore you should talk
- If you are pregnant or breast-feeding, think to your doctor if you are planning to
- Medicines that supress your immune you may be pregnant or are planning to become pregnant in the future; your eggs
system (immunosuppressive agents). have a baby, ask your doctor or pharmacist may need to be frozen. In men, no data are
- Antivitamin K, in particular if you are taking for advice before taking this medicine. available. However, in male animals,
Mitoxantrone Solution because you have damage to the testes and decreased sperm
cancer counts were observed.
Mitoxantrone 2 mg per ml concentrate for sol ution for infusion, Taj Phar ma : U ses, Side E ffe cts, Intera ctions , Picture s, Warni ngs, Mitoxantrone Dosage & Rx Info | Mitoxa ntrone U ses, Side E ffe cts – Antifungal/ Antiba cterial, Mitoxa ntrone 2 mg per ml concentrate for s olution for i nfusion : Indi cations, Side Effe cts, War nings, Mitoxantrone - Drug I nformation - Taj P harma, Mitoxantrone dose Taj phar mace uticals Mitoxantrone interactions, Taj P harma ceutical Mitoxantrone contraindi cations , Mitoxa ntrone pri ce, Mitoxantrone , Taj Phar ma Mitoxa ntrone 2 mg per ml conce ntrate for s olution for infusion, - Taj Pharma . Stay conne cted to all updated on Mitoxantrone Taj Phar mace uticals Taj pharma ceutical s Hyderaba d. Patient Infor mation Leaflets , PIL.

Driving and using machines The usual dose is initial dose of Mitoxantrone Solution should
Mitoxantrone Solution can has a minor Metastatic breast cancer, Non-Hodgkin’s be reduced by 2-4 mg/m2 below the doses
effect on your ability to drive and use lymphoma recommended when Mitoxantrone Solution
machines. This is caused by the possible side If Mitoxantrone Solution is used alone: is used alone.
effects, such as confusion or feeling tired The recommended initial dosage of
(see section 4). Mitoxantrone Solution is 14 mg/m2 of body Acute myeloid leukaemia:
surface area, given as a single intravenous If used alone for a recurrence (return of the
If you suffer from these side effects, do not dose, which may be repeated after 21 days cancer):
drive any vehicles and/or use any machines. intervals, if your blood values have returned The recommended dosage for remission
to acceptable levels. induction is 12 mg/m2 of body surface area,
3. How you will be given given as a single intravenous dose daily for
Mitoxantrone Solution A lower initial dosage (12 mg/m2 or less) is five concecutive days (total of 60 mg/m2 per
Always take/use this medicine exactly as recommended in patients with low bone 5 days).
your doctor or pharmacist has told you. marrow reserves e.g. due to prior
Check with your doctor or pharmacist if you chemotherapy or poor general condition. If used with other agents against cancer:
are not sure. - Your doctor will decide exactly what
Your doctor will decide precisely which dosage you need. This dose might be
Posology and method of administration subsequent dosage you need. For adjusted if:
subsequent courses, the prior dose can  The combination of medicines reduces the
Mitoxantrone Solution will be given to you usually be repeated if white blood cell and production of white and red blood cells as
under supervision of a doctor experienced platelet counts have returned to normal wellas platelets in your bone marrow more
in the use of cytotoxic chemotherapy levels after 21 days. than mitoxantrone used alone;
agents. It must always be administered as an  If you have serious liver or kidney
intravenous infusion (in a vein) and must Combination therapy (if used with other problems.
always be diluted before. The infusion liquid agents)
can leak out of the vein into the tissue Mitoxantrone Solution has been given as Treatment of blast crisis in (chronic) myeloid
(extravasation). If this happens, the infusion part of combination therapy. In metastatic leukaemia
must be stopped and restarted in another breast cancer, combinations of Used alone for recurrence
vein. You should avoid contact with Mitoxantrone Solution with other cytotoxic The recommended dosage in relapse is 10
Mitoxantrone Solution, especially with the agents including cyclophosphamide and 5- to 12 mg/m2 body surface area given as a
skin, mucous membranes (moist body fluorouracil, or methotrexate and mitomycin single intravenous dose daily over 5
surfaces, such as the lining of the mouth) C have been shoen to be effective. consecutive days (total of 50 to 60 mg/m2 ).
and eyes. The individual dose of
Mitoxantrone Solution is calculated by your Mitoxantrone 2 mg/ml has also been used in Advanced castrate-resistant prostate cancer
doctor. The recommended dose is based on various combinations for non-Hodgkin’s The recommended dosage of Mitoxantrone
your body surface area, which is calculated lymphoma; however, data are presently Solution is 12 to 14 mg/m2 given as a short
in square metres (m2 ) using your height limited and specific regimens cannot be intravenous infusion every 21 days, in
and weight. In addition your blood will be recommended. combination with low oral dose of
tested regularly during the treatment. The corticosteroids (hoemonal medicines that
dosage of the medicine will be adjusted in As aguide, when Mitoxantrone Solution is suppress the immune system).
