Amsidine 75mg/1.5ml Concentrate and Solvent for Concentrate for solution for infusion

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

AMSACRINE

Beszerezhető a:

Eurocept International BV Trapgans 5, 1244RL Ankeveen, Netherlands

ATC-kód:

L01XX01

INN (nemzetközi neve):

AMSACRINE 50 mg/ml

Gyógyszerészeti forma:

CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

Összetétel:

AMSACRINE 50 mg/ml

Recept típusa:

POM

Terápiás terület:

ANTINEOPLASTIC AGENTS

Engedélyezési státusz:

Authorised

Engedély dátuma:

2006-01-16

Betegtájékoztató

AMSA MT 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 injection 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 injection if any of
these ap

Termékjellemzők

AMSA MT SPC
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amsidine 75 mg/1.5 ml Concentrate and Solvent for Solution for
Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml contains 50mg of Amsacrine.
3
PHARMACEUTICAL FORM
Amsidine is formulated as two sterile liquids combined for
administration via
intravenous infusion to human beings.
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
AMSA MT SPC
The usual dosage of Amsidine in the induction phase is 90 mg/m
2
every day
for five consecutive days (total dose 450 mg/m
2
per course of treatment). If
bone marrow biopsy performed on day six displays over 50% cellularity
and
the blasts count is over 30%, the treatment may be extended for an
additional
three days, bringing the total dose per course of treatment to 720
mg/m
2
.
More than one course of treatment may be required to achieve
induction.
Depending
on
the
effectiveness
of
the
first
course
in
producing
myelosuppression, the subsequent courses
are
given at two-week (if
not
effective) t