Alkeran tablets film-coated

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

melphalan

Διαθέσιμο από:

EXCELLA GmbH & Co.KG

Φαρμακολογική κατηγορία (ATC):

L01AA03

INN (Διεθνής Όνομα):

melphalan

Δοσολογία:

2mg

Φαρμακοτεχνική μορφή:

tablets film-coated

Μονάδες σε πακέτο:

(25) in glass container

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2018-11-07

Φύλλο οδηγιών χρήσης

PHARMA
CODE
N°
1411
PHARMA
CODE
N°
1411
ASPEN
Ar
twork
Panel
•
May 2013
•
V
ersion
5
160 MM MEASURING BAR
ASPEN ARTWORK PANEL
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALKERAN
®
2 MG FILM-COATED TABLETS
melphalan
Warnings and precautions),
•
nalidixic acid (an antibiotic used
infections),
7000363-1002
to treat urinary tract
AW VERSION:
2
NEW ITEM CODE:
7000363-1002
PAGE:
1 of 2
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING 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, or nurse.
•
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Alkeran is and what it is used for
2.
What you need to know before you take Alkeran
3.
How to take Alkeran
4.
Possible side effects
5.
How to store Alkeran
6.
Contents of the pack and other information
1. WHAT ALKERAN IS AND WHAT IT IS USED FOR
Alkeran tablets contain a medicine called melphalan
which belongs to a group of medicines called
cytotoxics (also called chemotherapy) and is used to
treat certain types of cancer. It works by reducing the
number of abnormal cells your body makes.
Alkeran tablet is used for:
•
MULTIPLE MYELOMA -
a type of cancer that develops
from cells in the bone marrow called plasma cells.
Plasma cells help to fight infection and disease by
producing antibodies.
•
Advanced
CANCER OF THE OVARIES.
•
Advanced
BREAST CANCER.
•
POLYCYTHAEMIA RUBRA VERA -
a type of blood
cancer where the number of red cells in your
blood increases due to uncontrolled red blood cell
production in your body. This makes the blood
thicken and causes blood clots, and may result in
headaches, dizziness and shortness of breath.
Ask your doctor if you would like

Αρχείο Π.Χ.Π.

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE
_ _
MEDICINAL PRODUCT
_ _
Alkeran 2 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION.
Each tablet contains 2 mg melphalan.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated
tablet
White to off white, film-coated, round, biconvex tablets engraved
'GXEH3'
on one side and an
'A'
on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alkeran tablets are indicated in the treatment
of:

multiple
myeloma;

advanced ovarian
adenocarcinoma.
Alkeran tablets may be used in the treatment
of:

breast carcinoma: melphalan either alone or in combination with other
drugs has a significant
therapeutic
effect
in a proportion of patients suffering from advanced breast
carcinoma.
Alkeran Tablets may be used in the management of polycythaemia rubra
vera.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Since melphalan is myelosuppressive, frequent blood counts are
essential during therapy and the
dosage should be delayed or adjusted if necessary (see section 4.4).
_Thromboembolic events _
Melphalan in combination with lenalidomide and prednisone or
thalidomide and prednisone or
dexamethasone is associated with an increased risk of venous
thromboembolism (predominantly deep
vein thrombosis and pulmonary embolism). Thromboprophylaxis should be
administered for at least
the first 5 months of treatment especially in patients with additional
thrombotic risk factors. The
decision to take antithrombotic prophylactic measures should be made
after careful assessment of an
individual patient's underlying risk factors (see sections 4.4 and
4.8).
_ _
If the patient experiences any thromboembolic events, treatment must
be discontinued and standard
anticoagulation therapy started. Once the patient has been stabilised
on the anticoagulation treatment
and any complications of the thromboembolic event have been managed,
melphalan in combination
with lenalidomide and prednisone or thalidomide and prednisone or
dexamethasone may be resta