L-Aspara ginase 10, 000 I U Injection Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warni
ngs, L -Asparagina seDosag e & Rx Info | L-As paraginaseU ses, Side E ffe cts - Cancer, L-Asparagi nase 10,0 00 IU Inj ection : Indi cations, Side Effe cts, Warni ngs, L -Asparagina se- Dr ug Information - Taj P harma, L-As paraginased ose Taj pharma ceutical s L-Asparaginas einteractions, Taj Phar ma ceutical L-As paraginase contraindications, L -Asparagi nasepri ce, L-Asparagina se, Taj Phar ma L-A sparagi nase 10,0 00 IU Inj ection - Taj P harma . Stay conne cted to all updated on L-Asparaginas eTaj Phar mace uticals Taj pharma ceu ticals Hyderabad. Patient Infor mation Leaflets, PIL. L-ASparagina se Inje ction
What this medicine is used for
L-ASPARAGINASE FOR L-Asparaginase is used for the treatment of a
INJECTION 10,000 IU cancer of the white blood cells called Acute
Lymphoblastic Leukaemia. It may also be used to
Package leaflet: Information for the patient treat other cancers where lower levels of
L-Asparaginase 10,000 IU Injection. asparagine might have a useful effect.
L-Asparaginase may be used alone or with other
Read all of this leaflet carefully before you start treatments.
taking this medicine because it contains
important information for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU
- Keep this leaflet. You may need to read it again. TAKE L-ASPARAGINASE
- If you have any further questions, ask your You should not receive L-Asparaginase if :
doctor or pharmacist. ■ you are allergic (hypersensitive) to the active
- This medicine has been prescribed for you only. substance (Erwinia L-asparaginase) or any of the
Do not pass it on to others. It may harm them, other ingredients of L-Asparaginase (see section
even if their signs of illness are the same as yours. 6).
- If you get any side effects, talk to your doctor or ■ you have had a bad reaction to treatment with
pharmacist. This includes any possible side effects L-Asparaginase on a previous occasion.
not listed in this leaflet (see section 4). ■ you have history of pancreas problems (acute
pancreatitis).
■ you are pregnant or trying to get pregnant.
What is in this leaflet
■ you are breast-feeding.
1. What L-Asparaginase is and what it is used for
2. What you need to know before you take L- Warnings and precautions
Asparaginase Talk to your doctor or pharmacist or nurse before
3. How to take L-Asparaginase taking L-Asparaginase . Your body may become
4. Possible side effects sensitive to the active substance after repeated
5. How to store L-Asparaginase treatments. It could be the cause of allergic
6. Contents of the pack and other information reactions (see section 4. Possible side effects).
Blood and urine tests
1.WHAT L-ASPARAGINASE IS AND WHAT IT IS Treatment with L-Asparaginase can sometimes
USED FOR affect the results of certain blood or urine tests.
How does L-Asparaginase work Your doctor will be aware of this and may carry out
L-Asparaginase is an anti-blood-cell-cancer routine blood tests before and during your
treatment. It works by lowering the levels of treatment to check for any changes.
asparagine in your body, a substance the cancer Posterior reversible encephalopathy syndrome
cells need to survive. (characterised by headache, confusion, seizures
and visual loss) may require blood-pressure
lowering medicines and in case of seizure, anti-
epileptic treatment.
Other medicines and L-Asparaginase
Tell your doctor or pharmacist if you are taking,
have recently taken, or might take any other
medicines.
Please tell your doctor or your pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without a
prescription.
Your doctor or your nurse will not mix L-
Asparaginase with other medicines in the same
infusion.
However you will probably be given other
medicines before, during or after L-Asparaginase
treatment as part of your course of therapy.
Pregnancy and breast feeding
■ You must not use this medicine if you are
pregnant. Tell your doctor straightaway if you are
pregnant, become pregnant during treatment
with this medicine, or plan to become pregnant in
the near future.
■ You must not breast-feed your baby during your
treatment with L-Asparaginase .
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
L-Asparaginase is not known to affect your ability
to drive or operate machines. However, as in all
cases, you should not drive if you feel unwell or if
your doctor has advised you not to drive.
L-Asparaginase contains sodium and glucose
L-Asparaginase contains the following ingredients
L-Aspara ginase 10, 000 I U Injection Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warni ngs, L -Asparagina seDosag e & Rx Info | L-As paraginaseU ses, Side E ffe cts - Cancer, L-Asparagi nase 10,0 00 IU Inj ection : Indi cations, Side Effe cts, Warni ngs, L -Asparagina se- Dr ug Information - Taj P harma, L-As paraginased ose Taj pharma ceutical s L-Asparaginas einteractions, Taj Phar ma ceutical L-As paraginase contraindications, L -Asparagi nasepri ce, L-Asparagina se, Taj Phar ma L-A sparagi nase 10,0 00 IU Inj ection - Taj P harma . Stay conne cted to all updated on L-Asparaginas eTaj Phar mace uticals Taj pharma ceu ticals Hyderabad. Patient Infor mation Leaflets, PIL. L-ASparagina se Inje ction

