AMSIDINE 50MG/ML INJECTION

Active substance: AMSACRINE

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PATIENTINFORMATION LEAFLET
®

Amsidine 50 mg/ml Injection
Amsacrine Concentrat for Infusion

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If any of the side effects become serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Amsidine Injection is and what it is used for
2. Before you are given Amsidine Injection
3. How Amsidine Injection is given
4. Possible side effects
5. How to store Amsidine Injection
6. Further information

1. WHAT AMSIDINE INJECTION IS AND WHAT IT IS USED FOR
Amsidine Injection is one of a group of medicines called antineoplastic (anticancer) agents.
It is used to treat acute leukaemia, a form of cancer of the white cells in your blood.

2. BEFORE YOU RECEIVE AMSIDINE INJECTION
You should not be given Amsidine Injection if:
• You know that you are allergic to amsacrine or to any of the other ingredients (see section 6 of
this leaflet)
• You are already receiving other treatments for cancer, including radiation, which have affected
your bone marrow or you have received treatments in the past (your doctor will advise you)
• You are under 12 years old.
Speak to your doctor before you are given this injection if any of these apply to you.
Before you are given Amsidine Injection, your doctor will take special care if any of the
following situations apply to you. Make sure your doctor is aware of these situations if it is
not already obvious:





You
You
You
You

have
have
have
have

ever had kidney or liver disease
any problem with your heart
a problem with your nervous system or brain
been told that the potassium level in your blood is too low.

Speak to your doctor before you are given this injection if any of these apply to you.
Taking or receiving other medicines:
Tell your doctor before you are given this medicine if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
A large number of drugs can interact with Amsidine Injection which can significantly alter their
effects. These drugs include:
• Antibiotics of the Aminoglycoside group (e.g. Gentamicin, Kanamycin, Neomycin, Streptomycin
or Tobramycin) or other medicines known to risk kidney damage
• Diuretics (commonly known as ‘water tablets’ because they make you pass more urine), eg
furosemide, bendroflumethiazide or indapamide
• Other medicines or radiation used in the treatment of cancer.
If you are already taking one of these medicines, speak to you doctor before you receive Amsidine
Injection.
Pregnancy and breast-feeding
Tell your doctor before you are given this medicine if you are or think you may be pregnant or are
planning to become pregnant, or are breast-feeding.
As with all drugs, this medicine should only be given in pregnancy and when breast feeding
if absolutely necessary. You must speak to your doctor about the possible effects this medicine
might have on your baby before you are given this medicine.
Driving and using machines
Amsidine Injection should not affect your ability to drive or use machinery. However, if you
experience any side effects after having the injection ask your doctor’s advice if you can drive.

3. HOW AMSIDINE INJECTION IS GIVEN
You will be in hospital when you are given Amsidine Injection.
A dose of Amsidine will be dissolved in a sugar solution and slowly injected into a vein over 60 – 90
minutes. This is known as an infusion and will be performed under the supervision of a doctor
experienced in cancer treatment.
The dose will be calculated by your doctor according to your age and the surface area of your body
(normally 90 mg per square metre).
You will be given one infusion a day for 5 – 8 days.
Your doctor will monitor your treatment by taking regular blood tests to check your blood count
(number of blood cells), and kidney & liver function.
Following this initial dosing period, further doses will be given every 3 – 4 weeks, depending on the
number of your blood cells. This second course of treatment will generally be one third of the
original dose and will either be given all on one day or divided up over 3 days.

If Amsidine Injection decreases the number of your blood cells too much, it may be necessary for
your doctor to give you a blood transfusion.
If you have any further questions on the use of this product, ask your doctor.
If you think you have been given more Amsidine Injection than you should have
As the injection will be administered under the supervision of a doctor, it is unlikely that you will be
given more than is necessary. However, if you have any concerns about the dose of your medicine
discuss them with your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines Amsidine Injection can sometimes cause side-effects, although not everybody
gets them.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any
sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching
(especially affecting your whole body) should be reported to a doctor immediately.
Other side effects might be:
• An effect on blood cells which could increase the risk of infections or bleeding and bruising
• An upset stomach including feeling sick and being sick
• A sore mouth and discomfort on swallowing
• Fits
• Liver problems (eg. jaundice – this causes yellowing of the skin and of the whites of your eyes)
• Kidney problems (eg. blood in your urine, absence of urine and/or kidney failure),
• Heart problems (eg. racing heart, heart failure causing breathlessness)
• Irritation and pain at the injection site
• Hair loss
If you get any of these side effects, or if you notice any side effects not listed in this leaflet, please
tell your doctor at once.
Although the above list of possible side effects appears daunting, acute leukaemia is a serious
disease which requires aggressive treatment.
Special Warnings
If you have any medical problems in the future, tell your doctor that you have been given Amsidine
Injection in the past.

5. HOW TO STORE AMSIDINE INJECTION
The storage of Amsidine Injection will not be your responsibility.
However, keep in a dry place and do not store above 25°C. Keep in the outer carton in order to
protect from light.
Keep out of the reach and sight of children.
Do not use Amsidine Injection after the expiry date which is stated on the ampoule and outer
carton.
If only part used, discard the remaining solution.

6. FURTHER INFORMATION
What Amsidine Injection contains
The active substance is amsacrine.
The other ingredients are N,N, Dimethylacetamide, L-lactic acid and water for injection.
What Amsidine Injection looks like and contents of pack
Amsidine Injection comes as two types of small glass bottles. One small sealed clear glass bottle
(vial) contains the active ingredient, which is 75mg of amsacrine.
It also contains an inactive ingredient, which is N,N, dimethylacetamide in 1.5ml as a clear bright
orange/ red liquid.
A second glass bottle (vial) contains 13.5ml of a solution of L-lactic acid in Water for Injection.

Marketing authorization holder
NordMedica A/S
Jægersborg Allé 164,
DK.2820 Gentofte,
Denmark.
Manufacturer
SCM Pharma,
Unit 6 Regents Drive,
Low Prudhoe Industrial Estate,
Northumberland NE42 6PX,
United Kingdom.
Amsidine 50 mg/ml Injection is a trade mark.

This leaflet was last approved in July 2011.

10006/PL/B
1205 UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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