ALKERAN TABLETS 2 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MELPHALAN

متاح من:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC رمز:

L01AA03

الشكل الصيدلاني:

TABLETS

تركيب:

MELPHALAN 2 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

EXCELLA GMBH & CO.KG., GERMANY

المجموعة العلاجية:

MELPHALAN

المجال العلاجي:

MELPHALAN

الخصائص العلاجية:

For the treatment of : Multiple myeloma and Advanced ovarian adenocarcinoma

تاريخ الترخيص:

2019-05-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
ALKERAN TABLETS 2 MG
ACTIVE INGREDIENT AND ITS QUANTITY:
EACH TABLET CONTAINS: MELPHALAN 2 MG
Inactive ingredients and allergens in the preparation - see section 6
“Further Information” in the leaflet.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others. It may harm them even if it seems to
you that their illness is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Alkeran Tablets 2 mg is intended for the treatment of multiple
myeloma and ovarian adenocarcinoma (advanced stage).
THERAPEUTIC GROUP: The medicine belongs to the group of
cytotoxic medicines (also called chemotherapy), antineoplastic
and immunomodulatory factors, alkylating agents and nitrogen
mustard analogs.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic) to the active ingredient melphalan
or to any of the other ingredients of this medicine (see section
6 “Further Information”).
• You are breastfeeding.
If you are not sure, refer to the doctor or pharmacist before taking
the medicine.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH ALKERAN, TELL THE DOCTOR IF:
• You are undergoing, or have recently undergone, chemotherapy
or radiotherapy.
• You have a kidney problem.
• You are going to have a vaccination or were recently vaccinated.
This is because some vaccines (like polio, measles, mumps and
rubella) may give you an infection if you have them whilst you
are using Alkeran Tablets 2 mg.
• You are using combined oral contraception (the Pill). This is
because of the increased risk of venous thromboembolism (a
blood clot that forms in a vein and migrates to another location)
in pati

خصائص المنتج

_1_
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alkeran Tablets 2 mg
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, round, biconvex film-coated tablets, one side
engraved with an "A" and the other
side engraved "GX EH3".
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of multiple myeloma and advanced ovarian
adenocarcinoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Since Alkeran is myelosuppressive, frequent blood counts are essential
during therapy and the dosage
should be delayed or adjusted if necessary (see section 4.4).
Posology
_Multiple_
_ _
_myeloma _
A typical oral dosage schedule is 0.15 mg/kg bodyweight/day in divided
doses for 4 days repeated at
intervals of six weeks. Numerous regimens have, however, been used and
the scientific literature
should be consulted for details.
The administration of oral Alkeran and prednisone may be more
effective than Alkeran alone. The
combination is usually given on an intermittent basis.
Prolonging
treatment beyond one year in responders d
oes not appear to improve results.
_Advanced_
_ _
_ovarian_
_ _
_adenocarcinoma _
A typical regimen is 0.2 mg/kg bodyweight/day given orally in divided
doses for 5 days. This is
repeated every 4 to 8 weeks, or as soon as the bone marrow has
recovered.
_Paediatric population _
Alkeran is only rarely indicated in the paediatric population and
absolute dosage guidelines cannot be
provided.
_Older people _
Although Alkeran is frequently used at conventional dosage in the
older people, there is no specific
information available relating to its administration to this patient
sub
-
group. However, caution should be
taken where there is renal impairment.
_Renal im_
_pairment_
_ _
Alkeran clearance, though variable, may be decreased in renal
impairment (see section 4.4).
_2_
Currently available pharmacokinetic data do not justify an absolute
recommendation on