: If you have any further questions on this product, Uncommon (may affect up to 1 in 100 people) side
■ sodium (less than 23 mg per dose). You can ask your doctor or pharmacist. effects include:
consider this medicine as essentially sodium free if - Difficulty breathing or stopping breathing.
you are on a salt-free or low-salt diet. 4.POSSIBLE SIDE EFFECT - Increase in blood levels of sugars and lipids (fats).
■ glucose. If you are diabetic, please note that Like all medicines, L-Asparaginase can cause side - Runny nose.
each bottle of L-Asparaginase contains 5 mg effects, although not everybody gets them. L-
Asparaginase will be given under strict medical Rare (may affect up to 1 in 1,000 people) side
glucose
supervision and your doctor may give you other effects include:
3. HOW TO TAKE L-ASPARAGINASE medicines to treat these side effects. Most of the - Liver failure.
Dosage side effects will stop once you stop taking L- - Complication of diabetes.
Your doctor will decide what dose to Asparaginase . - Depressed level of consciousness or coma.
administer,how often you will be given L- The most common side effects experienced by - Difficulty speaking, difficulty swallowing,
Asparaginase and for how long. It varies according patients treated with L-Asparaginase are: Allergic impaired movement.
to your body weight, your specific condition being reactions: You may develop the following - Heart attack, usually secondary to other adverse
treated, and your response to therapy. symptoms: redness or inflammation of the skin, effects.
decrease in blood pressure, swelling of the face - Posterior reversible encephalopathy syndrome (a
Method of administration and/or the throat and difficulty breathing. You condition characterised by headache, confusion,
L-Asparaginase can be given to you in one of the may require emergency treatment and should seizures and visual loss).
following ways: seek medical advice immediately. L-Asparaginase Very rare (may affect upto 1 in 10,000 people) side
a) Into a vein (intravenous use). treatment should be discontinued. effects include:
b) Into a muscle (intramuscular use). Coagulation disorders: Asparaginase can increase - Severe inflammation of the pancreas.
c) Just under the skin (subcutaneous use). the risk of your blood clotting, which may block - Muscle pain, joint pain.
L-Asparaginase should be injected by your doctor major blood vessels in the brain or heart, or may - Low white blood cells as manifested by increased
or your nurse.Your treatment will normally be cause bleeding. susceptibility to infection.
given without interruption. If your dose is large, it
may be given at two different sites. Common (may affect up to 1 in 10 people) side Other side effects with unknown frequency
effects include: include:
If you receive more L-Asparaginase than you - Fits (convulsions), drowsiness, confusion, - High blood levels of ammonia.
should dizziness, tiredness or headache. - High or low blood pressure, flushing.
If you are concerned that you have been given too - Pancreas disorders with increase of the blood - Nausea, vomiting, abdominal pain.
much L-Asparaginase , contact your doctor or glucose level or other changes in blood tests. - Liver disorders.
another healthcare professional immediately. - Diarrhoea. - Pain in arms and legs.
- Pale skin.
If you don’t receive L-Asparaginase - Unusual blood test results in liver enzymes. Reporting of side effects
If you are concerned that you have missed a dose, - High temperature, chills, generalised pain, If you get any side effects, talk to your doctor or
contact your doctor or another healthcare swelling of legs and injection site reactions (pain, pharmacist. This includes any possible side effects
professional immediately. redness, bruising, swelling) not listed in this leaflet. By reporting side effects
L-Aspara ginase 10, 000 I U Injection Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warni ngs, L -Asparagina seDosag e & Rx Info | L-As paraginaseU ses, Side E ffe cts - Cancer, L-Asparagi nase 10,0 00 IU Inj ection : Indi cations, Side Effe cts, Warni ngs, L -Asparagina se- Dr ug Information - Taj P harma, L-As paraginased ose Taj pharma ceutical s L-Asparaginas einteractions, Taj Phar ma ceutical L-As paraginase contraindications, L -Asparagi nasepri ce, L-Asparagina se, Taj Phar ma L-A sparagi nase 10,0 00 IU Inj ection - Taj P harma . Stay conne cted to all updated on L-Asparaginas eTaj Phar mace uticals Taj pharma ceu ticals Hyderabad. Patient Infor mation Leaflets, PIL. L-ASparagina se Inje ction

you can help provide more information on the This leaflet was last revised in Nov 2018
safety of this medicine
5.HOW TO STORE L-ASPARAGINASE
Keep out of the reach and sight of children. L-
Asparaginase will be stored in a refrigerator (2°C
to 8°C) by the hospital and must not be used after
the expiry date which is stated on the label. The
expiry date refers to the last day of the month.
6. CONTENTS OF THE PACK AND FURTHER
INFORMATION
What L-Asparaginase contain
The active substance is L-asparaginase.
Each vial contains 10,000 Units L-asparaginase.
The other ingredients are sodium chloride and
glucose monohydrate.

What L-Asparaginase look like and contents of

the pack
L-Asparaginase comes as a white powder in a
glass bottle. Each pack contains 5 glass bottles of
powder.
Each lyophilized vial contains:
L-asparaginase 10,000 IU
Excipients q.s.

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