Alkeran

Country: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

melphalan

Disponibbli minn:

EXCELLA GmbH & Co.KG

INN (Isem Internazzjonali):

melphalan

Dożaġġ:

2mg

Għamla farmaċewtika:

tablets film-coated

Tip ta 'preskrizzjoni:

Prescription

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALKERAN 2 MG FILM-COATED TABLETS
melphalan
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 more explanation about these
diseases.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALKERAN
DO NOT TAKE ALKERAN IF:

You are allergic to melphalan or any of the other ingredients of this
medicine (listed in secti

Karatteristiċi tal-prodott

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