accordance with the results of these tests. used in combination chemotherapy, the
Mitoxantrone 2 mg per ml concentrate for sol ution for infusion, Taj Phar ma : U ses, Side E ffe cts, Intera ctions , Picture s, Warni ngs, Mitoxantrone Dosage & Rx Info | Mitoxa ntrone U ses, Side E ffe cts – Antifungal/ Antiba cterial, Mitoxa ntrone 2 mg per ml concentrate for s olution for i nfusion : Indi cations, Side Effe cts, War nings, Mitoxantrone - Drug I nformation - Taj P harma, Mitoxantrone dose Taj phar mace uticals Mitoxantrone interactions, Taj P harma ceutical Mitoxantrone contraindi cations , Mitoxa ntrone pri ce, Mitoxantrone , Taj Phar ma Mitoxa ntrone 2 mg per ml conce ntrate for s olution for infusion, - Taj Pharma . Stay conne cted to all updated on Mitoxantrone Taj Phar mace uticals Taj pharma ceutical s Hyderaba d. Patient Infor mation Leaflets , PIL.

Multiple Sclerosis Some side effects could be serious bleeding or bruising.

Mitoxantrone Solution will be given to you If any of the following happen, tell the doctor - Low number of special white blood cells
under the supervision of a doctor immediately: (granulocytes).
experienced in the use of cytotoxic • If your skin becomes pale and you feel - Loss of appetite.
chemotherapeutic agents for the treatment weak or experience sudden shortness of - Tiredness, weakness and lack of energy.
of multiple sclerosis. breath, this can be sign of reduction in red - Congestive heart failure (severe condition
blood cells. where the heart cannot anymore pup
The recommended dosage if mitoxantrone • Unusual bruising or bleeding, such as enough blood).
is usually 12 mg/m2 body surface area given coughing up blood, blood in your vomit or - Heart attack.
as a short (approximately 5 to 15 minutes) urine, or black stools (potential sign of - Shortness of breath.
intravenous infusion that may be repeated platelet reduction) - Constipation.
every 1 to 3 months. The maximum lifetime • New or worsening breathing difficulties - Diarrhoea.
cumulative dose should not exceed 72 • Chest pain, breathlessness, changes in your - Inflammation of the mouth and lips.
mg/m2 . heartbeat (fast or slow), fluid retention - Fever.
(swelling) in the ankles or legs (potential
If mitoxantrone is administered repeatedly, signs or symptoms of heart problems). Uncommon (may affect up to 1 in 100
dosing adjustments should be guided by • Severe itchy rash (hives), swelling of the people)
extent and duration of the reduction in the hands, feet, ankles, face, lips, mouth or - Reduced activity of the bone marrow. Your
number of white and red blood cells as well throat (which may cause difficulty in bone marrow can be more depressed or be
as platelets in your blood. swallowing or breathing), or if you feel you depressed for a longer period if you have
like you are going to faint, these may be had chemotherapy or radiotherapy.
Elderly patients signs of severe allergic reaction. - Insufficient production of bloods cells in
Elderly patient should receive doses at the • Fever or infections the bone marrow (bone marrow failure).
low end of the dosing range due to possible - Abnormal number of white blood cells.
reduced liver, kidney or heart function and For patients being treated for cancer: - Severe allergic reaction (anaphylactic
of possible illness or treatment with other reaction including anaphylactic shock) – you
medicines. Very common (may affect more than 1 in 10 may experience a sudden itchy rash (hives),
people): swelling of the hands, feet, ankles, face, lips,
If you have any further questions on the use - Infections. mouth or throat, which may cause difficulty
of this medicine, ask your doctor, - Low number of red blood cells which can in swallowing or breathing, and you may
pharmacist or nurse. cause a feeling of tiredness and shortness of feel you are going to faint).
breath (anaemia). You may require a blood - Infections of the upper airways.
4. Possible Side Effects transfusion. - Infections of the urinary tract.
Like all medicines, this medicine can cause - Low number of special white blood cells - Blood poisoning (sepsis).
side effects, although not everybody gets (neutrophils and leukocytes) - Infections caused by microorganisms
them. The most serious side effects are - Nausea (feeling sick). which do not normally cause diseases with a
damage to the heart (myocardial toxicity) - Vomiting (being sick). healthy immune system (opportunistic
and myelosuppression (reduced activity of - Hair loss. infections).
the bone marrow). - Cancer of the white blood cels (acute
Common (may affect up to 1 in 10 people): myeloid leukemia (AML)).
