Amsidine 75 mg/1.5 ml Concentrate and Solvent for Concentrate for Solution for Infusion

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Amsacrine

থেকে পাওয়া:

Eurocept International BV

এটিসি কোড:

L01XX; L01XX01

INN (International Name):

Amsacrine

ডোজ:

75 mg/1.5 millilitre(s)

ফার্মাসিউটিকাল ফর্ম:

Concentrate and solvent for concentrate for solution for infusion

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antineoplastic agents; amsacrine

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2012-08-17

তথ্য লিফলেট

AMSA IE PIL
1
PATIENT INFORMATION LEAFLET
AMSIDINE 75 MG/1.5 ML CONCENTRATE AND SOLVENT FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Amsacrine Concentrate and Solvent for Concentrate for Solution 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 is and what it is used for
2. Before you are given Amsidine
3. How Amsidine is given
4. Possible side effects
5. How to store Amsidine
6. Further information
1. WHAT AMSIDINE IS AND WHAT IT IS USED FOR
Amsidine 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
YOU SHOULD NOT BE GIVEN AMSIDINE 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.
• You are breast feeding
Speak to your doctor _before _you are given this infusion if any of
these apply to you.
BEFORE YOU ARE GIVEN AMSIDINE, 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 have ever had a kidney or liver disease
• You have any problem with your heart
• You have a problem with your nervous system or brain
• You have been told that the potassium level in your blood is too
low
• You have pre-existing bone marrow depression
• You have a raised uric acid level.
Speak to your doctor before you are given this infusion if any of
these apply

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
16 February 2023
CRN00DFHP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amsidine 75 mg/1.5 ml Concentrate and Solvent for Concentrate for
Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 75mg amsacrine in 1.5ml (50mg per ml).
Each solvent vial contains 13.5ml of Lactic Acid and water for
injection to give a concentration of 0.0353M L‐Lactic acid.
Each ml of the combined solution of the concentrate when diluted with
the solvent contains 5mg amsacrine per ml
For a full list of exipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate and solvent for concentrate for solution for infusion.
Concentrate is a clear, bright orange/red coloured solution and
solvent is clear colourless solution.
The pH of the combined solution is 3.5 ‐ 4.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amsidine is indicated for the induction and maintenance of remission
in acute leukaemia of adults. It is effective in patients
refractory to the anthracycline antibiotics used singly or in
combination with other chemotherapeutic agents, and in patients
who were formerly treated with maximum cumulative doses of these
antibiotics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous infusion
Amsidine must be diluted in 500ml 5% Dextrose Injection BP and infused
over 60 to 90 minutes. Phlebitis or pain at the
injection site may occur at doses greater than 70 mg/m
2
. (NOTE: DO NOT USE OTHER DILUENTS. AMSIDINE IS INCOMPATIBLE
WITH SALINE). Care must be taken that no extravasation occurs which
might produce severe irritation or necrosis. Caution in
the handling and preparation of the solution should be exercised, and
the use of polyethylene gloves is recommended. If the
solution of Amsidine contacts the skin or mucosae, immediately wash
thoroughly with soap and water.
Adults
Induction of remission phase
The usual dosage of Amsidine in the induction phase is 90mg/m
2
every day for five consecutive days (total dose 450 mg/m
2
per