Amsidine

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

AMSACRINE

Dostupné z:

NordMedica A/S

ATC kód:

L01XX01

INN (Medzinárodný Name):

AMSACRINE

Forma lieku:

CONCENTRATE FOR SOLUTION FOR INFUSION

Zloženie:

AMSACRINE 50 mg/ml

Typ predpisu:

POM

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2006-01-16

Príbalový leták

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMSACRINE NORDMEDICA 75 MG/1.5 ML CONCENTRATE AND SOLVENT FOR
CONCENTRATE FOR SOLUTION FOR
INFUSION
amsacrine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Amsacrine NordMedica is and what it is used for
2.
What you need to know before you use Amsacrine NordMedica
3.
How to use Amsacrine NordMedica
4.
Possible side effects
5.
How to store Amsacrine NordMedica
6.
Contents of the pack and other information
1.
WHAT AMSACRINE NORDMEDICA IS AND WHAT IT IS USED FOR
Amsacrine NordMedica belongs to a group of medicines called
cytostatics (medicine for the treatment
of cancer).
It is used to treat acute myeloid leukaemia also known as AML. AML is
a form of cancer of the blood
and bone marrow.
Amsacrine NordMedica is used in adults, whose disease has not
responded to other therapies or in case
of relapse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AMSACRINE NORDMEDICA
DO NOT USE AMSACRINE NORDMEDICA:
-
if you are allergic to amsacrine or acridine derivates or any of the
other ingredients of this
medicine (listed in section 6)
-
if you are already receiving (or have recently received) other
treatments for cancer
-
if you are breast-feeding.
Talk to your doctor before you use this medicine if any of these
conditions apply to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given
Amsacrine NordMedica.
Your doctor will take special care if any of the following conditions
apply to you.
-
You have ever had kidney or liver disease
-
You have any problem with your heart
-
You have been told that the potassium level in your blood is too low
-
You suffer from

Súhrn charakteristických

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amsacrine NordMedica 75 mg/1,5 ml concentrate and solvent for
concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 50 mg
amsacrine.
Each vial of 1.5 ml of concentrate for solution for infusion contains
75 mg amsacrine.
Each ml concentrate after the first dilution with the solvent contains
5 mg amsacrine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate and solvent for concentrate for solution for infusion.
The concentrate is a clear bright orange/red liquid, the pH of the
concentrate is between 3.50 –
4.50.
The solvent is a clear solution, the pH of the solvent is between 2.50
– 3.50.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Salvage
therapy
of
refractory/relapsed
acute
myeloid
leukaemia
(AML)
in
adults,
in
combination with other chemotherapeutic agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment with Amsacrine NordMedica should be introduced by or in
cooperation with a
doctor experienced in treatment with cytostatics. Before treatment is
started the potassium
level
in
serum
must
be
controlled
and
corrected.
Amsacrine
NordMedica
is
given
in
combination with other cytostatics.Serum potassium level >4 mEq/L
prior to administration is
recommended.
Induction phase: Optimal dose is individual and dependent on the
combination. Usual dose
per treatment period is 300-650 mg/m
2
and is divided over 3-7 days. The total dose during a
treatment period should not exceed 750 mg/m
2
. In order to achieve remission more than one
treatment period may be necessary.
Consolidation /Maintenance phase: Comparable or somewhat lower doses
compared with the
induction phase are given.
Page 2 of 10
Renal impairment
Caution is advised when administering amsacrine to patients with renal
impairment._ _ In
patients with mild-renal dysfunction, no starting dose_ _adjustment is
recommended._ _In patients
with mode