- Low level of platelets – which may cause - Bone marrow abnormality which causes
Mitoxantrone 2 mg per ml concentrate for sol ution for infusion, Taj Phar ma : U ses, Side E ffe cts, Intera ctions , Picture s, Warni ngs, Mitoxantrone Dosage & Rx Info | Mitoxa ntrone U ses, Side E ffe cts – Antifungal/ Antiba cterial, Mitoxa ntrone 2 mg per ml concentrate for s olution for i nfusion : Indi cations, Side Effe cts, War nings, Mitoxantrone - Drug I nformation - Taj P harma, Mitoxantrone dose Taj phar mace uticals Mitoxantrone interactions, Taj P harma ceutical Mitoxantrone contraindi cations , Mitoxa ntrone pri ce, Mitoxantrone , Taj Phar ma Mitoxa ntrone 2 mg per ml conce ntrate for s olution for infusion, - Taj Pharma . Stay conne cted to all updated on Mitoxantrone Taj Phar mace uticals Taj pharma ceutical s Hyderaba d. Patient Infor mation Leaflets , PIL.

the formation of abnormal blood cells which transplantation. - Inflammation of the mouth and lips.
leads to leukaemia (myelodysplastic - Abnormal results of blood tests to check - Abnormal number of white blood cells.
syndrome (MDS)). liver and kidney functions (raised aspartate - Headache.
- Changes in weight. aminotransferase levels, elevated creatinine - Irregular heart beat.
- Metabolic disturbances (tumour lysis and urea nitrogen concentration in the - Abnormal electrocardiogram.
syndrome). blood). - Reduction of the volume of blood that the
- Anxiety. - Damage to the kidneys, causing swelling left ventrical can pump, with no symptoms.
- Confusion. and weakness (nephropathy). - Abnormal results of blood tests to check
- Headache. - Urine discolouration. liver function (raised aspartate
- Tingling sensation. - Abnormal absence of menstruation aminotransferase levels).
- Irregular heart beat or slowed heart beat. (amenorrhoea).
- Abnormal electrocardiogram. - Swelling (oedema). Uncommon (may affect up to 1 in 100
- Reduction of the volume of blood that the - Taste disturbances. people)
left ventrical can pump, with no symptoms. - Lung inflammation (pneumonia).
- Bruising. Rare (may affect up to 1 in 1,000 people) - Blood poisoning (sepsis).
- Heavy bleeding. - Lung inflammation (pneumonia). - Infections caused by microorganisms
- Low blood pressure. - Damages to the heart muscle preventing it which do not normally cause diseases with a
- Abdominal pain. from pumping properly (cardiomyopathy). healthy immune system (opportunistic
- Bleeding in your stomach or bowels, this infections).
may include blood in vomit, bleeding when For patients being treated for Multiple - Cancer of the white blood cells (acute
emptying the bowels or black tarry stool. Sclerosis: myeloid leukemia (AML)).
- Mucosal inflammation. - A bone marrow abnormality which causes
- Inflammation of the pancreas. Very common (may affect more than 1 in 10 the formation of abnormal blood cells which
- Liver abnormalities. people) leads to leukaemia (myelodysplastic
- Skin inflammations (erythema). - Infections, including infections of the syndrome (MDS)).
- Nail abnormalities (e.g. detachment of the upper airways and urinary tract. - Insufficient production of blood cells in the
nail for the nail bed, changes in nail texture - Nausea (feeling sick). bone marrow (bone marrow failure).
and structure). - Hair loss. - Reduced activity of the bone marrow. Your
- Rash. - Abnormal absence of menstruation bone marrow can be more depressed or be
- Changes to the colour of the whites of the (amenorrhea). depressed for a longer period if you have
eyes. had chemotherapy or radiotherapy.
Common (may affect up to 1 in 10 people) - Low level of platelets – which may cause
- Skin discolouration.
- Low number of red blood cells which can bleeding or bruising.
- Leakage of fluid into surrounding tissue
cause a feeling of tiredness and shortness of - Low number of special white blood cells
(extravasation):
breath (anaemia). You may require a blood (neutrophils).
o Reddening (erythema).
transfusion. - Severe allergic reaction (anaphylactic
o Swelling.
- Low number of special white blood cells reaction including anyphylactic shock) – you
o Pain.
(granulocutes and leukocytes). may experience a sudden itchy rash (hives),
o Burning feeling and/or discolouration of
- Constipation. swelling of the hands, feet, ankles, face, lips,
the skin.
- Vomiting (being sick). mouth or throat, which may cause difficulty
o Death of tissue cells which can lead to the
- Diarrhoea. in swallowing or breathing, and you may
need to remove dead cells and skin
Mitoxantrone 2 mg per ml concentrate for sol ution for infusion, Taj Phar ma : U ses, Side E ffe cts, Intera ctions , Picture s, Warni ngs, Mitoxantrone Dosage & Rx Info | Mitoxa ntrone U ses, Side E ffe cts – Antifungal/ Antiba cterial, Mitoxa ntrone 2 mg per ml concentrate for s olution for i nfusion : Indi cations, Side Effe cts, War nings, Mitoxantrone - Drug I nformation - Taj P harma, Mitoxantrone dose Taj phar mace uticals Mitoxantrone interactions, Taj P harma ceutical Mitoxantrone contraindi cations , Mitoxa ntrone pri ce, Mitoxantrone , Taj Phar ma Mitoxa ntrone 2 mg per ml conce ntrate for s olution for infusion, - Taj Pharma . Stay conne cted to all updated on Mitoxantrone Taj Phar mace uticals Taj pharma ceutical s Hyderaba d. Patient Infor mation Leaflets , PIL.

feel you are going to faint). need to remove dead cells and skin the method of
- Loss of appetite. transplantation. opening/reconstitution/dilution precludes
- Changes in weight. - Abnormal results of blood tests to check the risk of microbial contamination, the
- Anxiety. liver and kidney functions (elevated product should be used immediately.
- Condusion. creatinine and urea nitrogen concentration If not used immediately, in-use storage
- Tingling sensation. in the blood). times and conditions are the responsibility
- Tiredness, feeling weak and having no - Damage to the kidneys, causing swelling of the user.
energy. and weakness (nephropathy).
- Severe condition where the heart cannot - Urine discolouration. Do not throw away medicines via
anymore pump enough blood (congestive - Swelling (oedema). wastewater or household waste. Ask your
heart failure). - Fever. pharmacist how to throw away medicines
- Damages to the heart muscle preventing it - Sudden death. you no longer use. These measures will help
from pumping properly (cardiomyopathy). protect the environment.
- Slowed heart beat. Rare (may affect up tot 1 in 1,000 people)
- Heart attack. None. 6. Further information
- Unusual bruising.
- Heavy bleeding. Reporting of side effects What Mitoxantrone Solution contains
- Low blood pressure. If you get any side effects, talk to your The active substance is mitoxantrone
- Shortness of breath. doctor or pharmacist or nurse. This includes hydrochloride, equivalent to 2 mg/ml
- Abdominal pain. any possible side effects not listed in this mitoxantrone.
- Bleeding in your stomach or bowels, this leaflet. By reporting side effects you can
may include blood in vomit, bleeding when help provide more information on the safety The other ingredients are: sodium chloride,
emptying the bowels or black tarry stool. of this medicine. anhydrous sodium acetate, glacial acetic
- Mucosal inflammation. acid, water for injections.
- Inflammation of the pancreas. 5. How Mitoxantrone Solution is
stored What Mitoxantrone Solution looks like
- Liver abnormalities.
Keep this medicine out of the sight and and contents of the pack
- Nail abnormalities (e.g. detachment of the
reach of children. Concentrate for solution for infusion in a
nail fro the nail bed, changes in nail texture
glass vial with a rubber stopper.
and structure).
- Rash. Do not use this medicine after the expiry
date which is stated on the package after 1 vial containing 5 ml concentrate for
- Changes to the colour of the ehites of the solution for infusion contains 10 mg
eyes. "EXP". The expiry date is the last day of the
month. mitoxantrone (as hydrochloride).
- Skin discolouration. 1 vial containing 10 ml concentrate for
- Leakage of fluid into surrounding tissue Unopened vial and diluted product: Store
below 25°C. Do not refrigerate or freeze. solution for infusion contains 20 mg
(extravasation): mitoxantrone (as hydrochloride).
o Reddening (erythema). 1 vial containing 15 ml concentrate for
o Swelling. Chemical and physical stability of the
diluted product has been demonstrated for solution for infusion contains 30 mg
o Pain. mitoxantrone (as hydrochloride).
o Burning feeling and/or discolouration of a period of 7 days or 14 days at 15-25°C and
the skin. 2-8 °C respectively in partially used vials.
From a microbiological point of view, unless Appearance: Dark blue solution
o Death of tissue cells which can lead to the
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Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
At: 615, GIDC, Kerala, Bavla, Dist.
Ahmedabad 438225, Gujarat, INDIA

This leaflet was last revised in July 2019